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Phio Pharmaceuticals Completes Enrollment in Phase 1b Trial of PH-762 for Skin Cancers

• Phio Pharmaceuticals has completed enrollment in the second cohort of its Phase 1b dose-escalating clinical trial of PH-762. • Early data from the trial shows one patient with cutaneous squamous cell carcinoma achieved a complete response and another a partial response. • The trial, evaluating intratumorally injected PH-762, now includes six clinical sites across the United States. • PH-762 leverages Phio's INTASYL siRNA technology to silence PD-1, enhancing T cell's ability to kill cancer cells.

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) has announced the completion of enrollment for the second patient cohort in its Phase 1b dose-escalating clinical trial of PH-762. This trial aims to assess the safety, tolerability, and tumor response of PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. The company has also expanded the trial to include a sixth clinical site in San Diego, CA.

Promising Early Results

Initial data from the ongoing clinical trial indicates encouraging outcomes. Among the first two patients treated in the second dose cohort, one patient with cutaneous squamous cell carcinoma experienced a complete response, demonstrating 100% tumor clearance. The second patient, also with squamous cell carcinoma, achieved a partial response, with a reported 90% tumor clearance.

Trial Design and Locations

The Phase 1b trial (NCT06014086) is designed as a dose escalation study, evaluating the neoadjuvant use of intratumorally injected PH-762. The study's primary objectives include assessing the safety and tolerability of PH-762, evaluating tumor response, and determining the appropriate dose range for further studies. In addition to the new site in San Diego at Paradigm Clinical Research Centers, the trial is being conducted at:
  • Banner MD Anderson Cancer Center in Gilbert, Arizona
  • The George Washington University-Medical Faculty Associates in Washington, D.C.
  • The University of Pittsburgh Medical Center (UPMC)-Department of Dermatology, Pittsburgh, PA
  • Integrity Research Clinical Associates in Delray Beach, Florida
  • Centricity Research in Dublin, Ohio

Mechanism of Action

PH-762 is based on Phio's proprietary INTASYL siRNA gene silencing technology. This technology is designed to enhance the ability of immune cells to effectively target and eliminate cancer cells by silencing specific genes. PH-762 specifically targets PD-1, a protein that inhibits the activity of T cells, thereby boosting the immune system's ability to fight cancer.

Management Commentary

"We are pleased with enrollment completion of the second dose cohort and the encouraging patient outcomes in the first two patients in this cohort," said Robert Bitterman, CEO of Phio Pharmaceuticals.
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Related Clinical Trials

Intratumoral PH-762 for Cutaneous Carcinoma

NCT06014086RecruitingPhase 1
Phio Pharmaceuticals Inc.
Posted 11/7/2023

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Reference News

[1]
Phio Pharmaceuticals Announces Completion of Enrollment in Second Cohort in Phase 1b ...
biospace.com · Nov 19, 2024

Phio Pharmaceuticals Corp. completed enrollment of its second patient cohort in the PH-762 Phase 1b trial, adding a sixt...

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