Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial for PH-762 to Treat Melanoma

Rhea-AI Summary

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) received regulatory clearance from the French National Agency for the Safety of Medicines and Health Products to initiate a clinical trial for its lead product candidate, PH-762, targeting melanoma. This Phase 1b trial will assess the safety, tolerability, and anti-tumor activity of PH-762, which works by reducing PD-1 expression to enhance cancer cell recognition and destruction by immune cells. The company aims to start dosing patients in Q1 2022, marking a significant milestone in the development of its INTASYL immuno-oncology platform.

Positive

• Regulatory clearance obtained for PH-762 clinical trial.
• First-in-human trial to assess safety and anti-tumor activity.
• Potential to address unmet need in advanced melanoma treatment.

Negative

• None.

 

 

MARLBOROUGH, Mass., Jan. 11, 2022 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today announced that it has received regulatory clearance to start a clinical trial with its lead product candidate, PH-762. The Company was granted the clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM - L'Agence nationale de sécurité du médicament et des produits de santé) to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute. The Company expects to dose the first patient in the first quarter of 2022.

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"Receiving this clinical trial authorization is an important milestone for Phio as it is the first clinical study of a new generation of immuno-oncology therapeutics based on our INTASYL self-delivering RNAi platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This milestone is the first of several planned for this year, as we continue to accelerate our development of our clinical and preclinical product candidates."

PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing other cells, including cancer cells. Therefore, reducing PD-1 expression can reduce the ability of cancer cells to evade T cell detection and killing. In preclinical studies, PH-762 has demonstrated robust and durable efficacy in various in vivo tumor models, and importantly has shown that it can elicit an abscopal effect or systemic immune response after local administration.

The Company's first clinical trial with PH-762 will be a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. There are currently no neoadjuvant treatment options approved for these patients. The study features a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose.   

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (INTASYL™) therapeutic platform. The Company's efforts are focused on silencing tumor-induced suppression of the immune system through its proprietary INTASYL platform with utility in immune cells and the tumor micro-environment. Our goal is to develop powerful INTASYL therapeutic compounds that can weaponize immune effector cells to overcome tumor immune escape, thereby providing patients a powerful new treatment option that goes beyond current treatment modalities. 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. Forward-looking statements are neither historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they 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 the ongoing coronavirus pandemic, the development of our product candidates, 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, results from our preclinical and clinical activities, 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.
ir@phiopharma.com 

Investor Contact
Ashley R. Robinson 
LifeSci Advisors
arr@lifesciadvisors.com

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SOURCE Phio Pharmaceuticals Corp.

FAQ

What is PH-762 and how does it work?

PH-762 is an immuno-oncology therapeutic aimed at melanoma, functioning by reducing PD-1 expression to enhance immune cell recognition and elimination of cancer cells.

What type of clinical trial is PH-762 undergoing?

PH-762 is entering a Phase 1b clinical trial to evaluate its safety, tolerability, and anti-tumor activity in advanced melanoma patients.

When will the first patient be dosed in the PH-762 trial?

Phio Pharmaceuticals expects to dose the first patient in the PH-762 trial in the first quarter of 2022.

What regulatory body approved the PH-762 clinical trial?

The clinical trial for PH-762 received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM).

What is the significance of the PH-762 clinical trial authorization?

This authorization represents a critical milestone for Phio Pharmaceuticals, marking the advancement of its innovative immuno-oncology therapeutic approach.