AstraZeneca's Fasenra keeps the heat on GSK's Nucala with new phase 2 data

AstraZeneca’s Fasenra is already pressuring GlaxoSmithKline's Nucala in severe eosinophilic asthma, and new data could help set up a showdown between the two in another indication. By week 12 of a phase 2 study in hypereosinophilic syndrome (HES), Fasenra cut patients' blood eosinophil counts by at least half, AstraZeneca showed with results published Thursday. Only 30% of patients taking placebo reached that mark. In patients with biopsies taken, results showed a “near-complete depletion” of eosinophils, the company said. “We are encouraged by these trial results for Fasenra in hypereosinophilic syndrome and the data are potentially important given the limited treatment options for this debilitating disease,” Mene Pangalos, AstraZeneca’s EVP of pharma R&D, said in a statement. AstraZeneca spokeswoman Abigail Bozarth said the estimated U.S. population affected by HES, a rare disease that can lead to fatal organ damage, is around 20,500, but the number could be higher.

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Iambic Therapeutics Announces Close of Oversubscribed $100 Million Series B Financing to Advance AI-Discovered Therapeutics into Clinical Development

Business Wire | October 10, 2023

Iambic Therapeutics a biotechnology company developing novel therapeutics from its unique generative AI discovery platform, today announced the closing of an oversubscribed $100 million Series B financing co-led by Ascenta Capital and Abingworth, and also including new investors NVIDIA, Illumina Ventures, Gradiant Corporation, and independent board member Bill Rastetter. Existing investors also participated, including Nexus Ventures, Catalio Capital Management, Coatue, FreeFlow, OrbiMed, and Sequoia Capital. As part of the Series B, Iambic is delighted to welcome two new board members, Evan Rachlin, M.D., from Ascenta Capital and Kurt von Emster from Abingworth. “At Iambic, our world-class team has combined physics and AI to create a differentiated drug discovery platform that achieves a step-change in the speed and success rate for delivering best-in-class and first-in-class development candidates to clinic,” commented Tom Miller, Ph.D., Co-founder and Chief Executive Officer of Iambic. “With the Series B funding, we intend to advance multiple AI-discovered candidates into the clinic and expand our pipeline, demonstrating how the Iambic platform can deliver better therapeutics to patients in less time, with optimized target product profiles for greater likelihood of clinical success.” “We were struck by the originality of these molecules, offering distinctive approaches in both deeply validated and more novel biological pathways,” added Evan Rachlin, M.D., Co-founder and Managing Partner of Ascenta Capital. “Iambic’s platform enables a more creative and expansive exploration of how to treat diseases with profound unmet needs. We are delighted to partner with Tom and his extraordinary team in translating these thoroughly tested medicines into humans.” “Abingworth is proud to support the remarkably talented team at Iambic in its drive to revolutionize drug discovery and speed to the market with highly selective drugs,” said Kurt von Emster, Managing Partner and Head of Life Sciences at Abingworth. “AI-driven technologies, including methods that Iambic and NVIDIA researchers have built together, are charting a new path for researchers in the discovery of new therapeutic candidates,” said Rory Kelleher, Director of Healthcare and Life Sciences at NVIDIA. “NVIDIA-accelerated computing and software are helping industry pioneers like Iambic drive scientific breakthroughs and our continued collaboration aims to speed innovation in drug discovery.” “We believe technology innovations powered by advanced computing and omics-derived data insights will transform drug discovery and pave the way for the next wave of groundbreaking medicines,” said Ron Mazumder, Ph.D., MBA, Partner of Illumina Ventures. “Iambic’s physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time.” Since its 2021 Series A financing, Iambic has rapidly built its AI-driven discovery platform, which unifies state-of-the-art, physics-informed machine learning and experimental automation, and has demonstrated the platform’s success in identifying therapeutic candidates with differentiated drug profiles. In addition to building out a deep bench of AI and drug-discovery experts, Iambic has discovered two candidates to advance into the clinic: IAM-H1, a highly selective and brain-penetrant inhibitor of HER2 and its oncogenic mutants, and IAM-C1, a potential first-in-class selective dual CDK2/4 inhibitor to address unmet needs in terms of therapeutic window and treatment resistance in cell-cycle-driven cancers. Further, Iambic has extended its leadership position in the AI community, creating methods such as NeuralPLexer and OrbNet to drive its discovery platform. With the funds raised in the Series B, Iambic intends to advance multiple candidates into clinical development, expand its pipeline with additional candidates with best-in-class and first-in-class potential, and continue to innovate and build next-generation AI and automation technologies for drug discovery. It plans to leverage NVIDIA technology such as the NVIDIA DGX Cloud AI supercomputing platform and the NVIDIA BioNeMo cloud service to accelerate discovery. The company retains the technology created under its prior name of Entos Inc., adopting the new name of Iambic Therapeutics to reflect its transition to a company with the additional capability of clinical development of candidates identified through its AI-driven discovery platform. About the Iambic Therapeutics Physics-Informed AI-Driven Discovery Platform The Iambic Therapeutics AI-driven platform was created to address the most challenging design problems in drug discovery, incorporating the most current AI technologies and purpose-built tools from Iambic. The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform’s algorithms enable identification of new chemical mechanisms for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and exploration of the chemical space to discover candidates for development with highly differentiated properties. Through close integration of AI-generated molecular designs with automated experimental execution, Iambic completes design-make-test cycles on a weekly cadence. About Iambic Therapeutics Founded in 2019 and headquartered in La Jolla, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinic with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs.

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Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals

PR Newswire | October 12, 2023

Indivior PLC a leading addiction treatment company, announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000. ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder ("OUD") patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system. Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved. "Alar provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD with potentially the first three-month buprenorphine LAI," said Christian Heidbreder, Chief Scientific Officer. "By providing a therapeutic option for patients who might benefit from less frequent dosing, ALA-1000 has the potential to broaden the spectrum of care for OUD treatment as well as enhance the addressable patient population." ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose ("SAD") study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD2. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039. Based in Taichung, Taiwan, Alar is a drug development company which focuses on developing long-acting drug products for central nervous system ("CNS") disorders and chronic diseases, utilizing its proprietary depot technology. Compared with other long-acting subcutaneous injection technologies, its proprietary platform has been associated with distinctive characteristics such as low viscosity solution, small injection volume and sustained drug release profile. The transaction is not expected to have a material impact on the Group's FY 2023 adjusted results. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder (SUD). Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in 39 countries worldwide.

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BioMap Establishes a Strategic Collaboration with Sanofi to Co-Develop AI Modules to Accelerate Drug Discovery for Biotherapeutics

Business Wire | October 17, 2023

BioMap announced a groundbreaking strategic collaboration with Sanofi to co-develop cutting-edge AI modules for biotherapeutic drug discovery leveraging BioMap’s AI platform. “As the largest foundational model-based approach within life sciences, we are thrilled to collaborate with Sanofi and leverage the potential of BioMap’s cutting-edge AI engine to help solve complex problems associated with new protein therapies to drive drug discovery,” said BioMap’s Chief Technology Officer, Le Song. “We have built what is essentially a biological map of proteins using data sets from public and private sources to inform our foundational models. Utilizing automation and integrated workflows to enhance the collection of high-quality data, we can catalyze the process of new hit discovery and lead optimization.” Traditional AI methods require vast amounts of labeled data to make accurate predictions. However, in life science, labeled data are often in short supply. BioMap’s foundational models are revolutionizing AI in biology by enabling one large model, trained on ubiquitous unlabeled data, to inform multiple downstream task models. This approach enables superior prediction from limited data in a range of therapeutic areas, including immunology, neurology, oncology, and rare diseases. Leveraging BioMap’s custom-built foundational models and world-leading AI expertise, as well as Sanofi’s proprietary data, computational innovations in protein engineering, and deep biologics development experience, both parties aim to create advanced AI models and protein Large Language Models that will enable biologics design and multiparametric optimization. "By combining Sanofi’s proprietary data sets, digital infrastructure, AI and data science capabilities, and drug development expertise with BioMap’s protein Large Language Models, high-performance computing, and deep understanding of AI, we can optimize the process of discovery and development of breakthrough biotherapeutics,” said Matt Truppo, Global Head of Research Platforms at Sanofi. “Our collaboration with BioMap further underscores Sanofi’s commitment to becoming the first pharma company powered by artificial intelligence at scale.” Under the terms of the agreement, BioMap will receive an upfront cash payment and near-term payments for reaching module development milestones from Sanofi. BioMap will be eligible to receive payments of over $1 billion based on achievement of pre-clinical development, clinical development, regulatory, and commercial milestones. About BioMap Founded in 2020 by Robin Li and Wei Liu, BioMap is a disruptive life science AI company responsible for building xTrimo, the first and largest protein-centric large language model platform. Their technology allows scientists to model life more accurately, from proteins to a system level, and extract novel insights and predictions from limited data. Supported by an international, cross-functional team of over 300 experts, BioMap is solving critical, protein-related drug development problems and charting a course to radically improve patients’ lives.

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