The multicenter Phase 1b study of Nuvectis Pharma Inc.'s (NVCT:NASDAQ) lead drug candidate NXP800 in platinum-resistant ARID1a-mutated ovarian carcinomas recently launched, and 18 patients have already been dosed, reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in an April 10 research note.
"While detailed results from the Phase 1a portion of the study are anticipated at a future scientific conference, we are excited to learn that NXP800's clinical assessment is progressing as planned," Pantginis wrote.
Good Potential Gain
The analyst reiterated H.C. Wainwright's Buy rating and US$21 per share target price on Nuvectis, which is currently trading at about US$13 per share. This price difference implies a notable 61.5% potential return on investment.
Pantginis wrote that "significant upside potential exists" for the biopharma's two assets, NXP800 and NXP900, based on "rapid advancement through clinical development, expansion to ex-U.S. markets, and pipeline development and expansion to other indications with currently no value contribution to our projections."
About the Study
Pantginis described the newly begun Phase 2b trial, highlighting that Phase 1a data informed the patient selection and dosing schedule for the Phase 2b. Study participants are patients with non-targeted advance solid tumors who, in Phase 1, received 50–150 milligrams (50–150 mg) of NXP800 once daily or 100–150 mg of NXP800 twice daily.
In this open-label Phase 2b trial, safety, tolerability, and preliminary efficacy will be assessed.
The study is taking place at multiple sites in the U.S., United Kingdom, and the European Union and is being carried out in collaboration with the GOG (Gynecologic Oncology Group) Foundation in Pennsylvania and the European Network of Gynaecological Oncological Trial groups.
In the trial, patients are divided into two dosing cohorts of NXP800 50 mg and NXP800 75 mg, both once daily. Each group consists of about 25 patients with ARID1a-mutant ovarian clear-cell carcinoma and patients with endometrioid ovarian carcinoma.
Pantginis relayed that so far, the most commonly reported treatment-emergent adverse events were vomiting, nausea, diarrhea, fatigue, decreased appetite, and weight loss. There were no higher-grade drug-related events reported. Lab tests showed some transient changes in platelets, liver enzymes, and red blood cells, which proved to be inconsequential clinically.
Another Target for Drug
Recent data from a preclinical study showed promise for NXP800 in ARID1A-mutated gastric carcinoma, wrote Pantginis. In that study, mice were transplanted with a human ARID1A mutant stomach cancer line and administered NXP800 35 mg for 28 days. The treated mice showed 72% tumor growth inhibition compared to the control group.
Pantginis pointed out that the prognosis for people with gastric cancer is "very poor," as the five-year survival rate is only 32%. Each year in the U.S., 26,000 new patients are diagnosed with the disease, and of those, 20–25% have ARID1A mutations.
"These observations," added Pantginis, "point to the potential of NXP800 to expand its target indications besides the original ovarian clear cell carcinoma and ovarian epithelial carcinoma."
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Disclosures For H.C. Wainwright & Co., Nuvectis Pharma Inc., April 10, 2023
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Joseph Pantginis, Ph.D., Matthew Keller, Ph.D. and Sara Nik, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Nuvectis Pharma, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of March 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Nuvectis Pharma, Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Nuvectis Pharma, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Nuvectis Pharma, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Nuvectis Pharma, Inc. during the past 12 months. The Firm does not make a market in Nuvectis Pharma, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results.
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