Unlearn Closes $50 Million Series B Funding to Advance the Use of Its Machine Learning-Powered TwinRCTs™ in Clinical Trials

Led by Insight Partners, financing builds on the company’s momentum in working with leading biopharmaceutical companies to improve clinical trial efficiency and increase confidence in results

SAN FRANCISCO–(BUSINESS WIRE)–Unlearn®, developer of the first machine-learning technology that creates digital twins of patients in clinical trials to enable smaller, faster studies, today announced that it has closed a $50 million Series B funding round. The financing was led by New York-based global venture capital and private equity firm Insight Partners with participation from new investor Radical Ventures, as well as all of the company’s existing investors including 8VC, DCVC, DCVC Bio and Mubadala Capital Ventures. Through its investment, Dylan Morris, Managing Director, Insight Partners, has joined the Unlearn Board of Directors.

Unlearn works with pharma sponsors, biotech companies, and academic institutions to optimize human clinical trials with TwinRCTs™. A TwinRCT™ is a randomized trial that uses machine learning and historical data to achieve a higher probability of success with a smaller number of patients. As in a traditional randomized controlled trial (RCT), patients are randomized to a treatment group and a control group; but, unlike a traditional trial, a digital twin is computed for every patient using a machine learning model trained on historical control data. The treatment effects for the primary and secondary outcomes can all be estimated with greater precision after correcting for each patient’s prognostic score derived from their digital twin. The European Medicines Agency (EMA) has published a draft qualification opinion indicating that this approach can be used for the primary analysis of phase II and III studies because it doesn’t introduce bias.

“By reducing the size of the control arm, more patients in a TwinRCT™ have access to a potentially beneficial experimental treatment instead of a placebo. Trials can be run faster and with the same resources so that patients can receive access to more effective treatments sooner,” said Dylan Morris, Managing Director at Insight Partners. “TwinRCTs™ not only increase trial efficiency but also provide rigorous evidence suitable for supporting regulatory decisions. We are excited to support the Unlearn team as they scale their TwinRCT™ solution to make clinical trials better for patients and for sponsors.”

“Unlearn continues to make rapid progress as we expand our work with global biopharmaceutical companies and advance productive conversations with global regulatory authorities who are committed to supporting innovation in clinical trials,” said Charles Fisher, Ph.D., founder and CEO of Unlearn. “This new financing is validation of our expanding footprint in clinical trials. We are proud to have the support of this world-class syndicate of investors and welcome both Insight Partners and Radical Ventures to the Unlearn team.”

Ahead of the Series B, Unlearn announced a multi-year collaboration with Merck KGaA, Darmstadt, Germany which is using TwinRCTs™ to incorporate prognostic information from digital twins into its randomized controlled trials. This will allow Merck KGaA, Darmstadt, Germany to enable smaller control groups and generate evidence suitable for supporting regulatory decisions in its immunology pipeline.

About Unlearn

Unlearn.AI is the only company creating TwinRCTs™, which combine AI, digital twins, and novel statistical methods to enable smaller, more efficient clinical trials. Unlearn’s technology has been published in conference abstracts and scientific journals, including Scientific Reports – Nature and The International Journal of Biostatistics. Unlearn is partnering with the world’s leading pharma companies, including Merck KGaA, Darmstadt, Germany, and continues to have discussions with regulators. The European Medicines Agency (EMA) published a draft qualification opinion for PROCOVA™ — a patent-pending method developed by Unlearn for leveraging historical data and machine learning to reduce sample sizes or increase power in Phase 2 or 3 clinical trials. For more information, please visit https://www.unlearn.ai or follow @UnlearnAI on Twitter, @unlearn-ai on LinkedIn.

About Insight Partners

Insight Partners is a global software investor partnering with high-growth technology, software, and Internet startup and ScaleUp companies that are driving transformative change in their industries. As of February 24, 2022, the closing of the firm's recent fundraise, Fund XII, brings Insight Partners’ regulatory assets under management to over $90B. Insight Partners has invested in more than 600 companies worldwide and has seen over 55 portfolio companies achieve an IPO. Headquartered in New York City, Insight has offices in London, Tel Aviv, and Palo Alto. Insight's mission is to find, fund, and work successfully with visionary executives, providing them with practical, hands-on software expertise to foster long-term success. Insight Partners meets great software leaders where they are in their growth journey, from their first investment to IPO. For more information on Insight and all its investments, visit insightpartners.com or follow us on Twitter @insightpartners.