TT125-802

BASEL, Switzerland--(BUSINESS WIRE)-- TOLREMO therapeutics AG (TOLREMO) today announced that the first patient has been dosed in its first-in-human clinical trial evaluating the safety and tolerability, pharmacokinetics, and pharmacodynamics of its lead candidate, TT125-802, in patients across a range of solid tumor indications. TT125-802 is an orally available small molecule CBP/p300 bromodomain inhibitor designed to prevent non-genetic cancer drug resistance and thereby improve the response rates and durability of targeted cancer treatments. In preclinical testing, the compound has demonstrated the ability to block critical transcriptional resistance pathways responsible for cancer’s earliest escape mechanisms to targeted therapies. "Initiating our Phase 1 clinical trial is an important corporate milestone for TOLREMO. With TT125-802, we are leveraging our scientific insights to develop an effective CBP/p300 inhibitor with the potential to prevent resistance mechanisms across a broad spectrum of current and future targeted cancer treatments,” said Stefanie Flückiger-Mangual, PhD, Co-founder and Chief Executive Officer of TOLREMO. “We are deeply committed to overcoming transcriptionally mediated cancer drug resistance for patient benefit, and this trial marks the start of an exciting new phase for the company.” The Phase I dose-escalation study will enroll patients across a range of solid tumor indications. The primary objective will be a safety assessment of TT125-802 as a monotherapy. Secondary objectives include the analysis of the drug’s biological activity, pharmacokinetics, pharmacodynamics, and target engagement, as well as the identification of the recommended dosing regimen and potential biomarkers for future patient stratification. The trial will be conducted initially at clinical centers in Europe, with the potential to include sites in the U.S. through an open Investigational New Drug (IND) application with the Food and Drug Administration (FDA). Stepwise, TOLREMO will advance TT125-802 into clinical testing in combination with targeted therapies, such as KRAS, EGFR or AR inhibitors, in specific advanced solid tumor indications. “TOLREMO’s in-depth preclinical analyses have showcased potency, selectivity, and safety data that demonstrate that TT125-802 has a highly differentiated profile, providing the foundation for translating these findings into the clinical setting. By specifically inhibiting transcriptional resistance pathways to targeted treatments, TT125-802 has the potential to profoundly improve the response rate and durability of other therapeutic interventions,” said Alessandra Cesano, MD, PhD, consulting Chief Medical Officer at TOLREMO therapeutics. About TOLREMO TOLREMO therapeutics' mission is to prevent non-genetic cancer drug resistance by dismantling the earliest defense to targeted therapies. Led by phenotypic insights, we discovered a pivotal mechanism that governs critical transcriptional resistance pathways. Our clinical compound TT125-802 is an orally available small molecule inhibitor designed to block these survival techniques to significantly improve the response rates and durability of established treatments. By stopping cancer drug resistance as it emerges, we aim to surmount a universal challenge for current and future targeted therapies for lasting patient benefit. View source version on businesswire.com: Contacts TOLREMO therapeutics AG Dr. Stefanie Flückiger-Mangual, CEO and co-founder stefanie.flueckiger@tolremo.com Trophic Communications Priscillia Perrin or Gretchen Schweitzer +49 151 21941277 or +49 172 861 8540 tolremo@trophic.eu Source: TOLREMO therapeutics AG View this news release online at:

TOLREMO therapeutics is pioneering a differentiated approach to preventing non-genetic drug resistance in cancer Funding will accelerate the company's lead program, TT125-802, into a first-in-human study in patients with solid tumors Julie M. Cherrington has been appointed as Chair of the Board of Directors BASEL, Switzerland--(BUSINESS WIRE)-- TOLREMO therapeutics AG (TOLREMO) today announced that it has completed its Series A financing, bringing the total amount raised to USD 39 million (CHF 34.1 million). BioMedPartners AG led the round with participation from a new investor, Pierre Fabre Invest, as well as existing investors. TOLREMO’s mission is to stop non-genetic cancer drug resistance as it emerges by dismantling cancer's earliest defenses to targeted therapies, thus surmounting a universal challenge for current and future targeted treatments. TOLREMO’s lead candidate, TT125-802, is an orally available small molecule CBP/p300 bromodomain inhibitor that blocks critical transcriptional resistance pathways responsible for cancer’s early escape mechanisms to targeted therapies. The proceeds of the Series A round will support the initiation of a Phase 1 monotherapy dose escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, and early signs of efficacy, including biological activity of TT125-802, in a range of solid tumor indications. Stepwise, TOLREMO will then advance to evaluating TT125-802 in combination with targeted therapies such as KRAS, EGFR or AR inhibitors in specific advanced solid tumor indications. "Cancer drug resistance is a major impediment to the long-term survival of patients and is most often addressed in the later stages of treatment when genetic mutations have already rendered the cancer permanently impervious to therapy. At TOLREMO, we have developed TT125-802 to specifically block early, non-genetic resistance pathways to targeted treatments. In combination with therapeutic agents, such as KRAS, EGFR, AR inhibitors, or other targeted therapies, TT125-802 has the potential to prevent therapy evasion and significantly improve treatment durability," said Stefanie Flückiger-Mangual, PhD, co-founder and Chief Executive Officer of TOLREMO. "We value the continued commitment from our current investors and warmly welcome Pierre Fabre Laboratories, the second largest private French pharmaceutical group, into our syndicate of investors through their dedicated investment body. With this strong support, we aim to advance the development of TT125-802 to bring long-term benefits to cancer patients." In conjunction with the financing, Julie M. Cherrington, PhD, an experienced life science executive with a track record of successfully bringing drugs into the clinic through to commercialization, has been appointed as Chair of the Board of Directors. In addition, Francesco Hofmann, PhD, Head of R&D for Medical Care at Pierre Fabre Laboratories, joined TOLREMO's Scientific Advisory Board. Dr. Hofmann has extensive experience in accelerating the delivery of new therapeutics, having facilitated the clinical development of more than twelve novel cancer drugs. "TOLREMO has a very distinct scientific approach to providing rational combination therapies that preemptively address the problem of drug resistance in cancer treatment. TT125-802 inhibits transcriptional changes, which are central for resistance development to a multitude of targeted cancer therapies. This new investment is very consistent with our renewed strategy to focus our R&D portfolio on targeted therapies," commented Francesco Hofmann, Head of R&D for Medical Care at Pierre Fabre Laboratories and new member of TOLREMO's Scientific Advisory Board. "I am truly impressed with TOLREMO’s achievements in discovering and advancing a highly differentiated new treatment approach originating from the analysis of non-genetic cancer resistance phenotypes," said Julie Cherrington, the new Chair of the TOLREMO Board of Directors. "I look forward to supporting the team at this critical juncture as the company advances its lead program into clinical development." Julie M. Cherrington is a seasoned biotech industry leader and holds board roles across several firms, including Mirati Therapeutics Inc, Syncona, Sardona Therapeutics, KisoJi Biotechnology, MycRx, and Actym Therapeutics, where she is also the Chair. In addition, she is a Venture Partner at Brandon Capital Partners. Dr. Cherrington has a proven track record as a company leader in her roles as CEO and R&D head at numerous companies. Furthermore, her earlier career contributions at SUGEN and Gilead Sciences were instrumental to the development of multiple FDA-approved drugs. Dr. Cherrington completed a postdoctoral fellowship at the University of California, San Francisco, and received her PhD training in microbiology and immunology from the University of Minnesota and Stanford University. She also holds a B.S. in biology and M.S. in microbiology from the University of California, Davis. About TOLREMO TOLREMO therapeutics' mission is to prevent non-genetic cancer drug resistance by dismantling the earliest defense to targeted therapies. Led by phenotypic insights, we discovered a pivotal mechanism that governs critical transcriptional resistance pathways. Our clinical compound TT125-802 is an orally available small molecule inhibitor designed to block these survival techniques to significantly improve the response rates and durability of established treatments. By stopping cancer drug resistance as it emerges, we aim to surmount a universal challenge for current and future targeted therapies for lasting patient benefit. View source version on businesswire.com: Contacts TOLREMO therapeutics AG Dr. Stefanie Flückiger-Mangual, CEO and co-founder stefanie.flueckiger@tolremo.com Trophic Communications Stephanie May or Dr. Alison Opalko +49 (0) 151 54041130 tolremo@trophic.eu Source: TOLREMO therapeutics View this news release online at: