Phio Pharmaceuticals Secures U.S. Manufacturing Partnership for PD-1 Silencing Cancer Therapy PH-762
Key Insights
Phio Pharmaceuticals has entered into a comprehensive drug substance development services agreement with a U.S. manufacturer for its lead compound PH-762, marking a critical advancement in its intratumoral cancer treatment program.
The company is currently enrolling patients for the fifth and expected final cohort in its Phase 1b dose escalation study evaluating PH-762 for cutaneous squamous cell carcinoma (search), Merkel cell carcinoma (search), and melanoma (search).
PH-762 utilizes Phio's proprietary INTASYL gene silencing technology to silence the PD-1 (search) gene and represents a potential non-surgical treatment option for various skin cancers.
Phio Pharmaceuticals Corp. has secured a strategic manufacturing partnership with a U.S.-based organization to advance development of its lead siRNA therapeutic PH-762, the company announced. The comprehensive drug substance development services agreement covers analytical and process development as well as cGMP manufacture of the experimental cancer treatment, representing a critical milestone in the company's intratumoral therapy program for cutaneous carcinomas.
Manufacturing Partnership Advances Clinical Development
The agreement with the unnamed U.S. manufacturer will support Phio's ongoing Phase 1b dose escalation study, which is currently enrolling patients for its fifth and expected final cohort. The trial (NCT# 06014086) is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma (search), melanoma (search), and Merkel cell carcinoma (search).
"We are delighted to be partnering with an organization known for its quality and expertise in oligonucleotide chemistry sequencing," said Mr. Bitterman, Phio's President and CEO. "Additionally, we value the strategic advantages to our management team of working with a U.S. based organization."
INTASYL Technology Targets PD-1 Pathway
PH-762 is built on Phio's proprietary INTASYL gene silencing technology, which is designed to enhance the body's immune cells to more effectively kill cancer cells. The compound specifically silences the PD-1 (search) gene, which is implicated in various forms of skin cancer (search). This approach positions PH-762 as a potential non-surgical treatment option for skin cancers.
The INTASYL platform represents Phio's core immuno-oncology approach, focusing on siRNA-based therapeutics that target key immune checkpoint pathways. By silencing PD-1 (search) expression, the therapy aims to remove inhibitory signals that prevent immune cells from effectively attacking tumor cells.
Clinical Trial Progress
The ongoing Phase 1b trial represents a significant step forward for Phio's clinical development program. The dose escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of PH-762 when administered intratumorally to patients with various cutaneous malignancies.
The company's focus on cutaneous carcinomas addresses a significant clinical need, particularly for patients who may not be candidates for surgical intervention or who have tumors in challenging anatomical locations. The intratumoral delivery approach allows for direct targeting of tumor tissue while potentially minimizing systemic exposure and associated side effects.