On September 8, 2021 Diaccurate, a French biotech company that develops sole-in-class drug candidates in oncology and immunotherapy, reported 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 (Press release, Merck KGaA, SEP 9, 2021, View Source [SID1234587501]).

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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.

On September 9, 2021 Varian, a Siemens Healthineers company, reported that China Medical University Hospital in Central Taiwan treated its first patient with Ethos therapy, making it the first hospital in Taiwan and within the Greater China region to use Ethos therapy for advanced cancer treatment (Press release, Varian Medical Systems, SEP 9, 2021, View Source,-Expanding-Access-to-Personalized-Cancer-Care [SID1234587498]).

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The Ethos therapy system combines an image-guided radiation therapy powerhouse with adaptive capabilities in one system, creating workflow efficiencies that benefit both patient and clinician. This solution, powered by artificial intelligence (AI), is designed to deliver an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery. Incorporating multi-modality image guidance, Ethos therapy provides the ability to personalize the patient’s treatment based on their anatomy and position at the time of treatment. The goal is to better target the tumor and potentially improve overall outcomes with a reduction in dose to healthy tissue.

"We are very excited to be able to use this sophisticated form of adaptive therapy for our patients. Ethos has addressed the challenges physicians have been encountering in adapting a course of radiotherapy to real-time changes in the patient. Now, physicians can effortlessly achieve their clinical treatment goals with the AI-driven Ethos solution," said Professor Liang, Ji-An, Director, Department of Radiation Oncology of China Medical University Hospital.

"Ethos has been recognized as a game-changer in cancer treatments. It optimizes the daily treatment plan and allows physicians to complete an adaptive treatment within a typical treatment time slot, which was impossible in the past. I believe we will set a new standard for cancer treatments and act as a model for personalized precision treatments in Taiwan," said Professor KS Clifford Chao, Superintendent, Proton Medical Center, China Medical University Hospital

"At Varian, we believe in patient-centric and personalized care," said Kevin O’Reilly, President, Radiation Oncology Solutions, Varian. "We are honored to partner with China Medical University Hospital to deliver personalized precision cancer treatments in Taiwan through our Ethos adaptive intelligence solution. Together, we are committed to expanding cancer patients’ access to advanced treatment in Taiwan."

On September 09, 2021 TG Therapeutics, Inc. reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13 – 15, 2021 (Press release, TG Therapeutics, SEP 9, 2021, View Source [SID1234587497]).

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The fireside chat will be available for on demand download beginning at 7:00 AM ET on Monday, September 13th, 2021, and will also be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On September 09, 2021 Tempest Therapeutics, Inc., a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the following investor conferences in September (Press release, Tempest Therapeutics, SEP 9, 2021, View Source [SID1234587496]).

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H.C. Wainwright 23rd Annual Global Investment Conference available on-demand Monday, September 13, 2021 at 7:00 a.m. ET
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday September 22, 2021 at 9:55 a.m. ET
To access the live or archived recording of the company presentations, please visit the investor section of the Tempest website at View Source

On September 9, 2021 Roche reported that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group (Press release, Hoffmann-La Roche, SEP 9, 2021, View Source [SID1234587495]). Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021.

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The acquisition of the TIB Molbiol Group will enhance Roche’s broad portfolio of molecular diagnostics solutions with a wide range of assays for infectious diseases, such as the identification of SARS-CoV-2 variants. TIB Molbiol’s comprehensive portfolio of over 45 CE-IVD assays and more than 100 research use assays are already today available on Roche’s large installed base of LightCycler PCR systems and MagNA Pure sample preparation systems.

The two companies have collaborated for more than 20 years to rapidly address critical healthcare needs including biological threats, such as SARS, anthrax, avian influenza virus H5N1, MERS, the novel influenza virus H1N1 swine, Ebola virus, Zika virus and most recently, SARS-CoV-2 virus and its variants. For example, in 2001 with anthrax and 2003 with SARS-CoV1, TIB Molbiol demonstrated their ability to develop PCR assays for the detection of new pathogens within days.

"With this acquisition, we can expand our offering of tests of existing pathogens and our response to emerging pathogens and potential health threats," said Thomas Schinecker, CEO Roche Diagnostics. "At the onset of the COVID-19 pandemic, our collaboration provided the first research-use-only SARS-CoV-2 detection test that was provided in January 2020, only days after the new coronavirus was first sequenced. Together, we can further improve patient outcomes with innovative diagnostic solutions that alleviate healthcare costs."

"We are very happy to join the Roche Group," said Olfert Landt, CEO and founder of TIB Molbiol. "We have been collaborating for two decades and have spearheaded innovation in the molecular diagnostics industry as partners. We are looking forward to contributing to the strong network of Roche Diagnostics."