Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study

Rhea-AI Summary

Phio Pharmaceuticals (NASDAQ: PHIO) has completed enrollment for the third safety cohort in its Phase 1b dose-escalation clinical trial of PH-762. The study (NCT 06014086) is evaluating the intratumoral administration of PH-762 as a neoadjuvant treatment for various skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.

The multi-center trial aims to assess safety, tolerability, and tumor response while determining the recommended dose for future studies. The company utilizes its proprietary INTASYL® siRNA gene silencing technology to enhance the effectiveness of immune cells in targeting cancer cells. Phio plans to begin screening for the fourth dose cohort in early April 2025.

Positive

• Successful completion of third safety cohort enrollment
• Trial progressing to fourth dose cohort
• On track with clinical development timeline

Negative

• Early-stage clinical trial with no efficacy data reported yet

Marlborough, Massachusetts--(Newsfile Corp. - March 5, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL^® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating clinical study for their lead compound PH-762. The company plans to initiate screening of the fourth dose cohort in early April.

Phio's Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study assesses the tumor response and determines the recommended dose for further study of PH-762.

"We are excited with the rapid completion of enrollment of the third safety cohort," said Robert Bitterman, CEO of Phio Pharmaceuticals. "We look forward to rapidly advancing the study to bring an innovative, alternative treatment option to patients with skin carcinomas."

About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company advancing its proprietary INTASYL siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually any gene with high degree of specificity across a wide range of cell types and tissues. INTASYL is designed to enhance the ability of immune cells to more effectively kill tumor cells. INTASYL has also demonstrated enhancement to adoptive cell therapy. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.

Phio's lead clinical program, PH-762, is an INTASYL compound that silences PD-1. PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the treatment of cutaneous SCC, melanoma and Merkel cell carcinoma in second quarter of 2023.

For additional information, visit the Company's website, www.phiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. Examples of forward-looking statements contained in this press release include, among others, the possibility that our INTASYL® siRNA gene silencing technology will make the body's immune cells more effective in killing cancer cells and statements regarding our commercial and clinical strategy, development plans and timelines and other future events.

These statements are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.

Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/243340

FAQ

What is the current status of Phio Pharmaceuticals' PH-762 Phase 1b clinical trial?

Phio has completed enrollment for the third safety cohort and plans to begin screening for the fourth dose cohort in April 2025.

Which types of cancer is PHIO's PH-762 being tested for in the Phase 1b trial?

PH-762 is being tested for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.

What is the primary objective of PHIO's Phase 1b study NCT 06014086?

The study aims to evaluate safety, tolerability, and tumor response of intratumoral PH-762 while determining the recommended dose for future studies.

How is PHIO's PH-762 administered to patients in the clinical trial?

PH-762 is administered intratumorally as a neoadjuvant treatment.