The goal of this clinical trial is to evaluate the safety and tolerability of intratumoral injections of PH-762 in squamous cell carcinoma, melanoma, or Merkel cell carcinomas of the skin, to understand what the body does to the PH-762, and to observe how the tumor responds to the drug. Participants will receive four injections of PH-762 at weekly intervals, into a single tumor, followed by surgical removal of the tumor approximately two weeks later.

Start Date07 Nov 2023

Sponsor / Collaborator

Phio Pharmaceuticals Corp.

[+1]

NCT05902520

/ Active, not recruitingPhase 1

Phase I Randomized Open Label Trial Investigating Adoptive Transfer of CD39+CD103+CD8+ Tumor-isolated T Cells (AGX148) Alone or Combined With siRNA Modulation of PD-1 (AGX148/PH-762) in Patients With Advanced Solid Tumors

The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies. The TIL selection process is based on evidence showing that CD8+ TIL which co-express both CD39 and CD103 harbor the bulk of tumor-reactivity and that the remaining CD8 TIL is mainly composed of non-tumor reactive bystander cells. All of the expanded TIL that are produced (1-40 billion are expected) will be delivered in the form of a cell suspension to the participants by intravenous infusion. It is proposed that these selected TIL will produce a more potent and efficacious treatment of late-stage cancer.

Start Date19 Jun 2023

Sponsor / Collaborator

AgonOx LLC

[+2]

100 Clinical Results associated with PH-762

100 Translational Medicine associated with PH-762

100 Patents (Medical) associated with PH-762

Literatures (Medical) associated with PH-762

Frontiers in Immunology

Self-delivering RNAi immunotherapeutic PH-762 silences PD-1 to generate local and abscopal antitumor efficacy

Article

Author: Fricker, Simon P ; Rivest, Brianna ; Yan, Dingxue ; Guemiri, Ramdane ; Boone, Andrew ; Maxwell, Melissa ; Cardia, James ; Bellet, Deborah ; Cuiffo, Benjamin ; Robert, Caroline

Objective:

Immunotherapeutic inhibition of PD-1 by systemically administered monoclonal antibodies is widely used in cancer treatment, but it may cause severe immune-related adverse events (irSAEs). Neoadjuvant PD-1 inhibition before surgery has shown promise in reducing recurrence by stimulating durable antitumor immunity. Local intratumoral (IT) immunotherapy is a potential strategy to minimize irSAEs, but antibodies have limited tumor penetration, making them less suitable for this approach. Therapeutic self-delivering RNAi (INTASYL) is an emerging modality well-suited for neoadjuvant immunotherapy. This study presents preclinical proof-of-concept for PH-762, an INTASYL designed to silence PD-1, currently in clinical development for advanced cutaneous malignancies (ClinicalTrials.gov#NCT06014086).

Methods and analysis:

PH-762 pharmacology was characterized in vitro, and in vivo antitumor efficacy was evaluated using a murine analogue (mPH-762) in syngeneic tumor models with varying PD-1 responsiveness. Bilateral Hepa1-6 models assessed abscopal effects of local treatment. Ex vivo analyses explored mechanisms of direct and abscopal efficacy.

Results:

PH-762 was rapidly internalized by human T cells, silencing PD-1 mRNA and decreasing PD-1 surface protein, enhancing TCR-stimulated IFN-γ and CXCL10 secretion. In vivo, IT mPH-762 provided robust antitumor efficacy, local and lymphatic biodistribution, and was well tolerated. Ex vivo analyses revealed that IT mPH-762 depleted PD-1 protein, promoted leukocyte and T cell infiltration, and correlated with tumor control. IT mPH-762 also demonstrated efficacy against untreated distal tumors (abscopal effect) by priming systemic antitumor immunity.

Conclusion:

These data support PH-762 as a promising candidate for neoadjuvant immunotherapy in clinical studies.

News (Medical) associated with PH-762

23 Jul 2026

·www.biospace.com

Correction to Announcement Regarding Phio Pharmaceuticals Participation in the Renmark Financial Communications Live Virtual Non-Deal Roadshow Series

Live Presentation and Q&A: Tuesday, July 28, 2026 12 PM EDT King of Prussia, Pennsylvania--(News - July 22, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® gene silencing technology to eliminate cancer. Phio Pharmaceuticals announced today that Robert Bitterman, CEO and Chairman of the Board, will present an overview of the Company's INTASYL ® siRNA platform, including its lead clinical candidate PH-762 for the treatment of cutaneous carcinomas. The presentation will be followed by a live Q&A session. This release corrects the day of the week that the presentation will be held. The presentation will be held on Tuesday on July 28, 2026 at 12 PM EDT. "We look forward to engaging with investors at the Renmark Financial Virtual Non-Deal Roadshow and sharing our perspective on how INTASYL may offer a unique and promising approach to advancing immuno-oncology therapies," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. Phio's presentation and live Q&A will take place on Tuesday July 28, 2026, at 12 PM EDT in the live Virtual Non-Deal Roadshow Series hosted by Renmark Financial Communications Inc. REGISTER HERE: Renmark Virtual Non-Deal Roadshow NASDAQ - PHIO | Register | Renmark Please Note: If the link does not work, please copy and paste into your browser. To ensure smooth connectivity, please access the link above using the latest version of Google Chrome. A replay of the event may be accessed on the Renmark Financial Communications Inc. website at . Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, . 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. These statements, which include statements, among other things, regarding the anticipated benefits of our INTASYL™ RNAi platform, the results from our ongoing clinical trials, our expectations regarding timing of FDA submissions intended to propose and seek guidance for next steps in clinical study design for PH-762, our expectations that such FDA submissions and any related FDA meetings will clarify next steps in advancing the PH-762 development program, details regarding our planned non-clinical toxicology study, and our ability to support ongoing clinical development, operational requirements and strategic initiatives with the capital we currently have on hand, 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 of future FDA interactions on the development of our product candidates; the impact to our business and operations by inflationary pressures; recession fears; the development of our product candidates, results from our nonclinical, 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 risks identified in our most recent 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 U.S. Securities and Exchange Commission. 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 Renmark Financial Communications Inc. James R. Kautz: jkautz@renmarkfinancial.com Tel: (416)-644-2020 or (212)-812-7680 To view the source version of this press release, please visit

Phase 1Immunotherapy

21 Jul 2026

·www.biospace.com

Phio Pharmaceuticals Announces Appointment of Dr. R. Todd Plott to the Board of Directors

Brings extensive experience in patient care, dermatologic research and commercialization King of Prussia, Pennsylvania--(News - July 21, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® gene silencing technology to eliminate cancer. Phio is pleased to announce that R. Todd Plott, M.D. has been appointed to the Board of Directors of Phio Pharmaceuticals. Todd Plott, MD, is a board-certified dermatologist, accomplished researcher, inventor, and former FDA advisory committee member with more than 30 years of experience in dermatologic care and innovation. He has played a significant role in advancing treatments for acne and other skin conditions through pharmaceutical research and development. Throughout his career, Dr. Plott oversaw and monitored hundreds of clinical trials, building deep expertise in drug development, clinical research, and patient care. He is now in private practice, focusing on complex skin diseases, acne, and skin cancer. Dr. Plott also served on the FDA Dermatologic and Ophthalmic Drug Advisory Committee from 2016 to 2021, reflecting his leadership and influence in the field of dermatology. "Dr. Plott's exceptional experience through his dermatology practice as well as clinical development expertise provides a valuable resource to Phio as we advance PH-762 for squamous cell carcinoma," said Robert Bitterman, CEO and Chairman of the Board. About Phio Pharmaceuticals Corporation Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, . 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. These statements, which include statements, among other things, regarding the anticipated benefits of our INTASYL™ RNAi platform, the results from our ongoing clinical trials, our expectations regarding timing of FDA submissions intended to propose and seek guidance for next steps in clinical study design for PH-762, our expectations that such FDA submissions and any related FDA meetings will clarify next steps in advancing the PH-762 development program, details regarding our planned non-clinical toxicology study, and our ability to support ongoing clinical development, operational requirements and strategic initiatives with the capital we currently have on hand, 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 of future FDA interactions on the development of our product candidates; the impact to our business and operations by inflationary pressures; recession fears; the development of our product candidates, results from our nonclinical, 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 risks identified in our most recent 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 U.S. Securities and Exchange Commission. 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

Phase 1Executive Change

15 Jul 2026

·www.biospace.com

Phio Pharmaceuticals Announces Patent Milestone with Multiple Notices of Allowance and Grant Decision

Securing additional patent protection in the United States, Canada, and Japan for INTASYL Compounds King of Prussia, Pennsylvania--(News - July 15, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® gene silencing technology to eliminate cancer. Phio Pharmaceuticals announced today significant progress in the protection of its proprietary innovations across key international markets. The company has received multiple favorable patent actions encompassing three notices of allowance and one grant decision to further strengthen Phio's global intellectual property portfolio in the United States, Canada, and Japan, respectively. This reinforces the Company's commitment to developing and safeguarding breakthrough technologies for the INTASYL compounds. "Strong patent protection is an important component of our strategy to advance innovative immuno-oncology therapies and maximize the long-term value of our INTASYL siRNA platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "These additional patent advancements across therapeutic areas and geographic regions will facilitate strategic partnerships, support R&D initiatives, and eventual commercialization." The patent portfolio consists of 54 issued patents. The portfolio encompasses the INTASYL ® chemistry, specific gene targets, immuno-oncology compounds and therapeutic indications in key countries. About Phio Pharmaceuticals Corporation Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, . 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. These statements, which include statements, among other things, regarding the anticipated benefits of our INTASYL™ RNAi platform, the results from our ongoing clinical trials, our expectations that our cash runway will extend into the first half of 2027, our expectations regarding timing of FDA submissions intended to propose and seek guidance for next steps in clinical study design for PH-762, our expectations that such FDA submissions and any related FDA meetings will clarify next steps in advancing the PH-762 development program, details regarding our planned non-clinical toxicology study, and our ability to support ongoing clinical development, operational requirements and strategic initiatives with the capital we currently have on hand, 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 of future FDA interactions on the development of our product candidates; the impact to our business and operations by inflationary pressures; recession fears; the development of our product candidates, results from our nonclinical, 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 risks identified in our most recent 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 U.S. Securities and Exchange Commission. 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

100 Deals associated with PH-762

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cutaneous Squamous Cell Carcinoma	Phase 1	United States	Phio Pharmaceuticals Corp.	07 Nov 2023
Melanoma, Cutaneous Malignant	Phase 1	United States	Phio Pharmaceuticals Corp.	07 Nov 2023
Metastatic Merkel Cell Carcinoma	Phase 1	United States	Phio Pharmaceuticals Corp.	07 Nov 2023
Advanced Malignant Solid Neoplasm	Phase 1	United States	AgonOx LLC	19 Jun 2023
Colorectal Cancer	Phase 1	United States	AgonOx LLC	19 Jun 2023
Female Genital Neoplasms	Phase 1	United States	AgonOx LLC	19 Jun 2023
Lung Cancer	Phase 1	United States	AgonOx LLC	19 Jun 2023
Squamous Cell Carcinoma of Head and Neck	Phase 1	United States	AgonOx LLC	19 Jun 2023
Melanoma	Phase 1	France	Phio Pharmaceuticals Corp.	01 Feb 2023
Breast Cancer	Preclinical	United States	Phio Pharmaceuticals Corp.	21 Aug 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06014086 (Company_Website) Manual	Phase 1	Skin Neoplasms Neoadjuvant	22	PH-762	bzarewnxsu(tsukkgetkr) = none ugvapfxapw (lmmdiitqvw ) View more	Positive	23 Mar 2026
				PH-762 (patients with cSCC)
Company_Website Manual	Phase 1	Skin Neoplasms	22	PH-762 (cSCC)	wwpienciau(veqilydzqx) = aqlphwdplu inxiyfsgdt (ktktsqqcfn ) View more	Positive	20 Jan 2026
				PH-762 (metastatic Merkel cell carcinoma)	azbzrecawv(hhffdjaukd) = wiyaiwnxbc ovthfeznup (igkzrxrrhz )
NCT06014086 (Company_Website) Manual	Phase 1	Metastatic melanoma \| Cutaneous Squamous Cell Carcinoma	10	PH-762 (cSCC)	geslkdqesb(pnvkogumxe) = juqubegrla enshgglvov (vcqqecnrlq ) View more	Positive	07 May 2025
				PH-762 (metastatic melanoma)	geslkdqesb(pnvkogumxe) = gvulrynfmg enshgglvov (vcqqecnrlq ) View more
NCT06014086 (Company_Website) Manual	Phase 1	Merkel Cell Carcinoma \| Melanoma \| Cutaneous Squamous Cell Carcinoma	4	PH-762	gzbisnsopt(uanqngpwpz) = none uousvjwhox (ncjqhcdkta ) View more	Positive	19 Dec 2024
NCT06014086 (Company_Website) Manual	Phase 1	Merkel Cell Carcinoma \| Melanoma \| Cutaneous Squamous Cell Carcinoma Neoadjuvant	-	PH-762	limunipczs(tieiblyzea) = None rcfkklybie (cuebebgptp ) View more	Positive	28 May 2024

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