Weekly Tech+Bio Highlights #28
Also: On Combination Therapies in Oncology, Alzheimer’s Prevention Antibody Trial, and more...
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Let’s get to this week’s topics!
Brief Insights
🔬 Insilico Medicine sets new AI-driven drug discovery benchmarks, reducing preclinical timelines to as little as 9 months, with an average of 13 months to developmental candidate (DC) nomination—compared to the industry standard of 2.5–4 years
🔬 Receptor.AI partners with Moexa Pharmaceuticals to advance AI-driven development of SMAD3 inhibitors for cancer and fibrosis.
🔬 The Chan Zuckerberg Initiative (CZI) launches the Billion Cells Project in collaboration with 10x Genomics and Ultima Genomics, generating a massive one-billion-cell dataset to train AI models for advancing research in cellular behavior, gene function, and precision medicine.
🔬 A research team from Northwestern University, Johns Hopkins University, and DOE JGI released GenomeOcean—genome foundation model trained on 220TB of metagenomic data. The preprint, published on bioRxiv, highlights GenomeOcean’s ability to generate DNA sequences 150× faster than natural polymerases and discover novel biosynthetic gene clusters (BGCs).
🔬 Washington University-led trial begins testing Eli Lilly’s remternetug in young adults at high genetic risk for Alzheimer’s, aiming to prevent disease decades before symptoms appear. Backed by over $130M in funding, the study will assess whether early amyloid removal can stop disease onset, potentially shaping future prevention strategies for all forms of Alzheimer’s.
🔬 LG AI Research is tackling the next frontier in protein prediction—multistate proteins—through a new AI collaboration with Seoul National University. This effort aims to predict proteins that shift between forms, which could improve drug discovery for diseases like Alzheimer's.
📈 Sionna Therapeutics raises $135M in IPO to advance cystic fibrosis treatments, focusing on an NBD1 stabilizer and CFTR modulators through Phase 2 trials. Sionna has an agreement with AbbVie for up to $360M to test its lead candidate alongside Vertex’s Trikafta.
🔬 An IQVIA report warns of a biosimilar void in the U.S., as 90% of 118 biologics losing patent protection by 2034 lack biosimilar competition, potentially limiting $189B in healthcare savings unless regulatory and market challenges are addressed.
🔬 Surgeons at Massachusetts General Hospital successfully transplanted a genetically modified pig kidney into a 66-year-old patient, marking the fourth such procedure in the U.S. as part of an FDA-approved clinical trial testing pig organs for long-term human use.
🔬 Meanwhile, the FDA approves clinical trials for gene-edited pig kidney transplants, allowing United Therapeutics and eGenesis to test their organs in kidney failure patients.
🔬 After two FDA rejections, Supernus Pharmaceuticals secures approval for Onapgo, a subcutaneous apomorphine infusion for Parkinson’s motor fluctuations. Backed by Phase III data showing rapid and sustained symptom relief, Onapgo enters a U.S. market valued up to $300M as a competitor to AbbVie’s Vyalev.
💰 Bain Capital Private Equity acquires Mitsubishi Tanabe Pharma from Mitsubishi Chemical for $3.3B, expanding its life sciences portfolio to Japan with a focus on autoimmune, diabetes, kidney, and CNS diseases.
🔬 The FDA approves Roche’s Susvimo as the first continuous delivery treatment for diabetic macular edema (DME), reducing the need for frequent eye injections and marking its second indication after neovascular age-related macular degeneration.
💰 Tectonic Therapeutic secures $185M to advance its GPCR-targeted therapies TX45 and TX2100, extending its financial runway by up to 24 months.
💰 Alumis and ACELYRIN to merge in an all-stock deal, creating a late-stage biopharma company focused on immune-mediated diseases, with a combined $737M cash runway and key clinical readouts expected through 2027.
🔬 Roivant's namilumab failed to show benefit in a Phase 2 trial targeting inflammation in sarcoidosis, leading to its development being discontinued. The anti-GM-CSF antibody did not meet efficacy endpoints in chronic active pulmonary sarcoidosis, though Roivant remains committed to pursuing other high-risk, high-reward programs.
🚀 Baxter Kidney Care, now Vantive, launches as a standalone vital organ therapy company after its acquisition from Baxter by Carlyle, focusing on kidney care innovation, and dialysis solutions.
🔬 AI-powered ECG screening isn’t just effective—it’s cost-efficient too, according to a Mayo Clinic study on detecting weak heart pumps. AI-enhanced heart failure screening in outpatient settings had a cost-effectiveness ratio of just $1,651 per quality-adjusted life year.
🔬 The Wyss Institute launches the Healthy Aging Fund with a $1.5M gift from The Colossal Foundation to advance research on aging, longevity, and biodiversity, including developing artificial womb technology for species preservation.
🚀 Pfizer launches Health Answers by Pfizer, a generative AI-powered digital tool providing consumers with science-backed health and wellness information, available in US only.
🔬 Despite early data suggesting disease-modifying potential, Pliant Therapeutics has paused its Phase 2b/3 lung fibrosis trial for bexotegrast following a safety board’s recommendation.
🔬 Researchers at Shandong University used AI to identify 25 new antimicrobial protein compounds, including AMP-24 and AMP-29, which effectively treated bacterial and fungal infections in mice.
🔬 A single strand of hair may help rule out autism—LinusBio launches the first biochemical test designed to detect molecular markers of autism as early as one month old, aiding early diagnosis and intervention.
🔬 Paige expands its AI-powered cancer detection tool to identify common and rare cancer variants across 40+ organs and tissues using its Virchow V2 foundation model, trained on 3 million digitized slides, enhancing pathology efficiency and diagnostic accuracy.
🔬 Recursion’s AI-driven platform identified REC-994 as a potential treatment for cerebral cavernous malformations (CCM), with its Phase 2 trial confirming safety and showing promising lesion reduction and functional improvements, guiding next steps with regulators and extension studies.
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The Future of Advanced Therapeutics
Sai Bhamidipati, CMC Regulatory Leader at Moderna, recently written an article on BiopharmaTrend that outlines how advanced therapeutics are being developed to tackle complex diseases. The discussion focuses on three areas—mRNA vaccines, cell and gene therapies, and personalized medicine.
mRNA vaccines, which use synthetic messenger RNA to instruct cells in producing specific proteins, have demonstrated rapid development potential, a feature that proved valuable during the COVID-19 pandemic. Their cell-free production process allows for quick adaptation to emerging health threats, albeit Sai notes that scaling up production and navigating evolving regulatory guidelines remain significant challenges.
Cell and gene therapies, designed to address genetic disorders by altering patients’ genetic material, also show promise. With over 2,000 gene-based treatments in various stages of clinical development, these approaches aim to provide long-term benefits for conditions that have been difficult to manage. At the same time, safety concerns—illustrated by recent FDA reviews—and the complexity of processes such as viral vector production highlight practical issues that need ongoing attention.
Sai argues that tailoring treatments based on an individual’s genetic, environmental, and lifestyle factors could lead to improved therapeutic outcomes. Yet, realizing this potential depends on establishing flexible manufacturing processes and adapting regulatory frameworks to better accommodate individualized treatment methods.
Read the full article here.
On Combination Therapies in Oncology
Contributor’s piece, by Andreas Dreps, Senior Vice President, Oncology Drug Development at ICON, and Bea Mann, PhD, Senior Director, Oncology Drug Development at ICON, discussing how combination treatments are reshaping cancer care and the hurdles that come with them.
Andreas and Bea argue that the expanding range of oncology treatments—from traditional chemoradiotherapy to targeted and immuno-based approaches—creates new opportunities for combination therapies that may offer patients more effective options. They point out that, with over 60 oncology approvals by the FDA in 2024 (including 11 first-in-class therapies), the field is witnessing a shift toward treatment regimens that blend different modalities for synergistic effects.
They note several key approaches:
Immune Response Activation: Pairing ICIs with agents like anti-angiogenic drugs (treatments that stop tumours from growing their own blood vessels), small molecules, or even mRNA cancer vaccines may overcome tumor resistance. For instance, anti-angiogenic therapies not only limit a tumor’s blood supply but also help immune cells penetrate the tumor more effectively. Similarly, combining ICIs with targeted immunotherapies, such as CAR T-cell therapies, has shown promise—evidenced by a Phase 2b study where a personalized mRNA vaccine combined with pembrolizumab led to a 49% reduction in recurrence or death in high-risk melanoma patients.
Multi-Pronged Attack: Bea writes about strategies that target cancer cells via different mechanisms simultaneously. An example provided is the combination of adagrasib, a KRAS G12C inhibitor, with cetuximab for KRAS-mutated colorectal cancer. This approach tackles resistance by inhibiting complementary pathways, resulting in improved response rates and a better safety profile compared to monotherapy.
Andreas and Bea also highlight several development challenges:
Clinical Trial Design and Regulatory Alignment: Combination treatments often come with stricter entry criteria and require non-traditional, adaptive trial designs. This complexity can lead to prolonged enrollment periods and increased data management challenges.
Dose Determination and Safety: Traditional rule-based dose selection methods fall short for combination regimens. Instead, model-based approaches are necessary to identify the optimal biological doses, especially since drugs may act more potently when combined—raising the risk of adverse drug interactions.
Biomarker Development: The integration of biomarkers becomes even more critical when therapies are combined. Existing thresholds used in monotherapy may need adjustments to accurately assess patient responses in combination settings.
Collaboration and Expertise: Both authors emphasize that partnering with experienced vendors, trial sites, and regulatory experts is essential to de-risk the clinical development process in this increasingly complex therapeutic landscape.
For a detailed discussion on combination oncology therapies, you can read the full article here.
Alzheimer’s Prevention Antibody Trial
A WashU Medicine-led study tests whether early intervention with an investigational antibody can halt Alzheimer’s progression before symptoms appear.
A recent press release from WashU Medicine details the launch of an international clinical trial aimed at preventing Alzheimer’s disease in young adults at high genetic risk. Led by Washington University School of Medicine in St. Louis, the trial focuses on individuals from families with mutations that nearly guarantee early-onset Alzheimer’s. Participants as young as 18—who are 11 to 25 years younger than the typical age of symptom onset—will be enrolled to determine if early intervention can stop the disease process before cognitive symptoms develop.
The study will evaluate remternetug, an investigational monoclonal antibody developed by Eli Lilly and Company, designed to either remove or block the accumulation of amyloid beta plaques in the brain. Early phase trials in symptomatic patients have shown that remternetug can reduce amyloid levels to a degree comparable with existing therapies, but with the added convenience of subcutaneous injections administered every three months instead of more frequent intravenous infusions. Each participant will receive treatment for two years, with mutation carriers eligible for an additional four-year open-label extension. Researchers will primarily assess the drug’s effect on plaque accumulation and related molecular markers in blood and cerebrospinal fluid, while long-term follow-up will help evaluate any cognitive benefits.
The trial is part of the Knight Family DIAN-TU clinical trials platform, a collaborative effort involving international research institutes and backed by over $130 million in funding from sources including the NIH’s National Institute on Aging, the Alzheimer’s Association, and the GHR Foundation.