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Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting
Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.
1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab
- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.
2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD
- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.
- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.
ARIA Incidence, Frequency, Severity and Modeling
ARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.
Study 201 Core ARIA-E Rates
ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.
Study 201 OLE ARIA-E Rates
Although ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).
Study 201 Core and OLE Pooled ARIA-E Rates
In the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.
ARIA-E Rates Frequency and Severity
In the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date.
Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4
The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.
ARIA-H Rates
In the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.
3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing
- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.
- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.
- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts.
4. Update on Lecanemab Clinical Development, Including New Subcutaneous Formulation
Eisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.
- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.
- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.
- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation (<15 second SC injection versus ~1h infusion). PK/PD modeling of Study 201 suggests that the average lecanemab concentration (Cave) predicts amyloid clearance while the maximal lecanemab concentration (Cmax) predicts ARIA-E rate. Since subcutaneous administration results in a blunted Cmax, the SC dose with comparable Cave to 10 mg/kg IV is hypothesized to have similar amyloid reduction with potentially reduced incidence of ARIA-E relative to IV but less than half the ARIA- E rate as IV. Eisai is evaluating the SC formulation in the Clarity AD OLE.
"The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease.
Contacts:
MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
+81-(0)3-3817-5120
Eisai Inc. (U.S.) Libby Holman
+ 1-201-753-1945
[email protected]
INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
+81-(0)70-8688-9685
MEDIA CONTACT:
Biogen Inc. Ashleigh Koss
+ 1-908-205-2572
[email protected]
INVESTOR CONTACT:
Biogen Inc. Mike Hencke
+ 1-781-464-2442
[email protected]
For more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.
Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the...
The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations. Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which begins April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.
"Four key presentations at AD/PD 2022 advance our understanding of the mechanism of action of Eisai's investigational anti- Abeta protofibril antibody lecanemab and the therapy's clinical and safety profile, including amyloid related imaging abnormalities, or ARIA, from the Phase 2b study and open-label extension, in the potential treatment of early Alzheimer's disease," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "In addition to lecanemab, Eisai's robust pipeline includes compounds targeting the tau pathway, other pathways leading to neurodegeneration, and the testing of combination therapies that may be the optimal approach to treat or even prevent Alzheimer's disease."
The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease. Eisai's investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration.
"Because of the robust design of the lecanemab Phase 2b study, Eisai was able to design the Phase 3 confirmatory Clarity AD clinical trial to optimally verify lecanemab's clinical efficacy and safety in early Alzheimer's disease," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "Part of the recruitment strategy for the Clarity AD confirmatory trial was to ensure greater inclusion of ethnic and racial populations. While there is still important work to be done in ensuring minority populations' participation in clinical trials, Eisai is proud that approximately 25% of the total U.S. enrollment in Clarity AD consists of African American and Hispanic persons living with early Alzheimer's disease, which mirrors the U.S. Medicare population."
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.
For more information, visit https://www.eisai.com/news/2022/news202218.html.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) from March 15-20 in Barcelona, Spain and virtually.
NEC OncoImmunity Acquires VAXIMM’s Neoantigen Vaccine Development Assets
Under the agreement, NOI will acquire VAXIMM's neoantigen vaccine-related patents, license the requisite manufacturing patents, and will take over several existing contracts with key collaborators and partners. Financial terms of the agreement have not been disclosed. In 2019, the companies entered into a strategic clinical trial collaboration agreement and an equity investment agreement to develop novel personalized neoantigen cancer vaccines. VAXIMM retains rights to its first-in-class oral T-cell activation platform technology and all other product candidates, including VXM01, which is being developed for the treatment of glioblastoma.
Commenting on the announcement, Richard Stratford, CEO of NOI, said, "We believe this is a transformative transaction for NOI/NEC. With it, NOI/NEC has acquired the rights to an attractive delivery platform with broad therapeutic potential in oncology and other areas. Following this acquisition, we expect to initiate the first clinical study delivering personalized neoantigens during 2022, which is an important milestone. Our unique artificial intelligence (AI) technology is focused on several attractive areas of unmet medical need with major market potential, and we now have the components in place to fully realize this significant commercial opportunity."
Thomas D. Szucs, MD, Chairman of the Board of VAXIMM, said, "I am excited to see the progress that has been made in advancing our neoantigen program, already with the strong support of NEC as partner and investor. I congratulate the VAXIMM team, under Dr. Lubenau's leadership, for bringing this important project to clinical testing stage. We are delighted that the NOI team will now take this program forward into the clinic with the goal of bringing a novel therapy to patients in desperate need of more treatment options."
Dr. Heinz Lubenau, CEO and Co-founder of VAXIMM, said, "We believe that NEC OncoImmunity is the ideal company to take VAXIMM's novel neoantigen programs through development and hopefully to the market to help patients. The first project from our earlier collaboration utilizing NEC's AI platform has received clinical trial approval in Europe, and we are excited that NEC will be putting its resources behind this and future neoantigen vaccine programs derived from VAXIMM's novel technology."
Motoo Nishihara, Executive Vice President, CTO (Chief Technology Officer) and Member of the Board, NEC Corporation, said, "Cancer and infectious diseases are two of the most serious healthcare challenges, with millions of new cases diagnosed worldwide annually. NEC's core AI technology is well positioned for the development of personalized medicines, and we are strongly committed to delivering effective treatments for cancer patients and infectious diseases. We are confident that this acquisition of assets from VAXIMM will enable us to further develop our AI-optimized and personalized therapies to benefit the health of individual patients worldwide."
The transaction expands NEC's neoantigen drug development pipeline by broadening its focus into several compelling therapeutic areas with high unmet medical need. VAXIMM's plug and play DNA vaccination technology is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients' cytotoxic T-cells to target a wide range of cancer-related antigens. The platform allows for fast and scalable manufacturing of personalized T-cell cancer vaccines and may overcome key challenges faced by many other approaches.
About NEC OncoImmunity AS
NEC OncoImmunity AS is an AI driven biotechnology company that has developed proprietary machine learning-based software which addresses the key knowledge gaps in the prediction of bona fide immunogenic neoantigens for personalized cancer immunotherapy, in addition to infectious disease vaccines. The AI technology can be used to identify optimal neoantigen targets for truly personalized cancer vaccines & cell therapies in a clinically actionable timeframe, and also facilitate effective patient selection for cancer immunotherapy. For more information, visit NEC OncoImmunity AS at https://www.oncoimmunity.com/.
About NEC's AI Drug Development Business
For more information, please visit https://www.nec.com/en/global/solutions/ai-drug/
About NEC's Neoantigen Prediction System
NEC's neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T-cell response. With NEC OncoImmunity now onboard, NEC continues to strengthen its top class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide. For more information, visit NEC at www.nec.com.
About VAXIMM
VAXIMM is a privately held, Swiss/German biotech company that is developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM's plug and play DNA vaccination technology is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients' cytotoxic T-cells to target a wide range of cancer-related antigens. The Company has a pipeline of complementary development candidates targeting different tumor structures. Lead product candidate, oral VXM01, activates killer cells targeting tumor-specific vasculature and certain immune-suppressive cells, thereby increasing immune cell infiltration in solid tumors. VXM01 is currently in clinical development for several tumor types, including brain cancer. VAXIMM has recently licensed its neoantigen program assets to NEC OncoImmunity, a subsidiary of NEC Corporation. VAXIMM's platform allows for fast manufacturing of personalized T-cell cancer vaccines and may overcome key issues faced by other neoantigen approaches. VAXIMM has a collaboration agreement with China Medical System Holdings (CMS), granting CMS full rights in China and other Asian countries (excluding Japan) to VAXIMM's existing programs.
VAXIMM's investors include: BB Biotech Ventures, BCM Europe, BioMedPartners, CMS, M Ventures, NEC and CSV as well as Sunstone Life Science Ventures. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company's development activities. For more information, please visit www.vaximm.com.
About NEC Corporation
NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comNEC OncoImmunity (NOI), a subsidiary of NEC Corporation (NEC), and VAXIMM AG, a Swiss/German biotech company focused on developing an oral plug and play DNA vaccination technology to stimulate patients' cytotoxic T-cells targeting a wide range of cancer-related antigens, today announced that the companies have signed an agreement under which NOI will acquire all of VAXIMM's neoantigen program assets.
Fujitsu and Tokyo Medical and Dental University leverage world’s fastest supercomputer and AI technology for scientific discovery to shed light on drug resistance in...
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Fujitsu and TMDU applied this technology to gene expression level(2) data obtained from cancer cell lines in order to analyze drug resistance(3) against anticancer drugs, and succeeded in extracting a new causal mechanism of a previously unknown gene that suggests a cause of resistance to lung cancer drugs. The new technology is expected to contribute to the acceleration of drug discovery and the realization of cancer therapies individualized for each patient.
The technology was developed under the theme of "elucidation of the cause and diversity of cancer using large-scale data analysis and AI technology," an initiative supported by TMDU, Kyoto University and Fujitsu as part of the supercomputer Fugaku achievement acceleration program(4).
Background
Even if a patient receives a targeted cancer drug(5) therapy, the appearance of drug-resistant cancer cells represents an ongoing threat to full remission. The mechanism for how certain cancers become drug resistant remains unclear, however, and researchers continue to work on new methods of analysis that shed light on how cells that have multiple driver mutations(6) acquire drug resistance. In drug development and clinical trials involving drug repositioning(7), it is important to identify patients for whom drugs are anticipated to have an effect. However, the effectiveness of drugs may differ depending on the organ and the individual and variations in gene expression, and the number of patterns combining expression levels of multiple genes exceeds 1,000 trillion(8). A comprehensive search of all 20,000 genes in the human genome would thus take more than 4,000 years with a conventional computer and finding ways to accelerate the process represents a major challenge.
Newly developed technology
Fujitsu implemented parallel conditional and causal algorithms to maximize computational performance with the supercomputer Fugaku to analyze the human genome within a timeframe needed for practical research. By utilizing Fujitsu's "Wide Learning"(9) AI technology to extract combinations of potential genes relating to the emergence of drug resistance based on statistical information, Fujitsu developed a novel technology that makes it possible to conduct a comprehensive search within a day.
Results
As a result of running data of the Dependency Map (DepMap)(10) portal using this technology on the supercomputer Fugaku, Fujitsu and TMDU were able to search the entire human genome for conditions and causality within a single day and determine the genes that cause resistance to drugs used to treat lung cancer(11).
Comment from Prof. Seiji Ogawa, Graduate School of Medicine, Kyoto University
Promising technologies like Fujitsu's AI technology for scientific discovery ("Wide Learning") may one day contribute to the discovery of biomarkers, which represent an area of growing interest in drug development. The key to the success of new drug development is to identify patients who are expected to benefit from new drugs and conduct clinical trials. If the marker that predicts who will benefit from the drug is known, the cost of clinical trials can significantly be reduced and the probability of success by conducting individual clinical trials can be increased. From this point of view, pharmaceutical manufacturers and others are expected to be very interested in this technology. The fact that it has been implemented using Fugaku has also raised expectations.
Future Plans
Moving forward, Fujitsu and TMDU will conduct a multilayered and comprehensive analysis that combines various data including time axis and location data with the aim of accelerating medical research, including in the field of drug efficacy, as well as to shed light on the causes of cancer.
Fujitsu and TMDU will also collaborate in experimental research in the fields of drug discovery and medicine. TMDU will further utilize the technology developed in this research to promote research on strategies for intractable diseases such as cancer.
In addition to medical care, Fujitsu will utilize the new technology to resolve challenges in a variety of fields, including marketing, system operations and manufacturing.
Acknowledgements
This research was conducted as part of Ministry of Education, Culture, Sports, Science and Technology's Fugaku Achievement Acceleration Program "Understanding the Origin and Diversity of Cancer through Large-scale Data Analysis and Artificial Intelligence Technologies" (JPMXP 1020200102). A part of the research was conducted with the computational resources of supercomputer Fugaku (Issue #: hp 200138, hp 210167).
(1) Supercomputer "Fugaku":
A computer installed at RIKEN as a successor to the supercomputer "K." From June 2020 to November 3, it ranked first in 4 categories in the supercomputer rankings for 4 consecutive years. Full operation started on March 9, 2021.
(2) Gene expression level :
Amount of RNA copied from DNA (the same nucleic acid as DNA synthesized by transcription using some DNA sequences as templates).
(3) Drug resistance :
A phenomenon in which the effect of a drug weakens while the drug is being administered.
(4) Supercomputer Fugaku Achievement Acceleration Program :
Program started in May 2020 by the Ministry of Education, Culture, Sports, Science and Technology with the aim to achieve early results.
(5) Targeted drug :
A drug designed to act only on the molecule (protein, gene, etc.) that is causing the disease.
(6) Driver mutations :
A genetic mutation that directly causes the development or progression of cancer.
(7) Drug repositioning :
The application of existing drugs developed and approved for the treatment of one disease to the treatment of another disease.
(8) More than 1,000 trillion :
Even if the expression level of each gene is restricted to a combination of 50 major genes known to be related to cancer and the expression level of each gene is classified into 2 categories (e.g., "high" or "low" gene expression), the condition number is 2 to the power of 50, which exceeds 1,000 trillion.
(9) Wide Learning :
Official site "Hello, Wide Learning!"
(10) Dependency Map (DepMap) :
Data on the sensitivity and resistance of approximately 4,500 drugs to approximately 600 different cancer cell lines, provided by the American Broad Institute. Mutation information of cancer cell lines and expression data of all genes are included.
(11) Fujitsu and TMDU analyzed gene expression data from DepMap of approximately 300 cancer cell lines, sensitivity and resistance data of Gefitinib (molecularly targeted drug used to treat lung cancer and other cancer types), and comprehensively searched for conditions and mechanisms of cancer cell lines that do not respond to Gefitinib. Fujitsu and TMDU identified conditions under which the expression levels of three transcription factors (genes that control gene transcription (synthesis of RNA)), ZNF516, E2F6, and EMX1, were low. In lung cancer cell lines that meet these conditions, a mechanism triggered by the transcription factors SP7 and PRRX1 was discovered as further potential causes of drug resistance in cancer cells (see reference image).
About Fujitsu
Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 126,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$34 billion) for the fiscal year ended March 31, 2021. For more information, please see www.fujitsu.com.
About Tokyo Medical and Dental University
Tokyo Medical and Dental University (TMDU) is Japan's only comprehensive medical university and graduate school, and has provided advanced medical treatment through a fusion of the medical and dental fields and worked to cultivate "professionals with knowledge and humanity." TMDU contributes to human health and the well-being of society by fostering outstanding healthcare professionals with a humane and global outlook.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comFujitsu and the Tokyo Medical and Dental University (TMDU) today announced a new technology that uses AI to discover new causal mechanisms of drug resistance in cancer treatments from clinical data.
Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid...
The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022.
In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.
About the Prior Assessment Consultation System
The prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
About Lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- Aβ antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD subjects. The study did not achieve its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.
Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017.
* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.
About the Collaboration between Eisai and Biogen for Alzheimer's Disease
Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab.
About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401).
Oculis Strengthens Leading Ophthalmology Pipeline by In-Licensing Neuroprotective Drug Candidate for Glaucoma from Accure Therapeutics
ACT-01, which is being renamed OCS-05, is a first-in-class small molecule with neuroprotective activity that has shown positive results in animal models of neuroinflammation and neurodegeneration. Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this action can protect the nerve axons in conditions where the optic nerve is affected, such as in acute optic neuritis and glaucoma, where the OCS-05 could prevent chronic vision loss.
Based on positive preclinical data and results of a phase 1 safety and PK study in healthy volunteers, a phase 2a study was initiated (the ACUITY study).
ACUITY is a two-arm, randomized, double-blind, placebo-controlled, monocentric study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis. In addition to safety, secondary outcome measures will include optic nerve anatomical measures, as well as visual function measures. The study is ongoing at the La Pitie-Salpetriere hospital in Paris within the neurology-ophthalmology network of the Public University Hospital Group in Paris (APHP). One third of the planned sample size has been enrolled.
Oculis is currently planning the expansion of the program in ophthalmology working with the regulatory agencies in the US, EU and China amongst others.
Riad Sherif, M.D., CEO of Oculis, said: "We are excited about this agreement as it combines Oculis's ophthalmology expertise with Accure's unique neuroprotective approach to help transform the treatment of neurodegenerative diseases in ophthalmology. At Oculis, our focus is on building a highly innovative and differentiated pipeline providing life changing treatments for ocular unmet medical needs, and OCS-05 is a perfect fit for that ambition. Glaucoma is a leading global cause of irreversible blindness, and despite IOP lowering treatments, a significant proportion of patients still go blind. With OCS-05, we have the potential to bring to market the first neuroprotective for glaucoma and other optic neuropathies."
Laurent Nguyen, M.D., Co-founder and Chief Executive Officer at Accure Therapeutics, said: "Having shown promising early data and potential in a number of ocular disease indications, the timing is right for a partnership between two like-minded companies committed to patients and driven by a passion for neuroscience. By leveraging its expertise in ophthalmology, Oculis has the potential to fulfill the promise of this exciting asset in a wide range of neurodegenerative diseases."
In reference experimental animal models of acute optic neuritis (acute inflammatory demyelinating disorder of the optic nerve) and high-pressure glaucoma (high eye pressure damaging the optic nerve and leading to permanent vision loss), OCS-05 reduces damage to the optic nerve and retina. It also decreases paralysis progression in an autoimmune encephalomyelitis animal model for multiple sclerosis (inflammation caused by the body's immune system, which destroys nerve cell processes and myelin in the brain and spinal cord).
Data from a completed phase 1 study show the safety and tolerability of single and multiple doses of OCS-05 in healthy volunteers.
Under the terms of the agreement, Accure Therapeutics will receive an upfront payment, potential milestone payments upon the achievement of certain development and commercial milestones, and tiered royalties on sales.
Anthony Rosenberg, Chairman of Oculis's Board of Directors, said: "The addition of OCS-05 to Oculis's pipeline is very much in line with the Company's strategy to develop transformative therapies that address the root cause of ocular disease to improve patients' sight and quality of life. There is a clear need for first-in-class therapies that can protect and prevent damage to the optic nerve and retina. Oculis has the team and expertise to bring OCS-05 through clinical trials and ultimately to patients around the world."
Montserrat Vendrell, Chairman of Accure Therapeutics and Partner at Alta Life Sciences added: "This licensing deal with Oculis is a proof-of-concept of the value creation that Accure Therapeutics brings as a translational R&D engine, taking forward truly unique science that spun-off from the University of Barcelona. This licensing agreement will enhance Accure's capabilities to accelerate and expand value potential for the rest of its pipeline."
About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide.
Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
About Accure Therapeutics
Accure Therapeutics is a private translational neuroscience R&D company. Based in Barcelona (Spain), it was launched in 2020 with a Series A funding led by Alta Life Sciences Spain I and supported by the Centre for Technological and Industrial Development (CDTI). This European company with an international mindset boasts a unique portfolio of three new chemical entity programs pursuing innovative targets - with potential to accommodate others. Accure aims to develop new disease modifying drugs to treat serious conditions such as optic neuritis, multiple sclerosis, Parkinson's disease and epilepsy. With an experienced business and scientific team, Accure Therapeutics is one of the few companies that operate in an agnostic fashion on initial science to deliver cutting-edge drugs in CNS.
To learn more visit https://accure.health/
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comOculis S.A., (Oculis) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, and Accure Therapeutics, a private translational neuroscience R&D company
Avance Clinical Announces New Office Opening in Sydney
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Avance Clinical's CEO Yvonne Lungershausen said: "We continue to offer a hybrid working environment for our team however, they are increasingly wanting more in-office face-to-face time with colleagues and clients - while still having the flexibility of working remotely".
"Avance is continuing to experience significant growth facilitating our expansion into North Sydney with new offices to accommodate our growing team," she said.
Check for our latest positions open and join our Sydney team here. https://www.avancecro.com/careers/
Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.
"With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions," said Lungershausen.
Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.
The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.
"We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector," said Lungershausen.
Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.
Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
For more information about the benefits of running your next study with Avance Clinical contact us: https://www.avancecro.com/contact-us/
About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.
Frost & Sullivan awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.
Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.
With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.
Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.
Media Contacts:
Avance Clinical
Chris Thompson
[email protected]
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comAvance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has opened new offices in Sydney to support its growing clinical team in the greater Sydney region.
Eisai: LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma
"Nearly one in three cases of renal cell carcinoma are diagnosed at an advanced stage,(1) and patients are in need of new treatment options that may improve survival outcomes,(2)" said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth,
N.J., U.S.A. Research Laboratories. "In the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61% versus sunitinib, a current standard of care. We are encouraged that patients with certain types of advanced renal cell carcinoma may have the opportunity to benefit from this combination."
"Today's milestone for LENVIMA plus KEYTRUDA as a treatment for radically unresectable or metastatic renal cell carcinoma is particularly exciting as it marks the second approval for the combination in Japan," said Terushige Iike, President of Eisai Japan, Senior Vice President, Eisai. "We are thrilled to be able to provide Japanese patients with a new treatment option, illustrating our shared commitment with Merck & Co., Inc., Kenilworth, N.J., U.S.A. to develop therapies with the aim of addressing the unmet needs of those living with difficult-to-treat cancers. We would like to thank the patients, families and healthcare providers who made this approval possible."
The Japanese package inserts for LENVIMA and KEYTRUDA note that in the CLEAR/KEYNOTE-581 trial, adverse reactions were observed in 341 (96.9%) of 352 patients (including 42 of 42 Japanese patients) in the safety analysis set. The most common adverse reactions included diarrhea in 192 patients (54.5%), hypertension in 184 patients (52.3%), hypothyroidism in 150 patients (42.6%), decreased appetite in 123 patients (34.9%), fatigue in 113 patients (32.1%), stomatitis in 113 patients (32.1%), palmar-plantar erythrodysesthesia syndrome in 99 patients (28.1%), proteinuria in 97 patients (27.6%), nausea in 94 patients (26.7%), dysphonia in 87 patients (24.7%), rash in 77 patients (21.9%), and asthenia in 71 patients (20.2%).
Renal cell carcinoma is the most common type of kidney cancer worldwide; about nine out of 10 kidney cancer diagnoses are RCC.(3) In Japan, there were more than 25,000 new cases of kidney cancer diagnosed and more than 8,000 deaths from the disease in 2020.(4) Approximately 30% of patients with RCC will have metastatic disease at diagnosis.(5) Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 14% for patients diagnosed with metastatic disease, the prognosis for these patients is poor.(6)
Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. continue to study the LENVIMA plus KEYTRUDA combination across several types of cancer with more than 20 clinical trials.
For more information, visit https://www.eisai.com/news/2022/pdf/enews202214pdf.pdf.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA.
Lepu Biopharma Co., Ltd. Successfully Listed on the Main Board of HKEX
The share price of the Company closed at HK$7.14 per H share, with an intra-day high of HK$7.34 per H share. A total of approximately 15.8 million H shares were traded, with an aggregate turnover of approximately HK$112 million.
Lepu Biopharma is listed on the main board of HKEX, with 126,876,000 H shares being offered globally, including 12,688,000 Hong Kong Offer Shares, 114,188,000 International Placing Shares. The net proceeds received are estimated at approximately HK$804.2 million from the Global Offering, after deduction of underwriting fees, commissions and other estimated expenses payable by the Company in connection with the Global Offering. The net proceeds are intended for funding the core products, funding the other key clinical-stage drug candidates and the key pre-clinical drug candidates, acquiring potential technologies and assets and expand our pipeline of drug candidates, including discovery of new drug candidates and business development activities and to fulfill the continuous payment obligation under the acquisition of HX008 from HanX, and general corporate purposes.
Lepu Biopharma has three synergistic core technology platforms around its pipeline specializing in ADC technology, antibody discovery and advanced process and analytical development. The company also advances the clinical development of its candidates including ADC candidates, oncolytic virus candidates and combination therapies, plans to stay focused on the development of innovative products, create a pipeline for novel therapies, design and develop innovative products and build advanced technology platforms.
While Lepu Biopharma advancing its drug candidates, it has mapped out and is implementing the manufacturing and commercialization strategies. Company commenced the operation of a 2,000L GMP-compliant antibody production line in Beijing in 2019 in support of clinical trials for the antibody products. It is building a production line for oncolytic virus drugs in Beijing with a designed capacity of 200L, as well as a biologics manufacturing center in Shanghai Biotech Park, including a production line with a designed capacity of 12,000L initially, coupled with laboratories and manufacturing facilities, and one production line with capacity of 6,000L under construction.
The Founder, Chairman and Executive Director of Lepu Biopharma Co., Ltd. Dr. Pu Zhongjie said, "Today, we are very delighted to witness Lepu Biopharma to be officially listed on the Hong Kong Stock Exchange. This is an important milestone in our history of development as well as a starting point of our new journey. We sincerely appreciated the long-term trust and cooperation from customers and shareholders. We would also like to thank our partners, the Hong Kong Stock Exchange and the Securities and Futures Commission for all the great support. With solid R&D capabilities, advanced development platforms and comprehensive pipeline, we will seize the future trend of the whole industry, strengthen our position in the market with our competitive advantages and create greater value for shareholders and investors."
About Lepu Biopharma Co., Ltd.
Lepu Biopharma was incorporated in 2018 and is a biopharmaceutical company focusing on oncology therapeutics. The Company has designed pipeline with a range of oncology products. As of [the Latest Practicable Date], the Company had pipeline including eight clinical-stage drug candidates, three pre-clinical drug candidates and three clinical-stage combination therapies of the candidates in the pipeline. In addition, the Company focus on the development of innovative drugs including ADC and oncolytic virus. According to Frost & Sullivan, the Company house the leading ADC drug candidate pipeline in China in terms of the number of clinical-stage ADC drug candidates. As of [the Latest Practicable Date], the Company had initiated 28 clinical trials, among which three had entered registration trial phase and two were ongoing in the U.S. In terms of patents, as of [the Latest Practicable Date], Company had 11 issued patents in China, 20 in the U.S., nine in Japan, seven in the European Union and one in each of South Korea, Australia, Chile, India, Colombia, Indonesia, New Zealand and Israel, and 74 pending patent applications, consisting of 15 in Mainland China and 59 in overseas jurisdictions such as the U.S., Japan, India, South Korea, Australia, Israel, India and the European Union. Patentportfolio of the Company spans across mAb structure, targeted epitope, CMC, usage, biopharmaceutical formulation and indications.
For more information on Lepu Biopharma, please visit the website https://www.lepubiopharma.com/
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comThe biopharmaceutical company focusing on oncology therapeutics - Lepu Biopharma Co., Ltd. ("Lepu Biopharma" or the "Company", stock code: 2157.HK), has successfully listed and commenced dealings on the Main Board of the Stock Exchange of Hong Kong Limited ("Hong Kong Stock Exchange") today
IND Application for SinoMab’s First-in-Class Asthma Therapeutic Product SM17 Accepted by FDA
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SM17 is the world's first monoclonal antibodies targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the United Kingdom). SM17 has a wide range of indications, including indications with large market volumes such as asthma and diseases with high mortality rates such as idiopathic pulmonary fibrosis. Comparing to other products on the market, SM17 enjoys differentiation advantages. With the preclinical data and unique mechanism of action of SM17, Company believes that SM17 potentially has a broader and more beneficial effect on asthma treatment than other approved biologics.
In the global market, the number of asthma patients is gradually increasing and is expected to reach 247.5 million by 2023 and further increase to 267.7 million by 2030. The number of asthma patients in the PRC is increasing at a greater pace than the global rate and is forecasted to reach 25.6 million by 2023 and further increase to 27.8 million by 2030. In terms of market size, the global asthma market is projected to reach US$25.1 billion by 2023 and US$34.6 billion by 2030. However, the asthma market in the PRC is expected to reach RMB36.4 billion by 2023 and RMB65.0 billion by 2030. In terms of treatment options, traditional asthma treatment is based on inhaled corticosteroid, but they are prone to serious adverse effects, especially in adolescents. Drug resistance can also develop if used for a long time. The introduction of SM17 is expected to provide a better treatment option in terms of the balance of efficacy and safety.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "following the acceptance of the IND application for SN1011 for the treatment of multiple sclerosis by the NMPA, the acceptance of the SM17 IND application by the FDA fully demonstrates the efficient execution of the Company's new drug R&D program. There is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. We are therefore confident in the enormous prospects of SM17's clinical development. Our core products, including SM03, SN1011 and SM17, is making progress on the clinical R&D smoothly, driving the Company moving steadily towards commercialization. In the future, we will accelerate our projects implementation to bring benefits to patients and create value for shareholders through innovation."
About SM17
SM17 is known to be the world's first humanized, IgG4-k monoclonal antibody for new drug development, which targets IL-17RB. And IL-17RB is a type-I single transmembrane glycoprotein belonging to IL-17 receptor family. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a category of cytokines called "alarmin", which has shown to be implicated in the pathogenesis of allergic disease and airway viral responses. Alternative approach targeting upstream mediators of the Th2 inflammatory cascade, such as "alarmins", is expected to have a broader effect on airway inflammation and to provide more effective asthma control than currently available therapies, and products with similar mechanism of action as SM17 have been approved by FDA.
About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases
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