MAIA Biotechnology Opens Enrollment for Phase 2 Expansion Trial of Novel Telomere-Targeting Agent at Winship Cancer Institute of Emory University

On June 18, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that the third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University ("Winship"), is activated and now enrolling patients. The trial studies MAIA’s lead investigational telomere-targeting agent, ateganosine, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).

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Matthew Failor, Director of Clinical Operations for MAIA, commented, "Winship is Georgia’s only National Cancer Institute (NCI)-designated Comprehensive Cancer Center and is recognized at the forefront of cancer innovation and discovery nationwide. Winship offers a renowned thoracic oncology clinical research program with a proven track record in clinical trial development and conduct. With its premier medical team and extensive body of research, this cancer center is well-suited for our U.S. Phase 2 trial of ateganosine."

The principal investigator for the THIO-101 expansion trial at Winship is Ticiana Leal, M.D., a professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine. Dr. Leal’s clinical research focuses on trials involving chemotherapy and immunotherapy agents for lung cancer.

Dr. Leal commented, "At Winship, we serve the state of Georgia and surrounding states where innovation in lung cancer treatment is a broad, underserved need. In Georgia, lung cancer is the leading cause of cancer-related deaths, with over 7,300 new cases in 2025. MAIA’s novel ateganosine agent, if approved, could address a significant gap in clinical care for the advanced-stage NSCLC patient population where there are no FDA-approved options available for treatment."

THIO-101 is an ongoing Phase 2, open-label trial evaluating ateganosine followed by cemiplimab for NSCLC patients resistant to checkpoint inhibitors and chemotherapy. Parts A and B of the trial have shown strong early efficacy, with some patients showing survival exceeding two years, and now MAIA continues to expand the trial in the U.S.

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.

(Press release, MAIA Biotechnology, JUN 18, 2026, View Source [SID1234668807])

Novocure Announces Topline Data from the Phase 3 TRIDENT Trial Evaluating Earlier Use of Tumor Treating Fields Therapy in Newly Diagnosed Glioblastoma

On June 18, 2026 Novocure (NASDAQ: NVCR) reported topline results today from its Phase 3 TRIDENT trial, which evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) at the start of chemoradiation (Early Start Arm) compared to initiating TTFields therapy during the subsequent maintenance phase of treatment (Maintenance Start Arm).

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The trial did not demonstrate a statistically significant improvement in the primary endpoint of overall survival for the Early Start Arm compared to the Maintenance Start Arm. In the intent-to-treat (ITT) population, the Early Start Arm had a median overall survival of 17.7 months compared to 17.5 months in the Maintenance Start Arm (HR 0.953; p=0.519).

"TRIDENT represents the largest glioblastoma trial focused on optimizing the integration of Tumor Treating Fields therapy into standard chemoradiotherapy," said Wenyin Shi, MD, PhD, Professor of Radiation Oncology, Co-Director of the Jefferson Brain Tumor Center at Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University. "Although the study did not meet its primary endpoint, it reaffirmed the clinical value of Tumor Treating Fields therapy and demonstrated promising signals that earlier initiation of TTFields treatment may improve outcomes for selected patients."

The survival results in the ITT population in both study arms were durable over a long-term period with the one-, two-, and three-year survival rates in the Early Start Arm achieving 70.9%, 33.9% and 22.5%, respectively. In the Maintenance Start Arm, the survival rates were 72.0%, 31.6% and 18.4%, respectively.

TRIDENT enrolled 981 patients who were randomized shortly after surgery, including those who experienced clinical or radiographic deterioration during chemoradiation therapy. Approximately 25% of patients did not initiate the maintenance phase across both arms of the trial. The median patient age was 60 years. Baseline characteristics of the patient population were balanced across both arms of the trial and included: 38% of patients with a KPS of 70 or 80; 39% with a methylated MGMT promoter and 5% had IDH-mutant tumors. The extent of surgical resection was also balanced across arms, 51% of patients had a gross total resection, 37% a partial resection, and 12% biopsy only.

"We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible," said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. "The study did not meet its primary endpoint, but the results from TRIDENT demonstrated the feasibility and safety of initiating Tumor Treating Fields therapy during chemoradiation. We look forward to sharing additional analyses from this trial, which may inform future treatment approaches for patients with specific characteristics."

TTFields therapy, including initiation with chemoradiation, was well-tolerated, and did not lead to any new safety signals. Device related safety was consistent with prior clinical studies of TTFields therapy in GBM.

About TRIDENT

TRIDENT is a Phase 3 global, pivotal, randomized, open-label, two-arm, multicenter trial designed to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) therapy given concomitantly with chemoradiation (radiation therapy and temozolomide), for newly diagnosed glioblastoma patients, compared to initiating TTFields therapy once chemoradiation therapy is complete. In both arms, TTFields therapy and maintenance temozolomide are continued following chemoradiation therapy.

The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival, one-, two- and three-year survival rates, overall radiologic response (ORR) based on the 2010 Response Assessment in Neuro-Oncology (RANO) criteria, next progression-free survival based on the 2010 RANO criteria, and progression-free survival at 6 months and 12 months, and the severity and frequency of adverse events.

RANO guidelines are an international, multidisciplinary set of recommendations designed to standardize the evaluation of treatment response in clinical trials for brain tumors.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

(Press release, NovoCure, JUN 18, 2026, View Source [SID1234668806])

Kovina Therapeutics Announces Publication in PNAS Validating HPV E6 Targeted Therapeutic Approach

On June 18, 2026 Kovina Therapeutics Inc. reported publication in the Proceedings of the National Academy of Sciences (PNAS) of research validating its HPV E6 targeted therapeutic approach.

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The publication, "Covalent Inhibitors of Human Papillomavirus Type 16 E6 Protein Restore p53 Function and Suppress Growth of HPV-Driven Tumors in vivo," reports that small molecules developed through Kovina’s HPV E6 program restore p53 tumor suppressor activity, induce apoptosis and senescence in HPV-positive cancer cells, and suppress tumor growth in multiple in vivo models.

HPV-associated cancers depend on sustained expression of the viral E6 oncoprotein, which mediates degradation of the tumor suppressor protein p53. Despite decades of research, E6 has remained a difficult therapeutic target.

The study included multiple controls demonstrating that compound activity is selective for HPV expressing cells. Genetic validation of mechanism was further established through an engineered E6 resistance mutation that prevented compound binding and rendered tumor cells resistant to treatment.

Key findings reported in the publication include:

Restoration of p53 protein stability and activity in HPV-positive cancer cells
Activation of downstream p53 transcriptional programs
Induction of apoptosis and senescence
Suppression of HPV-positive cervical and oropharyngeal tumor growth in vivo
"This publication validates our approach to directly targeting HPV E6 and restoring p53 function," said Kristin Sherman, Chief Executive Officer of Kovina Therapeutics. "These findings support HPV E6 as a therapeutic target and provide a strong scientific foundation for advancing our development programs in HPV-associated cancers and premalignant disease."

The paper was published in PNAS on June 5, 2026.

Read the publication: View Source

(Press release, Kovina Therapeutics, JUN 18, 2026, View Source [SID1234668805])

TORL BioTherapeutics Presents Preliminary Safety and Efficacy Data of Ixotatug Vedotin (TORL-1-23) in Combination with Bevacizumab in Recurrent Ovarian Cancer at ESMO Gynaecological Cancers Congress 2026

On June 18, 2026 TORL BioTherapeutics LLC (TORL), a clinical stage oncology-focused biotechnology company, reported preliminary Phase 1 safety and efficacy data of ixotatug vedotin (Ixo-V or TORL-1-23) in combination with bevacizumab in recurrent ovarian cancer at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026. The data presented suggest that the combination of Ixo-V and bevacizumab may expand therapeutic options for patients with Claudin 6 -positive (CLDN6+) ovarian cancer in both the platinum-resistant and platinum-sensitive settings.

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"We are encouraged by the emerging safety and efficacy profile of Ixo-V in combination with bevacizumab in patients with CLDN6-positive recurrent ovarian cancer, a population with particularly poor prognosis and high unmet need," said Aran Maree, M.D., Chief Executive Officer of TORL BioTherapeutics. "In parallel with our registrational study, CATALINA-2, these data provide important clinical support for Ixo-V in combination with existing standards of care, such as bevacizumab, and in earlier lines of ovarian cancer."

As a part of the ongoing Phase 1 first-in-human, dose-escalation study evaluating the safety, efficacy, and antitumor activity of Ixo-V in patients with advanced cancer, the combination of Ixo-V with bevacizumab is being assessed in patients with CLDN6+ and CLDN6-low recurrent ovarian cancer (greater than 30% or 1-30% tumor cell membrane staining of any intensity by immunohistochemistry, respectively). Data presented reflect Ixo-V (2.4 mg/kg or 3.0 mg/kg) plus bevacizumab (15 mg/kg) administered intravenously on day one and pegfilgrastim on day four of a 21-day cycle.

A total of 29 patients were treated, and 18 remain on treatment. Patients had received a median of two prior lines of therapy (range: 1-5). Prior treatments included platinum-based chemotherapy, taxanes, bevacizumab, PARP inhibitors, and mirvetuximab soravtansine.

Per RECIST v1.1 criteria, preliminary results suggest that the combination of Ixo-V and bevacizumab may expand therapeutic options for patients with CLDN6+ ovarian cancer in both the platinum-resistant and platinum-sensitive settings. Key study findings include the following:

Preliminary results showed favorable tolerability characterized by a manageable safety profile, with no clinically significant bleeding, ocular events, bowel perforation, or thromboembolic events reported.
The objective response rate (ORR) across all 29 participants was 32.1%, with ORRs of 33.3% in the 2.4 mg/kg cohort and 31.3% in the 3.0mg/kg.
The disease control rate (DCR) across all participants was 92.9%, including 83.3% in the 2.4 mg/kg cohort and 100% in the 3.0mg/kg cohort.
Clinical responses were observed in patients who received prior PARP inhibitors (7 of 13), prior bevacizumab (5 of 20), or prior mirvetuximab soravtansine (1 of 1).
Presentation Details

Title: Preliminary safety and efficacy of ixotatug vedotin (TORL-1-23), a Claudin 6-targeted ADC, in combination with bevacizumab in recurrent ovarian cancer
Lead Author: Jung-Yun Lee, M.D., Ph.D., Department of Obstetrics and Gynecology, Yonsei University College of Medicine
Presentation Number: 140P
Presentation Session: Poster Display Session
Presentation Session Date and Time: Thursday, June 18, 2026; 12:45-13:30 CEST

TORL continues to advance CATALINA-2, a global, randomized, open-label Phase 2 study of Ixo-V in women with CLDN6+ platinum-resistant ovarian cancer, with topline pivotal results anticipated in mid-2027. In parallel to this registrational program, CATALINA-4, a Phase 1b/2 study to investigate the safety and efficacy of Ixo-V with chemotherapy given before initial surgery in women with CLDN6+ advanced stage ovarian cancer, is ongoing. Beyond ovarian cancer, the Company continues to evaluate Ixo-V in other indications including non-small cell lung cancer.

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in several cancers with limited to no detectable expression observed in normal tissues, making it an ideal target for ADC development. CLDN6 is a transmembrane protein and member of a family of proteins important for cell-to-cell connectivity in normal tissues. CLDN6 expression normally occurs during embryonic and fetal development but not in adult tissues. Overexpression of CLDN6 occurs in specific malignancies and has been implicated in the pathogenesis of certain cancers including ovarian, non-small cell lung, endometrial and testicular malignancies. High expression correlates with shortened survival outcomes for patients with ovarian cancer.

About Ixotatug Vedotin (Ixo-V; TORL-1-23)

Ixotatug vedotin is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. Ixotatug vedotin has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of ixotatug vedotin in women with CLDN6+ PROC. Further details can be found at View Source

About CATALINA-2

CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC ixotatug vedotin in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at View Source

(Press release, TORL Biotherapeutics, JUN 18, 2026, View Source [SID1234668804])

Compugen Presents a Trial-in-Progress Poster on the MAIA-ovarian Adaptive Platform Trial at ESMO Gynaecological Cancers Congress

On June 18, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, reported a trial-in-progress poster on the MAIA-ovarian adaptive platform trial of COM701, a potential first-in-class anti-PVRIG antibody, at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026, in Copenhagen, Denmark.

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"We believe there is a strong biologic and clinical rationale for the MAIA-ovarian trial in relapsed platinum-sensitive ovarian cancer, where no standard of care for this maintenance setting exists," said Eran Ophir, Ph.D., President and CEO of Compugen. "COM701 is well tolerated and has previously shown consistent, durable responses in heavily pre-treated patients with platinum-resistant ovarian cancer. As highlighted in our poster, the differentiated biology of the PVRIG pathway, together with its high expression in ovarian cancer and prior clinical signals, supports our evaluation of COM701 in the MAIA-ovarian adaptive trial, with initial data expected by Q1 of 2027."

Poster details:

Title: MAIA-ovarian (NCT06888921) Adaptive Platform Clinical Trial to Evaluate Safety and Efficacy of COM701 Maintenance Treatment in Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

Speaker: Dr. Oladapo Yeku, Massachusetts General Hospital, Boston, MA, U.S.

Poster presentation number: 170

Date and time of poster presentation: June 18, 2026, 12:45 – 13:30 CEST

Following the presentation, the poster will be available in the publications section of Compugen’s website, www.cgen.com

About COM701

COM701 is Compugen’s potential first-in-class anti-PVRIG antibody, a novel immune checkpoint identified through Compugen’s computational discovery platform. COM701 has been evaluated in Phase 1 clinical studies as monotherapy and in combination, with data demonstrating initial signs of anti-tumor activity and a favorable safety and tolerability profile. COM701 is currently being evaluated in the randomized MAIA-ovarian adaptive platform trial as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer.

(Press release, Compugen, JUN 18, 2026, View Source [SID1234668803])