Dyve Biosciences is offering Moffitt Cancer Center a way around a long-standing drug delivery problem. After seeing patients repeatedly reject their oral cancer therapy, researchers at Moffitt have teamed up with Dyve to collaborate on the development of a transdermal formulation.
Around 10 years ago, Robert Gillies, Ph.D., and other Moffitt researchers were involved in a series of clinical trials of bicarbonate. The studies investigated the oral administration of the molecule, which is already used to treat heartburn, in the management of tumor-related pain and treatment of pancreatic cancer. However, the clinical trials never reached their target doses because of tolerability problems.
Patients disliked the taste of the therapy and suffered gastrointestinal adverse events such as diarrhea and vomiting. The researchers pondered whether using bicarbonate in a combination therapy may boost compliance but concluded monotherapy use isn’t clinically viable.
Enter Dyve. The California-based biotech is developing prospects based on a transdermal delivery system that is designed to open up a new route of delivery for molecules that cannot optimally be given orally or by injection. Dyve’s pipeline features candidates that, like the oral bicarbonate studied by Moffitt, are designed to alter pH.
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Moffitt and Dyve will study one of the pH-adjusting agents, DYV800, through a two-year collaboration. The research is intended to support the advance of DYV800 into the clinic in oncology indications.
“Our prior attempts to orally deliver our published therapy to patients failed due to poor taste and poor compliance. The prospect of transdermal delivery is truly exciting and may be a game changer,” Moffitt’s Gillies said in a statement.
While Moffitt has studied oral bicarbonate in the management of cancer-related pain, the Dyve alliance builds on preclinical work suggesting that raising the pH of the highly acidic tumor microenvironment can boost the efficacy of therapies such as checkpoint inhibitors. The theory is that an acidic pH environment blocks T-cell activation and can be altered with pH-adjusting agents to dull the negative effect on efficacy.