Ziftomenib

This partnership has effectively integrated DP's ADC Linker-Payload design platform with Lepu's ADC technology development platform, capitalizing on their respective strengths. The overall optimization of the ADC drug has been achieved in a relatively short time. BEIJING, Nov. 20, 2024 /PRNewswire/ -- Lepu Biopharma Co., Ltd. (Lepu Biopharma) and Beijing DP Tech Co., Ltd. (DP Technology) have recently announced a significant milestone in their Antibody-Drug Conjugate (ADC) drug collaboration. This partnership has effectively integrated DP's ADC Linker-Payload design platform with Lepu's ADC technology development platform, capitalizing on their respective strengths. The overall optimization of the ADC drug has been achieved in a relatively short time. This project has reached an important milestone, further validating the approach of accelerating ADC innovative drug development through computational design. Moving forward, both parties will continue to deepen their R&D collaboration in this field, jointly committed to promoting the continuous optimization and advancement of innovative drug development processes. The ADC Linker Payload design platform, meticulously crafted by DP Technology, utilizes "RiDYMO®", an AI-for-Science driven hit discovery platform. Furthermore, "AI + first principles" based computational methods are employed to predict linker cleavage sites and ensure the correct payload release, achieving outstanding cell-killing and bystander effects. Additionally, the designed antibody-drug conjugates (ADCs) maintain excellent hydrophilicity and plasma stability. Leveraging Lepu's mature and complete ADC development system, candidates developed by the new ADC platform have demonstrated significant efficacy in CDX models targeting multiple targets. This project has been successfully validated in animal models and is currently advancing the candidate ADC to the clinical stage. Lei Fang, Ph.D., Vice President of Lepu Biopharma and CEO of CtM Bio Co., Ltd., expressed high appreciation for this cooperation: "Introducing advanced computational methods to solve scientific problems and jointly pioneering breakthrough explorations is our goal in the ADC project collaboration. As a leader in 'AI for Science', DP Technology has played a crucial role in this project with its newly developed ADC design platform. By integrating Lepu Biopharma's advanced ADC development platform with AI-driven design, we proposed novel perspectives on ADC development while significantly expediting the process. By complementing each other's strengths, we jointly provide new inspiration and ideas for innovative ADC drug design." Weijie Sun, CEO of DP Technology, expressed great anticipation for future collaboration: "Lepu Biopharma, as an innovative biopharmaceutical company focused on cancer treatment, particularly in the areas of targeted therapy and immunotherapy, has extensive experience and a long-standing track record in developing innovative ADC drugs. We firmly believe that our close cooperation will significantly accelerate the design and development of ADC drugs, and we are optimistic about the potential to develop innovative, highly effective, and differentiated new ADC therapies. I am eagerly anticipating the ongoing and deepened collaboration between both companies in the field of pharmaceutical innovation!" Concerning the various demands from industry partners in the ADC field, DP Technology's ADC platform has successfully empowered various scenarios and projects. For instance, it utilizes AI combined with first-principles calculations to predict linker cleavage sites and improve attachment stability. By integrating pre-trained models with fine-tuning strategies and expert insights, the platform can predict and modify physicochemical properties such as payload efflux and bystander effects. Additionally, there is ongoing exploration and collaboration in the overall evaluation of properties like aggregation effects in ADCs. About Lepu Biopharma Lepu Biopharma Co., Ltd. is an innovation-driven biopharmaceutical company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. We are dedicated to developing innovative ADCs through an advanced ADC technology development platform. We aim to develop more optimal and innovative drugs to better serve the unmet medical needs of cancer patients. We endeavor to continuously develop a market-differentiating pipeline by combining in-house research and development as well as strategic collaborations, strengthen our in-house manufacturing capabilities and commercialize our pipeline products in China through dedicated sales and marketing forces, and internationally via partnerships. We have an integrated end-to-end capability across drug discovery, clinical development, CMC and GMP-compliant manufacturing, encompassing critical functions of the biopharmaceutical value chain, and are building dedicated sales and marketing forces. About DP Technology At DP Technology, we're at the forefront of integrating artificial intelligence into scientific research and industrial R&D. Our "AI for Science" initiative is redefining how we tackle complex scientific challenges, making groundbreaking discoveries more accessible and actionable. We've developed the "DP Particle Universe," a suite of advanced pre-trained models that seamlessly connect cutting-edge research with real-world industrial applications. Our software suite includes: Bohrium® Scientific Computing Space Station, Hermite® Computational Drug Design Platform, RiDYMO® Hit Discovery Platform, Piloteye® Battery Design Automation Platform. Together, these platforms form a robust foundation for industrial innovation and an open ecosystem for AI in science, fostering advancements in key areas such as drug discovery, energy, materials science and information technology. SOURCE DP Technology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Menin inhibitors have entered the haematological spotlight. Shortly after Syndax secured FDA approval for its compound, Revuforj (revumenib), to treat certain forms of leukaemia, Kura Oncology has begun readying the groundwork to launch its own asset — though ziftomenib is still in Phase II testing for acute myeloid leukaemia (AML). The San Diego-based biotech on Wednesday agreed to share development and commercialisation responsibilities for ziftomenib in AML with Japanese drug developer Kyowa Kirin in a deal worth roughly $1.4 billion. The tie-up comes ahead of a much-anticipated readout at the American Society of Hematology (ASH) meeting next month. Kura will be presenting data from the Phase Ia KOMET-007 trial of the menin inhibitor in newly diagnosed KMT2A-rearranged or NPM1-mutant AML patients (see – Spotlight On: Clinical readouts to watch at ASH 2024).Kura also recently completed enrollment in the "registration-directed" Phase II portion of the KOMET-001 trial in patients with relapsed or refractory NPM1-mutant AML, the specific patient population for which ziftomenib holds breakthrough therapy designation from the FDA. It's also the same patient subgroup where Syndax's Revuforj recently hit a stumbling block. Although the menin inhibitor met the primary endpoint of the pivotal Phase II portion of the AUGMENT-101 trial, the company lost nearly a quarter of its valuation on the readout earlier this month. Kura plans to submit regulatory applications for ziftomenib next year. For more on menin inhibitors' place in the AML treatment landscape, see Spotlight On: The AML treatment landscape gets personal and KOL Views Preview: How will the current wave of menin inhibitors impact the AML landscape?AML, GIST global strategyUnder Wednesday's deal, Kura will receive $330 million upfront and is eligible for up to $420 million in near-term milestones, including the approval of ziftomenib for AML, plus $741 million in development, regulatory and commercial milestones for a total potential payout of $1.16 billion. The company will share profits in the US evenly with Kyowa, which has exclusive commercialisation rights outside the country.Over the next several years, the partners plan to launch multiple Phase II and Phase III studies of the therapy for AML and other haematologic malignancies, with Kura responsible for global development costs until the end of 2028, after which it will evenly split costs with Kyowa. The companies will equally fund future trials in the US. "We believe that ziftomenib is a very promising investigational treatment for genetically defined AML patients," said Yasuo Fujii chief strategy officer and managing executive officer of Kyowa. "The addition of ziftomenib will complement Kyowa Kirin's existing hemato-oncology portfolio and pipeline and expand our clinical development efforts into combination therapies designed to generate improved outcomes for cancer patients."Kyowa can also opt-in to develop and commercialise ziftomenib in gastrointestinal stromal tumours (GIST) and other solid tumours after it reviews data from an ongoing proof-of-concept study. Kura would then be eligible for an additional $228 million in milestones under a deal structured similarly to the AML agreement.