On April 4, 2024 Odyssey Therapeutics, Inc., a biotechnology company pioneering next-generation precision medicines, reported that it has entered into a strategic research collaboration with Janssen Pharmaceutica NV, a Johnson & Johnson company, to jointly discover and optimize small molecule medicines against select therapeutic targets (Press release, Odyssey Therapeutics, APR 4, 2024, View Source [SID1234641785]). The companies will combine their expertise in artificial intelligence (AI), machine learning (ML), computational chemistry and drug discovery to unlock difficult-to-drug targets. The agreement was facilitated by Johnson & Johnson Innovation.

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Since its founding in 2021, Odyssey has assembled a team of expert drug hunters with deep experience in immunology, oncology, medicinal chemistry and structural biophysics, and armed them with next-generation computational tools to solve difficult therapeutic challenges. This integration of in silico methods, cutting-edge experimental capabilities, and wet lab infrastructure enables the scientists at Odyssey to rapidly discover and develop potentially transformative medicines for patients.

"We are excited about this collaboration to push the boundaries of the drug discovery and development process, using the latest advancements in AI and ML to find solutions for serious diseases," said Gary D. Glick, Ph.D., founder and CEO of Odyssey Therapeutics. "This collaboration between our chemists, biologists, and data scientists will help accelerate our joint drug discovery efforts through optimization of our tools, data sharing, and model development to discover and develop transformational medicines for patients in need."

Under the terms of the agreement, Odyssey will work with discovery and therapeutic area experts and data scientists at Johnson & Johnson to deploy AI and ML to discover and optimize small molecule therapeutics against multiple targets. Odyssey will receive an upfront payment and is eligible for milestone payments and royalties.

On April 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%) (Press release, Merck & Co, APR 4, 2024, View Source [SID1234641783]).

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"KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Based on early evidence showing MK-1084 in combination with KEYTRUDA had a manageable safety profile and promising anti-tumor activity, we are now proceeding to a larger Phase 3 trial to evaluate this combination in certain patients with metastatic non-small cell lung cancer."

Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial (NCT06345729) evaluating once daily MK-1084 in combination with KEYTRUDA administered once every three weeks compared with KEYTRUDA plus placebo in previously untreated patients with KRAS G12C-mutated metastatic NSCLC with a PD-L1 TPS ≥50%. The trial will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.

MK-1084 is currently being evaluated in a Phase 1, open-label multicenter clinical trial (NCT05067283) to assess safety, tolerability, pharmacokinetics and efficacy of MK-1084 as monotherapy and as part of various combination therapies in patients with KRAS G12C mutant advanced solid tumors. Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in 2023.

MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. This collaboration was announced in January 2020.

About MK-1084

MK-1084 is an investigational, potent and specific KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer, pancreatic, urogenital and colorectal cancers. The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of non-small cell lung cancers (adenocarcinoma). Despite decades of research and recognition of the therapeutic importance of targeting KRAS, the development of small molecule inhibitors targeting KRAS mutations has been challenging.

About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In 2024, the overall five-year survival rate for patients diagnosed with lung cancer is 25% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.

On April 4, 2024 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications (Press release, mAbxience, APR 4, 2024, View Source [SID1234641782]). Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.

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The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.

Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product. Teva will lead the regulatory processes and commercialization in the designated regions, to ensure access to a broader patient population.

"Partnering with Teva not only reinforces mAbxience’s position as a global biosimilar company but also aligns with our mission to deliver high-quality, affordable healthcare solutions across continents," says Jurgen Van Broeck, Global Commercial Director of mAbxience. "This agreement will assist healthcare systems in reducing costs, ensuring the provision of these vital cancer treatments to all patients who require them."

"Teva is pleased to form this strategic alliance with mAbxience, who share our commitment to accelerate the delivery of impactful medicines to patients worldwide," says Angus Grant, PhD, Executive Vice President of Business Development at Teva. "This collaboration reflects Teva’s ideal strategic partnership model to optimize development costs, mitigate risk and leverage our extensive commercial capabilities."

On April 4, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the following investor conferences in April (Press release, Immunocore, APR 4, 2024, View Source [SID1234641781]):

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Needham Virtual Healthcare Conference
Fireside Chat: Wednesday, April 10, 2024, at 11:00 a.m. EDT
Canaccord Horizons in Oncology
Panel: T-Cell Engagers for Solid Tumors: Monday, April 15, 2024, at 4:00 p.m. EDT
Kempen Life Sciences Conference
1×1 and small group meetings: Tuesday, April 16, 2024

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events’, under ‘News & Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

On April 4, 2024 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that an abstract reporting preclinical results of its non-viral, cell penetrating gene monoclonal antibody (GMAB) platform technology has been selected for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place April 5 – 10, 2024 in San Diego, CA (Press release, Gennao, APR 4, 2024, View Source [SID1234641780]). The poster presentation will showcase exploratory research conducted through Gennao’s ongoing collaboration with the laboratory of Peter M. Glazer, M.D., Ph.D., Chair of the Department of Therapeutic Radiology, Professor of Genetics and Robert E. Hunter Professor of Therapeutic Radiology at the Yale School of Medicine. Specifically, the presentation will demonstrate the potential application of the GMAB platform as an antibody-drug conjugate (ADC) for the treatment of solid tumors.

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The details of the poster presentation are as follows:

Abstract Number: 5801

Title: Targeted delivery of Exatecan to tumors via a novel cell-penetrating, anti-DNA antibody

Session Title: Cancer Treatment: New Technologies

Session Date and Time: Tuesday, April 9, 2024; 1:30 p.m. – 5:00 p.m. Pacific Daylight Time

Presenter: Zaira Ianniello, Ph.D., Yale School of Medicine

Location: Poster Section 22; Poster Number 10