TORL-1-23

Appointed Experienced Physician, Researcher and Global Life Sciences Leader Aran Maree, MD, as the Company’s Chief Medical Officer Initiated CATALINA-2, a Global Phase 2 Study of TORL-1-23 in Patients with Claudin 6 Positive Platinum-Resistant Ovarian Cancer LOS ANGELES, CA, USA I December 2, 2024 I TORL BioTherapeutics, LLC (TORL), 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 appointment of Aran Maree, MD, as Chief Medical Officer. Additionally, TORL has initiated CATALINA-2, a global Phase 2 study of its novel Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) TORL-1-23 in patients with CLDN6 positive (CLDN6+) platinum-resistant ovarian cancer (PROC). “2024 has been a transformational year for TORL, as the first Phase 2 study with our Claudin 6 targeted antibody-drug conjugate TORL-1-23 is underway and we continue to advance multiple antibody-based clinical programs,” said Mark J. Alles, Chairman and Chief Executive Officer of TORL Biotherapeutics . “Aran Maree is among the most accomplished and experienced physician-leaders in the biopharmaceutical industry, and TORL will significantly benefit from his long track record of improving patient outcomes in multiple disease categories and creating corporate value.” Dr. Maree most recently served as Chief Medical Officer for Johnson & Johnson (J&J) Innovative Medicines, the pharmaceuticals segment formerly known as Janssen. In this role, he oversaw a functionally independent team with a primary focus on clinical and scientific advancement of the established products portfolio, patient safety, pediatric portfolio advancement and was co-chair of the company’s R&D Development Committee reviewing the R&D clinical programs across therapeutic modalities in oncology, immunology, neurology, cardiovascular, metabolic and infectious disease. His impact on safety oversight and program development includes some of the most high-profile products in J&J’s history and many other important medicines under development. Dr. Maree joined J&J in 2006 and held medical roles of increasing responsibility for J&J’s MedTech company in Australia, New Zealand, Asia Pacific and Japan. In these positions, Dr. Maree established a comprehensive medical affairs capability while also leading and strengthening regulatory, quality and health outcomes/access capabilities. In 2012, he was promoted to global Chief Medical Officer of J&J MedTech, responsible for patient monitoring and safety surveillance practices, approaches to clinical data transparency, and scientific integrity at the intersection of biology and technology. In 2017, he was appointed Chief Medical Officer for the pharmaceuticals segment of the company. Prior to joining J&J, Dr. Maree worked at The Boston Consulting Group and Merck & Co. (MSD) in Australia and New Zealand. Dr. Maree holds an honors medical degree from the Royal College of Surgeons in Ireland/National University of Ireland. He trained as a physician in Dublin, obtaining his Membership of the Royal College of Physicians of Ireland (MRCPI) and in interventional cardiology between Dublin, Ireland and Sydney, Australia. “The promise of TORL-1-23 and the Company’s growing pipeline of new target programs represent an incredible opportunity to transform clinical practice in oncology,” said Aran Maree, MD, Chief Medical Officer . “I am thrilled to be joining the TORL team at such an important time and look forward to establishing and scaling a global medical organization to support the needs of the portfolio and the patients we seek to serve.” “Given our progress discovering and developing antibody-based immunotherapies for a large number of cancer patients, this is the right time for TORL to bring in the Company’s first Chief Medical Officer,” said Scientific Co-founder and Board Member Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA’s David Geffen School of Medicine . “Aran’s capability and expertise leading global medical functions and conducting early- to late-stage clinical trials will have an immediate and long-lasting effect on TORL’s ability to bring new compounds to patients as quickly as possible.” In November, TORL initiated CATALINA-2, a global, multi-institutional randomized, open-label Phase 2 study of TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The study is designed to support accelerated registration in CLDN6+ PROC. CATALINA-2 initiation was supported by Phase 1 data presented at the 2024 European Society of Medical Oncology Congress, which demonstrated that treatment with TORL-1-23 led to clinically meaningful, durable and confirmed responses with a manageable safety profile in patients with CLDN6+ PROC. Phase 1 evaluation of TORL-1-23 in non-small cell lung cancer and other CLDN6+ cancers is ongoing. “Since TORL’s founding, we’ve been focused on advancing our portfolio of antibody-based targeted therapies in indications with serious unmet medical need. Initiating our first registrational study and strengthening our leadership team are critical value-creating milestones as we enter our next phase as a Company. Aran’s outstanding multi-decade career and experience will have a significant strategic and operational impact on TORL,” said Co-founder, Board Member, President, and Chief Financial Officer Dave Licata. To date TORL has raised more than $350M from leading global biotechnology investors. In addition to the CLDN6 target, the Company’s pipeline includes programs for Claudin 18.2, Cadherin-17, Delta-like Non-canonical Notch Ligand 1 (DLK1) and other undisclosed targets in both solid tumor and hematologic malignancies. 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 ADC development. CLDN6 is a transmembrane protein important for cell-to-cell connectivity in normal tissues during development but not in adult tissues. Overexpression of CLDN6 occurs in certain malignancies and 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 ADC for the treatment of CLDN6+ solid tumors. The Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC is currently enrolling. Further details can be found at https://clinicaltrials.gov/study/NCT06690775 . TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. About CATALINA-2 CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints include duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at https://clinicaltrials.gov/study/NCT06690775 . About TORL BioTherapeutics, LLC TORL is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal antibodies and 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 has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising, and novel cancer targets. SOURCE: TORL Biotherapeutics