Biohaven to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On January 2, 2024 Biohaven Ltd. (NYSE: BHVN) reported that Vlad Coric, M.D., Chairman and Chief Executive Officer, reported that it will present at the 42nd Annual J.P. Morgan Healthcare Conference at The Westin St. Francis Hotel in San Francisco, California, on Monday, January 8, 2024 at 8:15 am (PT) (Press release, Biohaven Pharmaceutical, JAN 2, 2024, View Source [SID1234638883]).

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A slide deck of the presentation will be available on the Investors section of the Biohaven website at www.biohaven.com.

Allorion Therapeutics Announces Exclusive Option and Global License Agreement for Novel Preclinical-Stage EGFR L858R Allosteric Inhibitor Program with AstraZeneca

On January 2, 2024 Allorion Therapeutics ("Allorion"), a US and China-based biotechnology company that focuses on the discovery of new small molecule drugs for treating cancer and autoimmune diseases, reported that it has entered into an exclusive option and global license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize a novel epidermal growth factor receptor (EGFR) L858R mutated allosteric inhibitor, as a potential new treatment for advanced EGFR-mutant non-small cell lung cancer (NSCLC) (Press release, Allorion Therapeutics, JAN 2, 2024, View Source [SID1234638882]).

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Under the terms of the agreement, AstraZeneca will be granted an exclusive option to license a novel EGFR L858R allosteric inhibitor to develop and commercialize globally. Allorion is eligible to receive upfront and near-term payments of up to $40 million, and additional development and commercial milestone payments of over $500 million, as well as tiered royalties on net sales worldwide.

Fang Li, PhD., Cofounder and Chief Scientific Officer of Allorion remarked, "Allorion’s EGFR L858R allosteric inhibitor is designed to address mechanisms of resistance to current EGFR inhibitors and has the potential to enhance their activity, when used in combination. We are excited to enter into this agreement with AstraZeneca, a global leader in this field, to advance our EGFR inhibitor into the clinic and explore potential combinations with other EGFR targeting molecules such as Tagrisso."

WuXi XDC Enters into Partnership Agreement with IntoCell, Enabling Clients to Accelerate ADC Discovery and Development

On January 2, 2024 WuXi XDC, a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on ADC and the other types of bioconjugate market, and IntoCell, a Korean biotechnology company dedicated to developing novel ADC platform technologies, reported that they have signed a Memorandum of Understanding (MOU) for a comprehensive partnership in drug-linker technology and CRDMO services spanning from discovery to commercialization (Press release, IntoCell, JAN 2, 2024, View Source [SID1234638881]).

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Under the agreement, IntoCell will provide proprietary drug-linker technologies using their Ortho-Hydroxy Protected Aryl Sulfate (OHPASTM) Linker and novel Camptothecin drugs called NexatecansTM, a new class of OHPAS-able Camptothecins. WuXi XDC will provide fully integrated, one-stop bioconjugate platform and end-to-end CRDMO services. This synergy will empower clients of both parties to accelerate PCC (Pre-clinical candidates) selection further, develop more next-generation ADCs and other bioconjugates, and expedite the CMC development process.

Dr. Jimmy Li, CEO of WuXi XDC, commented, "IntoCell’s unique drug-linker technologies and our leading, open-access platform are a great combination to enable the fast delivery of pre-clinical candidates, especially in novel ADC programs. We are delighted to reach this comprehensive partnership with IntoCell and to forge the capability synergy. It demonstrates WuXi XDC’s platform development strategy, namely to grow continually and evolve to help our clients to accelerate and transform the discovery, development and manufacturing of ADCs and other bioconjugates. "

Tae Kyo Park, Founder and CEO of IntoCell, commented, "Given WuXi XDC’s ample experience and superb capabilities in the CRDMO business, along with IntoCell’s proprietary drug-linker technology, the collaborative efforts of the two companies will pave an easier path for potential ADC development companies to access a variety of drug-linker sets in a stable yet fast-cleavable format. We are eager to witness positive progress towards that goal."

Sarepta Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On January 2, 2024 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that senior management will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif. on Monday, Jan. 8, 2024 at 12:00 p.m. E.T. / 9:00 a.m. P.T (Press release, Sarepta Therapeutics, JAN 2, 2024, View Source [SID1234638880]). Following the presentation there will be a Q&A session starting at 12:20 p.m. E.T. / 9:20 a.m. P.T.

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The presentation will be webcast live under the Events & Presentations section of the investor relations section of Sarepta’s website at View Source and will be archived there following the presentation for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

Leap Therapeutics Announces Completion of Enrollment in Randomized Controlled Part C of the DisTinGuish Study of DKN-01 for the Treatment of Gastric Cancer Patients

On January 2, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that enrollment has been completed in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer (Press release, Leap Therapeutics, JAN 2, 2024, View Source [SID1234638879]).

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"The completion of enrollment in Part C of the DisTinGuish study is an important milestone and continues to underscore the high level of interest from both patients and investigators in DKN-01," said Cynthia Sirard, M.D., Chief Medical Officer of Leap. "Long-term follow-up data from Part A of the study clearly demonstrated the potential to induce durable responses and clinically meaningful survival outcomes in first-line advanced gastroesophageal junction and gastric cancer patients. We expect Part C to further validate the potential of DKN-01 and tislelizumab combination therapy and look forward to having initial data from Part C over the course of this year."

Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. Part C enrolled 170 first-line, HER2-negative patients. Patients were randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is progression-free survival (PFS) in DKK1-high and in all patients. Secondary objectives of Part C include overall survival and objective response rate as measured by RECIST v1.1 in DKK1-high and in all patients.