Syros Pharmaceuticals Inc.’s phase III failure with oral retinoic acid receptor alpha agonist tamibarotene in myelodysplastic syndrome (MDS) meant not only severe stock damage but also defaulting on the loan facility with Oxford Finance LLC, which means an obligation may be accelerated for the company of about $43.6 million, including principal, interest, and other amounts, according to an SEC filing.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Six main cell types form glioblastomas, the most aggressive brain cancer due to its high rate of recurrence. Of these six, quiescent cancer stem cells are responsible for resistance to therapy and the reappearance of the tumor, according to a study that identified the six groups and highlighted the importance of these stem cells for the design of more effective therapies.
Alentis Therapeutics SA is poised to expand its reach in Claudin-1 biology, after closing a $181.4 million series D that will fund phase I/II trials of two antibody-drug conjugates (ADCs) targeting the transmembrane protein, which is overexpressed on a number of squamous cell tumors.
The competitive menin-inhibitor space chalked further data from Syndax Pharmaceuticals Inc., which disclosed positive top-line results from the pivotal phase II portion of the Augment-101 study, designed to test oral small-molecule revumenib for safety and efficacy. But shares of the firm (NASDAQ:SNDX) closed Nov. 12 at $16.21, down $5.57, or 26%, after the Augment-101 numbers were disclosed.
Flare Therapeutics Inc. will receive $70 million in cash up front from Roche Holding AG, and the deal could ultimately bring the company about $1.8 billion plus royalties. Flare will search for small molecules that can be used to treat undruggable transcription factors to treat cancer. Also, Novartis AG will pay computational-chemistry expert Schrödinger Inc. $150 million up front and as much as $2.3 billion in milestones to develop several candidates along with up to $892 million in R&D and milestone payments.
Cancer therapies can eliminate specific tumors based on their genetic content. However, some cancer cells survive. How do they do it? Part of the answer lies in extrachromosomal DNA (ecDNA), an ace up the tumors’ sleeve to adapt and evade attack. Three simultaneous studies in the journal Nature lay all the cards on the table, revealing ecDNAs’ content, their origin, their inheritance, their influence in cancer, and a way to combat them.
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales.