Corvus Pharmaceuticals Initiates Registrational Phase 3 Clinical Trial of Soquelitinib for Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma
Corvus Pharmaceuticals (NASDAQ: CRVS) has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). Soquelitinib, a potential first-in-class ITK inhibitor, has been granted Orphan Drug Designation and Fast Track Designation by the FDA. The trial will enroll approximately 150 patients across 40 sites in the US, Canada, Australia, and South Korea.
The randomized, controlled study will compare soquelitinib to standard chemotherapy, with a primary endpoint of progression-free survival. Soquelitinib's unique mechanism of action, based on selective ITK inhibition, shows potential for treating T cell lymphomas, solid tumors, and immune diseases. This trial marks a significant milestone for Corvus and PTCL patients, as there are currently no fully approved agents for relapsed PTCL treatment.
Corvus Pharmaceuticals (NASDAQ: CRVS) ha avviato uno studio clinico registrativo di Fase 3 per soquelitinib, rivolto a pazienti con linfoma T periferico recidivante/refrattario (PTCL). Soquelitinib, un potenziale inibitore ITK di prima classe, ha ricevuto la Designazione di Farmaco Orfano e la Designazione Fast Track da parte della FDA. Lo studio arruolerà circa 150 pazienti distribuiti su 40 sedi negli Stati Uniti, Canada, Australia e Corea del Sud.
Il trial, randomizzato e controllato, confronterà soquelitinib con la chemioterapia standard, con un obiettivo primario di sopravvivenza libera da progressione. Il meccanismo d'azione unico di soquelitinib, basato sull'inibizione selettiva di ITK, presenta potenzialità nel trattamento dei linfomi T, dei tumori solidi e delle malattie immunitarie. Questo trial segna una pietra miliare significativa per Corvus e per i pazienti affetti da PTCL, poiché attualmente non esistono agenti completamente approvati per il trattamento del PTCL recidivante.
Corvus Pharmaceuticals (NASDAQ: CRVS) ha iniciado un ensayo clínico registrativo de Fase 3 para soquelitinib en pacientes con linfoma T periférico recidivante/refractario (PTCL). Soquelitinib, un potencial inhibidor ITK de primera clase, ha recibido la Designación de Medicamento Huérfano y la Designación de Vía Rápida por parte de la FDA. El ensayo inscribirá aproximadamente 150 pacientes en 40 sitios en Estados Unidos, Canadá, Australia y Corea del Sur.
El estudio controlado y aleatorizado comparará soquelitinib con la quimioterapia estándar, teniendo como objetivo primario la supervivencia libre de progresión. El mecanismo de acción único de soquelitinib, basado en la inhibición selectiva de ITK, muestra potencial para el tratamiento de linfomas T, tumores sólidos y enfermedades inmunitarias. Este ensayo marca un hito significativo para Corvus y los pacientes con PTCL, ya que actualmente no hay agentes completamente aprobados para el tratamiento del PTCL recidivante.
코르부스 제약(Corvus Pharmaceuticals) (NASDAQ: CRVS)가 재발성/내약성 말초 T세포 림프종(PTCL) 환자를 위한 소퀠리티닙(soquelitinib)의 등록 3상 임상시험을 시작했습니다. 소퀼리티닙은 첫 번째 클래스 ITK 억제제로 잠재력을 가진 약물로, FDA로부터 희귀의약품 지정 및 신속 심사 지정을 받았습니다. 이 시험은 미국, 캐나다, 호주, 한국의 40개 사이트에서 약 150명의 환자를 모집할 예정입니다.
무작위 대조 연구는 소퀼리티닙과 표준 화학요법을 비교하며, 주요 목표는 무진행 생존율입니다. 소퀼리티닙의 독특한 작용 메커니즘은 선택적 ITK 억제를 기반으로 하여 T세포 림프종, 고형 종양 및 면역 질환 치료에 대한 잠재력을 보여줍니다. 이 시험은 코르부스와 PTCL 환자에게 중요한 이정표가 되며, 현재 재발성 PTCL 치료를 위한 완전 승인된 약물은 없습니다.
Corvus Pharmaceuticals (NASDAQ: CRVS) a lancé un essai clinique d'enregistrement de Phase 3 pour le soquelitinib chez des patients atteints de lymphome T périphérique récurrent/réfractaire (PTCL). Le soquelitinib, un inhibiteur ITK potentiel de première classe, a reçu la désignation de médicament orphelin et la désignation de voie rapide de la FDA. L'essai recrutera environ 150 patients dans 40 sites aux États-Unis, au Canada, en Australie et en Corée du Sud.
L'étude contrôlée et randomisée comparera le soquelitinib à la chimiothérapie standard, avec un objectif primaire de sursistance sans progression. Le mécanisme d'action unique du soquelitinib, basé sur l'inhibition sélective de l'ITK, montre un potentiel pour traiter les lymphomes T, les tumeurs solides et les maladies immunitaires. Cet essai marque une étape significative pour Corvus et les patients atteints de PTCL, car il n'existe actuellement aucun agent totalement approuvé pour le traitement du PTCL récurrent.
Corvus Pharmaceuticals (NASDAQ: CRVS) hat eine registrierende Phase 3 klinische Studie für Soquelitinib bei Patienten mit rezidivierten/refraktären peripheren T-Zell-Lymphomen (PTCL) initiiert. Soquelitinib, ein potenzieller First-in-Class ITK-Inhibitor, hat von der FDA die Orphan Drug Designation und Fast Track Designation erhalten. Die Studie wird etwa 150 Patienten an 40 Standorten in den USA, Kanada, Australien und Südkorea einschreiben.
Die randomisierte, kontrollierte Studie wird Soquelitinib mit der Standardchemotherapie vergleichen, wobei das primäre Ziel das progressionsfreie Überleben ist. Der einzigartige Wirkmechanismus von Soquelitinib, der auf selektiver ITK-Hemmung basiert, zeigt Potenzial zur Behandlung von T-Zell-Lymphomen, soliden Tumoren und Immunerkrankungen. Diese Studie stellt einen bedeutenden Meilenstein für Corvus und PTCL-Patienten dar, da es derzeit keine vollständig zugelassenen Medikamente für die Behandlung von rezidivierenden PTCL gibt.
- Initiation of registrational Phase 3 clinical trial for soquelitinib in relapsed/refractory PTCL
- Soquelitinib granted Orphan Drug Designation and Fast Track Designation by FDA
- Potential first-in-class ITK inhibitor with broad applications in cancer and immune diseases
- Earlier stage trials showed soquelitinib to be well-tolerated with durable anti-tumor activity
- None.
Insights
The initiation of a registrational Phase 3 trial for soquelitinib in relapsed/refractory PTCL is a significant milestone for Corvus Pharmaceuticals. This trial could potentially lead to FDA approval if successful, addressing an unmet medical need in PTCL treatment. The study's design, comparing soquelitinib to standard chemotherapy, is robust and could provide compelling efficacy data. The primary endpoint of progression-free survival, along with secondary endpoints like overall survival, will offer comprehensive insights into soquelitinib's potential benefits.
The unique mechanism of action of soquelitinib as an ITK inhibitor is particularly intriguing, as it may offer a novel approach to treating T cell lymphomas and potentially other cancers and immune diseases. This broader potential could significantly impact Corvus's pipeline and market position if the drug proves successful.
As an oncologist, I'm cautiously optimistic about soquelitinib's potential in PTCL. The lack of fully approved agents for relapsed PTCL underscores the critical need for new therapies. Soquelitinib's Orphan Drug and Fast Track designations from the FDA highlight its promise and could expedite its path to market if efficacy is demonstrated.
The 200mg twice-daily dosing seems manageable and the comparison against established chemotherapies like belinostat and pralatrexate will provide valuable comparative data. The focus on patients who have failed 1-3 prior lines of therapy targets a population with options. If soquelitinib can demonstrate superior efficacy with a better safety profile than current chemotherapies, it could become a game-changer in PTCL treatment.
For Corvus Pharmaceuticals (NASDAQ: CRVS), this Phase 3 trial initiation is a pivotal moment. Success could lead to significant market opportunities, given the unmet need in PTCL treatment. The potential for soquelitinib to expand into other cancer types and immune diseases could substantially increase its market value.
Investors should note the trial's scope, involving approximately 150 patients across 40 sites internationally. This breadth suggests a substantial investment by Corvus, indicating confidence in soquelitinib's potential. However, it's important to remember that Phase 3 trials are costly and time-consuming, which could impact Corvus's financials in the short term. The orphan drug status could provide market exclusivity if approved, potentially boosting long-term revenue prospects. Overall, while promising, investors should balance optimism with awareness of the risks inherent in late-stage clinical trials.
Soquelitinib is a potential first-in-class ITK inhibitor with broad potential in cancer and immune diseases
There are currently no fully approved agents for the treatment of relapsed PTCL and soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA
BURLINGAME, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). The clinical trial is a randomized, controlled study that will evaluate the efficacy and safety of soquelitinib compared to standard of care chemotherapy.
"The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases.”
The clinical trial (NCT06561048) is designed to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Patients will be randomized in a 1:1 ratio to receive either 200mg dose of soquelitinib two-times a day or standard of care chemotherapy with either belinostat or pralatrexate. The primary endpoint of the clinical trial is progression-free survival and secondary endpoints include overall survival, objective response rate, and duration of response. The trial is expected to enroll patients at approximately 40 sites in the United States, Canada, Australia and South Korea.
"We are excited to participate in this Phase 3 trial evaluating a new therapy for patients with relapsed/refractory PTCL," said Swaminathan P. Iyer, M.D., principal investigator of the study and Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. "In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response. In general, chemotherapy drugs have not produced lasting remissions and are sometimes associated with significant toxicity. There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment."
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.
About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about
PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.
About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib; the potential use of soquelitinib to treat PTCL, solid tumors and a broad range of autoimmune diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 3 clinical trial for PTCL with soquelitinib; and the design of clinical trials, including the target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 3 clinical trial for PTCL with soquelitinib. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, filed with the Securities and Exchange Commission on August 6, 2024, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com
MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com
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