Phio Pharmaceuticals starts commercial-scale manufacturing of PH-762

Phio Pharmaceuticals said June 25 that Nitto Denko Avecia has begun first commercial-scale cGMP production of PH-762 drug substance. The milestone moves the company’s lead intratumoral cancer program closer to its next development phase after a completed Phase 1b study in cutaneous carcinomas.

Why it matters: - The manufacturing run marks a key step in advancing PH-762, Phio Pharmaceuticals’ lead clinical compound, toward the next stage of development. - Commercial-scale cGMP production can help support later-stage clinical work and future supply planning if the program advances. - PH-762 is designed as a potential non-surgical treatment for skin cancers, which could matter for patients facing cutaneous carcinomas.

What happened: - Phio Pharmaceuticals said on June 25 that Nitto Denko Avecia began manufacturing the first commercial-scale cGMP batch of PH-762 drug substance. - The work is taking place under a comprehensive drug substance services agreement signed in June 2025. - Phio Pharmaceuticals is based in King of Prussia, Pennsylvania. - Nitto Denko Avecia has already completed preliminary analytical and process development, method validation, cGMP manufacturing, and testing services for PH-762.

The details: - PH-762 is Phio’s lead clinical development compound. - The company completed its Phase 1b dose-escalation study of PH-762 in cutaneous carcinomas. - Phio’s platform is INTASYL®, a proprietary gene silencing technology the company uses in immuno-oncology research. - PH-762 silences the PD-1 gene, which Phio says is implicated in multiple forms of skin cancer. - The recently completed Phase 1b trial, NCT# 06014086, evaluated PH-762 as a neoadjuvant treatment for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. - Phio said the commercial-scale production underscores progress toward the next stage of development for PH-762. - Robert Bitterman, Phio’s president and CEO, said the batch production reflects meaningful progress toward the next stage of development of the lead compound.

Between the lines: - The manufacturing update signals that Phio is moving from clinical testing into the operational work needed to support the program’s next phase. - Completion of early manufacturing and testing steps can reduce one source of uncertainty before additional regulatory or clinical milestones. - Phio’s release also frames PH-762 as part of a broader strategy to develop immuno-oncology treatments that may avoid surgery for some skin cancers.

What's next: - Phio said it expects the commercial-scale batch to help advance the intratumoral program into its next phase of development. - The company also pointed to planned FDA submissions intended to seek guidance on next steps in PH-762 clinical study design. - Phio said those FDA interactions are expected to clarify the development path, though timing was not provided. - Phio said its cash runway is expected to extend into the first half of 2027. - More information is available on the company’s website.

The bottom line: - Phio has moved PH-762 past an important manufacturing checkpoint, and the next major test is whether the program can translate that progress into a clearer clinical and regulatory path.