Curevo Vaccine Inc. closed on a $60 million series A financing designed to take the company through releasing top-line data for its phase IIb study of CRV-101 for treating shingles in older adults. That means taking on a blockbuster, Shingrix from Glaxosmithkline plc.
Ventus Therapeutics Inc. closed a $140 million series C financing to continue scaling its platform to address previously undruggable targets. The company said it plans to advance programs targeting key modulators of the innate immune system and other therapies, including two targeting NLRP3 (NLR pyrin domain-containing 3) and one targeting cGAS, into the clinic. It plans to submit INDs for three programs in 2023.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
Congruence Therapeutics Inc. has closed on a $50 million series A financing to design small molecules to treat rare diseases with protein misfolding. Montreal-based Congruence uses structural bioinformatics, computational chemistry and machine learning in its in silico platform that detects key biophysical features on proteins. That data are used to then design drugs.
The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the agency endorse administering Moderna Inc.'s COVID-19 vaccine, Spikevax (elasomeran), to adults. The vote was a strong echo of the FDA’s full approval of the vaccine for adults only a few days earlier, on Jan. 31. After hearing safety and efficacy data from Moderna and an internal analysis of that data from the CDC, ACIP recommended by a vote of 13-0 that the CDC endorse the vaccine’s use for people 18 years and older.
HDT Bio Corp. looked at the world and saw health care inequity, so it built itself to help countries with developing economies help themselves. The company is bringing RNA technology for handling COVID-19 to underserved areas such as Brazil so they can develop, manufacture and distribute their own vaccine instead of relying on big pharma or developed-nation governments.
The FDA has placed Logicbio Therapeutics Inc.’s phase I/II clinical trial of LB-001, an investigational AAV genome-editing therapy for treating pediatric patients with methylmalonic acidemia (MMA), on a clinical hold. So far, four patients have been dosed in the study and two have had serious adverse events related to the candidate, the company’s lead asset.
Sio Gene Therapies Inc. is retrenching the business as it terminated the company’s AXO-Lenti-PD license agreement with Oxford Biomedica plc for treating Parkinson’s disease. Also, Sio’s CEO, Pavan Cheruvu, is leaving the company. Sio said it is deprioritizing its Parkinson’s disease program due to several factors, including resource requirements and development timelines “to reach meaningful value inflection for the program and an increasingly challenging market and regulatory environment” for the indication.
After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
Mighty Libtayo has stumbled. Because Regeneron Pharmaceuticals Inc. and Sanofi SA couldn’t find common ground with the FDA on postmarketing studies, the two are voluntarily withdrawing the sBLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. Discussion about the matter continues outside the U.S., the companies said.
