Optimism for the potential of a bifunctional fusion protein complex in development at HCW Biologics Inc. for the potential treatment of pancreatic cancer jolted company shares (NASDAQ:HCWB) skyward to $4.73 on Oct. 28, up 62%, though still far short of the company's $8 per share summer market debut. The company, founded and led by former Altor Bioscience Corp. CEO Hing Wong, gained FDA clearance to start a first-in-human phase Ib trial of the candidate, HCW-9218.
A phase III trial of Rafael Pharmaceuticals Inc.’s devimistat in pancreatic cancer has failed, sending shares in its publicly listed holding company through the floor. Shares in Rafael Holdings (NYSE:RFL) closed Oct. 28 down 73% to $8.09, for a loss of $22.08 after an independent data monitoring committee also recommended a separate phase III trial of devimistat in acute myeloid leukemia should be stopped due to lack of efficacy.
Diacarta Inc.’s diagnostic assay, Coloscape, could be the first to meet the Centers for Medicare and Medicaid Service (CMS)’s strict standards for Medicare coverage of a liquid biopsy for colorectal cancer screening if results seen in a Plos One study are borne out in larger trials and the test gets the nod from the FDA. That is a lot of ifs, but the study posted strong results: 100% specificity and 92.2% sensitivity for cancer and 95% specificity and 62.5% sensitivity for precancerous lesions.
To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.
Shares of Angion Biomedica Corp. tumbled more than 50% Oct. 27 on disappointing top-line data from its phase III study testing ANG-3777’s ability to improve organ function in patients receiving deceased donor kidney transplants. The company’s management, however, remained cautiously optimistic that the safety results and signals of biological activity could bode well for an exploratory phase II study testing the drug in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, which is expected to read out later this quarter.
What Cortexyme Inc.’s chief operating officer Christopher Lowe called “a giant step forward” in Alzheimer’s disease (AD) research with atuzaginstat (COR-388) was viewed differently by Wall Street, which walloped shares (NASDAQ:CRTX) by 76%, or $44.17, causing the stock to close at $13.51.
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone. “The detailed results of Orient-31 will be released in 2021, and Innovent will file for the new drug application for that indication around early 2022,” Ronnie Ede, chief financial officer and executive director at Innovent, told BioWorld.
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