Phio Pharmaceuticals Announces Agreement with U.S. Manufacturing Source for Drug Substance
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company, has secured a contract development and manufacturing agreement with a U.S.-based manufacturer for its lead compound PH-762. The manufacturer will provide analytical and process development services along with cGMP manufacturing of the drug substance.
The agreement marks a crucial step in advancing Phio's intratumoral program for treating cutaneous carcinomas. The company is currently enrolling patients for the 5th and final cohort in its Phase 1b dose escalation study targeting cutaneous squamous cell carcinoma, Merkel cell carcinoma, and melanoma.
Phio Pharmaceuticals (NASDAQ: PHIO), un'azienda biofarmaceutica in fase clinica specializzata in siRNA, ha stipulato un accordo di sviluppo e produzione con un produttore statunitense per il suo composto principale PH-762. Il produttore fornirà servizi di analisi e sviluppo del processo, oltre alla produzione cGMP della sostanza farmaceutica.
L'accordo rappresenta un passo fondamentale per il progresso del programma intratumorale di Phio per il trattamento dei carcinomi cutanei. L'azienda sta attualmente reclutando pazienti per la 5ª e ultima coorte dello studio di dose escalation di Fase 1b, rivolto a carcinoma squamoso cutaneo, carcinoma a cellule di Merkel e melanoma.
Phio Pharmaceuticals (NASDAQ: PHIO), una empresa biofarmacéutica en etapa clínica especializada en siRNA, ha asegurado un acuerdo de desarrollo y fabricación con un fabricante estadounidense para su compuesto principal PH-762. El fabricante proporcionará servicios de análisis y desarrollo de procesos, además de la fabricación cGMP de la sustancia farmacéutica.
El acuerdo representa un paso crucial para avanzar en el programa intratumoral de Phio para el tratamiento de carcinomas cutáneos. La compañía está actualmente reclutando pacientes para la 5ª y última cohorte en su estudio de escalada de dosis de Fase 1b, dirigido a carcinoma de células escamosas cutáneas, carcinoma de células de Merkel y melanoma.
Phio Pharmaceuticals (NASDAQ: PHIO)는 임상 단계의 siRNA 바이오제약 회사로, 주력 화합물인 PH-762에 대해 미국 소재 제조업체와 개발 및 제조 계약을 체결했습니다. 해당 제조업체는 분석 및 공정 개발 서비스와 함께 cGMP 기준에 따른 의약품 물질 제조를 제공할 예정입니다.
이번 계약은 피부암 치료를 위한 Phio의 종양 내 프로그램을 진전시키는 중요한 단계입니다. 회사는 현재 피부 편평세포암, 메르켈 세포암, 흑색종을 대상으로 하는 1b상 용량 증량 연구의 5번째이자 마지막 코호트 환자 모집을 진행 중입니다.
Phio Pharmaceuticals (NASDAQ: PHIO), une entreprise biopharmaceutique en phase clinique spécialisée dans les siRNA, a conclu un accord de développement et de fabrication avec un fabricant basé aux États-Unis pour son composé principal PH-762. Le fabricant fournira des services d'analyse et de développement des procédés ainsi que la fabrication cGMP de la substance pharmaceutique.
Cet accord représente une étape cruciale dans l'avancement du programme intratumoral de Phio pour le traitement des carcinomes cutanés. L'entreprise recrute actuellement des patients pour la 5e et dernière cohorte de son étude d'escalade de dose de phase 1b ciblant le carcinome épidermoïde cutané, le carcinome à cellules de Merkel et le mélanome.
Phio Pharmaceuticals (NASDAQ: PHIO), ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf siRNA spezialisiert hat, hat eine Entwicklungs- und Herstellungsvereinbarung mit einem US-amerikanischen Hersteller für seinen führenden Wirkstoff PH-762 abgeschlossen. Der Hersteller wird analytische und Prozessentwicklungsdienstleistungen sowie die cGMP-konforme Herstellung des Wirkstoffs übernehmen.
Die Vereinbarung stellt einen wichtigen Schritt zur Weiterentwicklung von Phios intratumoralem Programm zur Behandlung von kutanen Karzinomen dar. Das Unternehmen rekrutiert derzeit Patienten für die 5. und letzte Kohorte in seiner Phase-1b-Dosiseskalationsstudie, die sich auf kutanes Plattenepithelkarzinom, Merkelzellkarzinom und Melanom konzentriert.
- Secured U.S.-based manufacturing partnership for lead compound PH-762
- Phase 1b trial reaching final cohort enrollment stage
- Strategic advantages from working with U.S.-based manufacturer
- None.
Agreement covers contract development and manufacturing of lead compound PH-762
King of Prussia, Pennsylvania--(Newsfile Corp. - July 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today it has entered into a comprehensive drug substance development services agreement with a U.S. manufacturer. The company will provide analytical and process development and cGMP manufacture of Phio's lead clinical development compound PH-762. This represents a critical next step in advancing Phio's intratumoral program to treat cutaneous carcinomas. Phio is currently enrolling patients for the 5th and expected final cohort in its Phase 1b dose escalation study for cutaneous squamous cell carcinoma, Merkel cell carcinoma and melanoma.
"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."
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company advancing its INTASYL® gene silencing technology focused on immuno-oncology therapeutics. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The on-going Phase 1b trial (NCT# 06014086) is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers.
For additional information, visit the Company's website, www.phiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. Examples of forward-looking statements contained in this press release include, among others, the possibility that our INTASYL® siRNA gene silencing technology will make the body's immune cells more effective in killing cancer cells and statements regarding our commercial and clinical strategy, development plans and timelines and other future events.
These statements are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.
Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs
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