Appia Bio Inc. raised $52 million in a series A funding round to bring forward a novel take on allogeneic cell therapy for cancer, based on a rare lymphocyte population, invariant natural killer T (iNKT) cells, which exhibit aspects of both NK cell and T-cell biology.
Despite the demonstrated benefits of using patient-reported outcomes (PROs) in clinical trials assessing new cancer drugs in adults, PROs are rarely used in pediatric cancer trials. Hoping to change that, the FDA is convening the pediatric subcommittee of its Oncologic Drugs Advisory Committee (ODAC) May 11 to discuss how to effectively use a pediatric form of the PRO version of the common terminology criteria for adverse events.
Beigene Ltd.’s PARP inhibitor, pamiparib, won conditional approval from China’s National Medical Products Administration for treating patients with germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
Sporos Bioventures LLC closed a $38.1 million series A financing to develop a pipeline of therapies for treating cancer and immune diseases through four companies with a business structure that its chief financial officer, Michael Wyzga, described as a hub-and-spoke model that leans on diversification.
PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis.
Eikon Therapeutics Inc., a startup leveraging advanced optics and machine learning to track protein dynamics for drug discovery, has closed a $148 million series A financing. Led by a high-profile CEO, former Merck & Co. Inc. R&D chief Roger Perlmutter, and with the counsel of two Nobel prize winners, its team is working to "expand the druggable proteome by targeting protein dynamics directly."
HONG KONG – Lutris Pharma Ltd., a company taking on the dermal toxicity common to cancer therapy with EGFR inhibitors, has begun testing its lead product, the B-Raf inhibitor LUT-014, in a phase II trial targeting reduction of acne-like lesions associated with the class. Partial results are expected by the end of 2021.
Shares of Biolinerx Ltd. (NASDAQ:BLRX) shot up 53% to $4.88 May 4 on news that adding its lead candidate, motixafortide, to standard of care G-CSF for hematopoietic stem cell mobilization helped achieve significantly better mobilization than G-CSF alone in a phase III trial. The company said it's working "aggressively" to gain regulatory approval to market the drug for use in autologous bone marrow transplants for multiple myeloma (MM) patients, with plans to make an NDA submission in the first half of 2022.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
LONDON – In what is claimed as the largest series A for a Danish biotech, Adcendo ApS has raised €51 million (US$61.3 million) to take forward antibody-drug conjugate (ADC) drugs aimed at proprietary targets that are involved in cellular recycling processes.
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