Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease.
Escient Pharmaceuticals Inc. has obtained FDA clearance of its IND application for EP-262, a first-in-class, potent, highly selective small-molecule antagonist of Mas-related G-protein coupled receptor member X2 (MRGPRX2) for mast cell-mediated disorders.
Mantle cell lymphoma (MCL) patients developing resistance to existing BTK inhibitors now have a new treatment option, with the U.S. FDA’s accelerated approval of Jaypirca (pirtobrutinib) from Eli Lilly and Co.’s oncology unit, Loxo@Lilly. It is indicated for use in adults with relapsed or refractory disease who have received at least two lines of systemic therapy, including a BTK inhibitor.
Centessa Pharmaceuticals plc has received clearance of its IND application from the FDA to initiate a first-in-human phase I/IIa trial of LB-101 for the treatment of solid tumors.
Sana Biotechnology Inc. has received FDA clearance of its IND application to initiate a first-in-human study of SC-291 in patients with various B-cell malignancies. Initial clinical data from the study are expected later this year. SC-291 is a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy developed using Sana's hypoimmune platform.
Exegi Pharma LLC has received FDA clearance of its IND application for EXE-346, allowing the company to initiate a clinical trial to evaluate EXE-346 in the management of excessive stool frequency in patients with an ileal pouch-anal anastomosis (IPAA, J-Pouch).
Lapix Therapeutics Inc. has announced the successful outcome of its pre-IND meeting request with the FDA to achieve alignment on the company's IND-enabling plan for LPX-TI641, being developed for neuro-autoimmune indications such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein antibody disease (MOGAD).
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
The FDA has cleared Tango Therapeutics Inc.'s IND application for TNG-462, a next-generation methylthioadenosine-cooperative (MTA) inhibitor of protein arginine methyl transferase 5 (PRMT5) for the treatment of cancers with methylthioadenosine phosphorylase (MTAP) deletion.
RSS
