Recursion Reports Interim Phase 1 Clinical Data for REC-617 Monotherapy, a Potential Best-in-Class CDK7 Inhibitor, With Encouraging Patient Response and Favorable Tolerability
Recursion (RXRX) announced interim Phase 1 clinical data for REC-617, their CDK7 inhibitor, showing promising results in advanced solid tumors. The study included 18 response-evaluable patients with doses ranging from 2mg to 20mg once daily and 1mg twice daily.
Key highlights include a confirmed partial response in a platinum-resistant ovarian cancer patient, ongoing after 6+ months of treatment, and stable disease in four additional patients for up to 6 months. The drug demonstrated favorable tolerability with predominantly Grade 1-2 adverse events and no treatment discontinuations.
REC-617 showed rapid absorption, dose-linear pharmacokinetics, and robust biomarker modulation. The company plans to continue monotherapy dose escalation and initiate combination studies in first half of 2025.
Recursion (RXRX) ha annunciato dati clinici preliminari della Fase 1 per REC-617, il loro inibitore di CDK7, mostrando risultati promettenti in tumori solidi avanzati. Lo studio ha incluso 18 pazienti valutabili per la risposta con dosi variabili da 2mg a 20mg una volta al giorno e 1mg due volte al giorno.
I punti salienti includono una risposta parziale confermata in un paziente con cancro ovarico resistente al platino, mantenuta dopo oltre 6 mesi di trattamento, e una malattia stabile in ulteriori quattro pazienti per un periodo massimo di 6 mesi. Il farmaco ha dimostrato una tollerabilità favorevole con eventi avversi prevalentemente di Grado 1-2 e senza interruzioni nel trattamento.
REC-617 ha mostrato un'rapida assorbimento, farmacocinetica lineare rispetto alla dose e una robusta modulazione dei biomarcatori. L'azienda prevede di continuare l'aumento della dose in monoterapia e di avviare studi di combinazione nella prima metà del 2025.
Recursion (RXRX) anunció datos clínicos interinos de la Fase 1 para REC-617, su inhibidor de CDK7, mostrando resultados prometedores en tumores sólidos avanzados. El estudio incluyó 18 pacientes evaluables para la respuesta con dosis que varían de 2mg a 20mg una vez al día y 1mg dos veces al día.
Los aspectos destacados incluyen una respuesta parcial confirmada en un paciente con cáncer de ovario resistente al platino, mantenida después de más de 6 meses de tratamiento, y enfermedad estable en otros cuatro pacientes durante hasta 6 meses. El fármaco demostró una tolerabilidad favorable con eventos adversos predominantemente de Grado 1-2 y sin interrupciones en el tratamiento.
REC-617 mostró rápida absorción, farmacocinética lineal con respecto a la dosis y una robusta modulación de biomarcadores. La compañía planea continuar con la escalación de dosis en monoterapia e iniciar estudios de combinación en la primera mitad de 2025.
Recursion (RXRX)는 REC-617, 그들의 CDK7 억제제에 대한 1상 임상 데이터의 중간 결과를 발표했으며, 진행성 고형 종양에서 유망한 결과를 보여주었습니다. 이 연구에는 2mg에서 20mg까지의 복용량을 하루에 한 번 또는 1mg을 하루에 두 번 복용하는 18명의 반응 평가 가능 환자가 포함되었습니다.
주요 하이라이트는 플래티넘 내성 난소암 환자에서의 확인된 부분 반응으로, 치료 후 6개월 이상 지속되었고, 4명의 추가 환자에서 최대 6개월 동안 안정적인 병상이 나타났습니다. 이 약물은 주로 1-2등급의 부작용을 동반하며 치료 중단 없이 좋은 내약성을 나타냈습니다.
REC-617는 빠른 흡수, 복용량 선형 약물동태, 그리고 강력한 생물표지자 조절을 보여주었습니다. 회사는 단독 요법 용량 증가를 계속하고 2025년 상반기 중에 병용 연구를 시작할 계획입니다.
Recursion (RXRX) a annoncé des données cliniques préliminaires de phase 1 pour REC-617, leur inhibiteur de CDK7, montrant des résultats prometteurs dans les tumeurs solides avancées. L'étude a inclus 18 patients évaluables concernant la réponse, avec des doses allant de 2mg à 20mg une fois par jour et 1mg deux fois par jour.
Les points clés incluent une réponse partielle confirmée chez une patiente atteinte d'un cancer de l'ovaire résistant au platine, maintenue après plus de 6 mois de traitement, ainsi qu'une maladie stable chez quatre autres patients pendant jusqu'à 6 mois. Le médicament a montré une tolérance favorable avec principalement des événements indésirables de grade 1-2 et aucune interruption de traitement.
REC-617 a montré une absorption rapide, une pharmacocinétique linéaire par rapport à la dose et une modulation robuste des biomarqueurs. L'entreprise prévoit de poursuivre l'escalade de la dose en monothérapie et de commencer des études de combinaison au cours de la première moitié de 2025.
Recursion (RXRX) hat vorläufige klinische Daten der Phase 1 für REC-617, ihren CDK7-Inhibitor, veröffentlicht, die vielversprechende Ergebnisse bei fortgeschrittenen soliden Tumoren zeigen. Die Studie umfasste 18 auf Ansprechen evaluierbare Patienten mit Dosen von 2mg bis 20mg einmal täglich und 1mg zweimal täglich.
Zu den wichtigsten Highlights gehört eine bestätigte partielle Ansprechrate bei einer platinresistenten Ovarialkrebspatientin, die nach mehr als 6 Monaten Behandlung fortbesteht, sowie eine stabile Erkrankung bei vier weiteren Patienten über einen Zeitraum von bis zu 6 Monaten. Das Medikament zeigte eine günstige Verträglichkeit mit überwiegend Grad 1-2 unerwünschten Ereignissen und ohne Behandlungspausen.
REC-617 zeigte eine schnelle Absorption, dosislineare Pharmakokinetik und eine robuste Biomarker-Modulation. Das Unternehmen plant, die Dosissteigerung in der Monotherapie fortzusetzen und in der ersten Hälfte von 2025 Kombinationsstudien zu starten.
- Confirmed partial response achieved in platinum-resistant ovarian cancer patient with 6+ months durability
- Four additional patients achieved stable disease for up to 6 months
- No treatment discontinuations due to adverse events
- Maximum tolerated dose not yet reached, allowing for potential dose optimization
- Drug demonstrates favorable pharmacokinetics with rapid absorption
- Only 1 partial response out of 18 evaluable patients
- Three treatment-related serious adverse events reported in 2 patients
Insights
The interim Phase 1 data for REC-617 shows remarkable promise in treating advanced solid tumors. The confirmed partial response in a heavily pretreated platinum-resistant ovarian cancer patient is particularly significant, with a
The safety profile appears favorable with predominantly Grade 1-2 adverse events and no treatment discontinuations, suggesting a potentially better therapeutic window than existing CDK7 inhibitors. The additional four patients achieving stable disease for up to 6 months in late-line settings further validates the drug's potential clinical utility.
This early clinical data significantly derisks REC-617's development program and positions Recursion favorably in the competitive CDK7 inhibitor landscape. The confirmed partial response in a heavily pretreated patient is particularly noteworthy as efficacy signals in Phase 1 monotherapy trials are relatively rare. The clean safety profile and lack of mandatory antiemetic prophylaxis suggests a potential best-in-class profile.
The planned combination studies in H1 2025 could unlock additional value, as CDK7 inhibitors are expected to show enhanced efficacy when combined with standard-of-care treatments. This positive data should strengthen Recursion's position in discussions with potential partners and support continued development investment.
- REC-617, a precision designed molecule, demonstrated dose-linear pharmacokinetics (PK) with rapid absorption and robust pharmacodynamic (PD) biomarker modulation, suggesting substantial target engagement
- Confirmed partial response (PR) observed during monotherapy dose-escalation in a patient with platinum-resistant ovarian cancer, treated with 4 lines of prior therapy in advanced setting, durable response ongoing after more than 6 months of treatment
- Additional 4 patients demonstrated a best response of stable disease (SD) for up to 6 months of treatment
- Plans to continue monotherapy dose escalation and initiate combination studies in 1H 2025
SALT LAKE CITY, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) reported initial monotherapy dose-escalation data from the Phase 1/2 study (ELUCIDATE) of REC-617, a selective CDK7 inhibitor, in advanced solid tumors.
These results were presented today after market close at an AACR Special Conference in Cancer Research. The company will also hold a webinar on December 10 at 6:30 AM MT / 8:30 AM ET / 1:30 PM GMT to present the preliminary data broadcast from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts with an opportunity to submit questions here.
"Cell cycle dysregulation and transcriptional 'addiction' are both hallmarks of many aggressive cancers," said David Hallett, Ph.D., Chief Scientific Officer of Recursion. "By inhibiting CDK7, we have the potential to target both mechanisms while fine tuning the therapeutic index. Using our precision design platform, we created a molecule with rapid oral absorption to reduce GI tissue exposure, a suitable half life to manage side effects, and target engagement covering the IC80 level."
ELUCIDATE is an ongoing Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) of REC-617 in patients with advanced solid tumors. As of the November 15, 2024 data cutoff, preliminary findings include 18 patients with advanced solid tumors who were response evaluable in the monotherapy dose-escalation phase. Doses ranged from 2 mg to 20 mg once daily (QD) and 1 mg twice daily (BID).
REC-617 was generally well-tolerated across all dose levels, with no discontinuations due to adverse events (AEs). Adverse events to date were predominately Grade 1-2, on-target, and reversible. An MTD has not yet been reached.
While efficacy was not an endpoint in this Phase 1 study, or anticipated in monotherapy, a confirmed durable partial response (PR) by RECIST on REC-617 monotherapy was achieved in a patient with metastatic, platinum-resistant ovarian cancer. The response is on-going after more than 6 months of treatment. This patient had progressed following 4 lines of prior therapy in the advanced setting. In addition, four patients achieved a best response of stable disease (SD) across multiple dose levels for up to 6 months of treatment.
"These initial findings for REC-617 represent an exciting step forward in the development of CDK7 inhibitors, with a favorable PK/PD profile and a durable confirmed partial response observed in dose escalation in a highly pre-treated patient population," said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer, Recursion. "Designed using our AI-powered OS platform, REC-617 reflects our focus on enhancing the therapeutic index to deliver more effective and safer treatment options for patients. We are eager to continue this momentum in dose escalation and to initiate the next phase of the program next year."
In parallel to the ongoing monotherapy dose escalation (QD and BID), combination studies are expected to initiate for ELUCIDATE in H1, 2025. The company expects to present additional ELUCIDATE as well as preclinical REC-617 data at future medical meetings.
Summary of Interim REC-617 Monotherapy Dose Escalation Results
Study Design & Demographics
- Phase 1 monotherapy dose escalation in advanced solid tumors
- Data cutoff as of November 15, 2024 - 19 patients enrolled (18 response evaluable)
- Heavily pre-treated population (median of 4 prior lines of therapy in the advanced setting)
- Antiemetics and anti-diarrheals not mandated prophylaxis for nausea/vomiting/diarrhea
PK/PD Summary
- REC-617 exceeds CDK7 IC80 with rapid absorption (Tmax 0.5–2 hours) with a half-life of 5-6 hours
- Early POLR2A 3-4x modulation suggests ~80–
90% target engagement - Quick, time-limited target engagement with POLR2A normalization in 24 hours
- Twice-daily (BID) dosing under investigation
Safety Profile/AE Summary
- Adverse events (AEs) were predominantly low grade, on-target, and reversible upon treatment cessation
- Early data indicates a favorable safety profile – maximum tolerated dose (MTD) not reached
- No treatment discontinuations due to AEs
- 3 treatment related serious adverse events (SAE)s reported in 2/19 patients
- Events resolved and treatment continued after dose reduction
- Antiemetics and anti-diarrheals not mandated prophylaxis for nausea/vomiting/diarrhea
Confirmed Partial Response & Stable Disease Summary
- One confirmed partial response (PR) by RECIST 1.1 (decrease of more than
30% in the sum of the longest diameters of target lesions + no new lesions + no progression of non target lesions)- Partial response (-
34% ) achieved with reduction of 2 lymph nodes (para-aortic and mesenteric) at Week 16 with normalization of LDH - Reduction of tumor marker CA125 from 1249 to 694 kU/L (-
44% ) - Reduction of tumor marker TK1 from 174 to 56 DuA (-
68% ) - Response ongoing after more than 6 months of treatment
- Patient continues study therapy without need for antiemetics
- Partial response (-
- Four additional patients achieved durable (up to 6 months of treatment) response of stable disease (SD) as best response across multiple dose levels
- All four patients progressed prior to entering the study
- Three CRC patients (6L-7L) and one NSCLC patient (4L)
- One patient on 2mg QD and three patients on 10mg QD
About REC-617
REC-617 is a potential best-in-class CDK7 inhibitor, precision designed using AI-led approaches, with only 136 novel molecule synthesized from hit to candidate identification in less than 12 months. The molecule is designed to maximize its therapeutic index by enabling the tight control of both the extent and duration of target inhibition. CDK7 inhibition combines many potential benefits such as transcription inhibition, reduction of aberrant kinome activation, cell cycle inhibition, and modulation of estrogen receptor activity. This makes it an attractive target to overcome common resistance pathways associated with CDK4/6 inhibition, which only targets the cell cycle.
About ELUCIDATE
REC-617 is currently being evaluated as a monotherapy in the ELUCIDATE trial. ELUCIDATE is a multicenter, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics, and efficacy of REC-617 in advanced solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, pancreatic cancer, ovarian cancer, head and neck cancer.
Both the monotherapy and combination therapy dose escalation portion of the trial will enroll patients across multiple dose levels to determine the optimal biological dose (OBD). The dose expansion phase of the trial will commence upon identification of the OBD. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).
About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate 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.
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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-617; timing of the Phase 1/2 clinical trial of REC-617; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; 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 and Quarterly Reports on Form 10-Q. 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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