TORL Biotherapeutics LLC

TORL BioTherapeutics , the antibody-drug conjugate startup led by former Celgene chief Mark Alles , has brought aboard a chief medical officer with big pharma chops. Aran Maree will be overseeing clinical development at the Los Angeles biotech, born out of Herceptin founder Dennis Slamon ’s lab at UCLA. Maree departs a nearly 20-year career at Johnson & Johnson , where he was chief medical officer of the medtech unit before stepping into the same post at the pharmaceuticals division, which was recently renamed J&J Innovative Medicine . The J&J veteran’s move over to TORL comes as the biotech is just weeks into its first potentially registrational trial in CLDN6 positive platinum-resistant ovarian cancer. The well-funded startup is testing an ADC called TORL-1-23. The pipeline also contains early-stage ADCs against CLDN18.2, CDH17 and DLK1. Other immunotherapies are also in the works. Alles and crew raised a $158 million round in April 2023 . Almost a year to the day, they raised another round of the exact same size. They’ve kept a low profile the entire time, wishing not to speak with the news media. — Kyle LaHucik → Samsung Bioepis has promoted Kyung-Ah Kim to president and CEO, becoming the first female exec in the Samsung universe to hold this title that isn’t part of the founding family. Kim has worked at the biosimilar maker since 2015 and had been development division leader for the past three years. Her predecessor, Christopher Hansung Ko , was CEO since its founding in February 2012 and will be the new leader of Samsung’s Future Business Division. The FDA approved Samsung Bioepis’ Soliris biosimilar Epysqli in July, and the company will soon launch its Stelara biosimilar in the US. → Iskra Reic will lead AstraZeneca ’s China business as EVP of international. She’ll take over for detained exec Leon Wang while he is still under investigation in China, a market that CEO Pascal Soriot called “an important part of innovation in the industry” last month. Reic is a 23-year AstraZeneca vet who ran the vaccines and immune therapies unit after a stint as EVP for Europe and Canada. → On the same day President-elect Donald Trump nominated Marty Makary to lead the FDA, a commish from his first administration picked up a board seat. Stephen Hahn — the current CEO of Flagship company Harbinger Health — has joined the board at Faeth Therapeutics , a cancer startup that lists Sid Mukherjee and Lewis Cantley as founders. Faeth has also appointed Rivus Pharmaceuticals CEO and ex- Aimmune boss Jayson Dallas to the board. “Faeth’s approach of leveraging metabolic research in combination with AI has opened up metabolism as a new pillar in the treatment of cancer,” Hahn said in a statement . → Franklin Biolabs , a contract research organization that Jim Wilson founded after leaving his leadership post at the University of Pennsylvania’s Gene Therapy Program, has installed a CEO. Vatsala Naageshwaran got promoted to head of business development for US CGT & lab services for Pharmaron and had a long career with Absorption Systems before it was sold to Pharmaron in late 2020. Brazilian health research institute Fiocruz made a commitment of up to $100 million for Wilson’s other venture, GEMMABio , in an effort to make gene therapies more accessible globally. → Scott Wolchko will retire as president and CEO of Fate Therapeutics on Jan. 1, and R&D chief Bob Valamehr will take over, according to a Black Friday release . Wolchko was the San Diego biotech’s first CFO and vaulted to the top spot in 2015, succeeding former Escient Pharmaceuticals chief Christian Weyer . Valamehr has led R&D since 2018 and his promotion will coincide with his 15th anniversary at the company. You may recall that Fate, which has several CAR-T and CAR NK candidates in its pipeline, ended its development deal with J&J in January 2023 and subsequently laid off nearly half of its employees. → Paragon Therapeutics continues to churn out public biotechs — and now has a CEO at the mother ship. Susanna High is the former COO of bluebird bio and, more recently, Dyne Therapeutics . She also had several roles that spanned more than nine years at Alnylam , including SVP, strategy and business integration. Two Paragon companies — Jade Biosciences and Crescent Biopharma — reverse merged their way onto the Nasdaq in October, and Oruka Therapeutics did the same in April. → Volker Herrmann is out as CEO of Flagship’s Sonata Therapeutics , and about 20 other staffers have also been let go, Fierce Biotech reported. Flagship brought two of its companies together, Inzen Therapeutics and Cygnal Therapeutics , to form Sonata two years ago. Herrmann had led Inzen, while Cygnal chief Pearl Huang eventually took the CEO job at Dunad Therapeutics . Herrmann spent more than 15 years at Pfizer and joined Flagship from SQZ Biotechnologies , where he was COO for nearly two years. → Arcutis Biotherapeutics medical chief Patrick Burnett and chief commercial officer Todd Edwards have both been promoted to EVP, and Kent Taylor has been elevated to SVP of sales. Burnett is a Novartis vet who left Verrica Pharmaceuticals to take the CMO job at Arcutis in August 2020; Peer Review informed you about Edwards’ appointment in September 2023, when he took over for Ken Lock after three years with Incyte ; and Taylor — an Incyte vet in his own right — followed Edwards two months later as VP of sales. → OSE Immunotherapeutics co-founder Dominique Costantini is retiring at the end of the year. The French I/O and I&I player has selected Fiona Olivier as chief corporate affairs and investor relations officer, and research head Aurore Morello earns a spot on the executive committee. Costantini, the former CEO who also chaired the board at OSE, had been director of development and strategy. “Many of us have benefited from Dominique’s mentorship and guidance over the years and we have grown stronger as a result,” CEO Nicolas Poirier said in a statement . Olivier spent more than three years with Sanofi as global head of corporate affairs for the General Medicines division. She had several job titles over an eight-year period at AbbVie , including head of global patient relations and international public affairs. → CAR-T cell therapy developer AffyImmune has recruited Deyaa Adib as CMO. Adib just had a very short stay at FibroGen and has also held this position at Triumvira Immunologics . AffyImmune, a company in ORI Capital ’s portfolio, is under new management for the second time this year — in July, Daniel Janse took over for Matt Britz as CEO. Britz had been elevated to the top spot in March after two years as operating chief. → At another CAR-T shop, ex- Bellicum and Artiva Biotherapeutics CEO Tom Farrell has been named president of Shanghai-based Oricell . “Tom is a transformative leader who has consistently delivered results. We believe he will undoubtedly accelerate our clinical development momentum in the US,” CEO Helen Yang said in a statement . Oricell raised a $45 million Series B1 in February 2023 on top of a $120 million haul. → Merck ’s macrocyclic peptide partner Unnatural Products has tapped Simon Bailey as COO and president of R&D. Bailey left protein degradation biotech Plexium in March after more than four years as head of drug discovery and was SVP of research for Intercept from 2016-19. His 20-year career with Pfizer culminated in his role as senior director for worldwide medicinal chemistry in oncology. → Iovance Biotherapeutics has promoted Raj Puri to chief regulatory officer. Puri spent two decades as a director at CBER in the Office of Tissues and Advanced Therapies before coming to Iovance in March 2022 as EVP, regulatory strategy and translational medicine. Iovance fought through multiple delays to receive the first-ever FDA approval for a tumor-infiltrating lymphocyte with its cell therapy Amtagvi . → Synthetic cell specialist Slingshot Biosciences has welcomed Nimisha Srivastava as COO. Srivastava held a number of roles over a decade at Twist Bioscience , where she was VP of engineering and eventually head of R&D. Slingshot also said last month that it had named Tiffany Salas-Morris as chief commercial officer. → Sapience Therapeutics , which is testing its beta-catenin antagonist ST316 in colorectal cancer patients, has recruited Augustine Bourne as VP, business development. He previously worked for Mirati as its business development and corporate strategy leader when Bristol Myers Squibb purchased the Krazati maker for $4.8 billion. In other Sapience news, ex- Replimune CBO Pamela Esposito now has a seat on its board of directors. → Swiss cancer vaccine developer Nouscom has recruited Grünenthal and MorphoSys alum Eckhard Niemeier as CBO. Niemeier just ended a three-year run as business chief at Danish biotech Union Therapeutics , and he was head of business development & portfolio management for Pieris Pharmaceuticals . “Cancer vaccines are, let’s say, back in fashion,” Nouscom CEO Marina Udier told Endpoints News in November 2023, when the biotech announced its Series C funding. → Incendia Therapeutics has appointed Bradford Smith as its first finance chief. Smith has previously been CFO for a number of companies, including Homology Medicines , Ocular Therapeutix , OmniGuide , NeuroMetrix and Synarc . Smith also sits on the boards of Lyra Therapeutics and eGenesis . → Massachusetts-based ITF Therapeutics has recruited Erica Monaco as COO. Monaco joins with previous COO experience from Medicus Pharma and Biofrontera , where she also served as CEO and CFO). Earlier in her career, Monaco was with Sun Pharmaceuticals and Deloitte . → Portuguese CRO FairJourney Biologics has brought aboard Marc van Dijk as CSO, responsible for the company’s antibody discovery and engineering divisions. Dijk also served in the role at MiNK Therapeutics , and earlier in his career, Dijk was with Genmab as VP of antibody technology and chief technology officer at 4-Antibody and Agenus . → CRISPR Therapeutics veteran Chris Gemmiti has landed at Cellino as SVP of therapeutics development. Gemmiti was in charge of CMC for Casgevy , CRISPR and Vertex ’s sickle cell gene therapy, and became VP of technical operations in April 2022. Cellino recently caught our attention by appointing Recursion CEO Chris Gibson to its board of directors. → Looking for the next breakthrough in psychedelic therapy, MindMed has hired yet another exec, bringing in Javier Muniz as VP of research and development strategy. He just finished up a 10-year career with the FDA, where he was associate director for therapeutic review in the agency’s Division of Psychiatry within the Office of Neuroscience. This is MindMed’s third notable leadership move in the past few months, following the additions of chief regulatory and quality assurance officer Gregg Pratt and corporate affairs chief Stephanie Fagan . → Former Bristol Myers exec Kristen Hege leads a new crop of clinical advisory board members at Gilead ’s cancer partner Cartography Biosciences . Kevin Parker ’s crew has also welcomed Affini-T Therapeutics CMO Dirk Nagorsen , UCSF’s Bridget Keenan and Josep Tabernero from the Vall d´Hebron University Hospital in Barcelona. → Beam Therapeutics has added Chirfi Guindo to the board of directors. Guindo had a 27-year career with Merck before joining Biogen in 2017, then returned to Merck in July 2022 as chief marketing officer for the Human Health division. Click here for Andrew Dunn’s Slack interview from February with CEO John Evans , who also spoke to Endpoints for an early look at Beam’s gene-edited sickle cell data. → Ex- Decibel Therapeutics CEO Laurence Reid has sewn up a spot on the board of directors at hereditary angioedema biotech KalVista Pharmaceuticals . Reid sold Decibel to Regeneron for $109 million in August 2023 and chairs the board at Broken String Biosciences . The FDA has assigned a June 17 decision date for KalVista’s HAE drug sebetralstat . → Backed by The Column Group , 8VC and others, California ADC developer Hexagon Bio has elected Ideaya Biosciences CEO Yujiro Hata to its board of directors. This was Hexagon’s first press release of any kind since its $77 million Series B in February 2023. → Longtime EY vet Fran Schulz has joined the board of directors at Tim Lu ’s Senti Bio , as Seer chief Omid Farokhzad exits. Shares $SNTI went through the roof on Monday, rising more than 600% and settling on a 363% jump after Senti Bio disclosed Phase 1 data for its CAR-NK cell therapy SENTI-202 . → Day One Biopharmaceuticals co-founder and R&D leader Sam Blackman is headed to the board of directors at Bonum Therapeutics , the Seattle-based I/O biotech that sprouted from Good Therapeutics and nabbed a $93 million Series A two years ago. Blackman will retire from Day One at the end of the year. → Rare disease AI company Healx has named Abcam founder Jonathan Milner as non-executive chairman, taking over from co-founder David Brown , who will remain on the board. Despite Milner’s opposition , Abcam completed its acquisition of Danaher exactly one year ago.

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

TORL-1-23 Demonstrates Clinically Meaningful, Durable and Confirmed Responses with a Generally Manageable Safety Profile in Patients with Claudin 6 Positive (CLDN6+) Platinum-Resistant Ovarian Cancer Expansion Cohorts in Patients with Ovarian, Non-Small Cell Lung Cancer, and Other CLDN6+ Cancers Continue to be Studied in Current Phase 1 Trial Phase 1 Data Supports Initiation of a Registration-Enabling Phase 2 Study in Patients with CLDN6+ Platinum-Resistant Ovarian Cancer LOS ANGELES, Sept. 15, 2024 /PRNewswire/ -- TORL BioTherapeutics, LLC ("TORL Bio" or "the Company"), 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 presentation of additional results from the ongoing Phase 1 study of TORL-1-23, the Company's Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) in patients with advanced cancer at the 2024 European Society of Medical Oncology Congress (ESMO 2024) in Barcelona, Spain. This mini-oral presentation (ESMO Presentation #721MO) included updated results from the TORL123-001 (TRIO-049) trial up to the 4.0 mg/kg dose level of TORL-1-23. The data were presented by the Global Principal Investigator, Gottfried E. Konecny, M.D. of the University of California, Los Angeles (UCLA) Medical Center. "The latest efficacy and safety data from this Phase 1 study continue to support the potential of TORL-1-23 as a new treatment option for patients with Claudin 6 positive ovarian cancer," said Global Principal Investigator, Gottfried E. Konecny, M.D. of UCLA Medical Center. In this ongoing Phase 1 study, 81 patients with CLND6 positive (CLDN6+), heavily pretreated ovarian, testicular, endometrial, non-small cell lung cancer (NSCLC), and other cancers were enrolled and are evaluable for safety and efficacy across 11 dose cohorts ranging from 0.2 mg/kg to 4.0 mg/kg administered intravenously every 3 weeks. Patients had an average of 4 prior therapeutic regimens. Key study findings include the following: At doses from 0.2 mg/kg to 2.4 mg/kg every 3 weeks, TORL-1-23 is generally well tolerated. The most common adverse events were grade 1 or 2 fatigue, peripheral neuropathy, and alopecia. The most frequent grade 3+ adverse event was neutropenia. Febrile neutropenia, interstitial lung disease, and ocular toxicities were not observed. Prophylactic pegfilgrastim was implemented at doses 3.0 mg/kg or higher and was effective at mitigating neutropenia. The maximum tolerated dose (MTD) has yet to be identified. Encouraging antitumor activity was observed in this heavily pretreated population during dose finding across all enrolled cancer histologies and dose levels. At doses of 2.4 mg/kg and 3.0 mg/kg every 3 weeks, there were deep and durable confirmed responses in 9/20 (45%) patients with CLDN6+ platinum-resistant/refractory ovarian cancer (PROC). Median duration of response exceeded 6 months at both dose levels. "The objective of molecularly targeted therapeutics in cancer is to significantly enhance efficacy while simultaneously maintaining or improving safety over established treatments. The emerging Phase 1 profile of TORL-1-23 suggests that this ADC may achieve that goal for patients with platinum-resistant ovarian cancer, a serious unmet medical need," said Scientific Co-founder Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine. Phase 1 evaluation of TORL-1-23 in NSCLC and other CLDN6+ cancers is ongoing. A multi-dose Phase 2 study that is designed to support accelerated registration in CLDN6+ PROC is being initiated. Presentation Details Title: Phase 1, Two-Part, Multicenter First-In-Human (FIH) Study of TORL-1-23, A Novel Claudin 6 (CLDN6) Targeting Antibody Drug Conjugate (ADC) In Patient with Advanced Solid Tumors Lead Author: Gottfried Konecny, M.D., UCLA Medical Center Presentation Number: 721MO Presentation Session: Mini Oral Session 2: Gynaecological cancers Presentation Session Date and Time: September 15, 2024, at 15:50 CEST 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 antibody-drug conjugate development. CLDN6 is a tumor-specific transmembrane protein of tight junctions important for cell-to-cell connectivity. Overexpression of CLDN6 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 antibody-drug conjugate (ADC) for the treatment of Claudin 6 positive (CLDN6+) solid tumors. Select centers are enrolling patients in the Part 2 expansion of 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 . About TORL BioTherapeutics, LLC TORL BioTherapeutics, LLC (TORL Bio) 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 Bio has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising, and novel cancer targets. SOURCE TORL Biotherapeutics LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED