Antibody-drug conjugates (ADCs) are a mature technology. The first ADC, Mylotarg, was initially approved in 2000, and there are now 14 approved agents in both leukemias and solid tumors. According to Clarivate’s Cortellis Drug Discovery & Intelligence, those drugs collectively accounted for $13.55 billion in sales in 2024 – a figure that Cortellis projects will rise to $16 billion in 2025.
Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
Samsung Bioepis Co. Ltd. announced Oct. 21 the signing of a license deal to codevelop, manufacture and commercialize two of Phrontline Biopharma Suzhou Co. Ltd.’s novel bispecific dual-payload antibody-drug conjugate (ADC) candidates.
Step Pharma is financed to move its pipeline-in-a-product strategy forward on a broad front, after raising a €38 million (US$44.2 million) series C. That will see three ongoing trials testing the company’s potentially first-in-class, orally available cytidine triphosphate synthase 1 inhibitor, dencatistat, through to phase II in T-cell and B-cell lymphoma, in an ovarian, endometrial and lung cancer study, and in essential thrombocythemia.
Despite a recent stock surge, Olema Oncology Inc. shares (NASDAQ:OLMA) slipped 17% on Oct. 20 to close at $7.77 each in the wake of updated and positive phase Ib/II results for palazestrant, the company’s metastatic breast cancer drug.
The 2025 Annual Congress of the European Society for Medical Oncology (ESMO) featured a track on tumor-agnostic therapies – the first time such a track has been included at ESMO, or at any major medical oncology meeting. “It’s a milestone,” Vivek Subbiah told the audience at a session on how to accelerate tumor-agnostic drug development.
Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer and are expected to pave the way for an NDA filing later this year.
Grail LLC has presented data showing that when added to standard screening procedures for breast, cervical, colorectal and lung cancers, its Galleri circulating tumor DNA test led to a sevenfold increase in the number of cancers detected.
The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
Antibody-drug conjugate (ADC) specialist Aimedbio Inc. announced Oct. 16 the signing of a potential $991 million deal with Boehringer Ingelheim GmbH to license out its novel preclinical ADC asset targeting solid tumors, including KRAS mutations, which is set to enter phase I study next year.
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