Full Press Release Details
Phio Pharmaceuticals
Announces New Clinical
Program to Study PH-762 for the Treatment of
Cutaneous Squamous Cell Carcinoma
Marlborough, Mass., December 21, 2022/PR Newswire/-- Phio Pharmaceuticals
Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL
compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed
to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits
T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes
an anti-tumor immune response, and inhibits tumor growth.
Phio is currently conducting a Phase 1b clinical trial of PH-762 for
the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence
a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment
of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, following successful regulatory review of the IND.
"Therapeutic interventions for cSCC are limited, and there is
increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal
cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive
Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience
in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations.
"While monoclonal antibody
therapies (mAbs) are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the
cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell
to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that
"PH-762 has the potential
to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid
tumors," noted Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor. "Phio is committed to advancing the
study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors."
INTASYL compounds are chemically modified siRNAs that are designed
to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types
and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for
specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive
Cell Therapy (ACT) applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity
and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient.
Phio believes that INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.
About Phio Pharmaceuticals
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology
company whose proprietary INTASYL RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio
believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target
specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery
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 and include statements regarding the
anticipated timing of our PH-762 IND application and subsequent Phase 1b clinical trial, the clinical focus of the anticipated Phase
1b clinical trial, and the anticipated results of such clinical trial. 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,
military conflict between Ukraine and Russia, 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.