Veramorph LLC (VeraMorph), a science-driven startup developing a novel degradable gel as a solubility-enhancing oral drug delivery technology, has been awarded a Small Business Innovation Research (SBIR) Fast Track Grant from the National Cancer Institute (NCI) of the National Institutes of Health (grant number R44CA306533). The SBIR program is a highly competitive, awards-based program designed to stimulate technological innovations developed by U.S. small businesses on a path to commercialization. This Fast Track award will accelerate the clinical translation of an oral formulation of fulvestrant for estrogen receptor positive (ER+) metastatic breast cancer (mBC), which is the company’s first oral drug product using its oral drug delivery platform. VeraMorph’s oral fulvestrant product has been well tolerated and demonstrated 55% improved tumor growth inhibition relative to the currently approved monthly intramuscular injection in preclinical studies. This grant will financially support replication of the safety and efficacy outcomes as well as IND-enabling studies of orally dosed fulvestrant, and by association VeraMorph’s drug delivery technology. This SBIR award brings the company’s total funding to roughly $5M.

According to 2023 statistics from the American Cancer Society (ACS), only 27% of mBC patients survive within 5 years of diagnosis. The potential clinical benefit of orally administered fulvestrant is to prolong survival and improve quality of life for ER+ mBC patients. VeraMorph’s degradable gel technology will enable this outcome by maximizing the drug’s oral bioavailability, which has translated to 20 times higher maximum plasma concentrations in preclinical studies relative to the current injectable product without generating severe adverse events. While fulvestrant, known as a selective estrogen receptor degrader (SERD), is currently used as the standard of care for ER+ mBC patients after progression on another endocrine therapy (i.e., for 2^nd line therapy), its poor solubility has precluded its oral delivery, until now. The current injection limits systemic exposure, hindering efficacy, and has severe adverse events, including injection site pain and nerve damage.

The initial beneficiaries of oral fulvestrant’s improved exposure, and potential clinical superiority, are the roughly 70% of ER+ mBC patients that retain a “wild-type” ESR1 gene. While oral alternatives to fulvestrant have been evaluated in Phase 2/3 clinical trials (e.g., EMERALD, EMBER-3, SERENA-2, ELEVATE, EMBER-3, SERENA-4, SERENA-6, pionERA, perservERA, evERA), the only patients to achieve a clinical benefit in these studies relative to injectable fulvestrant were those with ESR1 mutations. In contrast, fulvestrant efficacy is independent of ESR1 mutation status. With this context, the oral fulvestrant product could capture a substantial portion of the estimated $3B to $6B oral SERD therapy market.

“Although fulvestrant is an efficacious endocrine therapy and serves as an important component of current standard of care for metastatic breast cancer, it has significant drawbacks from an efficacy and quality of life perspective for patients. During my clinical experience, many patients have begged to stop receiving fulvestrant injections due to the intense pain. Further, the current injection is limited in its clinical benefit by the lipid-based formulation. The capacity of VeraMorph’s oral formulation to avoid injection site pain and achieve higher systemic exposure levels could provide meaningful benefits to patients, both in terms of quality of life and clinical outcomes, respectively,” according to Dr. Patrick Dillon, professor of medicine at the University of Virginia Medical Center.

More broadly, VeraMorph’s degradable gel platform has the potential to improve and accelerate R&D on therapies for any indication, potentially driving down prescription costs. Roughly 90% of novel small molecules drugs are poorly soluble, requiring oral drug delivery technologies. According to a survey of formulation scientists conducted by the American Academy of Pharmaceutical Scientists (AAPS), 80% of novel small molecule therapies suffer delays and 30% are terminated due to the ineffectiveness of current technologies. By contrast, VeraMorph’s degradable gel platform provides simple and effective solubility enhancement for a more expansive range of drug substances.

“This SBIR grant supports VeraMorph’s goal of improving patient outcomes with cost-effective therapies across indications by leveraging the power of our degradable gel platform,” said Douglas Godfrin, Founder & CTO of VeraMorph. “The SBIR program’s rigorous technical review also validates the potential clinical benefit of our oral fulvestrant therapy and the financial support brings it one step closer to improving the standard of care and quality of life for breast cancer patients.”

Disclaimer:

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About VeraMorph:

Veramorph LLC is a science-driven oral drug delivery company dedicated to improving patients' lives by developing a pipeline of clinically superior therapies with its patented oral drug delivery platform. The pipeline spans all indications, maximizing the company’s ability to improve health-related outcomes.

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