Phio Pharmaceuticals Announces Upcoming Presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
Phio Pharmaceuticals (NASDAQ: PHIO) announced new clinical data presentation from its ongoing Phase 1b trial at the 39th Annual SITC Meeting. The trial evaluates PH-762 through intratumoral injection in patients with various skin cancers. Results show the treatment has been well-tolerated with no adverse events across five patients in Cohorts 1 and 2.
Notable outcomes include one complete response (100% tumor clearance) and one partial response (90% tumor clearance) in patients with cutaneous squamous cell carcinoma in the second cohort. The trial, expected to complete enrollment by Q3 2025, demonstrates promising results in making immune cells more effective at killing cancer cells using INTASYL® siRNA technology.
Phio Pharmaceuticals (NASDAQ: PHIO) ha annunciato una nuova presentazione di dati clinici dal suo ongoing trial di Fase 1b durante il 39° Meeting Annuale SITC. Lo studio valuta PH-762 attraverso iniezioni intratumorali in pazienti affetti da vari tipi di cancro della pelle. I risultati mostrano che il trattamento è stato ben tollerato, senza eventi avversi in cinque pazienti nei Coorti 1 e 2.
Tra i risultati significativi, si evidenziano una risposta completa (100% di eliminazione del tumore) e una risposta parziale (90% di eliminazione del tumore) in pazienti con carcinoma cutaneo a cellule squamose nel secondo coorte. Il trial, previsto per completare l'arruolamento entro il Q3 2025, dimostra risultati promettenti nel rendere le cellule immunitarie più efficaci nel distruggere le cellule cancerose utilizzando la tecnologia INTASYL® siRNA.
Phio Pharmaceuticals (NASDAQ: PHIO) anunció una nueva presentación de datos clínicos de su ensayo en curso de Fase 1b en la 39ª Reunión Anual del SITC. El ensayo evalúa PH-762 mediante inyección intratumoral en pacientes con varios tipos de cáncer de piel. Los resultados muestran que el tratamiento ha sido bien tolerado sin eventos adversos en cinco pacientes de los Cohortes 1 y 2.
Entre los resultados notables, se incluye una respuesta completa (100% de eliminación del tumor) y una respuesta parcial (90% de eliminación del tumor) en pacientes con carcinoma de células escamosas cutáneas en el segundo cohorte. Se espera que el ensayo complete la inscripción para el tercer trimestre de 2025, demostrando resultados prometedores en hacer que las células inmunitarias sean más efectivas para eliminar las células cancerosas utilizando la tecnología INTASYL® siRNA.
Phio Pharmaceuticals (NASDAQ: PHIO)는 39번째 연례 SITC 회의에서 진행 중인 1b상 시험의 새로운 임상 데이터 발표를 알렸습니다. 이 시험은 여러 피부암 환자에게 PH-762를 종양 내 주사를 통해 평가합니다. 결과는 치료가 잘 견뎌졌으며, 1, 2군의 다섯 명의 환자에서 부작용이 없음을 보여줍니다.
주목할 만한 결과로는 두 번째 군의 피부 편평세포 암 환자에서 완전 반응(100% 종양 제거)과 부분 반응(90% 종양 제거)이 있습니다. 이 시험은 2025년 3분기까지 모집을 완료할 예정이며, INTASYL® siRNA 기술을 사용하여 면역 세포가 암 세포를 죽이는 데 더 효과적이도록 하는 promising results를 보여줍니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a annoncé une nouvelle présentation de données cliniques de son essai de phase 1b en cours lors de la 39e réunion annuelle du SITC. L'essai évalue PH-762 par injection intratumorale chez des patients souffrant de divers cancers de la peau. Les résultats montrent que le traitement a été bien toléré, sans événements indésirables chez cinq patients dans les cohortes 1 et 2.
Des résultats notables incluent une réponse complète (100 % d'élimination de la tumeur) et une réponse partielle (90 % d'élimination de la tumeur) chez des patients atteints de carcinome épidermoïde cutané dans la deuxième cohorte. L'essai, dont l'inscription devrait être complétée d'ici le troisième trimestre 2025, démontre des résultats prometteurs pour rendre les cellules immunitaires plus efficaces dans la destruction des cellules cancéreuses en utilisant la technologie INTASYL® siRNA.
Phio Pharmaceuticals (NASDAQ: PHIO) gab die Präsentation neuer klinischer Daten aus seiner laufenden Phase 1b-Studie auf dem 39. jährlichen SITC-Treffen bekannt. Die Studie bewertet PH-762 durch intratumorale Injektion bei Patienten mit verschiedenen Hautkrebsarten. Die Ergebnisse zeigen, dass die Behandlung gut vertragen wurde, ohne unerwünschte Ereignisse bei fünf Patienten in den Kohorten 1 und 2.
Bemerkenswerte Ergebnisse umfassen eine vollständige Ansprechrate (100 % Tumorentfernung) und eine partielle Ansprechrate (90 % Tumorentfernung) bei Patienten mit kutanem Plattenepithelkarzinom in der zweiten Kohorte. Die Studie wird voraussichtlich im dritten Quartal 2025 mit der Rekrutierung abgeschlossen, und zeigt vielversprechende Ergebnisse bei der Verbesserung der Effektivität von Immunzellen zur Bekämpfung von Krebszellen mithilfe der INTASYL® siRNA-Technologie.
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Presenting new clinical data from Phio's on-going Phase 1b trial
Marlborough, Massachusetts--(Newsfile Corp. - November 7, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company creating new pathways towards a cancer-free future by using its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today that it is presenting clinical data from its on-going Phase 1b clinical trial at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held in Houston, TX from November 8-10, 2024.
Phio's presentation will highlight the clinical results from enrolled patients in Cohorts 1 and 2 in the Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma and melanoma.
Clinical Results To Date
Intratumoral (IT) injection of PH-762 has been well tolerated in all patients enrolled in the trial to date. There were no related adverse events, no serious adverse events, and no dose limiting toxicities or dose adjustments. Five (5) patients with cutaneous carcinomas have enrolled in Cohorts 1 and 2. Each enrolled patient received four (4) IT doses of PH-762. The patients were diagnosed with cutaneous squamous cell carcinoma (4 patients) and metastatic melanoma (1 patient).
At Day 36 (tumor excision), while each patient in the first cohort had stable disease, the following results were described for two patients enrolled in the second cohort:
- Complete response (
100% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma; and - Partial response (
90% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma.
The Phase 1b trial is on-going. Anticipated completion of the enrollment phase of this trial is Q3 2025.
"We are encouraged by the documented clinical and histopathological results observed to date," said Mary Spellman MD, Phio's acting Chief Medical Officer. "Corresponding safety and tolerability data supports continued assessment of intratumoral PH-762 in patients with cutaneous carcinomas."
Presentation Details are as follows:
| Title: | INTASYL PH-762: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinoma |
| Abstract Number: | 696 |
| Presenting Author: | Mary Spellman, M.D. |
| Date: | Saturday November 9, 2024 |
| Location: | Exhibit Halls A and B, George R. Brown Convention Center |
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company and a pioneer in the RNAi revolution advancing its proprietary INTASYL siRNA gene silencing technology to create new pathways towards a cancer-free future. INTASYL can target and silence virtually any gene with a 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 been used to enhance 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 the 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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/228924
FAQ
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