Termination of a Material Definitive Agreement

On May 5, 2025, IGM Biosciences, Inc. (the "Company") reported to have received a notice of termination of that certain Collaboration and License Agreement (the "Agreement"), dated as of March 28, 2022, by and between the Company and Genzyme Corporation, a corporation organized under the laws of Massachusetts ("Sanofi"), pursuant to which Sanofi has elected to terminate the Agreement, at will, in its entirety (Filing, IGM Biosciences, MAY 5, 2025, View Source [SID1234652744]). The effective date of the termination is thirty (30) days after the date of such notice.

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Under the original terms of the Agreement, the Company had agreed to generate, develop, manufacture and commercialize IgM antibodies directed to six primary targets, three of which were oncology targets and three of which were immunology targets. The parties concluded that conducting further activities under the Agreement was not in the interests of either party.

IND Application for NTS071, Nutshell Therapeutics’ p53 Y220C Allosteric Reactivator, Received US FDA clearance

On May 4, 2025 Nutshell Therapeutics ( Shanghai ) Co., LTD. reported to have received IND clearance from the FDA to initiate Phase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric reactivator targeting p53 Y220C mutation (Press release, Nutshell Therapeutics, MAY 4, 2025, View Source [SID1234652483]).

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NTS071 is an oral small molecule allosteric reactivator targeting p53 Y220C with a novel scaffold. It selectively binds to the p53 Y220C mutant protein, improving its thermal stability, thereby enhancing the mutant protein’s ability to bind with DNA and restoring its transcriptional activity as well as tumor-suppressing function.

NTS071 was discovered by leveraging Nutshell’s proprietary AI driven allosteric small molecule drug discovery platform ALLOSTAR. NTS071 demonstrated potential Best-in-Class preclinical properties for its target. NTS071 achieved a picomolar-level biochemical activity which is 20 folds more potent than the competitive compound PC14586. Additionally, NTS071 shows better stability in both liver microsomes and hepatocytes across different species and exhibits lower in vivo clearance rates and higher oral exposure s in preclinical PK studies across all tested species compared to PC14586. NTS071 has relatively lower plasma protein binding and higher free fraction than PC14586, which is beneficial for in vivo efficacy. NTS071 also addresses the CYP3A4 inhibition issue of PC14586, presenting lower risks for potential drug – drug interactions. NTS071 further displays a large safety window by exhibiting an overall good safety profile in non-clinical toxicology studies.

NTS071 exhibited dose-dependent in vivo anti-tumor activity in multiple CDX and PDX models harboring p53 Y220C mutation, spanning a number of different cancer types, including ovarian cancer, lung cancer, gastric cancer, breast cancer, head and neck cancer, esophageal cancer, pancreatic cancer, and bladder cancer, etc. Therefore, NTS071 has the potential to be a tumor-agnostic therapy for patients carrying p53 Y220C mutation. Compared to PC14586, NTS071 has shown significantly lower effective doses or better efficacy at the same dose level in all comparative preclinical in vivo studies, implying that NTS071 may overcome the limitation of its competitor that has a higher dose requirement, thereby potentially achieving better therapeutic effects. NTS071 is anticipated to initiate Phase 1 clinical trial in second half of 2025 and expected to benefit patients with solid tumors harboring this mutation.

p53 Y220C mutation is widespread in various solid tumors. Studies show that there are 125,000 to 150,000 new cases worldwide annually, representing a significant market potential. Enriched with years of accumulated experience with its proprietary computation-based allosteric drug development technology and breakthrough innovation capabilities at Nutshell Therapeutics, NTS071 has the potential to stand out among peer products and become the most competitive drug molecule for this target.

The NTS071 Poster presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) 2024 conference can be accessed here: View Source

TAE Life Sciences and The Ohio State University Forge Landmark Collaboration to Advance Boron Drug Innovation for Precision Cancer Therapy

On May 3, 2025 TAE Life Sciences (TLS) reported the signing of a Letter of Intent to collaborate with The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) in the development and evaluation of novel boron-based drug compounds—an essential component of Boron Neutron Capture Therapy (BNCT) (Press release, TAE Life Sciences, MAY 3, 2025, View Source [SID1234652484]).

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This partnership marks the first-of-its-kind U.S.-based academic-industry alliance dedicated to accelerating BNCT drug innovation and translational research. By optimizing boron delivery agents, TLS and OSUCCC aim to unlock BNCT’s full potential as a powerful, highly selective, and relatively non-toxic therapy and positioning it as a new modality in the next era of precision oncology.

"We are entering a pivotal moment in cancer therapy," said Dr. Arnab Chakravarti, Chair and Professor of Radiation Oncology, Klotz Family Chair of Cancer Research and Director of the Brain Tumor Program at Ohio State. "BNCT offers an unprecedented opportunity to treat malignancies that are otherwise unresponsive to conventional therapies, while sparing healthy tissue. Our laboratory is uniquely poised to lead this next wave of boron drug innovation, and we are excited to collaborate with TAE Life Sciences in accelerating this effort on a global scale."

The initial focus of the collaboration will be the preclinical evaluation of TLS’s proprietary boron-10 drugs in cellular and animal models, leveraging Ohio State’s specialized neutron source optimized for BNCT research. In parallel, the teams will pursue joint development of next-generation boron drugs for BNCT and adjacent applications—unlocking new possibilities in precision cancer treatment.

"This partnership marks a major leap forward for the future of BNCT," said Robert Hill, CEO of TAE Life Sciences. "We are deeply honored to collaborate with Dr. Chakravarti and his world-class team of research and clinical experts. Their pioneering track record of leadership and innovation will be instrumental not only in advancing the science behind novel boron drug compounds but also in paving the way toward potential regulatory approval. Together, we’re creating a dynamic force for innovation that has the potential to redefine cancer care."

Hill notes that this partnership establishes a key pillar for accelerator-based BNCT and significantly accelerate the path to breakthrough cancer therapies, positioning the United States to have a leading position in the next wave of innovation in precision oncology. Hill emphasized that the growing body of international clinical evidence—particularly from Japan, Taiwan, and Europe validates BNCT’s ability to deliver durable responses in patients with otherwise untreatable cancers. This collaboration will help position the United States in having a leading position in advanced drug development and establishing the next wave in precision medicine.

Agios to Present at the BofA Securities 2025 Health Care Conference on May 14, 2025

On May 2, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the BofA Securities 2025 Health Care Conference on Wednesday, May 14, 2025, at 8:00 am PT/11:00 am ET (Press release, Agios Pharmaceuticals, MAY 2, 2025, View Source [SID1234652475]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Lilly to participate in Bank of America Securities 2025 Healthcare Conference

On May 2, 2025 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Bank of America Securities 2025 Healthcare Conference, May 15, 2025. Lucas Montarce, Lilly executive vice president and chief financial officer, will take part in a fireside chat at 11:40 a.m., Eastern time (Press release, Eli Lilly, MAY 2, 2025, View Source [SID1234652476]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.