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, Non-Small Cell Lung Cancer, and Other CLDN6+ Cancers Continue to be Studied in Current Phase 1 Trial

Phase 1 Data Supports Initiation of a Registration-Enabling Phase 2 Study in Patients with CLDN6+ Platinum-Resistant Ovarian Cancer

LOS ANGELES, Sept. 15, 2024 /PRNewswire/ -- TORL BioTherapeutics, LLC ("TORL Bio" or "the Company"), a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, today announced the presentation of additional results from the ongoing Phase 1 study of TORL-1-23, the Company's Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) in patients with advanced cancer at the 2024 European Society of Medical Oncology Congress (ESMO 2024) in Barcelona, Spain. This mini-oral presentation (ESMO Presentation #721MO) included updated results from the TORL123-001 (TRIO-049) trial up to the 4.0 mg/kg dose level of TORL-1-23. The data were presented by the Global Principal Investigator, Gottfried E. Konecny, M.D. of the University of California, Los Angeles (UCLA) 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 Global Principal Investigator, Gottfried E. Konecny, M.D. of UCLA Medical Center.

In this ongoing Phase 1 study, 81 patients with CLND6 positive (CLDN6+), heavily pretreated ovarian, testicular, endometrial, non-small cell lung cancer (NSCLC), and other cancers were enrolled and are evaluable for safety and efficacy across 11 dose cohorts ranging from 0.2 mg/kg to 4.0 mg/kg administered intravenously every 3 weeks. Patients had an average of 4 prior therapeutic regimens.

Key study findings include the following:

• At doses from 0.2 mg/kg to 2.4 mg/kg every 3 weeks, TORL-1-23 is generally well tolerated. The most common adverse events were grade 1 or 2 fatigue, peripheral neuropathy, and alopecia. The most frequent grade 3+ adverse event was neutropenia. Febrile neutropenia, interstitial lung disease, and ocular toxicities were not observed.
• Prophylactic pegfilgrastim was implemented at doses 3.0 mg/kg or higher and was effective at mitigating neutropenia. The maximum tolerated dose (MTD) has yet to be identified.
• Encouraging antitumor activity was observed in this heavily pretreated population during dose finding across all enrolled cancer histologies and dose levels.
• At doses of 2.4 mg/kg and 3.0 mg/kg every 3 weeks, there were deep and durable confirmed responses in 9/20 (45%) patients with CLDN6+ platinum-resistant/refractory ovarian cancer (PROC). Median duration of response exceeded 6 months at both dose levels.

"The objective of molecularly targeted therapeutics in cancer is to significantly enhance efficacy while simultaneously maintaining or improving safety over established treatments. The emerging Phase 1 profile of TORL-1-23 suggests that this ADC may achieve that goal for patients with platinum-resistant ovarian cancer, a serious unmet medical need," said Scientific Co-founder Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine.

Phase 1 evaluation of TORL-1-23 in NSCLC and other CLDN6+ cancers is ongoing. A multi-dose Phase 2 study that is designed to support accelerated registration in CLDN6+ PROC is being initiated.

Presentation Details

Title: Phase 1, Two-Part, Multicenter First-In-Human (FIH) Study of TORL-1-23, A Novel Claudin 6 (CLDN6) Targeting Antibody Drug Conjugate (ADC) In Patient with Advanced Solid Tumors
Lead Author: Gottfried Konecny, M.D., UCLA Medical Center
Presentation Number: 721MO
Presentation Session: Mini Oral Session 2: Gynaecological cancers
Presentation Session Date and Time: September 15, 2024, at 15:50 CEST

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in multiple cancers with limited to no detectable expression observed in normal tissues, thus an ideal target for antibody-drug conjugate development. CLDN6 is a tumor-specific transmembrane protein of tight junctions important for cell-to-cell connectivity. Overexpression of CLDN6 is implicated in the initiation, progression, and metastasis of certain cancers, including ovarian, non-small cell lung, endometrial, testicular and others. High expression correlates with shortened survival outcomes for patients with ovarian cancer.

About TORL-1-23

TORL-1-23 is a first and potentially best-in-class 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 expansion of Phase 1 study TORL123-001 (TRIO-049), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-1-23. Further details including current study sites can be found at https://clinicaltrials.gov/show/NCT05103683.

About TORL BioTherapeutics, LLC

TORL BioTherapeutics, LLC (TORL Bio) is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal (mAbs) and drug conjugates (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 Bio has exclusive development and commercial rights to a large 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

SOURCE TORL Biotherapeutics LLC