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Phio Pharmaceuticals Presents This Week at the Society for Investigative Dermatology (SID)

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Phio Pharmaceuticals presented data on its lead candidate, PH-762, at the Society for Investigative Dermatology (SID) meeting in Dallas, Texas. PH-762, part of their INTASYL siRNA technology, targets PD-1 to enhance immune cell efficacy against tumors. The preclinical results showed promise, highlighting tumor growth inhibition and extended efficacy in untreated tumors. Toxicokinetic studies in marmoset monkeys confirmed PH-762's safety. PH-762 is in a Phase 1b clinical trial in the US, examining its safety and efficacy in various stages of skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.

Positive
  • PH-762 shows robust inhibition of tumor growth in murine models.
  • Preclinical studies suggest PH-762 extends efficacy to untreated distal tumors.
  • Data shows PH-762 is well-tolerated in marmoset monkeys with no detectable cytokine-release associated cytokines.
  • PH-762 is currently in a Phase 1b clinical trial aimed at assessing its safety and efficacy in specific skin cancers.
Negative
  • The Phase 1b trial is still ongoing, meaning definitive results on safety and efficacy are not yet available.
  • The success in murine models and preclinical studies do not guarantee similar results in human clinical trials.

Insights

Phio Pharmaceuticals' presentation on their lead candidate, PH-762, at the Society for Investigative Dermatology (SID) offers valuable insights into the potential of their INTASYL™ siRNA gene silencing technology for treating skin cancers. PH-762 targets PD-1, a protein that typically inhibits T cells from attacking cancer cells. This new approach, using RNA interference (RNAi) technology, is promising because it directly interferes with genetic messages that promote tumor growth.

The preclinical data highlights that PH-762 was well-tolerated and effectively reduced tumor growth in animal models. This suggests a solid safety profile, which is important for advancing to further clinical trials. The fact that the dosing in marmoset monkeys also showed no adverse cytokine release is a positive indicator, as cytokine release syndrome is a common side effect of many immunotherapies.

The ongoing Phase 1b clinical study aims to evaluate the safety and efficacy in various stages of cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma. This breadth of application could position PH-762 as a versatile treatment option across multiple types of skin cancer, which is attractive to investors. However, clinical data from human trials will be the ultimate test of its potential and market viability.

In the short term, the progression of this candidate could boost Phio Pharmaceuticals' stock value as investor confidence grows. In the long term, success in later-phase trials would be necessary to solidify PH-762’s place in the market and drive sustained financial gains.

-Phio’s lead candidate, PH-762, targets PD-1, a critical target in cutaneous carcinoma

MARLBOROUGH, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced it is presenting data about its lead clinical candidate, PH-762, an INTASYL compound. The data is being presented in three posters at the annual meeting of the Society for Investigative Dermatology (SID) this week in Dallas, Texas.

“We’re pleased to present the power of the INTASYL platform and specifically, the applicability of lead compound PH-762 in treating skin carcinomas, to this community dedicated to dermatological research and patient care,” stated Linda Mahoney, Phio’s SVP of Development.

PH-762 is an INTASYL compound that silences PD-1, a protein that inhibits T cells' ability to kill cancer cells. In a murine model, mPH-762 was well tolerated at the maximum administered dose and treatment with mPH-762 provided robust inhibition of tumor growth. Additionally, intratumoral mPH-762 treatment extended abscopal efficacy to untreated distal tumors in bilateral models. Toxicokinetic studies conducted in marmoset monkeys demonstrated that PH-762, when administered intravenously is well-tolerated, with no detectable cytokine-release associated cytokines found in the plasma. The preclinical profile of PH-762 supports the ongoing clinical development of the compound for the treatment of cutaneous malignancies.

PH-762 is currently being studied in a US clinical trial to assess safety and efficacy in specific skin cancers (NCT 06014086). This open-label Phase 1b clinical study is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. Stages 1 and 2 cSCC represent 77% of all new cSCC cases annually.

Presentation Details are as follows:

1.Title:INTASYL self-delivering RNAi: A Flexible Platform to Treat Dermatological Malignancies
 Abstract Number:575
 Session Title:Pharmacology and Therapeutic Development
 Presenting Author:Melissa Maxwell
 Session Date/Time:Thursday, May 16, 4:30-6:30pm
 Location:Trinity Exhibit Hall
   


2.Title:INTASYL PH-762: Intratumoral immunotherapy targeting PD-1
 Abstract Number:576
 Session Title:Pharmacology and Therapeutic Development
 Presenting Author:Melissa Maxwell
 Session Date/Time:Friday, May 17, 4:00-6:00pm
 Location:Trinity Exhibit Hall
   


3.Title:Intratumoral PH-762 targeting PD-1 for Cutaneous Carcinoma
 Abstract Number:283
 Session Title:Clinical Research - Interventional Research
 Presenting Author:Mary Spellman
 Session Date/Time:Thursday, May 16, 4:30-6:30pm
 Location:Trinity Exhibit Hall
   

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells. 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 systems.

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. 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. Examples of forward-looking statements include statements regarding the potential of PH-762 to inhibit tumor growth and extend abscopal efficacy to untreated distal tumors. 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.
ir@phiopharma.com

PR Contact
Michael Adams
Bridge View Media
adams@bridgeviewmedia.com


FAQ

What is PH-762?

PH-762 is an INTASYL siRNA compound designed to silence PD-1, enhancing the ability of T cells to kill cancer cells.

What are the recent findings on PH-762?

Recent findings presented at the SID meeting show that PH-762 inhibited tumor growth in murine models and extended efficacy to untreated tumors.

Is PH-762 safe?

Preclinical toxicokinetic studies in marmoset monkeys show that PH-762 is well-tolerated without detectable cytokine-release associated cytokines.

What stage of clinical trials is PH-762 in?

PH-762 is in a Phase 1b clinical trial in the US, studying its safety and efficacy in treating specific skin cancers.

Which cancers is PH-762 being tested on?

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

What is the significance of PH-762's presentation at the SID meeting?

The presentation at SID highlights PH-762's potential in treating skin carcinomas, attracting attention from dermatological researchers and clinicians.

Phio Pharmaceuticals Corp.

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