Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.
Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.
The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
Immatics NV’s IMA-203 “looks like a melanoma drug,” said Cantor Fitzgerald analyst Eric Schmidt after he took a peek at the latest data, prepared as part of an upcoming meeting with the U.S. FDA. The candidate emerged from Immatics’ Actengine platform, set up to formulate a personalized therapy in which a patient’s own T cells are collected, genetically modified and then reinfused. Immatics offered data with IMA-203 as a monotherapy that targets preferentially expressed antigen in melanoma from an ongoing phase I trial testing what’s been established as the recommended phase II dose of 1-10x109 TCR-T cells in 30 heavily pretreated metastatic melanoma patients who were evaluable for efficacy.
Vertex Pharmaceuticals Inc. has tapped into Treefrog Therapeutics SA’s high-throughput stem cell manufacturing technology in a deal worth potentially up to $780 million to help it advance its type 1 diabetes programs, including phase I/II asset VX-880.
About a year after the U.S. FDA cleared Krystal Biotech Inc.’s topical gene therapy, Vyjuvek (beremagene geperpavec), as the first drug for recessive or dominant dystrophic epidermolysis bullosa, competitor Abeona Therapeutics Inc. disclosed a complete response letter (CRL) from the FDA related to its cell-based graft therapy, prademagene zamikeracel.
After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
On the heels of a $4.6 million series A round in December 2023, cell therapy company Rxcell Inc. is planning to raise another $15 million in 2024 to take its iPSC-derived photoreceptors to the clinic for retinitis pigmentosa and other degenerative diseases of the retina.
On the heels of a $4.6 million series A round in December 2023, cell therapy company Rxcell Inc. is planning to raise another $15 million in 2024 to take its iPSC-derived photoreceptors to the clinic for retinitis pigmentosa and other degenerative diseases of the retina.
Enlivex Therapeutics Ltd. extolled the top-line “positive indication of effect and safety” from the phase II study of Allocetra in treating sepsis and sepsis shock, but the market took another view of the clinical trial. In an analysis of eligible adult patients from the cell therapy’s multicenter, randomized, placebo-controlled, dose-finding study of 120 enrolled patients, the company also reported low mortality rates.
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