Objective response rate across all 29 participants was 32.1%; Favorable disease control rate (92.9%) across all participants was observed

Data suggest that the combination of Ixo-V and bevacizumab may expand therapeutic options for Claudin 6-positive patients in both the platinum-resistant and platinum-sensitive settings

Pivotal data from the Phase 2 registrational CATALINA-2 study anticipated in mid-2027

LOS ANGELES, June 18, 2026 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a clinical stage oncology-focused biotechnology company, today announced 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) 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.

"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 https://clinicaltrials.gov/study/NCT06690775.

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 https://clinicaltrials.gov/study/NCT06690775.

About TORL BioTherapeutics LLC

TORL is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal antibodies and ADCs, with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets.

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