Phio Pharmaceuticals Secures U.S. Manufacturing Partner for Drug Candidate PH-762

Agreement Marks Key Milestone in Advancing Phio's Skin Cancer Treatment to Next Stage of Clinical Development

Apr. 1, 2026 at 10:23pm

Phio Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced a new cGMP drug product manufacturing services agreement with a U.S.-based organization. This partnership will enable Phio to manufacture its lead compound PH-762 for future clinical trials and potential commercial supply as the company works to develop a new treatment for various forms of skin cancer.

Why it matters

Securing a reliable U.S. manufacturing partner is a critical step for Phio as it prepares to advance its PH-762 program into the next stage of clinical development. Having domestic production capabilities will provide strategic advantages and help ensure a smooth transition as Phio seeks regulatory approval and, if successful, commercialization of its novel skin cancer therapy.

The details

Under the new agreement, the U.S. manufacturer will produce Phio's PH-762 compound, an INTASYL-based therapy being evaluated as an intratumoral treatment for cutaneous carcinomas. In Phio's recently completed Phase 1b trial, PH-762 demonstrated a pathological response rate of approximately 65% across five dose-escalation cohorts, with the highest dose cohort seeing an 85% response rate. The company plans to engage with the FDA in the second quarter of 2026 regarding the next stage of clinical development for PH-762.

  • Phio's Phase 1b trial of PH-762 enrolled 22 patients across five dose-escalation cohorts.
  • Phio has reported no dose-limiting toxicities or serious adverse events in the Phase 1b trial.
  • Phio is targeting FDA engagement regarding next-stage clinical development of PH-762 for the second quarter of 2026.
  • Phio has projected its current cash and cash equivalents will sustain operations into the first half of 2027.

The players

Phio Pharmaceuticals Corp.

A clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to treat various forms of cancer.

PH-762

Phio's lead clinical candidate, an INTASYL compound that silences the PD-1 gene, being evaluated as an intratumoral therapy for cutaneous carcinomas.

Robert Bitterman

President and CEO of Phio Pharmaceuticals.

Got photos? Submit your photos here. ›

What they’re saying

“It is a pleasure to partner with an organization known for its quality and expertise in drug product manufacturing services. Further, we value the strategic advantages of working with a U.S. based organization.”

— Robert Bitterman, President and CEO of Phio

What’s next

Phio has indicated that FDA engagement regarding next-stage clinical development of PH-762 is targeted for the second quarter of 2026.

The takeaway

Phio's new manufacturing partnership marks a significant milestone in the advancement of its PH-762 program, providing the company with a reliable U.S.-based source for clinical and potential commercial supply as it prepares to take this novel skin cancer therapy to the next stage of development and regulatory review.