The importance of artificial intelligence (AI) and machine learning (ML) continues to be acknowledged by drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been forged to deploy those tools.
Berg LLC, of Framingham, Mass., for example, a clinical-stage biotech company that uses AI to research diseases and develop innovative treatments, said it is tapping into the world’s most powerful supercomputer, Summit, located at the Department of Energy's Oak Ridge National Laboratory (ORNL) to conduct drug discovery research in the fight against COVID-19. The partnership will extend ORNL's ongoing drug development research on potential small-molecule drug compounds that might warrant further study against the SARS-CoV-2 coronavirus with Berg's human-derived disease model for rapid identification of targets. The company will be able to leverage its Interrogative Biology platform to assist in conducting research that identifies high priority targets where drug treatment could be introduced to treat COVID-19 infections.
Seattle-based Adaptive Biotechnologies Corp., in collaboration with Microsoft Corp., has launched Immunecode, which provides detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of COVID-19 blood samples from patients around the globe. The open database contains detailed information on the diverse set of T cells shown to specifically recognize unique features of the COVID-19 virus. The resource could help diagnose and manage COVID-19 from exposure through clearance of the virus, and potentially offer an accurate assessment of immunity.
Thousands of de-identified geographically and ethnically diverse patient blood samples from institutions around the world are being collected and analyzed alongside samples from Immunerace (Immune Response Action to COVID-19 Events), the companies' prospective study enrolling 1,000 U.S. participants to decode how immune systems detect and respond to the virus. Using Microsoft Azure's hyperscale cloud and ML capabilities, the T-cell response signature will be continuously refined by extending the number of matches of COVID-19-related T cells to antigens and directly associating that T-cell signature with disease and outcomes. In addition to making those data freely available, Adaptive said it is conducting its own research to develop a new kind of diagnostic looking specifically at the T-cell response to the COVID-19 virus. The companies partnered in 2018 to create a TCR-Antigen Map, an approach to translating the genetics of the massive adaptive immune system to understand how it works.
AI accelerating research
In addition to helping home in on promising therapies and vaccines to treat COVID-19, AI is being deployed in other therapeutic areas. GNS Healthcare Inc., of Cambridge, Mass., and the Multiple Myeloma Research Foundation (MMRF) have entered a five-year partnership to leverage the longitudinal multimodal patient registry data from the MMRF CoMMpass study, the largest genomics dataset of any cancer, with GNS' causal AI and simulation platform to create the next generation of individual patient-level computer models of disease progression and drug response. The collaboration is set up to address key questions for multiple myeloma patients, including identifying subtypes of aggressive disease progression and drivers of patient response to an increasing array of therapeutics, including emerging immunotherapies such as CAR T-cell therapy.
GNS Healthcare is developing in silico patients from real world and clinical data to reveal the complex system of interactions underlying disease progression and drug response. The technology is designed to simulate drug response at the individual patient level to precisely match therapeutics to patients and rapidly discover key insights across drug discovery, clinical development, commercialization and payer markets.
Investors taking notice
The increasing influence AI is having on drug research has attracted the attention of investors who are watching public companies that are utilizing advanced computer resources to aid their research and development. As a result, the BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 12% year-to-date. (See BioWorld Artificial Intelligence index, below.)
Biopharmaceutical company Bioxcel Therapeutics Inc., of New Haven, Conn., is utilizing AI to identify improved therapies in neuroscience and immuno-oncology. Its shares (NASDAQ:BTAI) have been on a tear so far this year, gaining a whopping 302%. Significant clinical progress in its product pipeline has certainly helped the valuation of the company’s shares.
In May, Bioxcel reported it had reached full enrollment of its pivotal phase III Serenity trials evaluating BXCL-501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. The company said it expects to report top-line data from both trials next month.
The achievement was lauded by Wainwright analyst Raghuram Selvaraju, who wrote in a report, “We feel that the attainment of this key milestone despite the emergence of the COVID-19 pandemic and the restrictions being imposed by regulators on many clinical studies constitutes an impressive achievement and bodes well for the timeline of the Tranquility phase II trial of BXCL-501 for acute agitation in patients with Alzheimer's disease.”
This month, the company announced that the first patient had been enrolled in the phase Ib/II Release trial of BXCL-501, a sublingual thin-film formulation of dexmedetomidine, for the treatment of opioid withdrawal symptoms.
Group member Simulations Plus has seen its shares almost double year to date. Recently, it announced that it had received a new grant award from the FDA for up to $400,000 over three years, to develop physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) approaches to support interspecies translation for ocular drug delivery in Gastroplus, a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal, subcutaneous and intramuscular absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals.
The PBPK/PD modeling strategies for ophthalmic drug products will inform regulatory decision-making, the company explained.
Under the cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with several leading pharmaceutical and generic drug companies.