Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October.
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
After more than two decades of working together, Genmab A/S has entered a new licensing agreement with Scancell Holdings plc to gain the exclusive rights to develop and commercialize an anti-glycan monoclonal antibody. All potential disease areas except cell therapy applications are on the table in the deal. Genmab will make an up-front payment of an undisclosed amount to Scancell as well as covering milestone payments of up to $208 million for each candidate that’s developed and commercialized. The amount is capped at $624 million to Scancell if Genmab manages to develop and commercialize products across all modalities the companies have defined. Scancell could also receive single-digit royalties on the net sales of products.
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.
Normunity Inc. emerged from stealth by unveiling $65 million in series A funding and bold plans to tackle one of the critical issues in immuno-oncology. Normunity is based on the research of scientific founder Lieping Chen, of Yale School of Medicine, an early immuno-oncology pioneer who identified and characterized the gene encoding PD-L1 (then called B7-H1) and shortly afterward reporting additional findings that contributed to its recognition as an important target in cancer immunotherapy.
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
Maxinovel Pharmaceuticals Inc. raised ¥100 million ($13.8 million) in a series C+ round to develop its candidates for acute myeloid leukemia, solid tumors, and autoimmune diseases.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free surviva vs. a placebo.
A second death in the study of davoceticept (ALPN-202) has prompted Alpine Immune Sciences Inc. to stop enrolling participants in two phase I studies of the CD28 co-stimulator and dual checkpoint inhibitor, throwing the program’s future into doubt.
Celltrion Healthcare Inc. has signed a deal with Pinotbio Inc. to develop antibody-drug conjugates for up to 15 separate cancer targets incorporating the linker-payload platform technology Pinot-ADC. Celltrion could pay Pinotbio as much as ₩1.77 trillion (US$1.24 billion) to exercise options for all 15 targets in the collaboration. But, for starters, it will pay Pinotbio ₩1 billion up front.
RSS
