Mersana Therapeutics Inc. followed grim June news with an even worse headline as the phase Ib/II study called Uplift with upifitamab rilsodotin (upri) did not meet its primary endpoint in platinum-resistant ovarian cancer (prOC). The antibody-drug conjugate (ADC) targets the sodium-dependent phosphate transport protein NaPi2b and was developed via the company’s platform called Dolaflexin. Shares of Mersana (NASDAQ:MRSN) tumbled 73%, or $2.84, to close July 27 at $1.07 on word of the failure of the trial.
The proportion of clinical data focused on COVID-19 therapeutics and vaccines has dropped from 21.3% in 2020 at the height of the pandemic to only 7.7% for 2022.
Clinical data through the last week of October 2022 has dropped 17% in comparison with 2021. So far in 2022, there have been a total of 2,812 phase I, II and III clinical entries, compared with 3,389 during the first 10 months of 2021.
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said. Company shares (TSX:APLI) plummeted Nov. 11, falling 53.6% to CA26 cents (US21 cents). Originally approved for the treatment of pandemic flu, favipiravir has since gained marketing authorizations for the treatment of COVID-19 in several markets.
China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards.
Zentera Therapeutics Inc. completed a $75 million series B financing round to help further its candidates in China, as it paves the way for a listing in Hong Kong next year.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
Fresh from showcasing preliminary evidence for the tolerability and potential benefits of LVGN-6051 at ASCO’s annual meeting in June, Lyvgen Biopharma Holdings Co. Ltd. is gearing up to move its CD40 agonist LVGN-7409 to clinical trials in China after initial U.S. patient dosing.