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

Agreement with cGMP manufacturer ensures clinical supply for future trials of Phio's lead compound targeting cutaneous carcinomas.

Apr. 1, 2026 at 11:41pm

Phio Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced a cGMP drug product manufacturing services agreement with a U.S. manufacturer to produce its lead compound PH-762 for future clinical trials. PH-762 is being evaluated as an intratumoral therapy for cutaneous carcinomas, with promising results reported from a Phase 1b trial.

Why it matters

Securing a reliable U.S.-based manufacturing partner is a critical step for Phio as it advances its PH-762 program through clinical development. Having a domestic source for clinical supply mitigates potential supply chain risks and aligns with Phio's strategy of leveraging its proprietary INTASYL gene silencing technology to develop innovative cancer treatments.

The details

Under the new agreement, the U.S. manufacturer will produce Phio's lead compound PH-762 for both clinical trial and commercial supply. PH-762 is being evaluated in a Phase 1b trial for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma, with Phio reporting a pathological response rate across all dosing cohorts of approximately 65%, including an 85% pathological response in the highest-dose cohort.

  • Phio has indicated that FDA engagement regarding next-stage clinical development for PH-762 is targeted for the second quarter of 2026.
  • Phio has reported cash and cash equivalents projected to 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 cancer.

Robert Bitterman

President and CEO of Phio Pharmaceuticals.

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.

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What they’re saying

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

— Robert Bitterman, President and CEO of Phio Pharmaceuticals

What’s next

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

The takeaway

Phio's partnership with a U.S.-based cGMP manufacturer to produce its lead compound PH-762 is a crucial step in advancing its innovative cancer treatment through clinical trials. This agreement helps mitigate supply chain risks and aligns with Phio's strategy of leveraging its proprietary gene silencing technology to develop new therapies.