Generate:Biomedicines today announced key advancements across its clinical pipeline and generative AI platform, including its first patient dosed in GB-0895, progress in the phase 1 study for GB-0669, and an expansion of its collaboration agreement with Amgen. Mike Nally, Chief Executive Officer, will overview these updates, as well as share more about the company’s strategy to further strengthen its leadership in generative biology, at the 42nd Annual J.P. Morgan Healthcare Conference, which will be occurring from January 8-11 in San Francisco. The presentation will take place on January 10 from 10:00-10:25am PST at the Golden Gate (32nd Floor) of The Westin St. Francis.
“In 2023, we saw meaningful advances in our computational and experimental capabilities that are shaping the era of generative biology, and in the year ahead we are poised to fortify our leadership in the field,” said Mike Nally, Chief Executive Officer, Generate:Biomedicines and CEO-Partner, Flagship Pioneering. “I look forward to presenting our progress across our advancing clinical pipeline and generative AI platform, demonstrating our commitment to programming novel medicines that will save and improve the lives of patients.”
Advancing Clinical Pipeline:
Generate:Biomedicines will provide an overview of key milestones and progress across its differentiated clinical pipeline, as well as its plans to deliver an additional 4-5 assets to the clinic over the next 24 months, including:
- Successfully dosed first patient in the study of GB-0895, an anti-TSLP monoclonal antibody for the treatment of mild-to-moderate asthma, in the United Kingdom. The primary endpoint of the study, which will also be conducted in Germany, aims to evaluate the safety and tolerability of GB-0895 for subcutaneous administration – with the goal of selecting 1-2 doses/regimens to advance in development.
- Continuing to progress the phase 1 study for GB-0669, a monoclonal antibody targeting the S2 stem helix, a highly conserved region of spike protein in SARS-CoV-2. Safety has been shown for the first four of five planned cohorts, including the putative recommended dose; analysis of key biomarkers is ongoing. GB-0669 continues to show potent in vitro neutralization of all major variants tested to date.
Industry Leading Generative AI Platform:
The company will also share ongoing efforts to advance its leadership position in the application of AI to therapeutic discovery and development with The Generate Platform, for example:
- Applying multiparameter co-optimization across its broad pipeline, successfully generating multiple assets with best-in-class profiles. This includes scaling the platform in immunology with a highly potent anti-IL-13 monoclonal antibody for certain type-2 inflammation-mediated diseases, such as atopic dermatitis and an anti-hemagglutinin (HA) monoclonal antibody targeting influenza.
- Generating de novo binders (e.g., molecules generated entirely by the computer and without a template) in order to unlock historically undruggable or hard-to-drug targets with controllable specificity. By enabling superior de novo hit rates, the company continues to pioneer the generation and validation of de novo antibodies, and this has now been demonstrated across nine distinct targets.
- Deploying structure in the learning loop utilizing CryoEM to generate data for iterative learning which has shown faster, improved outcomes.
Expanding Amgen Collaboration:
Generate:Biomedicines will highlight the expansion of its existing collaboration agreement with Amgen (NASDAQ: AMGN). Amgen has exercised its rights under the collaboration agreement to opt in for a sixth program. This represents the first expansion of the original agreement, and as a result, Amgen will make an undisclosed upfront payment and will pay up to $370 million in future milestones and royalties up to low double digits for this new program.
“Through our expanded collaboration, we will continue bringing Amgen’s renowned strength in therapeutics development together with our pioneering leadership in generative biology to design novel proteins with optimal therapeutic properties,” said Alex Snyder MD, Executive Vice President, R&D, Generate:Biomedicines. “We look forward to working even more closely together in order to deliver best-in-class therapies that address significant unmet patient needs.”
About Generative Biology
Generative biology represents a fundamental shift in therapeutic development driven by generative artificial intelligence (AI). This approach creates never-before-seen therapeutic molecules targeted to specific biological processes involved in disease that can be modulated with a wide range of protein modalities—from short peptides to complex antibodies, enzymes, and cytokines. But the promise of generative biology goes beyond existing proteins found in nature and can create novel proteins that are purpose-built to address an existing or emerging therapeutic need. As a result, generative biology promises to leave trial-and-error drug discovery methods behind to usher in a new era of programmable drug generation that’s faster, cheaper, and better tailored to specific conditions.
About Generate:Biomedicines
Generate:Biomedicines is the first drug generation company pioneering a machine learning-powered generative biology platform with the ability to create new drugs on demand across a wide range of biologic modalities. The Generate Platform – which is a continuous loop to generate, build, measure, and learn – can drastically increase the speed at which targets and therapeutics are identified and validated. This will improve the specificity of target engagement by generated proteins and reduce the time and cost of identifying and developing clinical candidates. Generate:Biomedicines is a clinical stage company that was founded by Flagship Pioneering after two years of foundational research in its Labs unit and launched in 2020. Learn more about Generate:Biomedicines by visiting www.generatebiomedicines.com or by following the company on Twitter and LinkedIn.
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