CDK7
~185,0001
REC-617 is a reversible, non-covalent small molecule CDK7 inhibitor being developed for the treatment of multiple advanced solid tumor indications. There are currently no CDK7 inhibitors approved by the FDA. The precision design of REC-617, resulting in high selectivity and optimized half-life, could distinguish it from other CDK7 inhibitors in development, by enabling the management of potential toxicities associated with CDK7 inhibition and maximizing on-target efficacy.
Learn more on clinicaltrials.gov.
RBM39
REC-1245 targets RBM39, a novel CDK12-adjacent target identified by the Recursion OS. We believe we can modulate this target to produce a therapeutic effect in biomarker-enriched solid tumors and lymphoma.
MALT1
~41,0002
REC-3565 is a small molecule MALT1 inhibitor, being developed for multiple hematology indications. There are currently no MALT1 inhibitors approved by the FDA. The precision design of REC-3565 has resulted in a well-balanced molecule with selectivity over UGT1A1, which distinguishes it from other MALT1 inhibitors in clinical development. Avoiding UGT1A1 inhibition can potentially reduce hyperbilirubinemia risk and allow a better combination profile with drugs that have known liver toxicity issues.
Learn more on euclinicaltrials.eu.
LSD1
~45,0003
Note: due to competitive landscape, REC-4539 is on strategic pause.
REC-4539 is the first LSD1 inhibitor designed to be both CNS-penetrant and reversible, and is being developed for multiple hematology and solid tumor indications, including small-cell lung cancer (SCLC) and acute myeloid leukemia (AML). There are currently no LSD1 inhibitors approved by the FDA. REC-4539’s combined properties distinguish it from other LSD1 inhibitors in development, with the potential to reduce adverse events seen from on-target platelet effects.
PI3Kα H1047R
~11,000
REC-7735 is a PI3Kα H1047R mutant selective inhibitor being developed for the treatment of HER2- HR+ Breast cancer where the PI3Kα-H1047R mutation is present, representing 14% of such cases in the US and EU5 and addressing ~11,000 patients. This highly selective inhibitor targets the most frequent PIK3CA mutation and a key driver of cancer. The molecule was designed to maximize the therapeutic window and to avoid dose-limiting hyperglycemia or other off-target AEs associated with wild-type PI3Kα inhibition. Preclinical models have shown tumor regression when used as a monotherapy treatment and when combination with standard of care.
MEK Inhibitor
~50K4
REC-4881 is an orally bioavailable, non-ATP-competitive, allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in people living with FAP. There are currently no FDA-approved therapies for the treatment of FAP, a rare tumor predisposition syndrome affecting approximately 50,000 people in the US, France, Germany, Italy, Spain and the UK.
Learn more on clinicaltrials.gov.
ENPP15
>7,8006
REV102 is an orally available, small molecule ENPP1 inhibitor, being developed for the treatment of hypophosphatasia (HPP). HPP is a rare, potentially life-threatening genetic disease, characterized by impaired mineralization of bones and teeth. Inhibiting ENPP1 reduces inorganic pyrophosphate (PPi) levels which may restore the PPi and phosphate balance needed to promote bone mineralization. With our collaborators, we have shown that ENPP1 inhibition is safe and well-tolerated by preclinical models, and for the first time demonstrated that ENPP1 is a druggable target for later-onset HPP.
~185,0001
REC-617 is a reversible, non-covalent small molecule CDK7 inhibitor being developed for the treatment of multiple advanced solid tumor indications. There are currently no CDK7 inhibitors approved by the FDA. The precision design of REC-617, resulting in high selectivity and optimized half-life, could distinguish it from other CDK7 inhibitors in development, by enabling the management of potential toxicities associated with CDK7 inhibition and maximizing on-target efficacy.
Learn more on clinicaltrials.gov.
REC-1245 targets RBM39, a novel CDK12-adjacent target identified by the Recursion OS. We believe we can modulate this target to produce a therapeutic effect in biomarker-enriched solid tumors and lymphoma.
~41,0002
REC-3565 is a small molecule MALT1 inhibitor, being developed for multiple hematology indications. There are currently no MALT1 inhibitors approved by the FDA. The precision design of REC-3565 has resulted in a well-balanced molecule with selectivity over UGT1A1, which distinguishes it from other MALT1 inhibitors in clinical development. Avoiding UGT1A1 inhibition can potentially reduce hyperbilirubinemia risk and allow a better combination profile with drugs that have known liver toxicity issues.
Learn more on euclinicaltrials.eu.
~45,0003
Note: due to competitive landscape, REC-4539 is on strategic pause.
REC-4539 is the first LSD1 inhibitor designed to be both CNS-penetrant and reversible, and is being developed for multiple hematology and solid tumor indications, including small-cell lung cancer (SCLC) and acute myeloid leukemia (AML). There are currently no LSD1 inhibitors approved by the FDA. REC-4539’s combined properties distinguish it from other LSD1 inhibitors in development, with the potential to reduce adverse events seen from on-target platelet effects.
~11,000
REC-7735 is a PI3Kα H1047R mutant selective inhibitor being developed for the treatment of HER2- HR+ Breast cancer where the PI3Kα-H1047R mutation is present, representing 14% of such cases in the US and EU5 and addressing ~11,000 patients. This highly selective inhibitor targets the most frequent PIK3CA mutation and a key driver of cancer. The molecule was designed to maximize the therapeutic window and to avoid dose-limiting hyperglycemia or other off-target AEs associated with wild-type PI3Kα inhibition. Preclinical models have shown tumor regression when used as a monotherapy treatment and when combination with standard of care.
~50K4
REC-4881 is an orally bioavailable, non-ATP-competitive, allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in people living with FAP. There are currently no FDA-approved therapies for the treatment of FAP, a rare tumor predisposition syndrome affecting approximately 50,000 people in the US, France, Germany, Italy, Spain and the UK.
Learn more on clinicaltrials.gov.
>7,8006
REV102 is an orally available, small molecule ENPP1 inhibitor, being developed for the treatment of hypophosphatasia (HPP). HPP is a rare, potentially life-threatening genetic disease, characterized by impaired mineralization of bones and teeth. Inhibiting ENPP1 reduces inorganic pyrophosphate (PPi) levels which may restore the PPi and phosphate balance needed to promote bone mineralization. With our collaborators, we have shown that ENPP1 inhibition is safe and well-tolerated by preclinical models, and for the first time demonstrated that ENPP1 is a druggable target for later-onset HPP.
At Recursion Pharmaceuticals, we are committed to radically improving the lives of patients and their families by developing therapies that will make a lasting, positive, and transformative impact on diseases and conditions for which there are high unmet needs.
We believe that the best way to succeed in our mission is through well-designed clinical trials that determine the safety and effectiveness of investigational medicines. We understand that in some rare and specific circumstances, when enrollment into a clinical trial is not possible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines. When appropriate and through an expanded access protocol, Recursion will consider individual Expanded Access, sometimes called “Compassionate Use” or “Early Access”, requests for an investigational medicine outside of an ongoing clinical trial for the indication being investigated by the company.
There may be additional requirements, but to start, a licensed treating physician must submit the request for Expanded Access in writing by contacting ExpandedAccess@Recursion.com. The physician must be able and willing to obtain a treatment IND, or regional equivalent, and Institutional Review Board or Ethics Committee approval, for the patient prior to initiating treatment with our investigational medicine.
We will consider applications to provide the investigational drug that will not, among other things, compromise the scientific validity of our broader development programs, or interfere with or delay clinical trials or regulatory filings designed to make the drug available to a larger patient population.
We endeavor to respond to Expanded Access requests within one week after the steps for submission are completed.
It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product. For information on available clinical trials visit: www.ClinicalTrials.gov.
Recursion is committed to maintaining the highest level of integrity and ethics across all clinical trials and investigational programs, including the timely and transparent disclosure of clinical trial information and results.
All company-sponsored Phase 2 and 3 clinical trials are posted on country-specific registries of clinical trials, such as clinicaltrials.gov. As part of our commitment to advancing science in the therapeutic areas in which we work, Recursion discloses results of these trials on public registries within 12 months following the trial completion date. To keep our patients informed, clinical trial results will be made available to participants in that trial upon request. Additionally, Recursion aims to submit an abstract of the primary analysis of clinical trial results for publication regardless of trial outcome or regulatory approval status.