The Pathology Department at Massachusetts General Hospital and Lunaphore, a Swiss life sciences company, entered a collaboration to develop an in vitro diagnostic that evaluates sensitivity of solid tumors to poly-ADP ribose polymerase inhibitors, with an initial focus on ovarian, breast, and prostate cancers.
FDA granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia.
Foundation Medicine Inc. and Eli Lilly and Company entered a collaboration for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for Retevmo (selpercatinib) and other therapies in Loxo Oncology at Lilly’s pipeline.
FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.
Veru Inc. and Eli Lilly and Company entered into a clinical trial collaboration and supply agreement to evaluate the efficacy and safety of enobosarm, Veru’s first-in-class, selective androgen receptor targeting agonist, in combination with Lilly’s Verzenio (abemaciclib), a CDK4/6 inhibitor, as a second line therapy in the treatment of AR+ER+HER2- metastatic breast cancer.
FDA granted Fast Track designation to the phase III registration program for enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, Faslodex (fulvestrant), and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).
Moderna Inc. and Carisma Therapeutics Inc. entered into a strategic collaboration agreement to discover, develop, and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.
Cullinan Oncology Inc. and Icahn School of Medicine at Mount Sinai entered into a collaboration agreement to develop novel small molecule immune modulators.
FDA has cleared the Investigational New Drug application for P-MUC1C-ALLO1, an allogeneic CAR T-cell product candidate targeting multiple solid tumor indications. The product is sponsored by Poseida Therapeutics.
FDA has granted Breakthrough Therapy designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
