Phio Pharmaceuticals Announces Positive Safety Monitoring Committee (SMC) Recommendation to Continue to Third Dose Cohort in its Clinical Study of PH-762

Rhea-AI Summary

Phio Pharmaceuticals (NASDAQ: PHIO) announced positive results from the second cohort of its Phase 1b clinical trial evaluating PH-762 for treating various skin cancers. The Safety Monitoring Committee (SMC) recommended proceeding to the third dose cohort following encouraging safety data. The second cohort, comprising 4 patients with cutaneous squamous cell carcinoma, showed promising results with the first two patients achieving complete response (100% tumor clearance) and partial response (90% clearance) at Day 36. The intratumoral injections were well-tolerated with no dose-limiting toxicities or serious adverse events reported.

Positive

• Complete response (100% tumor clearance) in first patient
• Partial response (90% clearance) in second patient
• No dose-limiting toxicities or serious adverse events reported
• SMC approval to proceed to third dose cohort

Negative

• Efficacy data pending for 2 out of 4 patients in second cohort

Phio's Lead Compound PH-762 demonstrates encouraging safety profile in 2nd cohort with recommendation to escalate to next dose concentration

Marlborough, Massachusetts--(Newsfile Corp. - December 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company that develops therapeutics using its INTASYL^® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells. Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.

In this Phase 1b clinical study with PH-762, dosed intratumorally, the second cohort had enrolled 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision), the first two patients who completed treatment showed a complete response (100% tumor clearance and a partial response 90% clearance), respectively. Pathology data assessing efficacy data on the remaining 2 patients is forthcoming.

The intratumoral injections have been well tolerated. There have been no dose-limiting toxicities, or serious adverse events in participants receiving intratumoral PH-762.

"Safety and efficacy data from our clinical trial continues to be encouraging as we develop PH-762 for the treatment of cutaneous carcinomas," said Mary Spellman MD, Phio's acting Chief Medical Officer. "We look forward to continued enrollment in the clinical study."

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 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/234425

FAQ

What were the results of PH-762's Phase 1b second cohort trial for PHIO?

The second cohort showed positive results with one patient achieving complete response (100% tumor clearance) and another showing partial response (90% clearance) at Day 36, with no safety concerns reported.

How many patients were enrolled in PHIO's PH-762 second cohort trial?

4 patients diagnosed with cutaneous squamous cell carcinoma were enrolled in the second cohort of the Phase 1b trial.

What types of cancer is PHIO's PH-762 being tested for?

PH-762 is being tested for Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

What safety results were reported for PHIO's PH-762 intratumoral injections?

The intratumoral injections were well-tolerated with no dose-limiting toxicities or serious adverse events reported in participants.