GB-7008-01-vcMMAE

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 : . 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 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 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

Co-founded by acclaimed oncologist Dennis Slamon, M.D., Ph.D., of University of California at Los Angeles (UCLA) and entrepreneur and CEO David Licata, as well as leadership from a distinguished set of industry veterans, including Executive Chairman Mark Alles, former Chairman and CEO of Celgene Corporation. Funding to advance TORL-1-23, a first-in-class, clinical-stage ADC targeting Claudin 6, TORL-2-307, a clinical-stage ADC targeting Claudin 18.2 and other novel clinical and preclinical stage programs. $158M Series B Financing led by Goldman Sachs Asset Management, with participation from UC, Office of the Chief Investment Officer, Bristol Myers Squibb, Deep Track Capital, Vertex Ventures HC, Moore Strategic Ventures, Cowen Healthcare Investments, Perceptive Xontogeny Venture Fund, and existing investors including Alexandria Venture Investments and OCV Partners. Amit Sinha, Head of Life Sciences Investing within Goldman Sachs Asset Management and Lynn Seely, M.D., President and CEO of Lyell Immunopharma to join TORL Board of Managers as part of Series B financing. LOS ANGELES, April 13, 2023 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a biopharmaceutical company focused on developing new biologics for cancer treatment, announced today its public launch and the closing of a $158 million Series B financing. TORL's pipeline of antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs) were discovered in the laboratory of scientific co-founder Dennis Slamon, M.D., Ph.D., Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine (DGSOM). He is an accomplished physician and scientist whose research was pivotal in identifying HER2 as a target in breast cancer and the development and initial approval of trastuzumab (Herceptin). Dr. Slamon's lab went on to discover CDK4/6 as an important target in hormone receptor (HR+) positive breast cancer. Subsequently, his group led the clinical development of CDK4/6 inhibitors, resulting in breakthrough status therapies palbociclib (Ibrance) and ribociclib (Kisqali), in HR+ breast cancer. TORL is built on a strategic partnership with the Slamon Research Lab at UCLA, whereby the Company has exclusive development and commercial rights to biologics-based drug candidates focused on promising cancer targets. TORL's lead drug programs target Claudin 6 (CLDN 6) and Claudin 18.2 (CLDN 18.2), both of which are currently in clinical trials. The Company also expects to put 2-3 additional compounds into clinical trials over the next 12 months, with plans to advance 1-2 new compounds each year. "It has been very rewarding to use 30 years of experience, lessons learned, and preclinical models developed in our lab for this new company for," said Dennis Slamon, M.D., Ph.D., Co-Founder of TORL. "This unique academic/corporate partnership allows us to quickly identify novel targets, validate them preclinically, then proceed to bring these new biologic treatments into clinical testing and development in an exceptionally rapid and efficient manner. Our goal is to develop compounds that address critical or as yet unmet medical needs while simultaneously providing new and effective treatment options for cancer patients that can be life and practice changing. There are more of these to come, and we are thrilled we have this partnership to expand cancer therapy." Leveraging the Slamon research lab's unique discovery engine and validation platforms, TORL was founded to promote its novel oncology biologics with industry leading speed and capital efficiency. Since its inception in 2018, TORL has moved forward three, internally developed drug programs into the clinic and advanced two more through IND-enabling studies with less than $50 million. "It has been tremendously gratifying to pioneer TORL's innovative approach to drug discovery and development, culminating in the launch of multiple clinical trials with our drugs over the past year", said David Licata, TORL's CEO. "We created and demonstrated an original, capital efficient structure which, despite the challenging market conditions, attracted a distinguished group of biotech investors with a shared vision for rapid cancer drug development. With the close of this Series B financing, we can advance our new programs into the clinic and existing clinical-stage programs into the next phase." "Despite meaningful advances in the diagnosis and treatment of cancer, most patients worldwide continue to face serious morbidity and significant mortality," said Mark Alles, TORL's Executive Chairman. "With strong support from our highly accomplished investors, we are building a preeminent biopharmaceutical company dedicated to the discovery, development and commercialization of first and best-in-class antibody-based immunotherapies to improve and extend the lives of people living with this terrible disease." "TORL represents a unique model for company formation. Through their holistic relationship with the Slamon research lab and UCLA, the Company can leverage decades of scientific expertise and deep research capabilities while avoiding the significant costs and risks associated with early-stage discovery," said Amit Sinha, Head of Life Sciences Investing within Goldman Sachs Asset Management. "We believe TORL-1-23 and TORL-2-307 represent promising potential therapies for ovarian and gastric cancers, two indications with significant unmet patient need. We look forward to partnering with the TORL team to rapidly advance the lead programs toward late-stage clinical trials while progressing the broader portfolio of novel programs." TORL builds on a 30-year history of scientific collaboration amongst a team of clinical pioneers and laboratory researchers. In addition to Dr. Dennis Slamon, the scientific founding team includes: John Glaspy, M.D., MPH, Professor of Medicine, DGSOM, UCLA Neil O'Brien, Ph.D., Associate Professor of Medicine, DGSOM, UCLA Martina McDermott, Ph.D., Adjunct Assistant Professor of Medicine, DGSOM, UCLA Ben Hoffstrom, Ph.D., Adjunct Assistant Professor, Medicine, DGSOM, UCLA Sarah Larson, M.D., Assistant Professor, Medicine DGSOM, UCLA Mike Press, M.D., Ph.D, Professor of Pathology, Keck School of Medicine of USC With scientific advisors including Tom Boone, Ph.D., Brian Lawliss, Ph.D., and Leonard Presta, Ph.D. TORL Board of Directors Mark Alles – Executive Chairman Mark Attanasio – Co-Founder and Managing Partner, Crescent Capital Group LP David Licata – Co-Founder and CEO Neil O'Brien, Ph.D. – Co-Founder Amit Sinha – Partner, Goldman Sachs Lynn Seely, M.D. – President and CEO of Lyell Immunopharma Dennis Slamon, M.D., Ph.D. – Co-Founder TD Cowen acted as exclusive placement agent for the Series B financing. Crandon Law LLC served as counsel to TORL BioTherapeutics LLC. Latham & Watkins LLP. served as counsel to Goldman, Sachs & Co. LLC. About TORL BioTherapeutics TORL BioTherapeutics LLC is a clinical-stage biopharmaceutical company with the objective of developing novel, antibody-based therapeutics to transform the lives of cancer patients. Its lead candidate, 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 CLDN 18.2. Additionally, TORL is developing a broad pipeline of novel preclinical ADCs and mAb in oncologic indications with a high unmet medical need. TORL is headquartered in Los Angeles. SOURCE TORL Biotherapeutics LLC