Recursion announces first patient dosed in Phase 1/2 clinical study of REC-1245, a potential first-in-class, RBM39 degrader for Biomarker-Enriched Solid Tumors and Lymphoma
- First program to result from end-to-end use of OS to identify a novel target and new chemical matter, which moved from target ID to IND enabling studies in under 18 months with ~200 compounds synthesized
- REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile in Solid tumors and Lymphoma
- >100,000 patients in the US and EU5 initially addressable
SALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Recursion (NASDAQ:RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced that the first patient has been dosed in its Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of biomarker-enriched solid tumors and lymphoma.
Recursion identified the novel regulatory role of RBM39 on CDK12 function using its AI-powered maps of biology. Recursion believes the modulation of RBM39 may be associated with a therapeutic effect in certain biomarker-enriched solid tumors and lymphoma. Preclinical data support that RBM39 degradation induces splicing defects which downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints.
Dr. McKean, a Clinical Investigator at START Mountain Region in Salt Lake City, Utah shared "The evolution of precision and personalized treatment options for oncology patients provides promising alternatives. We are so pleased to be working with Recursion as a participating site in the DAHLIA trial, and look forward to advancing the science of cancer treatment."
"Dosing the first patient in the DAHLIA trial marks a pivotal moment for Recursion as we combine the power of our AI-enabled platform with cutting-edge science to pioneer a new class of targeted therapies," added Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion "REC-1245 represents not only a potential breakthrough for patients with biomarker-enriched cancers but also a testament to our ability to rapidly translate novel insights into clinical programs. This milestone exemplifies our commitment to transforming the future of oncology with precision and speed."
The DAHLIA clinical trial is an open-label Ph1/2 study to characterize the safety, tolerability, PK, PD, and preliminary activity (ORR) of REC-1245 and to identify the maximum tolerated dose (MTD) and / or recommended phase 2 dose (RP2D). REC-1245 is a potential single agent or for use in combination with other agents (DDR inhibitors, checkpoint inhibitors, chemotherapy).
About the potential patient population
Based on an as of yet undisclosed specific set of biomarkers, Recursion estimates that the initially addressable population for this potential therapeutic to be >100,000 patients in the US and EU5.
About REC-1245
REC-1245 is a novel molecular glue that leads to the degradation of RBM39 via E3 ligase adaptor DCAF15, which disrupts RNA splicing to downregulate cell cycle checkpoints and DDR networks, including CDK12. REC-1245 was characterized to selectively mimic the phenotype associated with CDK12 loss of function, and is an alternative target for modulating DNA damage response (DDR) pathways. It was developed with Recursion's AI-enabled drug discovery platform.
About the Trial
The DAHLIA trial is a multi-center, open-label Ph1/2 study to characterize the safety, tolerability, PK, PD, and preliminary activity (ORR) of REC-1245 and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D).
In the DAHLIA trial REC-1245 will be administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic cancer and refractory to, had a relapse, or were intolerant of established standard of care treatments. Following the completion of Part 1A (monotherapy dose-finding), up to two previously examined dose levels will be randomized 1:1 in the monotherapy dose confirmation (Part 1B) portion of the study to determine the RP2D. The Phase 2 portion of this study will independently enroll one or more cohorts in parallel at the chosen RP2D dose.
About Recursion
Recursion (NASDAQ:RXRX) is a leading, clinical-stage TechBio company decoding biology to industrialize drug discovery. Central to its mission is the Recursion Operating System (OS), a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological, chemical and patient-centric datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale—up to millions of wet lab experiments weekly—and massive computational scale—owning and operating one of the most powerful supercomputers in the world—Recursion is uniting technology, biology, chemistry and patient-centric data to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has other primary offices in Toronto, Montreal, the San Francisco Bay Area, New York, the Oxford area, and London.
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Forward-Looking Statements
This document contains information that includes or is based upon "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC-1245; timing of the Phase 1/2 clinical trial of REC-1245; early and late stage discovery, preclinical, and clinical programs; prospective products and their potential future indications and market opportunities; Recursion OS and the ability achieve results of REC-1245 on other targets and/or compounds, and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as "plan," "will," "expect," "anticipate," "intend," "believe," "potential," "continue," and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings. All forward-looking statements are based on management's current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.
