Corvus Pharmaceuticals Granted FDA Fast Track Designation for Soquelitinib for Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Corvus Pharmaceuticals (Nasdaq: CRVS) has received FDA Fast Track Designation for soquelitinib, targeting adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy. This designation underscores the significant unmet need in PTCL treatment, where current options offer efficacy and high toxicity. Corvus is on track to initiate patient enrollment in a registrational Phase 3 trial for PTCL in Q3 2024.
The Fast Track program aims to expedite development and review of drugs addressing serious conditions and unmet medical needs. Soquelitinib has also received FDA Orphan Drug Designation for T cell lymphoma treatment, providing benefits such as tax credits and seven years of post-approval marketing exclusivity.
Corvus Pharmaceuticals (Nasdaq: CRVS) ha ricevuto la Designazione Fast Track della FDA per soquelitinib, rivolto a pazienti adulti con linfoma periférico a cellule T (PTCL) in recidiva o refrattari dopo almeno due linee di terapia sistemica. Questa designazione evidenzia il significativo bisogno insoddisfatto nel trattamento del PTCL, dove le opzioni attuali offrono efficacia ma alta tossicità. Corvus è sulla buona strada per avviare l'arruolamento dei pazienti in un trial registrativo di fase 3 per PTCL nel terzo trimestre del 2024.
Il programma Fast Track mira a velocizzare lo sviluppo e la revisione dei farmaci che affrontano condizioni gravi e bisogni medici non soddisfatti. Soquelitinib ha inoltre ricevuto la Designazione di Farmaco Orfano della FDA per il trattamento del linfoma a cellule T, fornendo benefici come crediti d'imposta e sette anni di esclusività di commercializzazione dopo l'approvazione.
Corvus Pharmaceuticals (Nasdaq: CRVS) ha recibido la Designación Fast Track de la FDA para soquelitinib, dirigido a pacientes adultos con linfoma periférico de células T (PTCL) en recaída o refractario después de al menos dos líneas de terapia sistémica. Esta designación subraya la significativa necesidad no satisfecha en el tratamiento del PTCL, donde las opciones actuales ofrecen eficacia pero son altamente tóxicas. Corvus está en camino de iniciar la inscripción de pacientes en un ensayo registrativo de fase 3 para PTCL en el tercer trimestre de 2024.
El programa Fast Track tiene como objetivo acelerar el desarrollo y la revisión de medicamentos que abordan condiciones graves y necesidades médicas insatisfechas. Soquelitinib también ha recibido la Designación de Medicamento Huérfano de la FDA para el tratamiento del linfoma de células T, proporcionando beneficios como créditos fiscales y siete años de exclusividad de comercialización tras la aprobación.
코르바스 제약(Corvus Pharmaceuticals, Nasdaq: CRVS)은 소퀼리티닙(soquelitinib)에 대해 성인 재발 또는 난치성 말초 T세포 림프종(PTCL) 환자를 대상으로 하는 FDA의 패스트트랙 지정을 받았습니다. 이 지정은 PTCL 치료에서의 중요한 미충족 수요를 강조하며, 현재의 치료 옵션은 효능이 있으나 높은 독성을 동반합니다. 코르바스는 2024년 3분기에 PTCL에 대한 등록 임상 3상 시험 환자 등록을 시작할 예정입니다.
패스트트랙 프로그램은 심각한 질병과 미충족 의료 수요를 해결하는 약물의 개발 및 검토를 가속화하는 것을 목표로 합니다. 소퀼리티닙은 또한 T세포 림프종 치료를 위한 FDA의 희귀의약품 지정을 받아 세금 공제 및 승인 후 7년간의 독점 판매 혜택을 제공합니다.
Corvus Pharmaceuticals (Nasdaq: CRVS) a reçu la désignation Fast Track de la FDA pour le soquelitinib, destiné aux patients adultes atteints de lymphome périphérique à cellules T (PTCL) en rechute ou réfractaire après au moins deux lignes de traitement systémique. Cette désignation souligne le besoin non satisfait important dans le traitement du PTCL, où les options actuelles offrent efficacité et haute toxicité. Corvus prévoit de commencer l'enrôlement des patients dans un essai clinique de phase 3 pour le PTCL au troisième trimestre de 2024.
Le programme Fast Track vise à accélérer le développement et l'examen des médicaments traitant des conditions graves et des besoins médicaux non satisfaits. Le soquelitinib a également reçu la dénomination de médicament orphelin de la FDA pour le traitement des lymphomes à cellules T, offrant des avantages tels que des crédits d'impôt et sept ans d'exclusivité de commercialisation après approbation.
Corvus Pharmaceuticals (Nasdaq: CRVS) hat die Fast-Track-Designierung der FDA für Soquelitinib erhalten, das sich an erwachsene Patienten mit rezidivierenden oder refraktären peripheren T-Zell-Lymphomen (PTCL) nach mindestens zwei Linien systemischer Therapie richtet. Diese Auszeichnung unterstreicht den erheblichen ungedeckten Bedarf in der PTCL-Behandlung, wo die derzeitigen Optionen sowohl Wirksamkeit als auch hohe Toxizität bieten. Corvus ist auf dem besten Weg, im registrierenden Phase-3-Studie für PTCL im dritten Quartal 2024 mit der Patientenanmeldung zu beginnen.
Das Fast-Track-Programm zielt darauf ab, die Entwicklung und Überprüfung von Arzneimitteln zu beschleunigen, die sich mit schweren Erkrankungen und ungedeckten medizinischen Bedürfnissen befassen. Soquelitinib hat auch die FDA-Orphan-Drug-Designierung für die Behandlung von T-Zell-Lymphomen erhalten, was Vorteile wie Steuererleichterungen und sieben Jahre Exklusivität nach der Genehmigung bietet.
- FDA granted Fast Track Designation for soquelitinib in relapsed/refractory PTCL
- Registrational Phase 3 clinical trial for soquelitinib in PTCL set to begin enrollment in Q3 2024
- Soquelitinib received FDA Orphan Drug Designation for T cell lymphoma treatment
- Fast Track status may accelerate development and review process
- None.
Insights
The FDA's Fast Track Designation for soquelitinib in relapsed or refractory peripheral T-cell lymphoma (PTCL) is a significant development for Corvus Pharmaceuticals. As an oncology specialist, I can attest to the critical unmet need in PTCL treatment, particularly for patients who have failed multiple lines of therapy.
PTCL is a rare and aggressive form of non-Hodgkin lymphoma with poor prognosis. Current treatment options are and often ineffective, with no FDA-approved drugs based on randomized trials. Soquelitinib, as a novel therapy, could potentially address this gap.
The Fast Track Designation offers several advantages:
- Increased communication with the FDA, potentially expediting development
- Rolling review of the drug application, which could speed up the approval process
- Possibility of Priority Review if supported by clinical data
Additionally, the Orphan Drug Designation provides incentives like tax credits and market exclusivity, which could enhance the commercial viability of soquelitinib.
However, it's important to note that these designations don't guarantee approval. The upcoming Phase 3 trial, set to begin in Q3 2024, will be pivotal. If successful, soquelitinib could become a game-changer in PTCL treatment, potentially improving outcomes for this underserved patient population.
From an investment perspective, the FDA's Fast Track Designation for soquelitinib is a positive catalyst for Corvus Pharmaceuticals (NASDAQ: CRVS). This development could significantly impact the company's valuation and market position in the oncology space.
Key financial implications include:
- Potential for accelerated revenue generation if soquelitinib reaches the market sooner
- Reduced R&D costs due to a potentially streamlined development process
- Enhanced attractiveness to potential partners or acquirers in the pharmaceutical industry
The orphan drug status adds another layer of value, offering
However, investors should remain cautious. PTCL is a niche market and the success of soquelitinib is not guaranteed. The Phase 3 trial results will be important in determining the drug's and Corvus's future. Additionally, as a clinical-stage company, Corvus likely has revenue streams and may require additional financing to bring soquelitinib to market.
In the near term, this news could drive increased investor interest and potentially boost Corvus's stock price. Long-term value will depend on the successful execution of the Phase 3 trial and eventual commercialization of soquelitinib.
Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3 2024
Fast track designation underscores unmet need for patients with relapsed or refractory PTCL, an indication with poor overall outcomes and no approved drugs based on randomized trials
BURLINGAME, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy.
“The granting of Fast Track Designation by the FDA highlights the significant unmet need for patients with relapsed or refractory PTCL,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The current treatment options for these patients provide limited efficacy and are associated with significant toxicity, and there are no FDA fully approved agents. There continues to be strong interest in soquelitinib from investigators at sites with deep experience treating T cell lymphomas and we are on track to initiate patient enrollment in our registrational Phase 3 trial in PTCL in the third quarter 2024.”
The Fast Track program is designed to facilitate the development and expedite the review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions and 2) demonstrate the potential to address unmet medical needs. Fast Track designation can accelerate development and review of new drug and biological products by increasing the level of communication between FDA and drug developers and by enabling the FDA to review portions of a drug application on a rolling basis. In addition to Fast Track Designation, soquelitinib has also been granted FDA Orphan Drug Designation for the treatment of T cell lymphoma, which provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
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 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 plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib also is 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 efficacy of the Company’s product candidates including soquelitinib; and the timing of clinical and other development milestones for the Company’s product candidates. 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 March 31, 2024, filed with the Securities and Exchange Commission on May 7, 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 results of preclinical studies, including preclinical studies conducted by third-parties using the Company’s product candidates, 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; and the costs of clinical trials may exceed expectations. 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
FAQ
What is the FDA Fast Track Designation granted to Corvus Pharmaceuticals (CRVS) for?
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