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, CA, USA I June 1, 2023 I 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:
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

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