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Phio Pharmaceuticals (NASDAQ: PHIO) announced that its Safety Monitoring Committee (SMC) has reviewed safety data from the first dose cohort of the Phase 1b clinical trial of its lead compound, PH-762. This trial evaluates the safety and tolerability of intratumoral PH-762 in cutaneous squamous cell carcinoma (stages 1, 2, 4), melanoma (stage 4), and Merkel cell carcinoma (stage 4). Encouragingly, no dose-limiting toxicities or significant treatment-emergent adverse events were reported. The SMC has recommended escalating to the next dose concentration and enrolling the next cohort.
The Phase 1b study (NCT 06014086) utilizes Phio’s INTASYL™ siRNA gene silencing technology aimed at enhancing the efficacy of immune cells in tumor destruction. Chief Medical Officer Mary Spellman MD emphasized the importance of safety and efficacy data in guiding the continued development of PH-762 and expressed optimism about further enrollment in the study.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage biotech firm, announced a major update at the ASCO annual meeting on May 23, 2024. They reported on the completion of the first dose cohort in a Phase 1b study of their lead candidate, PH-762. This open-label trial evaluates the safety and tolerability of PH-762 for neoadjuvant use in treating cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma. Stages 1 and 2 cSCC, which make up 77% of new cSCC cases annually, have no approved drug treatments. Mary Spellman, MD, the acting Chief Medical Officer, expressed optimism about PH-762's potential to benefit patients while reducing the need for surgery.
The presentation, titled 'INTASYL™ PH-762: PD-1 Intratumoral Immunotherapy for Cutaneous Carcinoma,' will be delivered by Mary Spellman, MD, on June 1, 2024, from 1:30 to 4:30 PM CDT.
Phio Pharmaceuticals (Nasdaq: PHIO) announced a purchase agreement with TRITON Funds on May 17, 2024. TRITON Funds will acquire up to 18.8% of Phio's common shares, potentially generating up to $621,000 in gross proceeds for the company. This investment underlines TRITON's confidence in Phio's proprietary INTASYL™ siRNA gene silencing technology, which aims to enhance the effectiveness of immune cells in targeting tumor cells. The funds were offered under a shelf registration statement filed with the SEC in May 2021, ensuring regulatory compliance. Phio's President and CEO, Robert Bitterman, expressed satisfaction with the investment, viewing it as further validation of their innovative approach to treating solid tumors.
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.
Phio Pharmaceuticals has completed dosing the first patient cohort in its Phase 1b trial for PH-762, a lead product designed to enhance immune cell tumor-fighting capabilities using INTASYL™ siRNA gene silencing technology. The trial, conducted across multiple centers, aims to assess the safety, tolerability, and tumor response of intratumoral PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. Screening for the next dose cohort is ongoing. The study’s results will help determine the recommended dose for further research.
Phio Pharmaceuticals reported its Q1 2024 financial results and provided updates on its lead product candidate PH-762. The company is conducting a Phase 1b clinical trial across four sites in the US, with promising preliminary results. Phio also presented new data on the immunotherapeutic activity of its INTASYL compound and received a patent for two compounds treating age-related skin disorders. Despite a decrease in cash position, the company managed to reduce research and development expenses, resulting in a lower net loss compared to the previous year.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announces the upcoming presentation of new data on its lead clinical product candidate, PH-762, at the Annual Meeting of the Society of Clinical Oncology (ASCO). PH-762, an INTASYL compound, is being studied in a US clinical trial for specific skin cancers. The open-label Phase 1b clinical study aims to assess safety and efficacy in cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The data will be presented by Dr. Mary Spellman at ASCO in Chicago, Illinois on June 1, 2024.
