TORL Biotherapeutics LLC

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

A London-based biotechnology company is capitalizing on investor interest in antibody-drug conjugates for cancer, announcing Sunday the completion of a Series A round that raised $114 million.Myricx Bio, which launched in 2019, claims its approach to antibody-drug conjugates, or ADCs, could offer advantages over existing treatments by using a new kind of payload to attack tumors.ADCs have emerged as a research hot spot in recent years. Theyre built from a monoclonal antibody, a precise dose of a toxin and a chemical linker pairing the two. More than a dozen ADCs are approved by U.S. regulators as cancer treatments, and over 100 programs are in clinical development, according to estimates. While early iterations of the drugs were effective in destroying tumor cells, developers next step has been dialing in the drugs precision and safety.All ADCs come through looking compelling in terms of potency in preclinical models, the challenges are often how they're differentiated, said Robin Carr, Myricxs CEO.Myricx is building its ADCs around N-myristoyltransferase inhibitors, compounds that block an enzyme thats important to cancer cell survival. Last year, the company licensed antibodies from two Chinese companies, Biocytogen and WuXi Biologics.Carr said that, in preclinical models, drugs using NMTi payloads were more effective than other types of ADCs. Furthermore, they showed activity in cancer models designed to be resistant to ADCs based around a toxin called topoisomerase inhibitors, like AstraZeneca and Daiichi Sanykos Enhertu as well as Gileads Trodelvy.The biotech was co-founded by a group of British researchers that included Exscientias chief research officer Andy Bell, former GSK executive Roberto Solari and former Myricx chief scientific officer Ed Tate. Launched with 4.5 million in seed financing, Myricx initially licensed its technology from Imperial College London, where Tate and Solari were professors. Carr came to Myricx from GSK, where he was an executive overseeing the companys small molecule and platform research.Initially, Myricx planned to develop NMTi inhibitors as standalone small molecule drugs for cancer. But, while having conversations with investors, the company pivoted to consider NMTi inhibitors as an ADC payload.Myricxs early backers included Sofinnova Partners and Brandon Capital Partners. Investors Novo Holdings and Abingworth co-led its Series A, with participation from British Patient Capital, Cancer Research Horizons, Eli Lilly, Brandon Capital and Sofinnova. The $114 million will go toward funding two proof-of-concept studies, as well as adding about 15 employees, Carr said.Not many U.K. and European institutes spinouts get out there with a Series A, so were super pleased, Carr said.Since January 2022, investors have put more than $2.7 billion into ADC companies, according to investment firm Piper Sandler. Notable private raises include TORL BioTherapeutics' $158 million Series B financing last year and Tubulis' $139 million Series B2 in March.ADC companies are on pharmaceutical companies radar, too: AbbVie spent $10 billion last year to acquire ImmunoGen, while more recently GenMab bought ProfoundBio for $1.8 billion. '

Pictured: A sign on a J.P. Morgan building in Hong Kong/iStock, danielvfung J.P. Morgan Private Capital announced Thursday that it has closed its first biotechnology-focused capital fund, securing over $500 million from various backers. The fund, called 270 Life Sciences Private Capital Fund I, attracted “strong support” from investors including family offices, corporate partners, institutional allocators and “high net worth individuals,” according to the announcement. JPMorgan Chase & Co. also contributed. The fund will focus its investments on private biotechnology companies and will be agnostic about the stage, modality, geography and therapeutic area of the investment. However, in an interview with Endpoints News, Stephen Squinto, chief investment officer and managing partner of J.P. Morgan Life Sciences Private Capital, said that the fund wants to make 20 to 25 investments primarily with early-stage companies. Early investments will target biotechs in the cardiometabolic disease, immunology, oncology and genetic medicine spaces. The fund is led by Squinto and managing partner Gaurav Gupta. “As investors and company builders, we are strongly positioned at J.P. Morgan Private Capital to identify and support highly innovative companies that can shape the future of how patients are treated. Our mission is to capitalize companies and utilize our collective experience to guide them towards successful outcomes and mentor a new generation of biotechnology founders and executives,” Squinto said in a statement. J.P. Morgan has been actively building its presence in the biotech funding space over the past few years. In 2022, J.P. Morgan Asset Management launched the life science-focused private equity team to support early and growth-stage biotechs. In April 2024, J.P. Morgan Asset Management’s Private Capital Division announced that it had raised a $100 million Series A round for Enlaza Therapeutics, with the funding aimed at advancing a covalent biological platform and pipeline for novel protein drugs. Other VC firms have been committing to sizable funds to invest more heavily in life sciences and biotech. In January 2024, Goldman Sachs Asset Management announced it closed its first $650 million life science fund called West Street Life Sciences I. Initially, the fund committed around $90 million to five biotechs including MOMA Therapeutics, Nested Therapeutics, TORL Biotherapeutics, Septerna and Rapport Therapeutics. On Wednesday, Foresite Capital closed its sixth fund with $900 million in commitments to invest in growth-oriented biotechs in precision therapeutics, healthcare delivery and life science infrastructure. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.