CytoDyn Announces Completion of FDA Meeting on Phase II Study of Leronlimab in Patients with Relapsed/Refractory Microsatellite Stable Colorectal Cancer
CytoDyn Inc. (OTCQB: CYDY) has completed a meeting with the FDA regarding its planned Phase II study of leronlimab in relapsed/refractory microsatellite stable colorectal cancer patients. The study will investigate leronlimab's safety and activity in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. The trial will be an open-label, randomized (1:1), multicenter study evaluating leronlimab doses of 350 mg and 700 mg in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC (mCRC). Patients must have measurable disease and prior treatment with specific chemotherapies. The company plans to submit its final study protocol to the FDA and engage a clinical research organization (CRO) to initiate the trial in the coming months.
CytoDyn Inc. (OTCQB: CYDY) ha completato un incontro con la FDA riguardo al suo previsto studio di Fase II su leronlimab per pazienti affetti da cancro colorettale microsatellite stabile in recidiva/riferimento. Lo studio esaminerà la sicurezza e l'attività di leronlimab in combinazione con trifluridina e tipiracil (TAS-102) e bevacizumab. La sperimentazione sarà uno studio multicentrico, randomizzato (1:1) e in aperto che valuterà dosi di leronlimab di 350 mg e 700 mg su circa 60 pazienti con CRC metastatico (mCRC) CCR5+. I pazienti devono presentare malattia misurabile e aver ricevuto precedentemente trattamenti con specifiche chemioterapie. L'azienda prevede di sottoporre il protocollo finale dello studio alla FDA e collaborare con un'organizzazione di ricerca clinica (CRO) per avviare lo studio nei prossimi mesi.
CytoDyn Inc. (OTCQB: CYDY) ha completado una reunión con la FDA sobre su planificado estudio de Fase II de leronlimab en pacientes con cáncer colorrectal estable en microsatélites en recaída/refractario. El estudio investigará la seguridad y actividad de leronlimab en combinación con trifluridina y tipiracil (TAS-102) y bevacizumab. El ensayo será un estudio multicéntrico, aleatorizado (1:1) y abierto que evaluará dosis de leronlimab de 350 mg y 700 mg en aproximadamente 60 pacientes con CRC metastásico (mCRC) CCR5+. Los pacientes deben tener enfermedad medible y haber recibido tratamientos previos con quimioterapias específicas. La compañía planea presentar su protocolo final de estudio a la FDA y contratar una organización de investigación clínica (CRO) para iniciar el ensayo en los próximos meses.
CytoDyn Inc. (OTCQB: CYDY)는 재발/내성 마이크로새틀라이트 안정 대장암 환자에 대한 leronlimab의 예정된 2상 연구와 관련하여 FDA와의 회의를 완료했습니다. 이 연구에서는 trifluridine과 tipiracil (TAS-102) 및 bevacizumab과의 병용에서 leronlimab의 안전성과 활성을 조사할 것입니다. 이 시험은 오픈라벨, 무작위(1:1) 다기관 연구로서 CCR5+인 약 60명의 mCRC 환자에서 350 mg 및 700 mg의 leronlimab 용량을 평가할 것입니다. 환자는 측정 가능한 질병을 가지고 있어야 하며 특정 화학요법으로의 이전 치료가 있어야 합니다. 회사는 FDA에 최종 연구 프로토콜을 제출하고 향후 몇 달 내에 임상 연구 기관(CRO)과 협력하여 시험을 시작할 계획입니다.
CytoDyn Inc. (OTCQB: CYDY) a terminé une réunion avec la FDA concernant son étude de Phase II prévue sur leronlimab chez des patients atteints de cancer colorectal à microsatellites stables en rechute/réfractaire. L'étude examinera la sécurité et l'activité de leronlimab en combinaison avec la trifluridine et le tipiracil (TAS-102) et le bévacizumab. L'essai sera une étude multicentrique, randomisée (1:1) et à étiquetage ouvert évaluant des doses de leronlimab de 350 mg et 700 mg chez environ 60 patients atteints de CRC métastatique (mCRC) CCR5+. Les patients doivent avoir une maladie mesurable et avoir subi un traitement préalable avec des chimiothérapies spécifiques. La société prévoit de soumettre son protocole d'étude final à la FDA et de s'associer à une organisation de recherche clinique (CRO) pour initier l'essai dans les mois à venir.
CytoDyn Inc. (OTCQB: CYDY) hat ein Treffen mit der FDA bezüglich seiner geplanten Phase-II-Studie zu leronlimab bei rezidivierenden/refraktären mikrosatellit-Stabilen Kolorektalkrebs-Patienten abgeschlossen. In der Studie wird die Sicherheit und Aktivität von leronlimab in Kombination mit Trifluridin plus Tipiracil (TAS-102) und Bevacizumab untersucht. Die Studie wird eine offene, randomisierte (1:1), multizentrische Studie sein, die Dosen von leronlimab von 350 mg und 700 mg bei etwa 60 Patienten mit CCR5+, mikrosatellit-stabilem metastasiertem CRC (mCRC) bewertet. Die Patienten müssen eine messbare Erkrankung aufweisen und zuvor spezifische Chemotherapien erhalten haben. Das Unternehmen plant, das endgültige Studienprotokoll bei der FDA einzureichen und eine klinische Forschungsorganisation (CRO) zu beauftragen, um die Studie in den kommenden Monaten zu initiieren.
- FDA meeting completed for Phase II study of leronlimab in colorectal cancer
- Company on track to commence oncology trial in the coming months
- Advancing leronlimab in oncology indication is a priority for CytoDyn
- None.
VANCOUVER, Washington, Aug. 12, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it completed a meeting with the U.S. Food and Drug Administration (FDA) to gain alignment on the rationale and proposed dosing for the Company’s Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC).
The Company intends to proceed with a submission of its final study protocol to the FDA, formal engagement of a clinical research organization (CRO), and related preparatory work towards initiating the proposed trial.
This open label, randomized (1:1), multicenter trial will evaluate the anti-tumor activity (via overall response rate, ORR) of leronlimab at doses of 350 mg and 700 mg in combination TAS-102 and bevacizumab in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC (mCRC).
Patients enrolled in the trial must have measurable disease per RECIST v1.1 and have received prior treatment with fluoropyrimidine‐, oxaliplatin‐, and irinotecan‐based chemotherapy, an anti‐VEGF therapy, and, if RAS wild‐type and medically appropriate, an anti-EGFR therapy. CCR5 tumor expression will be determined by immunohistochemistry assay (IHC) and diagnosis of MSS CRC will be confirmed by IHC or next-generation sequencing (NGS).
TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab (at doses of 350 mg or 700 mg) will be administered weekly. The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm.
“We are pleased to have received the FDA’s feedback on our Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer, and remain on track to commence our oncology trial in the coming months. Advancing leronlimab in the oncology indication has been an important priority for our team as we progress CytoDyn’s clinical pipeline,” said Dr. Jacob Lalezari, CEO.
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is developing leronlimab in multiple therapeutic areas, including oncology and inflammation.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements may include statements about leronlimab, its ability to provide positive health outcomes, the Company's ability to implement a successful operating strategy for the development of leronlimab and thereby create shareholder value, the ability to obtain regulatory approval of the Company’s drug products for commercial sales, and the strength of the Company’s leadership team. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties, including: (i) the regulatory determinations of leronlimab’s safety and effectiveness to treat the diseases and conditions for which we are studying the product by the U.S. Food and Drug Administration (the “FDA”) and various drug regulatory agencies in other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt and other payment obligations; (iv) the Company’s ability to recruit and retain key employees; (v) the Company’s ability to enter into partnership or licensing arrangements with third parties; (vi) the timely and sufficient development, through internal resources or third-party consultants, of analyses of the data generated from the Company’s clinical trials required by the FDA or other regulatory agencies in connection with applications for approval of the Company’s drug product; (vii) the Company’s ability to achieve approval of a marketable product; (viii) the design, implementation and conduct of the Company’s clinical trials; (ix) the results of any such clinical trials, including the possibility of unfavorable clinical trial results; (x) the market for, and marketability of, any product that is approved; (xi) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products; (xii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xiii) legal proceedings, investigations or inquiries affecting the Company or its products; (xiv) general economic and business conditions; (xv) changes in foreign, political, and social conditions; (xvi) stockholder actions or proposals with regard to the Company, its management, or its board of directors; and (xvii) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and risk factors or cautionary statements included in subsequent Form 10-Qs and Form 8-Ks, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CONTACT
Investor Relations
CytoDyn Inc.
ir@cytodyn.com
FAQ
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