Phio Pharmaceuticals Announces Promising Results of Second Cohort from Its Ongoing Clinical Study of PH-762
Phio Pharmaceuticals (NASDAQ: PHIO) announced positive results from the second cohort of its Phase 1b clinical study of PH-762. The study evaluates the safety and tolerability of intratumoral PH-762 in various skin cancers. Two patients with cutaneous squamous cell carcinoma achieved complete response (100% tumor clearance) at Day 36. Among other patients in the second cohort, one showed partial response (90% tumor clearance) and another had stable disease.
The trial included 7 patients total, with 6 diagnosed with cutaneous squamous cell carcinoma and 1 with metastatic melanoma. Importantly, no dose-limiting toxicities or clinically relevant treatment-emergent adverse events were reported, and the intratumoral injections were well tolerated. The study continues to enroll patients to assess higher dose concentrations of PH-762.
Phio Pharmaceuticals (NASDAQ: PHIO) ha annunciato risultati positivi dalla seconda coorte del suo studio clinico di Fase 1b su PH-762. Lo studio valuta la sicurezza e la tollerabilità dell'intratumorale PH-762 in vari tipi di cancro della pelle. Due pazienti con carcinoma cutaneo a cellule squamose hanno raggiunto una risposta completa (100% di riduzione del tumore) al Giorno 36. Tra gli altri pazienti della seconda coorte, uno ha mostrato una risposta parziale (90% di riduzione del tumore) e un altro ha avuto una malattia stabile.
La sperimentazione ha incluso un totale di 7 pazienti, di cui 6 diagnosticati con carcinoma cutaneo a cellule squamose e 1 con melanoma metastatico. È importante notare che non sono state segnalate tossicità limitanti la dose o eventi avversi clinicamente rilevanti emersi dal trattamento, e le iniezioni intratumorali sono state ben tollerate. Lo studio continua a arruolare pazienti per valutare concentrazioni di dosaggio più elevate di PH-762.
Phio Pharmaceuticals (NASDAQ: PHIO) anunció resultados positivos de la segunda cohorte de su estudio clínico de Fase 1b sobre PH-762. El estudio evalúa la seguridad y tolerabilidad de PH-762 intratumoral en varios tipos de cáncer de piel. Dos pacientes con carcinoma de células escamosas cutáneas lograron respuesta completa (100% de eliminación del tumor) en el Día 36. Entre otros pacientes de la segunda cohorte, uno mostró respuesta parcial (90% de eliminación del tumor) y otro tuvo enfermedad estable.
El ensayo incluyó un total de 7 pacientes, de los cuales 6 fueron diagnosticados con carcinoma de células escamosas cutáneas y 1 con melanoma metastásico. Es importante destacar que no se reportaron toxicidades limitantes de dosis ni eventos adversos clínicamente relevantes emergentes del tratamiento, y las inyecciones intratumorales fueron bien toleradas. El estudio continúa reclutando pacientes para evaluar concentraciones de dosis más altas de PH-762.
Phio Pharmaceuticals (NASDAQ: PHIO)는 PH-762의 1b상 임상 연구의 두 번째 집단에서 긍정적인 결과를 발표했습니다. 이 연구는 다양한 피부암에서 PH-762의 안전성과 내약성을 평가합니다. 두 명의 피부 편평세포 암 환자가 36일째에 완전 관해 (종양 100% 제거)에 도달했습니다. 두 번째 집단의 다른 환자 중 한 명은 부분 응답(종양 90% 제거)을 보였고, 다른 한 명은 안정된 질환을 보였습니다.
이 시험에는 총 7명의 환자가 포함되었으며, 이 중 6명은 피부 편평세포 암으로 진단받았고 1명은 전이성 흑색종으로 진단받았습니다. 중요한 것은 용량 제한 독성이나 임상적으로 관련 있는 치료 유도 부작용이 보고되지 않았으며, intratumoral 주사는 잘 견디는 것으로 나타났습니다. 이 연구는 PH-762의 더 높은 용량 농도를 평가하기 위해 환자를 계속 모집하고 있습니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a annoncé des résultats positifs de la deuxième cohorte de son étude clinique de Phase 1b sur le PH-762. L'étude évalue la sécurité et la tolérance du PH-762 intratumoral dans divers cancers de la peau. Deux patients atteints de carcinome cutané à cellules squameuses ont obtenu une réponse complète (100 % d'élimination de la tumeur) au Jour 36. Parmi les autres patients de la deuxième cohorte, l'un a montré une réponse partielle (90 % d'élimination de la tumeur) et un autre a eu une maladie stable.
L'essai a inclus un total de 7 patients, dont 6 diagnostiqués avec un carcinome cutané à cellules squameuses et 1 avec un mélanome métastatique. Il est important de noter qu'aucune toxicité limitante de dose ou événement indésirable cliniquement pertinent lié au traitement n'a été signalé, et les injections intratumorales ont été bien tolérées. L'étude continue de recruter des patients pour évaluer des concentrations de dose plus élevées de PH-762.
Phio Pharmaceuticals (NASDAQ: PHIO) gab positive Ergebnisse aus der zweiten Kohorte seiner Phase-1b-Studie zu PH-762 bekannt. Die Studie bewertet die Sicherheit und Verträglichkeit von intratumoralem PH-762 bei verschiedenen Hautkrebsarten. Zwei Patienten mit kutanem Plattenepithelkarzinom zeigten eine vollständige Remission (100% Tumorrückgang) am Tag 36. Unter den anderen Patienten der zweiten Kohorte zeigte einer eine partielle Remission (90% Tumorrückgang) und ein anderer hatte eine stabile Erkrankung.
Der Versuch umfasste insgesamt 7 Patienten, von denen 6 mit kutanem Plattenepithelkarzinom und 1 mit metastasiertem Melanom diagnostiziert wurden. Wichtig ist, dass keine dosisbegrenzenden Toxizitäten oder klinisch relevanten behandlungsbedingten unerwünschten Ereignisse berichtet wurden und die intratumoralen Injektionen gut vertragen wurden. Die Studie rekrutiert weiterhin Patienten, um höhere Dosierungskonzentrationen von PH-762 zu bewerten.
- Complete response (100% tumor clearance) in 2 patients
- 90% tumor clearance in 1 additional patient
- No dose-limiting toxicities or adverse events reported
- Treatment well tolerated by patients
- First cohort showed only stable disease, without tumor reduction
Insights
The Phase 1b clinical trial results for PH-762 represent a significant milestone for PHIO's oncology program. Two complete responses (100% tumor clearance) and one partial response (90% clearance) in the second cohort, specifically in cutaneous squamous cell carcinoma patients, are particularly noteworthy for an early-phase dose-escalation study.
In simpler terms: Think of this like testing different strengths of a new medicine - even at these early, lower doses, the treatment completely eliminated cancer in two patients and significantly reduced it in another.
The absence of dose-limiting toxicities and treatment-emergent adverse events is equally important, suggesting a favorable safety profile that could support higher dosing in future cohorts. This dual achievement of efficacy and safety is important for micro-cap biotechnology companies, as it can significantly de-risk their clinical programs.
The market opportunity for cutaneous squamous cell carcinoma treatments is substantial, with over 1 million cases diagnosed annually in the US alone. INTASYL's mechanism of action, which enhances immune cell effectiveness against cancer cells, could potentially position PH-762 as a competitive option in the growing immuno-oncology market.
These interim results could be transformative for PHIO's market position. For a company with a market cap under
Breaking this down for everyday investors: Imagine buying a small startup that's testing a new product and finding out it works perfectly even before they've tried the strongest version. That's essentially what's happening here.
The clean safety profile is particularly valuable for potential partnering discussions, as larger pharmaceutical companies often seek early-stage assets with demonstrated safety and preliminary efficacy. This could position PHIO for strategic partnerships or licensing deals, which typically command significant premiums in oncology.
However, investors should note that while these results are promising, the small patient population (7 total patients) means additional data will be needed to validate these findings. The ongoing enrollment and higher dose cohorts will be important for establishing a more comprehensive efficacy profile.
Pathologic Complete Response reported for 2 patients with cutaneous Squamous Cell Carcinoma
Marlborough, Massachusetts--(Newsfile Corp. - January 13, 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 pathologic responses for patients enrolled in the 2nd cohort, which includes 2 patients with a complete response or
Phio's ongoing Phase 1b clinical study (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.
Of the patients enrolled to date, 6 patients were diagnosed with cutaneous squamous cell carcinoma and 1 patient was diagnosed with metastatic melanoma. At Day 36 (tumor excision), while patients in the first cohort had stable disease, results are now available for the 4 patients who completed treatment in the 2nd cohort:
- Complete response (
100% tumor clearance) is reported for 2 patients with cutaneous squamous cell carcinoma. Partial response (90% tumor clearance) is reported for 1 patient with cutaneous squamous cell carcinoma and 1 patient had stable disease, having not progressed.
There have been no dose-limiting toxicities, or clinically relevant treatment-emergent adverse events in the patients receiving intratumoral PH-762. The intratumoral injections have been well tolerated.
"We are pleased and encouraged by the profound tumor response in the second dose cohort, coupled with reassuring safety data," said Mary Spellman MD, Phio's acting Chief Medical Officer. "We look forward to continued enrollment which will permit assessment of higher dose concentrations of PH-762."
"These positive results in the early stages of dose escalation offer promise for our vision, 'striving for a cancer free future' using INTASYL technology" said Robert Bitterman, CEO of Phio Pharmaceuticals.
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 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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/236693
FAQ
What were the results of PHIO's Phase 1b clinical trial second cohort for PH-762?
How many patients were enrolled in PHIO's PH-762 clinical trial as of January 2025?
What types of cancer is PHIO's PH-762 being tested for in the Phase 1b trial?
Were there any safety concerns in PHIO's PH-762 clinical trial?
