TORL BioTherapeutics Announces Appointment of Mark J. Alles as Chairman and Chief Executive Officer; Highlights Significant Progress of its Oncology Clinical Programs

• Mark Alles, Executive Chairman of TORL BioTherapeutics, LLC (TORL) and former Chairman and CEO of Celgene Corporation has been appointed TORL's Chairman and CEO. Mark brings more than 35 years of global biopharmaceutical experience, and will lead TORL as it advances its expanding clinical-stage antibody programs in oncology and builds additional programs through the high-value discovery pipeline established and led by TORL Scientific Founder Dennis Slamon, M.D., Ph.D.
  
  
• Dave Licata, Co-Founder, previous CEO of TORL, and the architect of its innovative approach to drug development, continues as a Board Member and President and is appointed TORL's first fully-dedicated Chief Financial Officer. As President and CFO, Dave will lead and manage future financing, business development and partnering, fiscal operations, and continue to provide strategic and operational support for the Company's novel approach to drug development
  
  
• Based upon the emerging and promising clinical response data and favorable safety profile demonstrated during dose finding and early expansion for TORL-1-23, the Company's first-in-class ADC targeting Claudin 6, TORL expects to begin a pivotal Phase 2 trial during the second half of 2024. This trial will be designed to facilitate review and potential approval by the FDA
  
  
• In addition to TORL-1-23 and TORL-2-307, the Company's second clinical-stage ADC designed to target Claudin 18.2 in pancreatic and gastric cancers, TORL has begun patient enrollment in Phase 1 trials for two additional new ADCs developed to address internally discovered targets overexpressed in approximately 80% of patients with colorectal cancer and in patients with small-cell-lung and liver cancers, respectively

LOS ANGELES, Jan. 9, 2024 /PRNewswire/ -- TORL Biotherapeutics, LLC (TORL), established in 2019, is a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide. Today, the company announced the appointment of Mark J.  Alles, TORL's Executive Chairman, as the company's new Chairman and CEO. Mr. Alles is the former Chairman and Chief Executive Officer of Celgene Corporation with over 35 years of biopharmaceutical experience and an outstanding record of driving innovation and growth at multiple companies focused on hematology and oncology. Mark succeeds Dave Licata, TORL Co-Founder and previous CEO, who successfully led the Company through the initiation of five (5) phase I clinical trials testing ADCs against four (4) cancer targets and led the closing of a $158 million Series B financing in April 2023, and who will continue as a Board Member, President, and has been appointed CFO.

"TORL has rapidly realized significant success in identifying novel cancer targets, developing first-in-class antibody-based therapies directed at these targets, and with the support of our world-class investors, has recently advanced multiple products into Phase 1 studies," said Board Member and TORL's scientific founder Dennis Slamon, M.D., Ph.D., of UCLA. "We have reached a major inflection point where our opportunity to generate value for patients, our investors and our team made it both possible and important for us to build on the great work Dave has done by adding and appointing Mark Alles as Chairman and CEO. He is a highly regarded industry veteran with proven operational, financial, business development, clinical development, and commercial experience building and scaling oncology-focused companies. I am extremely excited about what his proven level of experience and expertise will bring to TORL during its next critical phase."

"Since joining the TORL Board two years ago and becoming Executive Chairman in late 2022, I have had the privilege to work with Dave Licata and Dennis Slamon as they built the foundation for what has become an oncology-focused biotechnology company full of promise and potential," said Mr. Alles. "We are driven by a shared passion to discover, develop and commercialize breakthrough therapies for patients challenged with cancer worldwide. I am excited and honored to lead the Board and the company at such a pivotal time."

"I am proud of the prolific scientific discoveries and the remarkable progress we have made in advancing high potential biologics into the clinic since launching the company only four years ago," said Dave Licata, TORL Co-Founder, Board Member, President, and CFO. "After co-founding TORL with Dennis with a common vision for a new approach to drug development, and leading the company as CEO, I feel immense pride in what we have achieved. I am excited and eager to work even more closely with Mark as we continue to build TORL into what we believe will be a highly successful biopharmaceutical company."

During his 15-year tenure at Celgene, Mr. Alles executed several multi-billion-dollar company and asset acquisitions, helped to build a broad portfolio of globally marketed medicines and high-potential cancer therapeutics, and led the expansion of Celgene from a US-based organization of approximately 500 employees to a global company with more than 8,800 employees serving patients globally. As Chairman and CEO of Celgene, he led the company's acquisition by Bristol Myers Squibb for $74B in late 2019. He has served on the Boards of several biopharmaceutical companies and industry groups, including Board Chair of Turning Point Therapeutics (acquired by Bristol Myers Squibb for $4.1B in 2022), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Biotechnology Innovation Organization (BIO). He previously served on the Boards of Antengene Corporation and Syros Pharmaceuticals, and currently serves on the Boards of BioMarin Pharmaceutical and Wugen, Inc. Prior to joining Celgene in 2004, Mr. Alles was Vice President of the U.S. Oncology business unit at Aventis Pharmaceuticals. He began his industry career at Bayer and Centocor after serving as a Captain in the United States Marine Corps.

About the TORL123-001 (TRIO-049) Clinical Study
TORL Bio is currently enrolling patients in the expansion portion of their 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

Key study findings to date for this Claudin 6 targeting ADC include:

• TORL-1-23 is generally well tolerated from 0.2 to 2.4 mg/kg IV every 21 days
• With consistent use of prophylactic granulocyte colony-stimulating factor (G-CSF), current dosing regimen of 3 mg/kg every 21 days is well tolerated
• Pharmacokinetic data indicate sustained exposure of TORL-1-23 over the 21-day dosing period with low levels of the free monomethyl auristatin E (MMAE) payload
• Encouraging antitumor activity has been observed in heavily pretreated population during dose finding
• Confirmed responses in 12/36 (33%) patients across all enrolled disease types and all nine dose levels without G-CSF (0.2 mg/kg to 3 mg/kg every 21 days)
• At the two highest dose levels without G-CSF (2.4 mg/kg and 3 mg/kg every 21 days) there were confirmed responses in 7/12 (58%) patients with CDLN6+ platinum resistant/refractory ovarian cancer
• In preparation for a planned phase 2 study that could allow for regulatory approval, expansion cohorts of patients with pretreated ovarian, lung, and other CLDN6+ cancers have been initiated to further guide dose selection

About TORL2307MAB-001 (TRIO-051) Clinical Study
TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307MAB-001 (TRIO-051), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307MAB.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05159440

About TORL2307ADC-001 (TRIO-052) Clinical Study
TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307ADC-001 (TRIO-052), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307ADC.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05156866

About TORL3600-001 (TRIO-055) Clinical Study
TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL3600-001 (TRIO-055), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-3-600.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05948826

About TORL 4-500-001 (TRIO-056) Clinical Study
TORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL4500-001 (TRIO-056), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-4-500.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT06005740

About TORL BioTherapeutics, LLC
TORL Biotherapeutics, LLC (TORL or Company) 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 has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets.

The lead program, TORL-1-23, is a CLDN6-directed ADC for patients across multiple cancers. The Company has four (4) additional clinical-stage antibody programs. Additionally, TORL is building a broad pipeline of novel ADCs and mABs in cancers of high unmet medical need. TORL Bio is headquartered in Los Angeles, California.

SOURCE TORL Biotherapeutics LLC