New Haven’s Cybrexa Therapeutics will begin human testing in April on its new drug to treat solid tumors after getting the green light from the FDA.
The Phase 1 clinical trial for CBX-12 would be the first for the Science Park-based biotechnology company founded in 2017 by Yale physician-scientists and three successful Connecticut serial entrepreneurs.
The company raised $25 million in a Series B2 round earlier this month to fund the upcoming trial.
“The go-ahead from the FDA on our IND (investigational new drug) application for CBX-12 is a major step in the clinical development of what we believe could be a game-changing therapeutic for many cancer patients,” CEO Per Hellsund said in a statement.
The drug aims to fight solid tumors with fewer troublesome side effects by depositing powerful cancer-fighting agents directly into tumor cells, leaving healthy tissue unharmed.
It features a molecule that forms a corkscrew-like structure when meeting the acidic environment of a cancer cell. The structure then drills into the tumor cell to deliver the drug with precision.
The drug is also designed to target a broader scope of solid tumors, whether or not they express a substance that induces an immune response, thereby reaching more patients than existing immunotherapy treatments on the market, according to the company.
Hellsund said preclinical studies show a strong efficacy and safety profile, and the Phase 1 study will help the company learn more about potential therapeutic applications.
Hellsund joined well-known Connecticut entrepreneurs Kevin Rakin and Kevin Didden to found the company, along with Yale physician-scientists Dr. Ranjit Bindra and Dr. Peter Glazer.
The company’s technology was developed at Yale and the University of Rhode Island.
Contact Natalie Missakian at news@newhavenbiz.com
