Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
The latest global regulatory news, changes and updates affecting biopharma, including: CBO model touts savings of H.R. 3; FDA to ODAC: Are data ripe for 2nd TNBC Keytruda approval?; Fifth Circuit reiterates no liability remedy for generics; Consultant faces insider trading charges.
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
PERTH, Australia – Sydney-based Immutep Ltd. announced that Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
Positive results from the triple-combination arm of Biolinerx Ltd.’s phase IIa study of motixafortide as a combination therapy in incredibly tough-to-handle stage IV pancreatic cancer point toward a next study, yet the stock took a battering.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
Olema Pharmaceuticals Inc., a company looking to improve on current endocrine therapies with an oral estrogen receptor antagonist and degrader of its own, has filed for a $170 million IPO on Nasdaq. The offering follows an $87.4 million series C round, closed in September and a $54 million series B financing closed not long before in July.
Gastric cancers were the focus of the final plenary session of the European Society for Medical Oncology’s Virtual Congress 2020. Results from the Checkmate-649, ATTRACTION-4, and Keynote-590 studies showed that advanced gastroesophageal tumors can benefit from first-line treatment with PD-1 checkpoint blockers in addition to chemotherapy, staving off progression and death by a few months.
