📢 Highlights
EvolutionaryScale releases with ESM3 only weeks after Isomorphic’s AF3
BioNTech and MediLink’s Lung Cancer Clinical Trial Paused After 3 deaths
Insilico Medicine completes enrollment for its Chinese Phase IIa Study
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Ex-Meta Protein AI Team Releases ESM3 and Nets a $142M Round of Funding
With deep support from both Nvidia and AWS, the team behind Meta’s acclaimed protein folding tool ESM Fold have followed up their $40M pre-seed round with a second round of $142M. Following the surprising inclusion of the bulk of the team in the massive layoffs in August 2023, the all star squad of 8 was marshaled by the former head of the ESM project at Meta, Alex Rives. The company claims that its main product, ESM3 provides >50x increased speed over state of the art, amongst myriad other features. Their transformer-based approach has produced a frontier generative model for biology, “able to jointly reason across three fundamental biological properties of proteins: sequence, structure, and function”. In stark contrast to AlphaFold3, EvolutionaryScale has already provided an open version of their model on their GitHub. This is consistent with Meta’s historical dedication to open source AI tools, which has singularly been reviving the tech giant’s brand, mired in a contentious history of alleged misconduct. The company has indicated its seed round will fund it for 2 years, indicating a weekly burn of around $1.5M, with $16 million going to computing power in the first year alone. This may sound like a large number, but makes sense given in the company's pitch deck states it plans to release a new model every year.
The Bio-AI Community Has Tried AlphaFold3 … and Has Strong Opinions
Since its unveiling only weeks ago, DeepMind and Isomorphic Lab’s AlphaFold3 has inspired deep analysis and discussion across the global Bio-AI community - Simon Barnett wrote up a comprehensive (and delightfully opinionated) field guide on AlphaFold3, reviewing its new features and improvements. The Boston Protein Design Club (BPDC), led by Chris Bahl of AI Proteins, did a walkthrough. You can see a video of it here. Carlos Outeiral looks at integrating AF3 into existing workflows with focus on its advancements around complex protein structures. Eva Smorodina examined the evolution of AlphaFold2 to AlphaFold3, including AlphaFold Multimer. Finally, while the absence of open source code and the limitations of the usage server make it tough to replicate or verify AF3's claims, the Open Source community has been hard at work making the first Pytorch implementations, with more to come. To their credit, DeepMind and Isomorphic labs have assured they will open source the model in around 5 months.
Merck KGaA Partners with Biolojic Design for $376M Antibody Discovery
The Germany based pharmaceutical giant, Merck KGaA has partnered with Biolojic Design to develop multi-specific antibodies using Biologic’s artificial intelligence tools and data. This collaboration, valued at $376 million, aims to create antibodies that can simultaneously target multiple disease mechanisms. By integrating Biolojic’s AI platform, the partnership seeks to enhance the precision and effectiveness of antibody therapies, potentially leading to significant medical breakthroughs in treating complex diseases such as cancer and autoimmune disorders
AI-Designed Oncology Drug Receives Patent for Oncology Drug in Japan
Lantern Pharma has been granted a composition of matter patent in Japan for its AI-designed oncology drug candidate, LP-284. Currently undergoing Phase 1 trials for non-Hodgkin’s lymphoma and specific sarcomas, this patent strengthens Lantern Pharma’s intellectual property portfolio and supports the global development of LP-284. The drug is designed to target unique molecular pathways involved in cancer progression, offering a promising new treatment option that could improve patient outcomes through a precision medicine approach.
FDA Pauses BioNTech/MedLink Trial Amid Safety Concerns
A partial hold has been imposed by the FDA on the Phase I trial of the BioNTech/MedLink antibody-drug conjugate BNT326/YL202 following the deaths of three patients. This multi-center study sponsored by Suzhou based MedLink Therapeutics (NCT05653752) was designed to assess BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer. The study will continue with current patients while new U.S. enrollments are paused. The focus now shifts to exploring safer dosing regimens to mitigate observed risks. BioNTech and MedLink are working closely with the FDA to address these safety concerns and ensure that the trial can proceed under improved conditions.
Insilico Completes Enrollment for Phase IIa Study, Moves to Cambridge, Mass.
Participant enrollment has been completed by Insilico Medicine for its Chinese Phase IIa trial in China, targeting idiopathic pulmonary fibrosis with its compound INS018_055. The trial (NCT05938920) expected to generate a comprehensive dataset by late Q4 2024, providing readouts on the drug’s efficacy and safety. The nature of the clinical trial has drawn broad skepticism around the iconoclastic company. With promising early results, Insilico plans to proceed with a Phase IIb proof-of-concept study in 2025. This progression highlights the potential of INS018_055 as a novel therapeutic option for patients suffering from this debilitating condition. In connection with this milestone, Insilico has announced that it will relocate its operational HQ’s from Hong Kong to Cambridge, Massachusetts.
Enveda Biosciences Secures $55M in Series B2 Round
In a recent funding round, Enveda Biosciences has raised $55 million, bringing its total funding to $230 million. This round included investments from notable entities such as Premji Invest, Microsoft, and Kinnevik. The capital infusion is reported to enable Enveda to accelerate its drug discovery efforts and expand its therapeutic pipeline. The company’s proprietary platform uses computational methods to identify and develop novel compounds from plants and other often overlooked phytological sources.
Iambic Therapeutics Closes $50M for GNN Driven AI Oncology Drugs
NeuralPLexer, an AI-driven platform from Iambic Therapeutics, has demonstrated superior performance in predicting protein-ligand structures, outperforming established systems like AlphaFold2. This achievement was featured in Nature Machine Intelligence. Alongside their ProPANE platform, which utilizes graph neural networks to optimize multiple drug properties, Iambic announced a significant funding boost with a $50 million round led by Mubadala Capital and Exor Ventures. This funding will support the advancement of their lead program IAM1363, targeting HER2-positive cancers, and the upcoming IAM-C1 program for solid tumors.
SR One Secures Additional $200M for Biotech Investments
With an additional $200 million raised for its growth opportunities fund, SR One doubles down on biotech following a successful $600 million fund closed in March 2023. This latest funding will support innovative biotech startups developing breakthrough therapies and technologies. SR One, formerly the corporate venture arm of GSK, focuses on companies at various stages of development, providing financial support and strategic guidance to drive innovation and advancement in the life sciences sector, ultimately aiming to improve patient outcomes.
Roche Clears FDA for Digital Pathology System and Does $1.8B deal with Ascidian
The Basel-based powerhouse Roche has received FDA 501(k) clearance to its Digital Pathology Dx system. This integrated system, featuring the VENTANA DP 200 slide scanner and workflow software, promises to accelerate pathologist diagnostic review and interpretation of patient histopathology slides. This integrated offering stands in stark contrast from the model-only innovations in routine diagnostic ML/AI, such a Microsoft’s recently unveiled GigaPath model, which should result in accelerated adoption amongst the notoriously conservative pathologist community. Additionally, Roche has entered into a strategic partnership with Ascidian Therapeutics to develop RNA exon editing therapies. This collaboration includes an initial investment of $42 million and potential milestone payments totaling up to $1.8 billion, aimed at advancing new treatments for neurological diseases.
Kid-Sized Cures: Pediatric Access to Advanced Therapeutics
A multi-institution perspective piece in Nature Medicine speaks to the challenges in making cell and gene therapies (CGTs) accessible for pediatric patients. Despite the transformative potential of CGTs in childhood diseases, their development has been hindered by high costs, small market sizes, complex regulatory landscapes, and the biological complexities of modifying the genes of a pre-pubescent human. To overcome these barriers, the authors propose the creation of the Pediatric Advanced Medicines Biotech (PAMB), which the authors describe as “an entity that would conduct registrational trials, sponsor biological license applications and commercialize approved CGTs for children”. The PAMB would leverage academic resources for manufacturing, collaborate closely with regulatory bodies, and implement new licensing practices tailored for pediatric needs. This approach aims to reduce manufacturing costs and expedite the approval process, getting more life-saving therapies to the children who need them. Examples of successful CGTs like Tisagenlecleucel (Kymriah) and Onasemnogene abeparvovec-xioi (Zolgensma) highlight the potential impact of these therapies. The authors, hailing from prestigious institutions such as Stanford University, Children’s National Hospital, and Baylor College of Medicine, bring a wealth of expertise and clout that may help the PAMB become a reality.
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