PH-762 ACT / Phio Pharma - LARVOL DELTA

Phio Pharmaceuticals Announces Dosing of First Patient in Collaborative Clinical Trial with AgonOx, Inc. and Providence Cancer Institute (GlobeNewswire) - "Phio Pharmaceuticals Corp...today announced that its clinical development partners, AgonOx, Inc. and Providence Cancer Institute of Oregon, have dosed their first patient in an Adoptive Cell Therapy clinical trial...This first-in-human trial is investigating the safety and the potential for enhanced therapeutic benefit from the administration of AgonOx’s AGX148 'double positive' (DP) CD8 tumor-infiltrating lymphocytes (TIL) alone and in combination with Phio's PD-1 silencing PH-762 in patients with melanoma and other advanced solid tumors."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Melanoma • Oncology • Skin Cancer • 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

Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification (PRNewswire) - P1b | N=3 | "Phio Pharmaceuticals Corp....announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company's Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma. The trial is ongoing at the Gustave Roussy Institute (Villejuif, France), one of the largest cancer centers in Europe....Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol....Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, early in the 2nd half of 2023."

DSMB • New P1 trial • P1 data • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial With PH-762 and AgonOx's Tumor Infiltrating Lymphocytes (AGX148) to Treat Solid Tumors (PRNewswire) - "Phio Pharmaceuticals...announced their clinical development partner, AgonOx, Inc. has received confirmation from the FDA that their planned Phase 1 clinical trial in patients with advanced solid tumors may proceed. The initial Phase 1 clinical trial is designed to assess safety and to study the potential for an enhanced therapeutic benefit from the administration of Phio's PH-762 treated 'double positive' (DP) CD8 tumor infiltrating lymphocyte (TIL) in patients with melanoma and other advanced solid tumors....Preclinical data from in-vitro studies using autologous human tumor cells demonstrated that treating AGX148 with Phio's PH-762 increased by two-fold their tumor killing activity. The trial will be conducted at Providence under the leadership of Dr. Weinberg and Principal Investigator Brendan Curti, MD, Medical Oncologist and Robert W. Franz Endowed Chair for Clinical Research."

IND • New P1 trial • Melanoma • Oncology • Solid Tumor

Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma (PRNewswire) - "Phio Pharmaceuticals...announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells."

IND • Oncology • Solid Tumor

Manufacturing of a clinical scale CD8 TIL product, AGX148, with and without gene silencing of PD-1 using self-delivering RNAi INTASYLTM PH-762 (SITC 2022) - "Conclusions We have generated a potent tumor-specific ACT TIL product (AGX148) at clinical scale through the isolation and selective expansion of tumor-reactive T cells. Knocking down PD-1 with PH-762 INTASYL™ has the potential to further enhance the function of the AGX148 product and this ACT product will soon be tested in cancer patients."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD8 • ENTPD1 • ITGAE • PD-1

Phio Pharmaceuticals Announces Study Results at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 10th and 11th (PRNewswire) - 'Phio Pharmaceuticals...announced the results of several studies of its INTASYL™ compounds....The posters will be presented on November 10th and 11th at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which is being held in Boston, MA from November 8 – 12, 2022."

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

Phio Pharmaceuticals Announces Acceptance of Six Abstracts at The 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (PRNewswire) - "Phio Pharmaceuticals Corp...announced that six abstracts have been accepted for poster presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held in Boston, MA from November 10 – 12, 2022....'These posters will highlight in vitro as well as, in vivo tumor efficacy, and clinical work with our INTASYL compounds targeting PD-1, CTLA-4, CTGF, TIGIT, and BRD4, as well as the manufacturing, in collaboration with our partner AgonOx, Inc., of clinical scale batches of TIL with and without PH-762, our PD-1 gene silencing INTASYL™ compound...'"

Preclinical • Oncology

Phio Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones: (i) Plans to initiate a clinical trial evaluating the use of PH-762 and DP TILs in ACT during the fourth quarter of 2022 in partnership with AgonOx, Inc.; (ii) Expects to finalize IND-enabling studies for PH-894 in the second half of 2022; (iii) Expects to report top-line data from the first group of subjects with advanced melanoma in the clinical trial for PH-762 in the first quarter of 2023; (iv) Additional data publications on the Company's pipeline programs."

Clinical data • IND • New trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Reports 2021 Year End Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones for 2022: Expect to start patient enrollment in a Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma in the first quarter of 2022."

Enrollment status • Melanoma • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial for PH-762 to Treat Melanoma (PRNewswire) - "Phio Pharmaceuticals Corp....announced that it has received regulatory clearance to start a clinical trial with its lead product candidate, PH-762. The Company was granted the clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM - L'Agence nationale de sécurité du médicament et des produits de santé) to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute. The Company expects to dose the first patient in the first quarter of 2022....The Company's first clinical trial with PH-762 will be a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma."

New P1 trial • Melanoma • Oncology • Solid Tumor

Locally administered immunotherapy self-delivering RNAi PH-762 results in abscopal clearance of untreated distal tumors, suggesting systemic immune response, in a murine hepatocarcinoma model (SITC 2021) - "This data and other recently published data showing evidence of a specific antitumor immune response in a tumor rechallenge model after prior treatment with INTASYL compounds, demonstrate the desired systemic immune response can be obtained with local administration of PH-762. INTASYL represent an alternative to antibody therapy for IT checkpoint blockade with potential for improved efficacy and reduced systemic toxicity which will be investigated in an upcoming clinical trial."

IO biomarker • Preclinical • Oncology • CXCL10 • IFNG • IL10 • IL6 • PD-1

Phio Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Expect to initiate a first-in-human clinical study on the direct therapeutic use of PH-762 in patients with advanced melanoma in the first quarter of 2022. Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022. Expect to file a clinical trial application for PH-894 in the second half of 2022."

IND • New trial • Melanoma • Oncology • Solid Tumor

Phio Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones: (i) Expect to initiate a first-in-human clinical study on the use of PH-762 using direct drug therapy (IT) administration for patients with advanced melanoma in the first quarter of 2022; (ii) Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022."

New trial • Melanoma • Oncology

Phio Pharma's PH-762 Shows Encouraging Antitumor Efficacy In Preclinical Studies (Yahoo Finance) - "Phio Pharmaceuticals Corp...announcing positive new in vivo data showing that PH-762 significantly enhanced the antitumor efficacy of HER2-targeted CAR-T cells (HER2CART) in solid tumors...Compared to untreated, HER2CART cells treated with PH-762 showed statistically significant and durable inhibition of tumor growth."

Preclinical • Oncology

Phio Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones for 2021: (i) Initiate a first-in-human clinical study on the use of PH-762 in adoptive cell therapy with tumor infiltrating lymphocytes in patients with metastatic melanoma or squamous cell carcinoma of the head and neck (SSCHN); (ii) Initiate a first-in-human clinical study on the use of PH-762 direct drug therapy (intratumoral injection) in patients with advanced melanoma."

New trial • Head and Neck Cancer • Melanoma • Oncology • Squamous Cell Carcinoma of Head and Neck

Phio Pharmaceuticals Reports 2020 Year End Financial Results and Provides Business Update (PRNewswire) - "Upcoming pipeline milestones for 2021: (i) Scheduled to present new study data regarding direct drug therapy with PH-762 at the AACR Annual Meeting 2021; (ii) Additional data publications on the Company's pipeline programs, expected during Q2-Q3 2021; (iii) Start of a first-in-human clinical study, on the use of PH-762 in adoptive cell therapy with TILs, namely, to enhance the therapeutic responses in cancer patients. The study, to be executed in collaboration with Agonox, Inc., is expected to be initiated in Q3 2021; (iv) Start of a first-in-human clinical study on the use of PH-762 as directly administered drug in patients with advanced melanoma. The study is expected to be initiated in Q4 2021."

New trial • Preclinical • Melanoma • Oncology