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AI-Developed Drugs in Active Clinical Trials

A New Frontier in Clinical Trials

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AIVOLVE BIO
May 28, 2024

AI-Developed Drugs in Active Clinical Trials

AI-designed drugs represent a groundbreaking category of medications developed using artificial intelligence throughout the drug discovery process. According to a report by Boston consulting group in March 2022, biotechs leveraging AI in drug discovery had over 150 small-molecule drugs in the discovery phase, with more than 15 progressing through clinical trials. Currently, numerous AI-designed drugs are already in or entering clinical trials:

Recursion Pharmaceuticals

Founded: 2013, Salt Lake City, Utah Recursion Pharmaceuticals has developed the Recursion Operating System, a closed-loop system that combines proprietary in-house data generation with advanced computational tools. This platform generates novel insights to initiate or accelerate therapeutic programs, validated through repeated cycles in their own laboratories. Their high-dimensional data repository contains approximately 19 petabytes of proprietary information.

Clinical Trials:

  • REC-994 in phase 2 for Cerebral Cavernous Malformation (CCM). Phase 2 SYCAMORE clinical trial is a randomized, double-blind, placebo-controlled study. Data expected in 2024.

  • REC-2282 in phase 2 for Neurofibromatosis Type 2 (NF2). Phase 2/3 POPLAR clinical trial is a randomized, two-part study. Data expected in 2024.

  • REC-4881 in phase 2 for Familial Adenomatous Polyposis (FAP). Phase 1b/2 TUPELO clinical trial is an open-label, multicenter study. Data expected in 2025.

  • AXIN1 or APC Mutant Cancers. Phase 2 LILAC clinical trial is an open-label, multicenter study. Data expected in 2025.

  • REC-3964 in phase 1 for Clostridioides difficile Infection. Phase 2 study initiation expected in 2024.

  • RBM39 for HR-Proficient Ovarian Cancers and Other Solid Tumors. IND submission expected in H2 2024.

  • Undisclosed Indication in Fibrosis (Target Epsilon) from the collaboration with Bayer, now entering IND-enabling studies.

Founded: 2014, Hong Kong, New York Insilico Medicine combines genomics, big data analysis, and deep learning for in silico drug discovery. Their AI platform, pharma.AI can discover new targets, design new drugs, and predict clinical trial outcomes.

Clinical Trials:

  • INS018_055 is in phase 2 trials for idiopathic pulmonary fibrosis. It is the first drug discovered and designed using AI to reach phase I clinical trials.

  • ISM3091 for solid tumors. IND application approved by the FDA. Collaboration with Exelixis announced in September 2023.

  • ISM004-1057D, a first-in-class small molecule inhibitor, in collaboration with Fosun Pharma, is in preclinical development.

  • KAT6 inhibitor for breast cancer and other oncology indications, under a global exclusive license agreement with Menarini Group.

Founded: 2013, London, UK BenevolentAI employs a computational R&D platform centered on their Knowledge Graph, integrating all relevant data and scientific literature.

Clinical Trials:

  • BEN-2293 for atopic dermatitis (Phase I/II proof-of-concept trial).

  • BEN-28010, an oral brain-penetrant CHK1 inhibitor, completed IND-enabling studies in 2024.

Founded: 2012, Oxford, UK Exscientia uses genetic data and global literature in machine learning models to predict disease-target associations and confirm responses in real patient samples.

Clinical Trials:

  • GTAEXS617 (CDK7) in Phase 1/2 trials for advanced solid tumors.

  • EXS74539 (LSD1) with IND submission expected in Q1 2024.

  • DSP-0038 and DSP-2342 for Alzheimer's disease psychosis, in collaboration with Sumitomo Pharma and Bristol Myers Squibb.

Founded: 2013, Texas, US Lantern Pharma's RADR® platform predicts patient responses to new drugs, transforming oncology drug discovery and development.

Clinical Trials:

  • LP-184 for solid tumors, currently in Phase I trials.

  • LP-284 for non-Hodgkin’s lymphoma, initiated Phase I trials in March 2024.

  • TTC-352 for metastatic estrogen receptor-positive breast cancer, in collaboration with TTC Oncology.

  • Elraglusib in collaboration with Actuate Therapeutics.

Founded: 2015, California, US Verge Genomics' ConVERGE discovery platform combines human genomics with advanced computational tools to predict new drugs.

Clinical Trials:

  • VRG50635 for ALS, in collaboration with Ferrer.

Founded: 2019, Boston, Massachusetts Valo Health's Opal platform integrates drug discovery and development processes using AI.

Clinical Trials:

  • OPL-0401 for diabetic retinopathy.

  • OPL-0301 for cardiovascular outcomes post-myocardial infarction.

Founded: 2015, Massachusetts, US Relay Therapeutics' Dynamo platform leverages insights into protein dynamics for drug design.

Clinical Trials:

  • RLY-4008 for FGFR2-altered cancers.

  • RLY-2608 for PI3Kα mutations.

  • GDC-1971 (formerly RLY-1971) for SHP2 inhibition, in collaboration with Genentech.

News Highlights

  • Odyssey Therapeutics has partnered with Janssen Inc. to discover and optimize small molecule medicines.

  • Cantos invests in startups intersecting life sciences and AI, including Sixfold Bio, Debut, Aizon, Catalog Technologies, Character Bio, Modulo Bio, Nabla Bio, and Spaero Bio.

That's a wrap for this week.