Recursion Announces First Patient Dosed in Phase 1 Clinical Study of REC-3565, a Selective MALT1 Inhibitor for Relapsed or Refractory B-cell Lymphomas
Recursion (RXRX) has initiated dosing in the Phase 1 EXCELERIZE clinical study of REC-3565, a selective MALT1 inhibitor designed for treating relapsed or refractory B-cell lymphomas. The compound, developed using Recursion's AI-powered platform, showed promising preclinical results with durable tumor regressions both as monotherapy and combined with BTK inhibitors.
The study consists of two parts: Part A will evaluate monotherapy dosing, while Part B will assess combination regimens. REC-3565's allosteric design aims to enhance potency and selectivity while potentially reducing liver toxicity risks associated with UGT1A1 inhibition, a common side effect in other MALT1 inhibitors.
Notably, the development timeline was accelerated, with the lead candidate delivered in just 15 months using the Recursion OS platform, which combines physics-based modeling with molecular dynamics and hotspot analysis.
Recursion (RXRX) ha avviato la somministrazione nel studio clinico di Fase 1 EXCELERIZE di REC-3565, un inibitore selettivo di MALT1 progettato per il trattamento dei linfomi a cellule B in recidiva o refrattari. Il composto, sviluppato utilizzando la piattaforma basata su AI di Recursion, ha mostrato risultati preclinici promettenti con regressioni tumorali durature sia come monoterapia che in combinazione con inibitori di BTK.
Lo studio è composto da due parti: la Parte A valuterà la somministrazione in monoterapia, mentre la Parte B esaminerà i regimi combinati. Il design alosterico di REC-3565 mira a migliorare la potenza e la selettività, riducendo potenzialmente i rischi di tossicità epatica associati all'inibizione di UGT1A1, un effetto collaterale comune in altri inibitori di MALT1.
È notevole che la tempistica di sviluppo sia stata accelerata, con il candidato principale consegnato in soli 15 mesi utilizzando la piattaforma Recursion OS, che combina modellazione basata sulla fisica con dinamiche molecolari e analisi dei punti critici.
Recursion (RXRX) ha iniciado la dosificación en el estudio clínico de Fase 1 EXCELERIZE de REC-3565, un inhibidor selectivo de MALT1 diseñado para tratar linfomas de células B en recaída o refractarios. El compuesto, desarrollado utilizando la plataforma impulsada por IA de Recursion, mostró resultados preclínicos prometedores con regresiones tumorales duraderas tanto como monoterapia como en combinación con inhibidores de BTK.
El estudio consta de dos partes: la Parte A evaluará la dosificación en monoterapia, mientras que la Parte B evaluará los regímenes de combinación. El diseño alostérico de REC-3565 tiene como objetivo mejorar la potencia y selectividad, al tiempo que potencialmente reduce los riesgos de toxicidad hepática asociados con la inhibición de UGT1A1, un efecto secundario común en otros inhibidores de MALT1.
Es notable que la línea de tiempo de desarrollo se haya acelerado, con el candidato principal entregado en solo 15 meses utilizando la plataforma Recursion OS, que combina modelado basado en física con dinámicas moleculares y análisis de puntos críticos.
Recursion (RXRX)는 REC-3565의 1상 EXCELERIZE 임상 연구에서 투약을 시작했습니다. REC-3565는 재발성 또는 난치성 B세포 림프종 치료를 위해 설계된 선택적 MALT1 억제제입니다. 이 화합물은 Recursion의 AI 기반 플랫폼을 사용하여 개발되었으며, 단독 요법 및 BTK 억제제와의 병용 요법 모두에서 지속적인 종양 퇴축을 보여주는 유망한 전임상 결과를 보였습니다.
이 연구는 두 부분으로 구성됩니다: A 부분은 단독 요법 투약을 평가하고, B 부분은 병용 요법을 평가합니다. REC-3565의 알로스테릭 디자인은 효능과 선택성을 향상시키는 동시에 UGT1A1 억제와 관련된 간 독성 위험을 줄이는 것을 목표로 합니다. 이는 다른 MALT1 억제제에서 흔히 나타나는 부작용입니다.
특히 개발 일정이 가속화되어, Recursion OS 플랫폼을 사용하여 단 15개월 만에 주요 후보가 전달되었습니다. 이 플랫폼은 물리 기반 모델링과 분자 역학 및 핫스팟 분석을 결합합니다.
Recursion (RXRX) a lancé l'administration dans l'étude clinique de Phase 1 EXCELERIZE de REC-3565, un inhibiteur sélectif de MALT1 conçu pour traiter les lymphomes à cellules B en rechute ou réfractaires. Le composé, développé à l'aide de la plateforme alimentée par l'IA de Recursion, a montré des résultats précliniques prometteurs avec des régressions tumorales durables tant en monothérapie qu'en combinaison avec des inhibiteurs de BTK.
L'étude se compose de deux parties : la Partie A évaluera la posologie en monothérapie, tandis que la Partie B examinera les schémas de combinaison. Le design allostérique de REC-3565 vise à améliorer la puissance et la sélectivité tout en réduisant potentiellement les risques de toxicité hépatique associés à l'inhibition de l'UGT1A1, un effet secondaire courant chez d'autres inhibiteurs de MALT1.
Il est à noter que le calendrier de développement a été accéléré, le candidat principal ayant été livré en seulement 15 mois grâce à la plateforme Recursion OS, qui combine modélisation basée sur la physique avec dynamique moléculaire et analyse des points chauds.
Recursion (RXRX) hat die Dosierung in der Phase-1-EXCELERIZE-Studie von REC-3565 begonnen, einem selektiven MALT1-Inhibitor, der zur Behandlung von rezidivierenden oder refraktären B-Zell-Lymphomen entwickelt wurde. Die Verbindung, die mit der KI-gesteuerten Plattform von Recursion entwickelt wurde, zeigte vielversprechende präklinische Ergebnisse mit dauerhaften Tumorrückgängen sowohl als Monotherapie als auch in Kombination mit BTK-Inhibitoren.
Die Studie besteht aus zwei Teilen: Teil A wird die Dosierung der Monotherapie bewerten, während Teil B die Kombinationsregime untersucht. Das allosterische Design von REC-3565 zielt darauf ab, die Potenz und Selektivität zu erhöhen und gleichzeitig möglicherweise die mit der UGT1A1-Hemmung verbundenen Risiken für die Lebertoxizität zu reduzieren, die ein häufiges Nebenwirkung bei anderen MALT1-Inhibitoren ist.
Bemerkenswert ist, dass der Entwicklungszeitplan beschleunigt wurde, wobei der Hauptkandidat in nur 15 Monaten unter Verwendung der Recursion OS-Plattform bereitgestellt wurde, die physikbasierte Modellierung mit molekularer Dynamik und Hotspot-Analyse kombiniert.
- Successful initiation of Phase 1 clinical trial with first patient dosed
- Accelerated development timeline - lead candidate delivered in just 15 months
- Promising preclinical results showing durable tumor regressions
- Potential competitive advantage with reduced liver toxicity risk compared to other MALT1 inhibitors
- Early-stage Phase 1 trial with uncertain outcomes
- Faces competition from existing MALT1 inhibitors in development
Insights
Recursion's advancement of REC-3565 into Phase 1 clinical trials represents an important pipeline milestone, though still at an early stage in the drug development process. The MALT1 inhibitor targets relapsed/refractory B-cell lymphomas, addressing an area with significant unmet needs where patients often exhaust available treatment options.
The compound's key differentiation is its design to reduce hyperbilirubinemia (elevated bilirubin causing jaundice), a dose-limiting toxicity that has hindered other MALT1 inhibitors in development. This safety-focused design could potentially provide a competitive advantage if clinical data confirms the preclinical safety profile.
The EXCELERIZE trial structure is standard for early oncology assets, with dose-escalation followed by combination studies. What's noteworthy is how Recursion's AI platform apparently expedited lead candidate selection to just 15 months, demonstrating potential operational efficiencies in their discovery process.
However, investors should recognize that Phase 1 studies primarily assess safety, with preliminary efficacy as secondary endpoints. The preclinical data showing durable tumor regressions is encouraging but requires validation in humans. Only about 10-15% of oncology drugs that enter Phase 1 ultimately receive approval, placing this news in proper context as a positive but early milestone.
This clinical milestone has moderate positive implications for Recursion's technology platform validation, though immediate financial impact remains The advancement showcases the company's AI-powered Recursion OS platform capabilities—delivering a lead candidate in just 15 months represents significantly accelerated drug development compared to traditional timelines.
For investors, this serves as a proof point validating Recursion's TechBio approach. The company's technology appears to be successfully identifying promising drug candidates and moving them into clinical testing, which is essential for demonstrating the platform's value creation potential.
From a portfolio perspective, REC-3565 expands Recursion's clinical-stage pipeline in oncology, a high-value therapeutic area. The potential "best-in-class" positioning—if the differentiated safety profile proves accurate—could enhance future commercial prospects and partnership opportunities.
However, market impact should be tempered by the early-stage nature of this program. With Phase 1 trials typically lasting 1-2 years and multiple additional clinical phases required before potential approval, REC-3565 remains years from commercialization. While the news validates Recursion's technology approach, investors should view this as incremental long-term value creation rather than a near-term catalyst.
REC-3565 is a potential best-in-class MALT1 inhibitor for multiple hematology indications, designed to reduce the risk of hyperbilirubinemia, a common side effect of other MALT1 inhibitors
Salt Lake City, UT, April 08, 2025 (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 the Phase 1 EXCELERIZE clinical study evaluating REC-3565 for the treatment of relapsed or refractory B-cell lymphomas.
"REC-3565 showed durable tumor regressions in preclinical studies, both as a monotherapy and in combination with a BTK inhibitor. Leveraging our AI-powered Recursion OS platform, which combines physics-based modeling with molecular dynamics and hotspot analysis, we delivered a lead candidate in just 15 months," said Najat Khan, Chief R&D Officer and Chief Commercial Officer at Recursion. "Its allosteric design enhances potency, selectivity, and safety, potentially reducing liver toxicity risks associated with UGT1A1 inhibition seen in other MALT1 inhibitors. This is particularly promising for patients with B-cell malignancies, where unmet needs remain high."
EXCELERIZE, the Phase 1, open-label, multicenter dose-escalation study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of REC-3565 in two parts. Part A will assess monotherapy dosing to identify a recommended dose for combination in Part B, which will evaluate combination regimens to inform future studies in B-cell cancers.
“We’re advancing REC-3565, a potential best-in-class MALT1 inhibitor, to improve outcomes for patients with B-cell malignancies with limited treatment options,” said David Mauro, Chief Medical Officer at Recursion. “This milestone reflects our unwavering commitment to advancing patient-centric solutions and recruitment with AI-driven innovation.”
About REC-3565
REC-3565 is a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor designed using Recursion’s AI-driven multi-parameter optimization approach. MALT1, a key protease in the NF-kB pathway, drives malignant B-cell proliferation in hematological cancers. While current therapies (e.g., BTK inhibitors) have advanced treatment, resistance remains a significant challenge. REC-3565 targets MALT1 to potentially overcome resistance and improve outcomes, either as a monotherapy or in combination with BTK and BCL2 inhibitors. Unlike other MALT1 inhibitors, REC-3565 significantly minimizes UGT1A1 inhibition, reducing the risk of drug-drug interactions and liver toxicity, potentially enabling safer dose escalation and higher target engagement for better clinical efficacy. Approximately 41,000 relapsed and/or refractory (R/R) patients with CLL and B-cell lymphomas in the U.S. and EU5 are eligible for treatment each year.
About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical 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 and chemistry 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 offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.
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-3565, including the potential to be a best-in-class treatment; timing of and outcomes of the EXCELERIZE clinical trial; the effects of our partnerships and our platform on trial outcomes, efficiency, or enrollment; the potential size of the market opportunity for our drug candidates; the relevance of pre-clinical data; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications; Recursion OS 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. 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.
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FAQ
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