TORL BioTherapeutics to Present Updated Phase 1 Results of Novel Targeted Claudin-6 Antibody-Drug Conjugate TORL-1-23 at the European Society of Medical Oncology 2024 Congress |

TORL-1-23 demonstrates clinically meaningful, durable and confirmed responses with a generally manageable safety profile in patients with claudin 6-positive (CLDN6+) platinum-resistant ovarian cancer

Expansion cohorts in patients with ovarian cancer, non-small cell lung cancer and other CLDN6+ cancers are being further investigated in the current Phase 1 study

Phase 1 data support initiation of a pivotal Phase 2 study in patients with CLDN6+ platinum-resistant ovarian cancer

LOS ANGELES, 15 September 2024 /PRNewswire/ — TORL BioTherapeutics, LLC (“TORL Bio” or “the Company”), a clinical-stage biotechnology company discovering and developing novel antibody-based immunotherapies to improve and prolong the lives of cancer patients worldwide, today announced the presentation of additional results from the ongoing Phase 1 study of TORL-1-23, the Company's targeted antibody-drug conjugate (ADC) to claudin 6 (CLDN6) in patients with advanced cancer at the 2024 European Society of Medical Oncology (ESMO 2024) Congress in Barcelona, ​​​​Spain. This mini-presentation (ESMO Presentation No. 721MO) provided updated results from study TORL123-001 (TRIO-049) up to the dose of 4.0 mg/kg of TORL-1-23. The data were presented by the Global Principal Investigator, Gottfried E. KonecnyManaging Director of University of California, Los Angeles (University of California) Medical Center.

“The latest efficacy and safety data from this Phase 1 study continue to support the potential of TORL-1-23 as a new treatment option for patients with claudin-6-positive ovarian cancer,” said the global principal investigator. Gottfried E. KonecnyMD from UCLA Medical Center.

This ongoing Phase 1 trial enrolls 81 patients with CLND6-positive (CLDN6+), heavily pretreated ovarian, testicular, endometrial, non-small cell lung (NSCLC) and other cancers. Its safety and efficacy are being evaluated in 11 dosing cohorts ranging from 0.2 mg/kg to 4.0 mg/kg administered intravenously every 3 weeks. Patients had received an average of 4 prior regimens.

The key findings of the study include:

• At doses ranging from 0.2 mg/kg to 2.4 mg/kg every 3 weeks, TORL-1-23 is generally well tolerated. The most common adverse reactions were Grade 1 or 2 fatigue, peripheral neuropathy, and alopecia. The most common Grade 3+ adverse reaction was neutropenia. Febrile neutropenia, interstitial lung disease, and ocular toxicity were not observed.
• Pegfilgrastim was administered prophylactically at doses of 3.0 mg/kg or higher and effectively alleviated neutropenia. The maximum tolerated dose (MTD) remains to be determined.
• In this heavily pretreated population, encouraging antitumor activity was observed during dose-finding across all cancer histologies and dose levels studied.
• At doses of 2.4 mg/kg and 3.0 mg/kg every 3 weeks, 9/20 (45%) patients with CLDN6+ platinum-resistant/refractory ovarian cancer (PROC) experienced deep and durable confirmed responses. The median duration of response was greater than 6 months at both doses.

“The goal of molecularly targeted therapies against cancer is to significantly increase efficacy while maintaining or improving safety over established treatments. The emerging Phase 1 profile of TORL-1-23 suggests that this ADC could achieve this goal for patients with platinum-resistant ovarian cancer, a serious unmet medical need,” said scientific co-founder Dennis SlamonMD, PhD, Professor of Medicine and Head of the Department of Hematology/Oncology at The UCLA David Geffen School of medicine.

Phase 1 evaluation of TORL-1-23 in NSCLC and other CLDN6+ cancers is ongoing, and a Phase 2 multiple-dose study to support accelerated approval in CLDN6+ PROC is initiating.

Presentation details

Title: Two-part, multicenter, Phase 1 first-in-human (FIH) study of TORL-1-23, a novel antibody-drug conjugate (ADC) targeting claudin 6 (CLDN6) in patients with advanced solid tumors

Main author: Gottfried KonecnyMD, UCLA Medical Center

Presentation number: 721MO

Presentation session: Mini-Session 2: Gynecological Cancers

Date and time of the presentation session: 15 September 2024at 15:50 CEST

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in several cancers, with limited or no detectable expression observed in normal tissues, making it an ideal target for the development of antibody-drug conjugates. CLDN6 is a tumor-specific tight junction transmembrane protein important for cell-to-cell connectivity. Overexpression of CLDN6 is involved in the initiation, progression, and metastasis of certain cancers, including ovarian cancer, non-small cell lung cancer, endometrial cancer, testicular cancer, and others. High expression correlates with reduced survival in patients with ovarian cancer.

About TORL-1-23

TORL-1-23 is a first and potentially best clinical-stage antibody drug conjugate (ADC) for the treatment of claudin 6-positive (CLDN6+) solid tumors. Select centers are enrolling patients in the Part 2 extension of the Phase 1 TORL123-001 (TRIO-049) study evaluating the safety, pharmacokinetics, biomarkers and antitumor activity of TORL-1-23. For more details, including current study sites, visit https://clinicaltrials.gov/show/NCT05103683.

About TORL BioTherapeutics, LLC

TORL BioTherapeutics, LLC (TORL Bio) is a clinical-stage biopharmaceutical company developing novel antibodies, both monoclonal (mAbs) and drug conjugates (ADCs), with the goal of transforming the lives of patients suffering from a wide range of human malignancies. Through a strategic partnership with the Slamon Research Lab in University of CaliforniaTORL Bio has exclusive development and commercialization rights to a broad program of biologics-based drugs for new, promising and novel cancer targets.

View original content to download multimedia: https://www.prnewswire.com/news-releases/torl-biotherapeutics-presents-updated-phase-1-results-of-novel-claudin-6-targeted-antibody-drug-conjugate-torl-1-23-at-the-2024-european-society-of-medical-oncology-congress-302248489.html

Never miss a story from TORL Biotherapeutics LLC again.