PH-762 TME / Phio Pharma - LARVOL DELTA

Phio announced today the completion of enrollment in its ongoing Phase 1b clinical trial of INTASYL siRNA PH-762 (Phio Pharma Press Release) - "In connection with completing enrollment, Phio continues to treat additional patients in the fifth cohort at the highest dose concentration of PH-762. Pathology results for these patients are expected in Q1 2026."

P1 data • Trial status • Cutaneous Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Pathology Results: Final Maximum Dose Cohort for INTASYL PH-762 Skin Cancer Trial (FinancialContent) - "The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance)....In addition, the Safety Monitoring Committee (SMC) completed its pre-specified review of safety results for the first three patients in the fifth cohort and confirmed that there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects at this maximum dose concentration."

DSMB • P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

PD-1–directed intratumoral immunotherapy for cutaneous carcinomas: A clinical study of INTASYL PH-762 (SITC 2025) - P1 | "Patients receive IT PH-762 once weekly, 4 times over a 3-week period prior to surgical excision, which occurs 5 weeks after the initial injection. Tumor changes are evaluated per iRECIST criteria and pathological response.Trial Registration Clinicaltrials.gov: NCT 06014086Ethics Approval This study was approved by Advarra Institutional Review Board (00023875)."

Clinical • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • IFNG

Phio Pharmaceuticals to Present at the Life Sciences Future Conference (Phio Pharma Press Release) - "Mr. Robert Bitterman...will deliver an update on its on-going Phase 1b clinical trial for skin cancer. He will also be discussing strategy and anticipated next steps in the PH-762 development program upon completion of the treatment phase of the study."

P1 data • Pipeline update • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Pathology Results for Four of Five Patients in Fourth Cohort (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio announced today that pathologic results are available for four of the five patients treated in the fourth cohort. A complete pathologic response (100% tumor clearance) has been reported for one patient with cutaneous squamous cell carcinoma (cSCC). One patient with metastatic Merkel cell carcinoma was reported as a partial response (> 50% clearance). Two patients with cSCC were reported as having a pathologic non-response (90% clearance) and one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance)."

P1 data • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Agreement with U.S. Manufacturing Source for Drug Substance (Newsfile) - "Phio Pharmaceuticals...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."

Commercial • Trial status • Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma

Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Clinical Trial to Fifth Dose Escalation Cohort (Phio Pharma Press Release) - "Phio announced...that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma...Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported...To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma."

DSMB • P1 data • Trial status • Cutaneous Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At Day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance)....Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling and treating patients; Phio expects to complete enrollment in the trial in the third quarter of 2025."

Enrollment status • P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort. The third patient was reported as having a pathologic non-response (<50% tumor clearance)....To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling patients; Phio expects to complete enrollment in the trial in the third quarter of 2025."

P1 data • Trial status • Melanoma • Merkel Cell Carcinoma • Skin Cancer • Squamous Cell Skin Cancer

Phio Pharmaceuticals Reports 2024 Year End Financial Results and Provides Business Update (Phio Pharma Press Release) - "PH-762 is currently being evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762 in up to 30 patients....To date, intratumoral injection of PH-762 has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762. The third dose cohort is fully enrolled and patients in this cohort are currently in the treatment or follow-up phase of the study. Phio expects to complete enrollment of all patients in the study in the third quarter of 2025."

Trial status • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study (Phio Pharma Press Release) - "Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating clinical study for their lead compound PH-762. The company plans to initiate screening of the fourth dose cohort in early April. Phio’s Phase 1b study (NCT06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study assesses the tumor response and determines the recommended dose for further study of PH-762."

Trial status • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Announces Data Showcasing INTASYL’s Role in Helping Immune Cells Target and Kill Cancer Cells (Phio Pharma Press Release) - "Phio Pharmaceuticals Corp....today announced that it is presenting data about its proprietary INTASYL platform and INTASYL compounds....INTASYL compound PH-762 silences PD-1, improving therapeutic efficacy in vivo. The PH-894 compound precisely silences BRD4 to enhance tumor cell immunogenicity and induce apoptosis. Silencing TIGIT in NK cells, using compound PH-804, enhances their activation, cytokine release, and target cell killing. The PH-905 compound silences CBLB, increasing NK cell cytotoxicity and proliferation....The data is being presented on October 8th at the 20th Annual Oligonucleotide Therapeutics Society (OTS) Meeting in Montreal."

Preclinical • Oncology

Phio Pharmaceuticals Announces Addition of Clinical Trial Site for its Phase 1b study of PH-762 (Newsfile) - "Phio Pharmaceuticals Corp...announced the addition of the University of Pittsburgh Medical Center (UPMC) Department of Dermatology in Pittsburgh, PA as a clinical trial site for its lead product candidate, PH-762...The UPMC Department of Dermatology joins four other sites engaged in the clinical study: The George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio....The Phase 1b trial is a non-comparative study of neoadjuvant monotherapy using PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma."

Trial status • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Recommendation from Safety Monitoring Committee (SMC) of Phase 1b Clinical Study of Phio's Lead Compound PH-762 (Newsfile) - P1b | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio Pharmaceuticals Corp...announced that a Safety Monitoring Committee (SMC) reviewed safety data from the first dose cohort treated in the Phase 1b clinical trial with Phio's lead compound PH-762. Based on these findings, the SMC recommended the escalation to the next dose concentration...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....There have been no dose-limiting toxicities, or clinically relevant treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The intratumoral injections have been well tolerated. The SMC has recommended dose escalation and enrollment of the next planned cohort in the clinical study."

DSMB • P1 data • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Announces Upcoming Presentation at the 27th Annual Meeting of the American Society of Cell and Gene Therapy (ASCGT) (GlobeNewswire) - "Phio Pharmaceuticals Corp....today announced it is presenting new data about its lead clinical product candidate, PH-762, an INTASYL compound....Preclinical studies demonstrate that PH-762 is effective in silencing PD-1, boosting immune response, and inhibiting tumor growth. PH-762 is currently being studied in a U.S. clinical trial to assess safety and efficacy in specific skin cancers (NCT 06014086)."

Preclinical • Trial status • Oncology • Skin Cancer

Phio Pharmaceuticals Reports Q1 2024 Results and Provides Business Update (GlobeNewswire) - "Phio’s INTASYL compound PH-762 is currently being investigated in an open-label Phase 1b clinical study (NCT 06014086) to evaluate the safety and tolerability of intratumoral PH-762 in cutaneous squamous cell (cSCC), melanoma, or Merkel cell carcinoma. Two patients have already completed treatment. Four sites across the US are now engaged in the Phase 1b study....Presented new data on the immunotherapeutic activity of INTASYL at...27th Annual American Society of Gene and Cell Therapy (ASGCT): this preclinical data demonstrates that intratumoral injection of PH-762 significantly inhibits tumor growth in murine cells and may generate memory-specific T cells."

Preclinical • Trial status • Merkel Cell Carcinoma

Phio Pharmaceuticals Announces Upcoming Presentation at the Annual Meeting of the Society of Clinical Oncology (ASCO) (GlobeNewswire) - "Phio Pharmaceuticals Corp...announced it is presenting new data about its lead product candidate, PH-762, an INTASYL compound."

Clinical • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Announces Upcoming Presentations at the 81st Annual Meeting of the Society for Investigative Dermatology (SID) (GlobeNewswire) - "Phio Pharmaceuticals Corp...announced it is presenting new data about its lead clinical candidate, PH-762, an INTASYL compound. The data will be presented in three posters at the annual meeting of the Society for Investigative Dermatology (SID) on May 16th in Dallas, Texas."

Clinical data • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Announces First US Patient Enrolled in Phase 1B Clinical Trial with Intratumoral PH-762 anti-PD-1 Therapy for Treatment of Skin Carcinomas (GlobeNewswire) - "Phio Pharmaceuticals Corp....today announced that the first patient has been dosed in the Phase 1b clinical trial of PH-762, an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. This clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma."

Trial status • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Phio Pharmaceuticals Announces Initiation of Collaborative Clinical Trial with PH-762, AgonOx's Tumor Infiltrating Lymphocyte Program (AGX148) and Providence Cancer Institute (PRNewswire) - "Phio Pharmaceuticals Corp...announced its clinical development partner, AgonOx, Inc, in collaboration with Providence Cancer Institute, has completed the site initiation visit and can commence with patient accrual. The clinical trial will assess the safety and the potential for enhanced therapeutic benefit from the administration of Phio's PH-762 treated 'double positive' (DP) CD8 tumor infiltrating lymphocytes (TILs) in patients with melanoma and other advanced solid tumors."

New trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Announces FDA Clearance to Initiate Clinical Trial of PH-762 for Treatment of Skin Carcinomas (PRNewswire) - "Phio Pharmaceuticals Corp...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to proceed with a clinical trial of Phio's lead product candidate, PH-762....Phio plans to initiate its Phase 1b clinical trial of intratumoral PH-762 in patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell in the second half of 2023."

IND • New P1 trial • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Presents Preclinical Study Showing PH-762 Induces Systemic Memory T Cell Mediators of Anti-Tumor Immunity (PRNewswire) - "Phio Pharmaceuticals Corp...announced that in vivo data from a hepatocellular carcinoma model provides insight into the mechanism by which locally administered mouse-targeted PH-762 (mPH-762) exerts systemic anti-tumor efficacy ('abscopal effect')....In the study, intratumoral administration of mPH-762 stimulated a local anti-tumor immune response and generated systemic tumor-reactive memory T cells, suggesting that the abscopal effects of PH-762 are mediated by the immune system."

Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Phio Pharmaceuticals Reports 2022 Year End Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones: (i) Plan to commence a U.S. Phase 1b clinical trial with PH-762 focused on the treatment of cutaneous squamous cell carcinoma ('cSCC') and other selected cutaneous malignancies in the second half of 2023; (ii) In partnership with AgonOx, Inc., plan to commence enrollment of subjects in a clinical trial evaluating the use of PH-762 and DP TIL in ACT during the second quarter of 2023."

Enrollment status • New P1 trial • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of neoadjuvant use of PH-762 administered intratumorally in subjects with advanced melanoma (SITC 2022) - "The first cohort has been enrolled. Trial Registration EudraCT number 2021-002859-10 Ethics Approval Approval was provided by: Comite de Protection de Personnes Sud Mediterranee III, 2021.12.04 bis _21.04174.000055"

Clinical • P1 data • PK/PD data • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Phio Pharmaceuticals Announces Upcoming Presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (PRNewswire) - "Phio Pharmaceuticals...announced it is scheduled to provide an update on its programs at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held in Boston, MA from November 8 - 12, 2022. This will include an update on its first-in-human clinical trial with PH-762 in advanced melanoma; data demonstrating the potential of PH-762 to further enhance the function of tumor infiltrating lymphocytes (TILs) with its partner AgonOx, Inc.; and new preclinical data on relevant targets identified in cancer immunotherapy using our INTASYL compounds."

P1 data • Preclinical • Breast Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor