TORL BioTherapeutics Announces Initial Results of Novel Claudin 6 (CLDN6) Targeted Antibody Drug Conjugate (ADC) TORL-1-23 Selected for Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Encouraging antitumor activity in heavily pretreated population during dose finding

Well tolerated across broad dose range in phase 1 first-in-human study

Poster Presentation at ASCO on June 3, 8:00-11:00 a.m. CT

LOS ANGELES, June 1, 2023 /PRNewswire/ -- TORL BioTherapeutics LLC ("TORL Bio" or "the Company") announces the initial results from an ongoing phase I study of their claudin 6 (CLDN6) targeted antibody drug conjugate (ADC), TORL-1-23, in patients with advanced cancer on the American Society of Oncology (ASCO) website : https://meetings.asco.org/meetings/2023-asco-annual-meeting/299/program-guide/scheduled-sessions#date-6/3/2023. The poster presentation (ASCO Abstract 3082) of the TORL123-001 (TRIO-049) trial will include updated data through the 2.4mg/kg dose level and will be presented by the Global Principal Investigator, Dr. Gottfried Konecny of the University of California Los Angeles (UCLA) Medical Center.

Twenty-five (25) patients with heavily pretreated (an average of 5 prior lines of therapy) metastatic ovarian (n=19), testicular (n=3), and endometrial (n=3) cancers were enrolled and evaluable for safety and efficacy across 8 dose levels ranging from 0.2 to 2.4 mg/kg IV every 3 weeks. "We are excited to provide the first clinical data with TORL-1-23, a novel claudin 6 targeted ADC" stated Dave Licata, CEO and Co-Founder of TORL Bio. "We are very encouraged by the current TORL-1-23 efficacy and safety data indicating that this drug could represent a new potential treatment for patients with ovarian and other CLDN6+ cancers" said Dennis Slamon, MD, PhD, and Co-Founder of TORL Bio.

Key study findings include:

• TORL-1-23 is well tolerated with no dose limiting toxicities from 0.2 to 2.4 mg/kg IV every 21 days

• Confirmed responses were observed in 7/25 (28%) patients across all dose levels and all patients treated with TORL-1-23

• Confirmed responses were observed in 6/19 (32%) patients with platinum-resistant ovarian cancer across all dose levels, with 3/4 (75%) responses at the 2.4 mg/kg dose level

• Pharmacokinetic data indicate sustained exposure of TORL-1-23 over the 21-day dosing period and low levels of free MMAE payload

Expansion cohorts are planned in CLDN6+ ovarian cancer and non-small cell lung cancer (NSCLC), and other CLDN6+ cancers upon determination of the recommended phase 2 dose (RP2D).

Poster Presentation Details:
Title: Initial results of dose finding in a first-in-human phase I study of a novel Claudin 6 (CLDN6) targeted antibody drug conjugate (ADC) TORL-1-23 in patients with advanced solid tumors.
Lead author: Gottfried E. Konecny, M.D, University of California Los Angeles Medical Center, Los Angeles, CA
Abstract #: 3082
Poster Board #: 280
Session Title: Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 3, 2023, 8:00-11:00 a.m. CT
https://meetings.asco.org/meetings/2023-asco-annual-meeting/299/program-guide/scheduled-sessions#date-6/3/2023

About TORL-1-23

TORL-1-23 is an anti-CLDN6 humanized monoclonal antibody coupled to MMAE via a cleavable linker. CLDN6 is overexpressed in multiple cancers with limited to no detectable expression in normal tissues, thus an ideal target for an ADC. TORL 1-23 is highly selective; in vitro TORL-1-23 exhibited robust and selective binding to CLDN6-overexpressing cell lines without binding to cell lines over-expressing other claudins, such as CLDN3, CLDN4, and CLDN9. TORL-1-23 is in clinical trials for treatment of CLDN6+ cancers including ovarian cancer and NSCLC.

About TORL123-001 (TRIO-049) Clinical Study

TORL BioTherapeutics is currently enrolling patients in a phase I study, TORL123-001 (TRIO-049), to assess 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

TORL BioTherapeutics, LLC is a clinical-stage biopharmaceutical company developing novel, antibody-based therapeutics with the goal of transforming the lives of patients with cancer. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL Bio has exclusive development and commercial rights to biologics-based drug candidates focused on promising cancer targets. The lead program, TORL-1-23, is a CLDN6-directed ADC developed for patients across multiple cancer types. The Company also has two other clinical-stage programs; an ADC and mAb targeting claudin 18.2 (CLDN 18.2). TORL Bio is further developing a broad pipeline of novel preclinical ADCs and mAb in oncologic indications having a high unmet medical need. TORL Bio is headquartered in Los Angeles, California.

SOURCE TORL BioTherapeutics