The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Cancer biotech Adlai Nortye Ltd. raised $57.5 million from its U.S. IPO on Nasdaq and $40 million from a concurrent private placement, ringing up $97.5 million in funding to develop its combo immunotherapy pipeline.
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
After considering the evidence, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-6 Oct. 4 that the data from a single external-controlled trial and well-established preclinical animal models present sufficient evidence to demonstrate that US Worldmeds LLC’s DFMO (eflornithine) improves event-free survival in pediatric patients with high-risk neuroblastoma.
Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy.
For the second time in two weeks, the extent of regulatory flexibility will be at the heart of a U.S. FDA advisory committee meeting. The Oct. 4 meeting of the Oncologic Drugs Advisory Committee (ODAC) comes exactly a week after the Cellular, Tissue and Gene Therapies Advisory Committee voted overwhelmingly that the evidence presented for Brainstorm Cell Therapeutics Inc.’s amyotrophic lateral sclerosis drug, Nurown (debamestrocel), didn’t meet the agency’s flexibility standard. If the FDA’s briefing document for the ODAC meeting is anything to go by, the outcome for US Worldmeds LLC’s eflornithine, also known as DFMO, could be more positive, even though once again the agency is asking if the evidence from a single trial, along with supportive data, is sufficient.
Indianapolis-based Eli Lilly and Co. agreed to acquire Point Biopharma Global Inc. for $12.50 per share in cash, or about $1.4 billion, in a deal that would bring the pharma company a pipeline of preclinical and clinical radioligand therapies for cancer. The purchase price is an 87% premium to Point’s closing stock price on Oct. 2, and a 68% premium to the 30-day volume-weighted average price. Shares (NASDAQ:PNT) of Point, also of Indianapolis, rose 84.9%, or $5.67, to close at $12.36 on Oct. 3.
Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia.
I-Mab Biopharma Co. Ltd. has regained full rights to its CD47 antibody program from Abbvie Inc., including lemzoparlimab, the most advanced candidate. The move, disclosed in a Sept. 22 U.S. SEC filing, eliminates the potential $1.295 billion in milestones associated with the amended collaboration deal signed in 2022.
The rapid migration of gene editing technologies from the bench to the clinic has opened up new therapeutic possibilities for patients with previously intractable genetic diseases and difficult-to-treat cancers. But mobilizing gene editing components into a target cell or organ remains a critical step for the field. Integra Therapeutics SL, an early stage Spanish firm, is now engaged in that process with a novel gene writing platform.
RSS
.webp?height=488&t=1670008838&width=650 "Acute myeloid leukemia")
