Novel HSF1 Pathway Inhibitor to Be Studied in Ovarian Carcinoma

Nuvectis Pharma announced that it has initiated a phase 1b study to assess a novel HSF1 pathway inhibitor for the treatment of patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.

According to a press release from Nuvectis Pharma, the manufacturer of the therapy, NXP800 is an oral, small molecule inhibitor of the HSF1 pathway inhibitor that has demonstrated strong antitumor activity in xenograft models (transplanting a tissue, organ or cells to an individual of another species) of several disease models including ARID1a-mutated ovarian carcinoma.

“We are excited to announce the initiation of the phase 1b study in which NXP800 will be tested for the first time in patients with a target disease,” Ron Bentsur, chairman and chief executive officer of Nuvectis, said in the release.

The design for this phase 1b study is based on findings from the phase 1a study, which included patients with various types of non-target, advanced solid tumors. Researchers aim to enroll patients with platinum-resistant, ARID1a-mutated ovarian cancer to assess the safety, tolerability and efficacy of NXP800.

Two dosing regimens — 50 milligrams and 75 milligrams — will be assigned to two groups of 25 patients each, according to the release. Each dosing regimen will be administered to patients once per day.

“The robust preclinical antitumor activity of NXP800, coupled with the data from the phase 1a dose-escalation study, led to the design of the phase 1b study, including the definition of the patient population and selection of doses and dosing schedules. Based on the totality of the data generated to date, we believe that NXP800 has the potential to become an effective

This phase 1b study will be conducted in 25 to 30 sites in the United States, the United Kingdom and Europe.

NXP800 for the treatment of patients with platinum-resistant, ARID1a-mutated ovarian cancer has been granted Fast Track Designation by the Food and Drug Administration (FDA). According to the FDA’s website, the Fast Track Designation is granted to therapies to facilitate its development and expedite the review of drugs to treat serious conditions and fill an unmet need.

ARID1a-mutated ovarian carcinoma mainly consists of ovarian clear-cell carcinoma and ovarian endometrioid carcinoma, according to the release. Each of these histologies (or microscopic anatomy) represents an estimated 10% of all patients with ovarian cancer in the U.S., and each type is diagnosed in approximately 2,200 patients per year.

Platinum-resistant ovarian carcinoma is considered a condition of unmet medical need since there is a lack of effective treatments for this patient population, of whom typically have a poor prognosis, according to the release. An estimated 66% of patients with ovarian clear-cell carcinoma and 40% of patients with ovarian endometroid carcinoma have the ARID1a mutation, which may indicate that NXP800 can provide patients with an effective treatment option.

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