CytoDyn Announces Encouraging Survival Data in Patients with Metastatic Colorectal Cancer Previously Treated with Leronlimab
CytoDyn (OTCQB: CYDY) has announced promising survival data for leronlimab in treating metastatic colorectal cancer (mCRC). The clinical findings showed that 3 out of 5 patients treated with leronlimab achieved at least a partial response, with one patient achieving complete response and surviving for five years.
Dr. Benjamin Weinberg from Georgetown University will present these results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona. The data comes from patients treated under a compassionate use protocol and demonstrates both a favorable safety profile and potential clinical benefits. The company is currently conducting a Phase II trial in patients with relapsed/refractory microsatellite stable CRC, with the first patient already dosed.
Additionally, CytoDyn reported evidence of leronlimab's potential as a "priming" agent for cancer patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors, showing particular promise in metastatic triple-negative breast cancer (mTNBC) treatment.
CytoDyn (OTCQB: CYDY) ha annunciato dati promettenti sulla sopravvivenza ottenuti con leronlimab nel trattamento del cancro colorettale metastatico (mCRC). I risultati clinici hanno mostrato che 3 pazienti su 5 trattati con leronlimab hanno raggiunto almeno una risposta parziale, con un paziente che ha ottenuto una risposta completa e ha vissuto per cinque anni.
Il dottor Benjamin Weinberg della Georgetown University presenterà questi risultati al Congress ESMO sui Tumori Gastrointestinali 2025 a Barcellona. I dati provengono da pazienti trattati sotto un protocollo di uso compassionevole e dimostrano sia un profilo di sicurezza favorevole sia potenziali benefici clinici. L'azienda sta attualmente conducendo uno studio di Fase II su pazienti con CRC microsatellite stabile recidivante/refrattario, con il primo paziente già trattato.
Inoltre, CytoDyn ha riportato evidenze del potenziale di leronlimab come agente di "priming" per pazienti oncologici con bassi livelli di PD-L1, precedentemente non responsivi agli inibitori dei checkpoint, mostrando particolare efficacia nel trattamento del carcinoma mammario triplo negativo metastatico (mTNBC).
CytoDyn (OTCQB: CYDY) ha anunciado datos prometedores de supervivencia para leronlimab en el tratamiento del cáncer colorrectal metastásico (mCRC). Los hallazgos clínicos mostraron que 3 de 5 pacientes tratados con leronlimab lograron al menos una respuesta parcial, con un paciente alcanzando una respuesta completa y sobreviviendo cinco años.
El Dr. Benjamin Weinberg de la Universidad de Georgetown presentará estos resultados en el Congreso ESMO de Cánceres Gastrointestinales 2025 en Barcelona. Los datos provienen de pacientes tratados bajo un protocolo de uso compasivo y demuestran tanto un perfil de seguridad favorable como posibles beneficios clínicos. La compañía está llevando a cabo actualmente un ensayo de Fase II en pacientes con CRC estable de microsatélites recidivante/refractario, con el primer paciente ya dosificado.
Además, CytoDyn informó evidencia del potencial de leronlimab como agente de "priming" para pacientes con cáncer con bajos niveles de PD-L1 que previamente no respondieron a inhibidores de puntos de control, mostrando especial promesa en el tratamiento del cáncer de mama triple negativo metastásico (mTNBC).
CytoDyn (OTCQB: CYDY)는 전이성 대장암(mCRC) 치료에 있어 leronlimab의 유망한 생존 데이터 발표했습니다. 임상 결과에 따르면 leronlimab으로 치료받은 5명 중 3명이 부분 반응 이상을 보였으며, 한 명의 환자는 완전 반응을 얻고 5년간 생존했습니다.
조지타운 대학교의 Benjamin Weinberg 박사가 이 결과를 2025년 ESMO 위장관암 학회에서 바르셀로나에서 발표할 예정입니다. 이 데이터는 동정적 사용 프로토콜 하에 치료받은 환자들로부터 얻은 것으로, 안전성 프로필이 우수하며 잠재적 임상 이점을 보여줍니다. 회사는 현재 재발/불응성 미세위성 안정성 CRC 환자를 대상으로 한 2상 임상시험을 진행 중이며, 첫 환자 투여가 완료되었습니다.
또한 CytoDyn은 이전에 면역관문억제제에 반응하지 않았던 낮은 PD-L1 수치의 암 환자들에게 leronlimab이 "프라이밍"제로서의 가능성을 보여주었으며, 특히 전이성 삼중음성 유방암(mTNBC) 치료에 유망하다고 보고했습니다.
CytoDyn (OTCQB : CYDY) a annoncé des données prometteuses sur la survie avec le leronlimab dans le traitement du cancer colorectal métastatique (mCRC). Les résultats cliniques ont montré que 3 patients sur 5 traités avec leronlimab ont obtenu au moins une réponse partielle, avec un patient ayant obtenu une réponse complète et une survie de cinq ans.
Le Dr Benjamin Weinberg de l'Université de Georgetown présentera ces résultats lors du Congrès ESMO des Cancers Gastro-intestinaux 2025 à Barcelone. Ces données proviennent de patients traités dans le cadre d'un protocole d'usage compassionnel et démontrent à la fois un profil de sécurité favorable et des bénéfices cliniques potentiels. La société mène actuellement un essai de phase II chez des patients atteints de CCR microsatellite stable en rechute/réfractaire, avec le premier patient déjà traité.
De plus, CytoDyn a rapporté des preuves du potentiel du leronlimab en tant qu'agent de « priming » chez les patients cancéreux présentant de faibles niveaux de PD-L1, auparavant non réactifs aux inhibiteurs de points de contrôle, montrant une promesse particulière dans le traitement du cancer du sein triple négatif métastatique (mTNBC).
CytoDyn (OTCQB: CYDY) hat vielversprechende Überlebensdaten für Leronlimab bei der Behandlung von metastasiertem kolorektalem Krebs (mCRC) bekannt gegeben. Die klinischen Ergebnisse zeigten, dass 3 von 5 Patienten, die mit Leronlimab behandelt wurden, mindestens eine partielle Remission erreichten, wobei ein Patient eine komplette Remission erzielte und fünf Jahre überlebte.
Dr. Benjamin Weinberg von der Georgetown University wird diese Ergebnisse auf dem ESMO Gastrointestinal Cancers Congress 2025 in Barcelona vorstellen. Die Daten stammen von Patienten, die im Rahmen eines Compassionate Use-Protokolls behandelt wurden, und zeigen sowohl ein günstiges Sicherheitsprofil als auch potenzielle klinische Vorteile. Das Unternehmen führt derzeit eine Phase-II-Studie bei Patienten mit rezidivierendem/refraktärem mikrosatellitenstabilem CRC durch, wobei der erste Patient bereits behandelt wurde.
Darüber hinaus berichtete CytoDyn über Hinweise auf das Potenzial von Leronlimab als "Priming"-Agent bei Krebspatienten mit niedrigen PD-L1-Werten, die zuvor nicht auf Checkpoint-Inhibitoren angesprochen hatten, und zeigte dabei besondere Wirksamkeit bei der Behandlung von metastasiertem triple-negativem Brustkrebs (mTNBC).
- 3 out of 5 mCRC patients showed at least partial response to leronlimab treatment
- One patient achieved complete response with 5-year survival
- Favorable safety profile demonstrated in compassionate use protocol
- Evidence of potential effectiveness as a priming agent for checkpoint inhibitor non-responsive patients
- Phase II trial actively enrolling patients across multiple clinical sites
- Small sample size of only 5 patients in the reported data
- Results are from compassionate use protocol, not a controlled clinical trial
Positive results in patients with advanced mCRC emphasize potential significance of CytoDyn’s ongoing
Phase II CRC trial
Dr. Benjamin Weinberg to present final results at the ESMO Gastrointestinal Cancers Congress 2025 in
Barcelona, Spain
VANCOUVER, Washington, July 01, 2025 (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, today announced encouraging clinical findings among patients with advanced metastatic colorectal cancer (“mCRC”) previously treated with leronlimab. The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later.
Dr. Benjamin Weinberg, Associate Professor at Georgetown University and Principal Investigator of CytoDyn’s colorectal cancer (“CRC”) program, will present the Company’s clinical data at the ESMO Gastrointestinal Cancers Congress 2025 taking place in Barcelona, Spain from July 2 to July 5, 2025.
The results, from patients treated under a compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. They also support the rationale for the design and therapeutic potential of CytoDyn’s ongoing Phase II trial in patients with relapsed/refractory microsatellite stable CRC. CytoDyn recently announced the dosing of the first patient in this study, and is now enrolling additional patients across multiple clinical sites.
If the observed results in the previously treated CRC patients are confirmed prospectively, the Company believes leronlimab could be used effectively to treat a wide range of solid tumor types. In addition to its potential as a “stand-alone” agent in oncology, the Company presented exciting evidence of leronlimab’s activity as a “priming” agent for cancer patients with low levels of PD-L1 who were previously unresponsive to, or ineligible for, checkpoint inhibitors at the 2025 ESMO Breast Cancer meeting. The data driving this working theory has shown particular promise in the treatment of patients with advanced metastatic triple-negative breast cancer (“mTNBC”).
“At the 2025 ESMO Gastrointestinal Cancers Congress, Dr. Weinberg will share the data and evidence that form the basis for our belief in the potential of leronlimab as a treatment in CCR5 positive solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn. “Our ongoing Phase II trial in patients with mCRC was designed to prospectively confirm these observations, and we look forward to enrolling additional patients as we pursue clinical confirmation of our working theory.”
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 has studied leronlimab in multiple therapeutic areas, including oncology, infectious disease, and autoimmune conditions.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media Contacts
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