Diaccurate Acquires Clinical Stage Sole-in-Class Targeted Cancer Therapy from Merck KGaA, Darmstadt, Germany

  • DIACC3010, formerly M2698, is a Phase II-ready dual PAM inhibitor with rare brain-penetration properties

  • Merck KGaA, Darmstadt, Germany, to become a shareholder of Diaccurate, remains fully committed to the success of the drug candidate

  • Diaccurate to start exploratory Phase II programs in incurable solid tumors and lymphomas by H2 2022

  • Acquisition broadens Diaccurate’s sole-in-class oncologyand immunotherapy product pipeline and transforms it into a clinical−stage biotech company

Diaccurate, a French biotech company that develops sole-in-class drug candidates in oncology and immunotherapy, today announces the exclusive worldwide in-licensing of the dual targeted PAM inhibitor, formerly M2698, now DIACC3010, from Merck KGaA, Darmstadt, Germany, thus, transforming Diaccurate into a clinical-stage company.

DIACC3010 is an oral small molecule inhibitor of the PAM pathway*, one of the most frequently dysregulated molecular circuits involved in cancer progression and resistance to therapies). By acting simultaneously on two key steps of the pathway - AKT1/3 and p70S6 - DIACC3010 is expected to result in a more favorable efficacy and safety profile when compared to other PAM inhibitors. Pre-clinical and Phase I studies have demonstrated that DIACC3010 crosses the blood-brain barrier, a physical frontier that protects the brain from numerous threats but also prevents most drugs from reaching it.

Merck KGaA, Darmstadt, Germany, has completed a multi-institutional Phase I trial led by Apostolia-Maria Tsimberidou, M.D., Ph.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. The study evaluated the safety and efficacy of DIACC3010 as monotherapy in patients with advanced, refractory solid tumors who failed standard therapies, or as combination therapy with trastuzumab and/or tamoxifen in patients with advanced breast cancer**. DIACC3010 was well tolerated as monotherapy. Combined with trastuzumab or tamoxifen, DIACC3010 demonstrated early signs of antitumor activity in patients with advanced breast cancer resistant to multiple standard therapies. Potential biomarkers of DIACC3010 pharmacological activity were seen in peripheral blood mononuclear cells and tumor tissues. Diaccurate will continue to characterize this potential sole-in-class asset in Proof-of-Concept (PoC) Phase II clinical trials in solid tumors enriched with PAM mutations and aggressive lymphomas to be initiated by H2 2022.

“We are confident that Diaccurate’s strong scientific background in developing novel mechanisms makes them the right partner to advance the development of M2698 in cancers with high unmet needs,” said Andreas Stickler, Chief Financial Officer and Head of Strategy, Business Development and Portfolio Management of the Healthcare business sector of Merck, KGaA, Darmstadt, Germany.

“We are very proud that, after a highly competitive selection process, Merck KGaA, Darmstadt, Germany, has chosen Diaccurate to bring DIACC3010 into advanced clinical development”, said Dominique Bridon, Ph.D., CEO of Diaccurate. “This dual PAM inhibitor could overcome limitations of existing anti-cancer treatments, and, if successful, would be a breakthrough innovation providing hope to patients with high unmet medical needs.”

As part of its plan to develop DIACC3010, Diaccurate has designed an extensive PoC clinical program exploring both incurable solid tumors and refractory hemato-oncology indications. The solid tumor component of the program will first focus on cancers associated with a high-prevalence of PAM mutations: Triple Negative Breast Cancer and Gastric Cancer. The hemato-oncology program will address cancers in which the PI3K pathway plays a major role: relapsed/refractory B-cell and T-cell lymphomas. Both Phase II trials are scheduled to be initiated in H2 2022. Further details on the clinical program will be provided in due time.

“Diaccurate is laying the foundations of a successful modern biotech company with a new highly specialized portfolio approach. This is an exciting agreement that will take the Company to the next level, bringing the best of medical science innovation to patients”, concluded Philippe Pouletty, M.D., Co-founder & Chairman of Diaccurate, Co-founder & CEO of Truffle Capital.

* PAM, by reference to the three main factors that condition the pathway activity:  PI3K, AKT and mTOR.

** Tsimberidou, AM., Shaw, J.V., Juric, D. et al. Phase 1 study of M2698, a p70S6K/AKT dual inhibitor, in patients with advanced cancer. J Hematol Oncol 14, 127 (2021).