In late February 2021, Oncopeptides AB scored a big win on the FDA’s accelerated approval for the first cancer peptide-drug conjugate, Pepaxto (melphalan flufenamide), in multiple myeloma. Less than eight months later, it was shutting down commercial operations and heading back to the drawing board after safety issues emerging in the confirmatory Ocean study prompted the Stockholm-based firm to pull Pepaxto from the market, just ahead of what was likely to be a negative FDA advisory panel vote.
Sana Biotechnology Inc. has acquired rights to two CAR T constructs through a pair of deals, one with partners Innovent Biologics Inc. and Iaso Biotherapeutics Co. Ltd. and a second with the U.S.-based National Cancer Institute (NCI). In the Innovent-Iaso deal, Sana secured nonexclusive commercial rights to a B-cell maturation antigen-targeted CAR T construct for in vivo gene therapy and ex vivo hypoimmune cell therapy applications. The NCI deal, for exclusive commercial rights to the NCI’s CD22 CAR asset, could help Sana “address key relapse challenges for CD19-directed CAR T-cell therapies,” the company said.
LONDON – Natural killer (NK) cell therapy specialist Onk Therapeutics Ltd. has raised $21.5 million in a series A, enabling it to move three lead programs into proof-of-concept animal testing and to progress manufacturing and scale-up of its cord blood-derived cells.
Recent word that Johnson & Johnson submitted the BLA for teclistamab may have reminded Wall Street that a combo-therapy face-off is in progress between the big pharma firm – with partner Springworks Therapeutics Inc. – and Novartis AG, paired with Ayala Therapeutics Inc.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma, specifically those who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
DUBLIN – Oncopeptides AB has withdrawn its troubled multiple myeloma
drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA. The move comes less than a week before the FDA’s Oncologic Drugs Advisory Committee was due to consider the drug’s safety profile because of data anomalies that surfaced over the summer.
Cell therapy developer Cellular Biomedicine Group Inc. (CBMG) completed a $120 million series A financing, its first since becoming a private company. The funds will benefit the U.S. and China-based firm’s CAR T pipeline, and the round was jointly led by Astrazeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital. Existing investors including GIC Private Ltd. (formerly Government of Singapore Investment Corp.) and TF Capital also took part.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.
