Category: Health

Release – Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine

Posted on by [email protected]
Primary Logo

June 8, 2026

PDF Version

– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D

– All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline

– No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation in all enrolled patients

IRVINE, Calif., June 08, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The results were presented by trial investigator Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C (“HbA1c”) below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort.

While all patients enrolled reported recurrent severe hypoglycemic events pre-transplant, no severe hypoglycemic episodes were reported following transplantation. Severe hypoglycemia is a serious complication of type 1 diabetes that may require emergency medical intervention and can cause loss of consciousness, seizures, injury, or death. Recurrent severe hypoglycemic episodes can significantly impact patients’ daily activities and quality of life.

Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart-based immunosuppression regimen than in historical patients treated with a tacrolimus-based immunosuppression regimen at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Tegoprubart-based immunosuppression was generally well tolerated, with immunosuppression-related adverse events generally successfully treated by lowering the mycophenolic acid dose, if necessary. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors such as tacrolimus.

The investigator-initiated pilot study enrolled 12 adults with long-standing T1D undergoing allogeneic islet transplantation at UChicago Medicine with a median duration of diabetes of approximately 33 years and mean HbA1c of approximately 8.0% prior to transplantation. Participants received tegoprubart, as part of a calcineurin inhibitor-free immunosuppression regimen. Calcineurin inhibitors such as tacrolimus are commonly used to prevent transplant rejection but can be associated with kidney toxicity, hypertension, neurological side effects, and harm to insulin-producing islet cells, limiting their suitability for long-term use in patients with T1D receiving an islet cell transplant.

“T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

“Insulin independence without the burden of traditional immunosuppression has long been one of cell replacement therapy’s biggest goals,” said Aaron Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D. “Results like these show that this goal is becoming increasingly achievable. Breakthrough T1D is proud to fund this important study.”

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Eledon Announces Presentation of Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at American Diabetes Association (ADA) 2026 Scientific Sessions

Posted on by [email protected]
eledon logo

Research News and Market Data on ELDN

June 4, 2026

PDF Version

IRVINE, Calif., June 04, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated results from an investigator-initiated trial being conducted at the University of Chicago Medicine Transplant Institute will be presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

Details of the oral presentation are as follows:

Presentation Title: Anti-CD40L to Induce Graft Survival and Function in Islet Allotransplantation
Session: Immune Modulatory Strategies for Next-Generation Cell Therapies
Date: Sunday, June 7, 2026
Time: 2:30 p.m. – 3:00 p.m. CT
Room: 343 (Level 3)

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:
Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Primary Logo

Release – MAIA Biotechnology Reports Strong Enrollment and Dosing Momentum in Pivotal Phase 3 Non-Small Cell Lung Cancer Trial

Posted on by [email protected]
Primary Logo

Research News and Market Data on MAIA

June 04, 2026 9:45am EDTDownload as PDF

MAIA’s novel telomere-targeting therapy being evaluated as a third-line treatment for advanced non-small cell lung cancer

CHICAGO, June 04, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a patient enrollment update for 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). To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries.

Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, commented, “Enrollment and dosing in our Phase 3 study is progressing at a strong pace. Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027.”

Dr. Vitoc has previously stated that statistical assessments of MAIA’s lead therapeutic, ateganosine, suggest a high probability of technical success in the THIO-104 full approval trial if Phase 3 data is consistent with Phase 2 THIO-101 trial results. Median overall survival was 17.8 months in parts A and B of the Phase 2 trial. With chemotherapy, which is the standard utilized treatment for 3L NSCLC patients, expected survival in a heavily pre-treated population is 5.8 months.1

Ateganosine is a first-of-its-kind dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. As a potential breakthrough therapeutic, ateganosine holds substantial commercial opportunity in a projected $70 billion global NSCLC treatment market by 2030.2

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine as a 3L NSCLC treatment.

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-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

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. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

1 Girard N, et al. J Thorac Onc 2009;12:1544-1549
2 Research and Markets, Non-Small Cell Lung Cancer (NSCLC) Global Market Trends and Regional Growth Insights 2026-2030, March 2026

Primary Logo

Source: MAIA Biotechnology, Inc.

Released June 4, 2026

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on by [email protected]

June 03, 2026

 Download as PDF

BOTHELL, Wash., June 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company developing novel therapeutics to meet the growing need for effective, safe antiviral treatments, has appointed James Sapirstein Chief Executive Officer, effective immediately. The Company also plans to appoint Mr. Sapirstein as a member of the Board of Directors. He has extensive pharmaceutical industry leadership and development experience. Mr. Sapirstein replaces Sam Lee and Jim Martin, who served as Co-Chief Executive Officers. Sam Lee will continue as President and transition to Chief Scientific Officer, and Jim Martin will continue as Chief Financial Officer.

“James brings the right experience in the biopharma business as we’re accelerating the advancement of multiple clinical programs,” said Roger Kornberg, Ph.D., Chairman of Cocrystal Pharma. “We have known him for many years, and our management team and board are appreciative of his decision to join us as Chief Executive Officer.”

Mr. Sapirstein commented, “Cocrystal’s pipeline comprises transformative antivirals developed using its structure based drug discovery platform. We are well positioned with the right technology and team to create meaningful benefits for patients as well as our shareholders. The potential to address the need for new antivirals is highly motivating for me with my product development and launch background.”

Mr. Sapirstein has participated in or led 23 product launches. He has also driven numerous business development transactions. Mr. Sapirstein was Chief Executive Officer of Contravir Pharmaceuticals, served as the founding Chief Executive Officer of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories.

Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

Mr. Sapirstein is a member of several industry boards and previously served as Chairman of BioNJ as well as Biotechnology Innovation Organization board member for more than a decade. He is also a founding member of the board of advisors of the Miami Biotech Collective.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal Pharma is leveraging its structure based drug discovery platform technology to design next generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off target effects, offering potentially safer, broad spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

The Company’s platform provides a three dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. This technology permits the development of novel broad spectrum antivirals.

About Cocrystal Pharma

Cocrystal Pharma Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. Cocrystal employs unique structure based technologies to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on by [email protected]

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being researched as a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on by [email protected]

June 03, 2026 9:45am EDT

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) — 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 U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the 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. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

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. For more information, please visit www.maiabiotech.com.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on by [email protected]
Primary Logo

Research News and Market Data on MAIA

June 03, 2026 9:45am EDTDownload as PDF

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) — 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 U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the 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. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

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. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Primary Logo

Source: MAIA Biotechnology, Inc.

Released June 3, 2026

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on by [email protected]

Research News and Market Data on CVKD

Lead asset CAD-1005 being researched for prevention of life-threatening blood clots in patients with Heparin-induced Thrombocytopenia (HIT), targets $2 billion peak annual revenue potential

12-LOX could play a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis, and is a potential target for therapy and prevention of cancer

Late-stage anticoagulant tecarfarin has U.S. Food and Drug Administration (FDA) Orphan Drug and Fast Track designations for high-risk patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and those patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs)

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being researched as a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the Company showcasing its Phase 3-ready CAD-1005 and novel 12-LOX platform at BIO 2026; CAD-1005 being researched for the prevention of life-threatening blood clots in patients with HIT; CAD-1005 targeting $2 billion peak annual revenue potential; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis; 12-LOX being a potential target for therapy and prevention of cancer; the Company advancing novel therapies for life-threatening immune and thrombotic conditions; the Company’s participation in BIO 2026, taking place June 22-25, 2026, at the San Diego Convention Center; the Company’s executive management team hosting partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-LOX inhibitor being investigated for the treatment of patients with HIT, and tecarfarin, a late-stage oral VKA being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal; Cadrenal preparing to initiate its Phase 3 registration trial for CAD-1005; the Company believing it is uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades; the Company engaging with potential partners who share its vision of the potential to bring this breakthrough mechanism to patients; CAD-1005 being a potential first-in-class solution for HIT; CAD-1005 being investigated to target the root cause of HIT; CAD-1005 being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT; CAD-1005 reducing thrombotic events in patients with HIT; Cadrenal leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity; 12-LOX being a potential target for therapy and prevention of cancer; the Company’s platform representing a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents; Cadrenal aiming to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications; tecarfarin being a potentially superior anticoagulant for complex cases; Cadrenal presenting opportunities for tecarfarin, its late-stage oral anticoagulant, at BIO 2026; tecarfarin being designed with the goal of being a uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and DOACs; Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; CAD-1005 being researched as a first-in-class 12-LOX inhibitor for treating HIT; the development of second-generation 12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices; and frunexian being used in acute hospital settings. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on by [email protected]
Cocrystal Pharma, Inc.

Research News and Market Data on COCP

June 03, 2026

 Download as PDF

BOTHELL, Wash., June 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company developing novel therapeutics to meet the growing need for effective, safe antiviral treatments, has appointed James Sapirstein Chief Executive Officer, effective immediately. The Company also plans to appoint Mr. Sapirstein as a member of the Board of Directors. He has extensive pharmaceutical industry leadership and development experience. Mr. Sapirstein replaces Sam Lee and Jim Martin, who served as Co-Chief Executive Officers. Sam Lee will continue as President and transition to Chief Scientific Officer, and Jim Martin will continue as Chief Financial Officer.

“James brings the right experience in the biopharma business as we’re accelerating the advancement of multiple clinical programs,” said Roger Kornberg, Ph.D., Chairman of Cocrystal Pharma. “We have known him for many years, and our management team and board are appreciative of his decision to join us as Chief Executive Officer.”

Mr. Sapirstein commented, “Cocrystal’s pipeline comprises transformative antivirals developed using its structure based drug discovery platform. We are well positioned with the right technology and team to create meaningful benefits for patients as well as our shareholders. The potential to address the need for new antivirals is highly motivating for me with my product development and launch background.”

Mr. Sapirstein has participated in or led 23 product launches. He has also driven numerous business development transactions. Mr. Sapirstein was Chief Executive Officer of Contravir Pharmaceuticals, served as the founding Chief Executive Officer of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories.

Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

Mr. Sapirstein is a member of several industry boards and previously served as Chairman of BioNJ as well as Biotechnology Innovation Organization board member for more than a decade. He is also a founding member of the board of advisors of the Miami Biotech Collective.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal Pharma is leveraging its structure based drug discovery platform technology to design next generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off target effects, offering potentially safer, broad spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

The Company’s platform provides a three dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. This technology permits the development of novel broad spectrum antivirals.

About Cocrystal Pharma

Cocrystal Pharma Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. Cocrystal employs unique structure based technologies to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s potential to address the need for new antivirals through its research and development of product candidates. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:

Nicolas Johnson
Russo Partners
[email protected]
(303) 482-6405

Media Contact:

David Schull
Russo Partners
[email protected]
(858) 717-2310

Attachment

Primary Logo
Cocrystal Pharma Inc.
Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Infectious Disease Therapeutics Development Experience

Source: Cocrystal Pharma, Inc.

Released June 3, 2026

Release – Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting

Posted on by [email protected]
Cardiff Oncology, Inc. logo

Research News and Market Data on CRDF

June 2, 2026

PDF Version

-​ The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -​

-​ 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -​

-​ Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -​

– Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -​

– Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -​

– Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib –

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

“RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers,” said Dr. Lenz. “With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients.”

Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):
In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

  • Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
  • Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
  • Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Safety/Tolerability:
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

“We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC,” said Mani Mohindru, PhD, President and Chief Executive Officer. “The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months.”

The ASCO presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.

Conference Call and Webcast
The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Cardiff Oncology, Inc. 
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; ; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. with respect to our license agreement with Nerviano; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact: 
Candice Masse 
astr partners 
[email protected]

Media Contact: 
Amy Bonanno 
Lyra Strategic Advisory 
[email protected]

Release – MAIA Biotechnology Announces Open Market Purchases by CEO and Director

Posted on by [email protected]
Primary Logo

Research News and Market Data on MAIA

June 02, 2026 9:45am EDT Download as PDF

CHICAGO, June 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that its founder and CEO Vlad Vitoc, M.D. and Director Stan V. Smith, Ph.D. have increased their ownership positions through open market purchases.

Approximately 72,700 shares of MAIA common stock were purchased by Dr. Vitoc on June 6, 2026, at an average common stock price of $1.3877. Approximately 75,000 shares of MAIA common stock were purchased by Dr. Smith on June 6, 2026, at an average common stock price of $1.336.

“Our continuing investments underscore our strong confidence in the telomere-targeting immuno-oncology platform we’ve established,” said Dr. Vitoc. “As the ateganosine program advances toward later-stage development, we believe ateganosine could become an important new standard of care for patients with advanced non-small cell lung cancer.”

“MAIA continues to advance what I believe is a differentiated approach to cancer treatment with strong scientific rationale and encouraging clinical momentum,” Dr. Smith added. “I’m a strong believer in the incredible potential future that MAIA has in contributing to the patients and investors alike.”

To date, directors and officers of MAIA hold a 20.46% 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. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Primary Logo

Source: MAIA Biotechnology, Inc.

MAIA Biotechnology (MAIA) – Phase 3 THIO-104 Trial Design Presented At ASCO

Posted on by [email protected]


Tuesday, June 02, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Phase 3 THIO-104 Design Is Consistent With Expectations. MAIA presented a poster on May 31, 2026, at the Annual ASCO (American Society of Clinical Oncology) Meeting. The poster detailed the design of its ongoing Phase 3 THIO-104 trial that tests ateganosine (aka THIO) in combination with the checkpoint inhibitor cemiplimab as a third-line treatment for patients with non-small cell lung cancer (NSCLC) who have become resistant to CPI treatment and chemotherapy.

Trial Design Is Consistent With Results From Phase 2 THIO-101 Trial. The patient population, selected dose, and combination regimen with Ateganosine 180mg and cemiplimab (Libtayo, from Regeneron) are the same as those in the Phase 2 THIO-101 study. At last analysis as of June 30, 2025, this regimen showed a median observed Overall Survival (OS) of 17.8 months, compared with published studies reporting an OS of 5.8 months.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Greenwich LifeSciences, Inc. (GLSI) – Additional Phase 3 FLAMINGO-01 Data Presented At ASCO Meeting

Posted on by [email protected]


Tuesday, June 02, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Additional Data Presented At ASCO. Greenwich LifeSciences presented an abstract and poster at the ASCO Annual Meeting.  The data assessed non-HLA-A*02 patients in the open-label arm after six monthly doses of GLA-100. The data show statistically significant injection site reaction (ISR) and immune response at baseline, with increases over time.

Patients Were Evaluated After Initial Immune Stimulation. Patients received the Primary Immunization Series (PIS), consisting of six vaccinations over the first six months of the trial. The fourth, fifth, and sixth vaccinations showed a significant increase in the percentage of patients showing an ISR compared to baseline. Of the 247 patients enrolled, 208 had both baseline vaccination and assessments at 4, 5, or 6 months.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.