Privately held Memgen LLC and the H. Lee Moffitt Cancer Center agreed to technology licensing agreements covering intellectual property the two jointly developed. The deal includes MEM-288, Memgen’s lead candidate, which the company said exhibits significantly enhanced selectivity and activity against a range of tumor types.
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product.
Less than a year after backing Tscan Therapeutics Inc.'s $48 million series B round, Novartis AG is tapping the Waltham, Mass.-based company to discover and develop new T-cell receptor (TCR)-engineered T-cell therapies for up to three new solid tumor targets. The collaboration includes an up-front technology access fee and research funding totaling $30 million, as well as potential clinical, regulatory and sales-based milestone payments that could total hundreds of millions of dollars, Tscan said.
The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers.
Arriving at MEI Pharma Inc.’s deal with Kyowa Kirin Co. Ltd., focused on phase II-stage ME-401 for B-cell malignancies, was a competitive process that brought large and midsized pharma bidders to the table, MEI Chief Operating Officer David Urso said, but the terms proposed by suitors tended to “look a lot the same.”
Following a priority review, partners Astrazeneca plc and Merck & Co. Inc. have gained a green light from the FDA for U.S. marketing of the oral MEK1/2 inhibitor Koselugo (selumetinib), the first FDA-approved treatment for the rare genetic disorder neurofibromatosis type 1 (NF1).
Princeton, N.J.-based Urogen Pharma Ltd. is transforming itself into a commercial operation in anticipation of an FDA approval for UGN-101 this week. Wall Street also apparently expects a positive decision by the April 18 PDUFA date, as listed in BioWorld’s Drugs on Deck record. Urogen’s stock (NASDAQ:URGN) has climbed 40% since the month began, and 11.31%, or $2.41, on April 13, closing out the day at $23.71.
Boston-based Pieris Pharmaceuticals Inc., during its March 12 earnings call, talked up gastric cancer prospect PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, which has turned up single-agent and checkpoint-combination antitumor activity.
A little more than eight months after Pfizer Inc.'s $11.2 billion acquisition of Array Biopharma Inc., a combination of Array-developed Braftovi (encorafenib) and cetuximab has won FDA approval for the second-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC), becoming the first approved therapy specifically targeting that mutation.
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