8-K: Phio Pharmaceuticals Presents Promising Clinical Data at SITC Annual Meeting

Phio Pharmaceuticals announced the presentation of clinical data from its Phase 1b trial at the Society for Immunotherapy of Cancer (SITC) annual meeting, showcasing positive responses in patients with cutaneous carcinomas.

Summary

• Phio Pharmaceuticals is presenting clinical data from its ongoing Phase 1b clinical trial at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
• The trial is evaluating the safety and tolerability of intratumoral injections of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma, and melanoma.
• Five patients with cutaneous carcinomas have been enrolled in Cohorts 1 and 2, each receiving four intratumoral doses of PH-762.
• The patients were diagnosed with cutaneous squamous cell carcinoma (4 patients) and metastatic melanoma (1 patient).
• At Day 36, one patient in the second cohort showed a complete response (100% tumor clearance), and another showed a partial response (90% tumor clearance).
• The Phase 1b trial is ongoing, with anticipated completion of the enrollment phase in Q3 2025.

Sentiment

Score: 8

Explanation: The document presents positive clinical results with a good safety profile, suggesting a promising outlook for the company's lead program. The complete and partial responses are significant and the lack of adverse events is encouraging.

Positives

• The intratumoral injection of PH-762 has been well tolerated in all patients enrolled in the trial.
• There were no related adverse events, no serious adverse events, and no dose limiting toxicities or dose adjustments.
• One patient experienced a complete response with 100% tumor clearance.
• Another patient experienced a partial response with 90% tumor clearance.
• The safety and tolerability data supports continued assessment of intratumoral PH-762.

Risks

• The company's actual results may differ materially from forward-looking statements due to various factors.
• These factors include inflationary pressures, rising interest rates, recession fears, and the success of clinical trials.
• The company's ability to obtain future financing and the success of collaborations are also risks.
• The company's ability to manufacture and supply product candidates for clinical activities and commercial use is a risk.

Future Outlook

The company plans to continue the Phase 1b trial and assess the safety and efficacy of PH-762. The enrollment phase of the trial is expected to be completed in Q3 2025.

Management Comments

• Mary Spellman MD, Phio's acting Chief Medical Officer, stated that they are encouraged by the documented clinical and histopathological results observed to date.
• Mary Spellman MD also stated that the corresponding safety and tolerability data supports continued assessment of intratumoral PH-762 in patients with cutaneous carcinomas.

Industry Context

This announcement is relevant to the immuno-oncology field, where there is a growing focus on developing targeted therapies that enhance the body's immune response to cancer. The use of RNAi technology to silence specific genes like PD-1 is a novel approach in this space.

Comparison to Industry Standards

• The reported complete and partial responses in the Phase 1b trial are promising compared to standard treatments for cutaneous carcinomas.
• Companies like Merck with Keytruda and Bristol Myers Squibb with Opdivo have established PD-1 inhibitors as a standard of care, but Phio's approach is different as it is an intratumoral injection.
• The use of RNAi technology is a novel approach compared to traditional antibody-based therapies, and the results are encouraging.
• The safety profile of PH-762 appears favorable compared to some other immuno-oncology treatments that can have significant side effects.

Stakeholder Impact

• Shareholders may view the positive clinical results favorably.
• Patients with cutaneous carcinomas may benefit from this potential new treatment.
• Employees may be encouraged by the progress of the clinical trial.
• The company's partners may be interested in the positive results.

Next Steps

• The company will continue the Phase 1b clinical trial.
• The company will continue to assess the safety and efficacy of intratumoral PH-762.
• The enrollment phase of the trial is expected to be completed in Q3 2025.

Key Dates

Keywords

Phio Pharmaceuticals, INTASYL, siRNA, PH-762, Immunotherapy, Cancer, Clinical Trial, SITC, Cutaneous Carcinoma, Melanoma, Merkel Cell Carcinoma, PD-1, RNAi