Concluding 2024: Weekly Highlights #24
ALSO: Legal Challenges of AI in Drug Discovery; Virtual Cells in Real Tissue; Disrupting In Vitro Fertilization Status Quo
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’s weekly newsletter, Where Tech Meets Bio, where we explore technologies, breakthroughs, and the great companies driving the biopharma and medtech industries forward.You might remember
covering the Aging Research and Drug Discovery Meeting in September’s article, From the Trenches of the 11th ARDD Meeting.Registration is now open for the 12th Aging Research & Drug Discovery Meeting, happening August 25–29, 2025, at the University of Copenhagen’s Ceremonial Hall and online.
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Let’s get to this week’s topics.
Brief Insights
🔬 Tissue Dynamics concludes 2024 with the largest human organoid screen to date. It tracked 7,680 liver organoids exposed to 126 FDA-approved drugs, generating over 20 million data points to develop the MechaniX model. The model achieved 96% predictive accuracy for drug-induced liver injury (DILI).
🔬 Gilead Sciences partners with Terray Therapeutics to use its AI-driven tNova platform for small molecule drug discovery, combining Terray’s high-throughput experimentation and generative AI with Gilead’s therapeutic expertise; financial terms include upfront payments, milestones, and royalties.
🔬 Gameto achieves the first live birth using Fertilo, its ovarian support cell technology that matures eggs outside the body, reducing hormone injections by 80% and IVF cycles from 14 to 3 days, with regulatory approvals expanding globally and U.S. trials underway.
🔬 Sanofi launches its 2025 iNext Awards in North America, inviting high-risk, high-reward immunoscience proposals with up to $500,000 funding for 18-month projects; submissions are open to startups and academic labs until January 30, 2025.
🔬 Sanofi and Teva report positive Phase 2b results for TL1A monoclonal antibody duvakitug, with 47.8% of patients achieving remission in ulcerative colitis and Crohn’s disease at high doses; Phase 3 trials are planned.
🔬 insitro earns $25M milestone payment from Bristol Myers Squibb for identifying a novel ALS genetic target using its ML-driven insitro Human platform; the collaboration could yield over $2B in total payments as the target advances to drug discovery.
💰 Irish AI startup Nuritas secures $42M in Series C to expand its AI-powered peptide discovery platform, Magnifier, which identifies bioactive peptides for health and wellness products like PeptiStrong and PeptiYouth; the funding supports scaling operations and global growth.
🔬 NOETIK launches foundational AI model OCTO-VirtualCell and its visualization tool Celleporter, enabling virtual cell behavior simulations in tissue environments to uncover hidden disease biology and drive advancements in precision oncology and spatial biology research.
🚀 After raising $13M in May 2024, AI-driven protein expression biotech ExpressionEdits appoints Dr. Paul Bolno, former CEO of Wave Life Sciences, as Board Chair; the company is advancing its Genetic Syntax Engine to optimize protein-based and gene therapies.
💰 BioAge Labs and Novartis sign a $500M collaboration deal to target aging-related diseases by combining BioAge's human longevity data platform with Novartis' expertise, including $20M upfront and milestone-based payments of up to $530M.
💰 SandboxAQ, raises $300M at a $5.3B valuation to advance its AI-driven Large Quantitative Models (LQMs) for biopharma, finance, and cybersecurity; recent collaborations include AstraZeneca, Sanofi, and MJFF, alongside acquisitions and innovations in molecular simulation and diagnostics.
🔬 In his guest article Nikhil Pradhan, Intellectual Property Lawyer at Foley & Lardner LLP, outlines key legal and governance frameworks for AI drug discovery, emphasizing robust IP strategies, data protection, and readiness for regulatory guidance to ensure innovation aligns with commercial and ethical standards.
🔬 Thomas Fessard, Co-Founder and CEO of SpiroChem AG, explores how chemistry CROs are adapting to market shifts by focusing on high-value expertise in bRo5 molecules, PROTACs, ADCs, and radiopharmaceuticals, emphasizing innovation, sustainability, and flexible, results-driven business models to meet the evolving needs of biotech and pharma.
📈 An FTI Consulting survey reveals renewed optimism in healthcare and life sciences for 2025, with 79% expressing confidence in the industry, driven by M&A resurgence, GLP-1 obesity treatments, immuno-oncology investments, and AI's transformative potential in drug development and operations; cybersecurity and ESG remain key challenges.
💰 Ottimo Pharma, led by former Seagen CEO David Epstein, raises $140M in Series A, led by OrbiMed, Avoro Capital, and Samsara BioCapital, to advance jankistomig, a PD1-VEGFR2 bifunctional antibody positioned to contend with Keytruda; IND filing is planned for late 2025.
💰 Syncromune, a Florida-based biotech specializing in combination immunotherapies, raises $100M in Series A to advance its in situ therapy platform for metastatic solid tumors; Phase 1 trials are underway for its lead candidates, SV-101 and SV-102.
🔬 The U.S. Congress failed to pass the Biosecurity Act this year, a bill targeting Chinese biotech firms, prompting WuXi Biologics to resume construction of its $300M biopharmaceutical plant in Worcester, Massachusetts, which was previously halted amid legislative uncertainty.
🚀 Y Combinator-backed General Proximity, led by CEO Armand Cognetta, raises $8M in seed funding led by Felicis to advance its proximity therapeutics platform targeting "undruggable" proteins for diseases like cancer, dementia, and aging-related conditions, bringing total funding to $16M.
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AI Drug Discovery in 2025—Legal and Governance Considerations
As FDA prepares to release draft guidance relating to the use of AI in drug development, Nikhil Pradhan, our guest contributor from Foley & Lardner LLP, reflects on the rapidly evolving landscape of AI in drug discovery in his new article, "Legal and Governance Considerations in AI for Drug Discovery: New Paradigms and 2025 Outlook".
He builds upon a recent survey of the field by Chris Bradbury, which categorizes the evolution of AI drug discovery into four distinct waves:
Bradbury’s survey highlights how these four waves have shaped—and continue to shape—new business models, faster clinical timelines, and novel approaches to analyzing patient data. Pradhan, in turn, uses this framework to examine the legal and governance dimensions that must evolve in parallel:
Value Proposition Clarity: Firms need to define their unique strengths in data, technology, and talent, while identifying risks tied to specific use cases.
Strategic Resource Allocation: Building robust IP portfolios and balancing patents and trade secrets ensures protection of critical assets and competitive advantage.
AI/Data Governance Frameworks: Establishing dedicated teams to align governance policies with risk controls is essential for managing sensitive data and AI deployment.
Operational Execution: Success hinges on integrating these strategies into model development, data management, licensing, partnerships, and investment diligence.
For a more granular view, including concrete examples and practical advice, read Nikhil Pradhan’s article.
Virtual Cells in Real Tissue
After securing $40 million in August 2024, Noetik—an AI-native biotechnology company—announced in a recently released technical report the launch of OCTO-VirtualCell, an AI model designed to suggest how cells behave in both healthy and disease contexts. With the goal to advance precision therapies, the startup leverages self-supervised machine learning and high-throughput spatial data.
More about OCTO, a world model for biology, here.
Complementing OCTO-vc, Noetik introduced Celleporter, an interactive simulator enabling researchers to predict gene expression patterns by simulating virtual cell behaviors embedded in patient tissue samples. OCTO-vc leverages a multi-scale, multi-modal transformer architecture trained via masked token modeling to predict spatial gene expression patterns, trained on nearly 40 million cells from over 1,000 patient tumor samples.
See also: 19 Companies Pioneering AI Foundation Models in Pharma and Biotech
“We place virtual cells in different regions of real tissue samples to probe specific biology in specific patients. For example, we can drop a virtual T cell into various parts of a tumor to infer whether the T cell will be activated – capable of killing cancer cells – or not. By running virtual cell simulations at many locations, we create a holistic picture of the underlying biology.” — Noetik
Prompts set certain genes to be on or off, and by positioning this virtual cell—which Noetik likens to a “high-dimensional thermometer”—across different regions of real tissue, the model hints at local biological properties.
In a proof-of-concept study involving tertiary lymphoid structures (TLS), simulations of immature B cells (prompted to express certain B cell genes) produced high levels of TCL1A precisely within TLS, aligning with known expression patterns in real samples. OCTO-vc can likewise highlight potential biomarkers and targets in treatment-resistant cancer populations.
CSO and Co-Founder Jacob Rinaldi comparing the technology to a new kind of microscope, suggested that these methods could pave the way for self-supervised science and help redefine the taxonomy of disease at a systems level.
While oncology is Noetik’s initial focus, the technology’s applications extend beyond cancer, serving as a general interface for spatial biology and enabling foundational research and drug discovery capabilities across a broad range of therapeutic areas.
To explore OCTO-vc and interact with Celleporter, visit Noetik’s OCTO-vc page and Celleporter’s page.
Live Birth Using Ex Vivo Egg Maturation
Gameto, a biotech specializing in fertility treatments, announced the world’s first live birth using Fertilo, its ovarian support cell technology that matures eggs outside the body. The birth took place on December 7, 2024, at Santa Isabel Clinic in Lima, Peru.
Women’s reproductive life spans have remained stagnant despite increases in overall life expectancy, with most women experiencing menopause in their 40s due to running out of eggs. This "accelerated ovarian aging" has profound implications, limiting choices around careers, relationships, and family planning.
Gameto, founded by fertility entrepreneur Martin Varsavsky and now led by CEO Dina Radenkovic in 2021, focuses on reducing the time, cost, and physical toll of egg freezing and IVF. Inspired by Radenkovic's own challenges with the traditional egg-freezing process, the company aims to simplify the procedure significantly.
Fertilo uses engineered, young ovarian support cells to replicate the natural egg maturation process in a laboratory setting, co-culturing immature eggs with these cells in a dish to facilitate maturation outside the body.
This approach mimics the body’s natural process, cutting hormone injections by about 80%, reducing IVF or egg freezing cycles from 14 days to just about 3, potentially lowering risks like ovarian hyperstimulation syndrome (OHSS) while minimizing side effects from high hormone doses.
The technology is rooted in innovations from George Church’s Harvard lab, which pioneered methods to engineer granulosa cells from stem cells (as illustrated on the cover of this newsletter, image by Wyss Institute). These cells play a big role in egg maturation, facilitating molecular communication that guides the egg’s development. By licensing this technology, Gameto developed Fertilo as a potential alternative to traditional IVF protocols, with applications extending to both egg freezing and donor egg programs.
Gameto has received regulatory clearance for Fertilo in markets including Australia, Japan, Argentina, Paraguay, Mexico, and Peru. The company recently partnered with IVFAustralia, part of the Virtus Health group, to advance availability of the technology.
In addition to the live birth in Peru, there are currently ten ongoing pregnancies using Fertilo, including one set of twins. Phase 3 clinical trials are being prepared in the United States to further assess its efficacy and safety.
Read also:
11 Biopharma Trends to Watch in 2024