Repare Therapeutics Inc. offered phase I data from the Mythic gynecologic expansion trial testing the combination of lunresertib and camonsertib at the recommended phase II dose in patients with endometrial cancer and platinum-resistant ovarian cancer that harbor lunre-sensitizing biomarkers. Lunresertib is a first-in-class precision oncology small-molecule PKMYT1 inhibitor that targets cell cycle regulation in Lunre BM-positive tumors (CCNE1 amplifications or FBXW7 or PPP2R1A deleterious alterations). Camonsertib is a potential best-in-class oral small-molecule inhibitor of ATR. As Wall Street digested the news, shares of Cambridge, Mass.-based Repare (NASDAQ:RPTX) were trading at $2.09, down $1.88, or 47%.

Welireg, Emcitate among drugs EMA recommends for approval

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel. More than three years after it was approved by the FDA and 2.5 years after the U.K. Medicines and Healthcare products Agency gave the nod, CHMP is recommending approval of Merck and Co. Inc.’s Welireg (belzutifan) in adults with von-Hippel-Landau disease. The EMA is poised to beat the FDA with its recommendation to approve Egetis Therapeutics AB’s Emcitate (tiratricol), an oral treatment for thyrotoxicosis in patients with monocarboxylate transporter 8 deficiency, also known as Allan-Herndon-Dudley syndrome.

Beigene, CSPC strike $1.5B deal for phase I MAT2A inhibitor

Beigene Ltd. struck a global licensing deal with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. worth up to $1.5 billion for its phase I selective methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH-2039, which is being explored for solid tumors. Beigene, which will soon change its name to Beone Medicines Ltd., gains an exclusive license to develop, manufacture and commercialize SYH-2039 worldwide. CSPC will receive up-front payments totaling $150 million and is eligible to receive potential development milestone payments of up to $135 million and commercialization milestone payments of up to $1.5 billion, plus sales-based royalties.

New cancer data from Bicycle precedes stock drop

Mixed results for three of Bicycle Therapeutics plc’s zelenectide pevedotin development programs preceded a strong drop in the company’s stock. At the 2024 San Antonio Breast Cancer Symposium, the company presented data on zelenectide pevedotin monotherapy for treating triple-negative breast cancer with NECTIN4 gene amplification, top-line data for zelenectide pevedotin plus pembrolizumab for treating first-line cisplatin-ineligible patients with metastatic urothelial cancer, and top-line monotherapy data for zelenectide pevedotin in non-small-cell lung cancer patients with NECTIN4 gene amplification. Bicycle shares (NASDAQ: BCYC) had dropped 30% at midday to $13.80 each.

Second insulin receptor offers new therapeutic avenues

Investigators at the Helmholtz Institute have shown that inceptor, an inhibitor of the insulin signaling pathway, acted by binding insulin and targeting it for degradation. “Insulin was discovered 100 years ago, and the insulin receptor was discovered 50 years ago,” Heiko Lickert told BioWorld. “Now we have a new insulin receptor, which degrades insulin.” Lickert is the director of the Institute of Diabetes and Regeneration Research at Helmholtz Munich, professor at the Technical University of Munich, and member of the German Center for Diabetes Research. He is the senior author of the paper reporting the new insights into how inceptor works, which were published online in Nature Metabolism on Nov. 25, 2024.

GC Biopharma to buy Abo Holdings for ₩138B, grow US plasma biz

GC Biopharma Corp. will buy plasma collector Abo Holdings Inc. in a ₩138 billion (US$96.28 million) cash acquisition as the vaccine and plasma-derived medicinal products developer works to accelerate entry of Alyglo (IVIG-SN 10%) in the U.S., where it was approved last year. The acquisition of Abo Holdings will close Jan. 31, 2025, and involve the purchase of 100 million shares, according to GC Biopharma’s disclosure on the Korea Exchange Dec. 11. Incorporated in October 2020, Irvine, Calif.-headquartered Abo is a health care company that collects medical-grade blood plasma for use in biotherapeutic pharmaceutical therapies.

Also in the news

Acadia, Agenus, Amarin, Atyr, Blue Lake, Briacell, Caliway, Conduit, Corcept, DBV, Dewpoint, Dpbio, Elevation Oncology, Eli Lilly, Enable Medicine, Fonseca, General Inception, Gilead, Halia, Hutchmed, Immuneering, Immutep, Keros, Kineta, Kiromic, Krystal, Leveragen, Lumos, Menarini, Merck, Monte Rosa, Neuraxpharm, Neurosense, Newamsterdam, Novo Nordisk, Ose, Peptidream, Pfizer, Pharmathen, Polyrizon, Protara, Scilex, SK Bioscience, Sobi, Synaffix, Tanner, Tuhura