American Academy of Dermatology Awards Podium Presentation to Phio Pharmaceutical's Clinical Research at 2025 Annual Meeting
Phio Pharmaceuticals (NASDAQ: PHIO) presented interim results from its Phase 1b clinical study of PH-762 at the American Academy of Dermatology's Late-Breaking Research session. The study evaluates the safety and tolerability of intratumoral PH-762 in cutaneous carcinomas.
In the second dose cohort of four patients, two patients with cutaneous squamous cell carcinoma (cSCC) achieved complete response (100% pathological cure), one achieved partial response (90% pathological cure), and one showed stable disease. The study has completed required safety enrollment for its third dose cohort, with the fourth dose cohort screening planned for early April.
PH-762 utilizes INTASYL® siRNA gene silencing technology to enhance immune cells' effectiveness in killing cancer cells. The research focuses on cSCC, melanoma, and Merkel cell carcinoma, with stages 1 and 2 cSCC representing 77% of all new cSCC cases annually.
Phio Pharmaceuticals (NASDAQ: PHIO) ha presentato risultati intermedi del suo studio clinico di Fase 1b su PH-762 durante la sessione di ricerca dell'American Academy of Dermatology. Lo studio valuta la sicurezza e la tollerabilità di PH-762 intratumorale nei carcinomi cutanei.
Nella seconda coorte di dosaggio di quattro pazienti, due pazienti con carcinoma squamoso cutaneo (cSCC) hanno raggiunto una risposta completa (cura patologica del 100%), uno ha ottenuto una risposta parziale (cura patologica del 90%) e uno ha mostrato una malattia stabile. Lo studio ha completato l'arruolamento di sicurezza richiesto per la sua terza coorte di dosaggio, con lo screening della quarta coorte di dosaggio pianificato per inizio aprile.
PH-762 utilizza la tecnologia di silenziamento genico INTASYL® siRNA per migliorare l'efficacia delle cellule immunitarie nell'uccisione delle cellule tumorali. La ricerca si concentra su cSCC, melanoma e carcinoma a cellule di Merkel, con le fasi 1 e 2 di cSCC che rappresentano il 77% di tutti i nuovi casi annuali di cSCC.
Phio Pharmaceuticals (NASDAQ: PHIO) presentó resultados intermedios de su estudio clínico de Fase 1b sobre PH-762 en la sesión de investigación de última hora de la American Academy of Dermatology. El estudio evalúa la seguridad y tolerabilidad de PH-762 intratumoral en carcinomas cutáneos.
En la segunda cohorte de dosis de cuatro pacientes, dos pacientes con carcinoma de células escamosas cutáneas (cSCC) lograron respuesta completa (cura patológica del 100%), uno logró respuesta parcial (cura patológica del 90%) y uno mostró enfermedad estable. El estudio ha completado el reclutamiento de seguridad requerido para su tercera cohorte de dosis, con el cribado de la cuarta cohorte de dosis programado para principios de abril.
PH-762 utiliza la tecnología de silenciamiento génico INTASYL® siRNA para mejorar la efectividad de las células inmunitarias en la eliminación de células cancerosas. La investigación se centra en cSCC, melanoma y carcinoma de células de Merkel, siendo las etapas 1 y 2 de cSCC responsables del 77% de todos los nuevos casos anuales de cSCC.
Phio Pharmaceuticals (NASDAQ: PHIO)는 미국 피부과학회(American Academy of Dermatology)의 최신 연구 세션에서 PH-762의 1b상 임상 연구 중간 결과를 발표했습니다. 이 연구는 피부암에서의 PH-762의 안전성과 내약성을 평가합니다.
네 명의 환자가 포함된 두 번째 용량 집단에서, 두 명의 피부 편평세포암(cSCC) 환자가 완전 반응을 달성했습니다 (100% 병리적 치유), 한 명은 부분 반응을 보였고 (90% 병리적 치유), 한 명은 안정적인 질병을 보였습니다. 이 연구는 세 번째 용량 집단의 안전성 등록을 완료했으며, 네 번째 용량 집단의 스크리닝은 4월 초로 예정되어 있습니다.
PH-762는 INTASYL® siRNA 유전자 침묵 기술을 사용하여 면역 세포의 암 세포 제거 효과를 향상시킵니다. 연구는 cSCC, 멜라노마 및 머켈 세포 암에 중점을 두며, 1기 및 2기 cSCC가 매년 발생하는 모든 새로운 cSCC 사례의 77%를 차지합니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a présenté des résultats intermédiaires de son étude clinique de Phase 1b sur PH-762 lors de la session de recherche de dernière minute de l'American Academy of Dermatology. L'étude évalue la sécurité et la tolérabilité de PH-762 intratumoral dans les carcinomes cutanés.
Dans la deuxième cohorte de dosage de quatre patients, deux patients atteints de carcinome à cellules squameuses cutanées (cSCC) ont atteint une réponse complète (guérison pathologique à 100%), un a obtenu une réponse partielle (guérison pathologique à 90%) et un a montré une maladie stable. L'étude a complété l'enrôlement de sécurité requis pour sa troisième cohorte de dosage, avec le dépistage de la quatrième cohorte de dosage prévu pour début avril.
PH-762 utilise la technologie de silençage génique INTASYL® siRNA pour améliorer l'efficacité des cellules immunitaires dans l'élimination des cellules cancéreuses. La recherche se concentre sur cSCC, le mélanome et le carcinome à cellules de Merkel, les stades 1 et 2 de cSCC représentant 77 % de tous les nouveaux cas annuels de cSCC.
Phio Pharmaceuticals (NASDAQ: PHIO) hat interimistische Ergebnisse aus seiner Phase 1b-Studie zu PH-762 während der Late-Breaking Research-Session der American Academy of Dermatology präsentiert. Die Studie bewertet die Sicherheit und Verträglichkeit von intratumoralem PH-762 bei kutanen Karzinomen.
In der zweiten Dosierungsgruppe mit vier Patienten erreichten zwei Patienten mit kutanem Plattenepithelkarzinom (cSCC eine vollständige Ansprechrate (100% pathologische Heilung), einer erreichte eine partielle Ansprechrate (90% pathologische Heilung) und einer zeigte eine stabile Erkrankung. Die Studie hat die erforderliche Sicherheitsanmeldung für ihre dritte Dosierungsgruppe abgeschlossen, mit dem Screening der vierten Dosierungsgruppe, das für Anfang April geplant ist.
PH-762 nutzt die INTASYL® siRNA-Gensilencing-Technologie, um die Effektivität von Immunzellen beim Abtöten von Krebszellen zu erhöhen. Die Forschung konzentriert sich auf cSCC, Melanom und Merkelzellkarzinom, wobei die Stadien 1 und 2 von cSCC 77% aller neuen cSCC-Fälle jährlich ausmachen.
- Strong interim efficacy data: 2 complete responses and 1 partial response out of 4 patients
- Successfully completed safety enrollment for third dose cohort
- Advancement to fourth dose cohort screening
- Treatment shows potential to minimize surgical interventions
- Study still in early Phase 1b stage
- Small patient sample size (only 4 patients) in reported results
Insights
Phio Pharmaceuticals has reported encouraging interim results from its Phase 1b clinical study of PH-762, showcasing the potential of its INTASYL® siRNA gene silencing technology in treating skin cancers. The data, presented at the prestigious American Academy of Dermatology's Late-Breaking Research session, revealed that two patients with cutaneous squamous cell carcinoma achieved complete responses (100% pathological cure), while a third patient achieved a partial response (90% pathological cure). The fourth patient showed stable disease.
This represents a
The market opportunity is substantial, as the article notes that Stages 1 and 2 cutaneous squamous cell carcinoma represent
While these results are from a small patient sample and preliminary in nature, the strong efficacy signals and progression through multiple dose cohorts suggest PH-762 may have meaningful clinical potential. The recognition through a podium presentation further validates the scientific interest in Phio's approach to making immune cells more effective at killing cancer cells.
Interim Results from clinical study for cutaneous carcinomas presented at Late-Breaking Research Session
Marlborough, Massachusetts--(Newsfile Corp. - March 10, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced that a podium presentation addressing its lead product candidate, PH-762, was given in the Academy's Late-Breaking Research session. The Late-Breaking Research session includes oral presentations of the top-scoring abstracts that address common and complex dermatological conditions.
Mary Spellman, MD, FAAD, presented "PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: Interim Results from an Ongoing Study of INTASYL PH-762" which provided details on the design and progress of Phio's ongoing open-label Phase 1b clinical study (NCT 06014086), to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma. Stages 1 and 2 cSCC represent
Recent data showed that, of the four patients who have completed treatment in the second dose cohort, two patients with cutaneous squamous cell carcinoma achieved a complete response (
The study recently fulfilled the required enrollment for safety in its third dose cohort. Initiation of screening of the fourth dose cohort is planned for early April.
"We are excited to share our progress in this trial with the dermatology community," said Mary Spellman M.D., Phio's acting Chief Medical Officer. "We believe that this immuno-oncology therapy may offer patients meaningful clinical benefit, while minimizing surgical interventions."
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company advancing its proprietary INTASYL siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually any gene with high degree of specificity across a wide range of cell types and tissues. INTASYL is designed to enhance the ability of immune cells to more effectively kill tumor cells. INTASYL has also demonstrated enhancement to adoptive cell therapy. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.
Phio's lead clinical program, PH-762, is an INTASYL compound that silences PD-1. PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the treatment of cutaneous SCC, melanoma and Merkel cell carcinoma in second quarter of 2023.
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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FAQ
What are the interim results of Phio's PH-762 Phase 1b clinical trial for cutaneous carcinomas?
When will PHIO begin screening for the fourth dose cohort in their PH-762 clinical trial?
What types of cancer does PHIO's PH-762 clinical trial target?
What percentage of new cSCC cases are represented by stages 1 and 2?
