The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
Exsilio Therapeutics emerged from stealth mode on June 25, 2024, with $82 million from a series A financing that was co-led by Novartis Venture Fund and Delos Capital. The company plans to use naturally occurring, mobile genetic elements to integrate therapeutic genes at a defined location in the genome, making it safer than random integration, which can cause tumor formation.
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
A group of researchers in India have looked into the role of estrogen-related receptor γ (ERRγ) in the progression of colorectal cancer (CRC), and studied the effect of combination therapy with an ERRγ inverse agonist, DN-200434, and the AKT inhibitor MK-2206 in in vitro and in vivo assays.
Kanvas Biosciences Inc. has raised $12.5 million in additional funding to support development of the company’s spatial biology platform and advance two novel therapeutics in its immuno-oncology program, KAN-001 and KAN-003.
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer cell therapies. GC Cell disclosed news of the terminated deal on the Korea Exchange near market close of June 25, saying it was notified by Artiva after the decision was reached by MSD’s internal decision makers.
At a time when much of the biopharma space can’t seem to get enough of antibody-drug conjugates (ADC), Bristol Myers Squibb Co. is backing away from a potential $3 billion-plus collaboration with Eisai Co. Ltd., handing back full rights to the latter’s folate receptor alpha-targeting ADC, farletuzumab ecteribulin (FZEC), citing a portfolio reprioritization. Global rights to FZEC now reside with Tokyo-based Eisai, which said it intends to accelerate work on the candidate, which is in three clinical studies, including two phase II trials in gynecological cancers and non-small-cell lung cancer.
Merck & Co. Inc. is getting the exclusive, global rights from Orion Corp. to develop the oral prostate therapy, ODM-208, which the two companies hammered out a deal for in 2022. Orion could now bring in up to $30 million in development milestones, as much as $625 million in regulatory milestone payments, and up to $975 million in sales-based milestones. The deal adds up to $1.6 billion for Espoo, Finland-based Orion. Orion, which has a number of other deals with other companies, could also receive annually tiered royalty payments ranging from a low double-digit rate up to a rate in the low 20s on net sales for any commercialized licensed product.