Phio Pharmaceuticals Announces Successful Completion of First Commercial-Scale cGMP Batch of PH-762 Drug Substance

 

Source:  Phio Pharmaceuticals Corp.  10/13/2026

Critical Manufacturing Milestone Supports Supply Chain Readiness and Planned Phase 2b Clinical Trial Initiation in First Quarter 2027

Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary INTASYL® siRNA gene-silencing platform, today announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing a critical operational and strategic milestone as the Company advances PH-762 to the next stage of clinical development.

The batch was manufactured in accordance with established specifications and quality requirements, as confirmed by the accompanying Certificate of Analysis and Certificate of Compliance. Manufacturing was conducted in compliance with current Good Manufacturing Practice (cGMP) regulations, the approved Master Batch Record, and applicable ICH Q7 guidelines.

Validated drug substance will now proceed through the final steps of drug product completion for use in Phio's planned Phase 2b clinical study, which drug product is expected to be initiated in the first quarter 2027. Successful completion of this commercial-scale manufacturing milestone underscores the Company's supply chain readiness and supports the next steps in its clinical development and potential commercialization strategy for PH-762.

"This achievement culminates a complex coordination and cross functional execution process started some 16 months ago among numerous highly skilled scientists and engineers," said Robert Bitterman, President and CEO of Phio Pharmaceuticals. "This is a meaningful advancement in the PH-762 program, mitigating key development and manufacturing risks, and positions the Company to execute on important upcoming clinical and regulatory milestones."

About Phio Pharmaceuticals Corp.

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.

 

Phio Announces Key Development Milestone for PH-762 with FDA Submission Supporting Next Stage of Clinical Development in Cutaneous Squamous Cell Carcinoma

Source:  Phio Pharaceuticals Corp. 9/14/2026

Company Proposes Planned Phase 2b Neoadjuvant Study Following Successful Completion of Phase 1b Trial

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 announced today that, following the formal completion of the Phase 1b clinical study, it has submitted a meeting request and comprehensive briefing package to the U.S. Food and Drug Administration (FDA).

The submission describes the nonclinical development program and integrated clinical pharmacology data for PH-762 and provides details of the completed Phase 1b study as well as the next planned Phase 2b neoadjuvant clinical study in cutaneous squamous cell carcinoma. The briefing package includes the scientific rationale, study design, and pharmacokinetic strategy intended to support the next stage of clinical development.

"Delivering this comprehensive briefing package to the FDA is a key achievement for the PH-762 program and an important step toward unlocking its clinical potential in cutaneous squamous cell carcinoma," said Robert J. Bitterman, President and CEO of Phio Pharmaceuticals. "We are encouraged by the Phase 1b findings and look forward to working with the FDA as we pursue the next phase of development."

Phio is currently preparing to manufacture clinical supplies for the next planned study, which are expected to be available in the first quarter of 2027. In addition, the dosing phase of the company's nonclinical toxicology study has been completed. Final activities supporting the next phase of clinical development are expected to be completed during the first quarter of 2027.

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.

 

Phio Pharmaceuticals Secures U.S. Notice of Allowance for INTASYL Composition Selectively Targeting BRD4 Protein with Compound PH-894

 

Source:  Phio Pharmaceuticals Corp. 8/11/2026

PH-894 protection for chemical structure, genetic sequencing and broad application for proliferative and infectious diseases in U.S.

Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing immuno-oncology therapeutics based on its proprietary INTASYL® gene-silencing technology, today announced the receipt of a U.S. Notice of Allowance for a patent covering PH-894, further strengthening the Company's intellectual property portfolio.

The patent allowance represents a critical milestone in protecting Phio's strategic interest in the Company's INTASYL® platform. PH-894, designed to selectively silence BRD4, is a key regulator of gene expression associated with proliferative and infectious disease.

"Robust intellectual property protection is a continuous focus in our development strategy to advance novel immuno-oncology therapies and maximize the long-term value of the INTASYL platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "This patent advancement solidifies our commitment to advance PH-894 in the U.S. and pursue strategic collaborations internationally."

Phio has built a comprehensive patent estate supporting its INTASYL® technology and therapeutic pipeline. The Company's portfolio currently includes 54 issued patents covering INTASYL chemistry, specific gene targets, immuno-oncology compounds, and therapeutic applications across major global markets.

The newly allowed patent further reinforces Phio's commitment to protecting its proprietary innovations and advancing next-generation cancer therapies based on targeted gene silencing.

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.

 

MAIA Biotechnology Expands Pivotal Phase 3 THIO-104 Non-Small Cell Lung Cancer Trial into Spain and Portugal

 

Source:  MAIA Biotechnology, Inc. 9/23/2026

 THIO-104 advances toward key 2027 interim survival analysis

MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National Authority of Medicines and Health Products (INFARMED) to begin screening patients for its ongoing pivotal Phase 3 THIO-104 clinical trial in non-small cell lung cancer (NSCLC).

Spain and Portugal represent important European markets for NSCLC, with an estimated 30,000 new cases annually across the two countries. Spain has a substantial lung cancer burden associated with historical tobacco exposure, with lung cancer incidence among women continuing to rise. In Portugal, NSCLC accounts for approximately 82% of lung cancer cases, the highest proportion reported among five European populations evaluated in a comparative study.

“Expanding THIO-104 into Spain and Portugal represents another important step in the execution of our pivotal Phase 3 program,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “Clinical trial participation can provide patients with access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged. By establishing THIO-104 sites in Spain and Portugal, we are broadening access to a potentially important new treatment option for patients with advanced NSCLC who have progressed following standard of care treatments.”

To date, THIO-104 has enrolled 65 NSCLC patients resistant to chemotherapy and checkpoint inhibitor treatments at 28 clinical sites in 6 European countries and 10 sites in Taiwan. Among the six European countries, sites in Hungary, Poland, and Turkey are actively enrolling and dosing patients from populations with the highest lung cancer incidence and mortality rates in Europe and globally.¹

MAIA targets 100 patients dosed in THIO-104 by year-end 2026 and expects to have sufficient survival data to conduct an interim data analysis in 2027.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells.

 

MAIA Biotechnology Reports Pivotal Phase 3 Clinical Trial Progress in Advanced Non-Small Cell Lung Cancer

 

Source:  MAIA Biotechnology, Inc. 

Strong pace of patient enrollment supports continued advancement toward regulatory milestones

Most recent assessment of novel telomere targeting agent sequenced with a checkpoint inhibitor showed 90.5% disease control rate (DCR) in heavily pretreated NSCLC

MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary).

“Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “As we’ve stated previously, statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.¹ We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited.”

In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed 90.5% interim disease control rate (DCR) in heavily pretreated 3L NSCLC in MAIA’s ongoing phase 2 THIO-101 clinical trial. This measure contrasts with reported 25%–35% DCRs for standard third-line chemotherapy regimens.

In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells.

 

MAIA Biotechnology Doses First U.S. Patient in Ongoing Phase 2 Non-Small Cell Lung Cancer Clinical Trial

 

 

Source:  MAIA Biotechnology, Inc. 9/16/2026

 

Milestone follows FDA clearance of MAIA’s amended investigational new drug (IND) submission highlighting improved manufacturing capabilities and efficiencies 

U.S. expansion is funded by a $2.3 million NIH grant to MAIA to support third-line treatment evaluation

MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the first U.S. patient has been dosed in its Phase 2 THIO-101 trial expansion evaluating its telomere-targeting lead candidate, ateganosine, in third-line non-small cell lung cancer (NSCLC). The U.S. Phase 2 expansion is funded by a $2.3 million grant from the National Institutes of Health (NIH) to support third-line treatment evaluation and MAIA has activated 3 sites in the U.S.

MAIA holds FDA Fast Track designation for ateganosine, a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. Prior data from THIO-101 Parts A and B show overall survival (OS) beyond 24 months in eight patients receiving ateganosine sequenced with a checkpoint inhibitor.

“We have worked diligently to advance ateganosine into the U.S. market, and dosing the first patient in the United States represents a major milestone for our ongoing Phase 2 clinical trial,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “Our collaborations with some of the nation’s top institutions and foremost oncologists further strengthen the trial as we evaluate ateganosine for patients in advanced stages of this exceedingly hard-to-treat disease. We believe the data generated through the THIO-101 program may also support a potential pathway toward FDA accelerated approval. With patients now enrolled across four continents, the study has evolved into a truly global effort focused on addressing a critical unmet need in cancer care.”

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo^®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo^®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells.

 

MAIA Biotechnology Announces Open Market Purchases of Company Stock by Long-Standing Board Member and CEO

 

Source:  MAIA Biotechnology, Inc. 9/15/2026

MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that Board member Ramiro Guerrero, JD, LL.M. has increased his ownership stake in the Company through open market purchases totaling approximately $252,284. A total of 185,078 shares of MAIA common stock were acquired by Mr. Guerrero between August 20, 2026, and September 10, 2026, at an average common stock price of $1.36. MAIA also announced that 73,000 shares of MAIA common stock were acquired by Founder and CEO Vlad Vitoc, M.D. on September 14, 2026, at an average common stock price of $1.37.

“Our increased investments reflect the confidence we share across our leadership team in MAIA’s science, clinical strategy and long-term commercial potential,” said Dr. Vitoc. “With a growing body of clinical evidence supporting the ateganosine program, we believe MAIA is entering an increasingly important period in its development.”

“As MAIA has stated previously, its ongoing pivotal Phase 3 trial offers a statistically high probability of technical success,” Mr. Guerrero added. “I continue to believe MAIA is well positioned to create a great deal of value for its shareholders over time.”

MAIA’s ongoing pivotal Phase 3 trial THIO-104 evaluates ateganosine sequenced with checkpoint inhibitor cemiplimab versus investigator’s choice in third-line non-small cell lung cancer (NSCLC). Statistical assessments of ateganosine suggest a high probability of technical success and potential early full commercial approval if Phase 3 interim data is consistent with Phase 2 THIO-101 trial results. MAIA recently announced positive initial efficacy data from the ongoing Phase 2 THIO-101 clinical trial expansion, Part C, with third-line studies showing a disease control rate (DCR) of 90.5%¹ in the efficacy evaluable population who had at least one tumor scan after starting treatment. 

As of September 14, 2026, MAIA’s directors and officers hold a 21.34% stake in the Company.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells.