Minneapolis-based Celcuity Inc. sealed a deal for the rights to Pfizer Inc.’s pan-PI3K/mTOR inhibitor, gedatolisib, for ER-positive/HER2-negative advanced or metastatic breast cancer. Preliminary data from 103 patients in the expansion portion of a phase Ib trial showed the drug was well-tolerated, and researchers noted antitumor activity. Celcuity paid Pfizer, of New York, $5 million cash and $5 million in stock up front. As much as $330 million in development and sales-based milestone rewards, plus tiered royalties on sales, could follow. Shares (NASDAQ:CELC) were trading midday at $21.54, up $7.23, or 50%.

Greenwich shares climb as immunotherapy keeps breast cancer recurrences at bay

After climbing nearly 37% since the start of the week, shares of Greenwich Lifesciences Inc. (NASDAQ:GLSI) gained another 4.7% by midday as the company reported that treatment with HER2/neu peptide GP-2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reduced recurrence rates to 0% over a five-year follow-up period. A poster presentation of the phase IIb trial outcome will be made Saturday as part of the American Association for Cancer Research annual meeting. Meanwhile, the company is planning to start a phase III trial of the immunotherapy candidate this year.

FDA finds deficiencies in Provention’s BLA for diabetes

The FDA told Provention Bio Inc. that its BLA for teplizumab needs some work, but the May 27 advisory committee meeting to discuss the application in full is still on the calendar. According to Provention, the company received a notification on April 2 stating that deficiencies precluded a discussion of labeling and postmarketing work. Provention added that the notice will likely delay the timeline that teplizumab could be approved for slowing or preventing clinical type 1 diabetes. The FDA also said the notification does not reflect a final decision on the information it is reviewing. Meanwhile, the Red Bank, N.J.-based company’s stock (NASDAQ:PRVB) dropped 18% in midday trading.

Hutchmed closes $100M private placement, expects third China approval and first FDA NDA this year

The newly renamed Hutchmed (China) Ltd., previously known as Hutchison China Meditech Ltd. (Chi-Med), plans to sell $100 million of its American depository shares (ADSs) at $30.50 per ADS in a private placement to funds affiliated with Baring Private Equity Asia. In what looks like a busy year ahead, the company expects to obtain a China approval for its c-MET inhibitor savolitinib in mid-2021 and complete its first NDA for surufatinib in the U.S.

Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III

CAJICA, Colombia – Following the start of phase III trials for its COVID-19 vaccine, Soberana 02, Cuban researchers have started phase III trials for Abdala (CIGB-66), another vaccine candidate developed in the island country. Abdala is being developed by Cuba’s Center for Genetic Engineering and Biotechnology (CIGB). The Cuban government said 48,000 doses of the first of three shots of the jab were administered to members of CIGB and health care workers in the country, reaching the whole target of participants proposed for the trial. Abdala is designed to be administered three times, every 14 days. Three different COVID-19 vaccines have been developed in Cuba, and two have made it to phase III trials in the country, although no papers have been published about preclinical trial results from either Soberana 02 or Abdala.  

Newco news: Nammi steps out with two cancer candidates

Having emerged from the California Nanosystems Institute two years ago, Nammi Therapeutics Inc. is prepping to unveil its first two cancer drug candidates at this weekend’s American Association for Cancer Research conference. Preclinical QXL-138AM is composed of a CD-138-targeted antibody fused with interferon alpha masked with a with a tumor-selectively releasable peptide. NTI-55 is a combination of immune modulator prodrugs that include a TLR7 agonist and an A2AR inhibitor designed to stimulate an immune response and block an immune checkpoint. Los Angeles-based Nammi, formed in 2018, said it plans to file INDs for both therapies in mid-2022.

Also in the news

Aelis, Affimed, Amyris, Aprea, Artiva, Atyr, Bioaegis, Bionomics, Bristol Myers Squibb, Captor, Celcuity, Cellectis, Cytodyn, Deargen, EV Biologics, Everest Medicines, Exscientia, Galapagos, Gilead Sciences, Greenwich Lifesciences, Humanigen, Imcheck, In8bio, Intelgenx, Iovance, Kempharm, Mersana, Mina, Nimbus, Oncoinvent, Onxeo, Organon, Palleon, Provention, Redhill, Regeneron, Reneo, Repare, Rubius, Ryvu, Sana, Sanofi, Syndax, Tenax, Theralase, Theramex, Therapeuticsmd, Transgene, Turning Point, Vascular Biogenics, Vectivbio, Werewolf