Mersana Therapeutics Announces Additional FDA Fast Track Designation Granted to Emiltatug Ledadotin (XMT-1660)
Mersana Therapeutics (NASDAQ: MRSN) announced that the FDA granted an additional Fast Track designation to XMT-1660, now named emiltatug ledadotin (Emi-Le). The new designation covers advanced or metastatic breast cancer treatment in patients with HER2 low or HER2-negative disease, including triple-negative breast cancer (TNBC), who have received prior topoisomerase-1 inhibitor ADC treatment.
This adds to the previous Fast Track designation for treating adult patients with advanced or metastatic recurrent TNBC. The FDA's Fast Track program could enable benefits like more frequent FDA communications and potential Accelerated Approval. The company is also announcing initial Phase 1 clinical data for Emi-Le, with results being discussed in a separate conference call.
Mersana Therapeutics (NASDAQ: MRSN) ha annunciato che la FDA ha concesso una nuova designazione Fast Track a XMT-1660, ora chiamato emiltatug ledadotin (Emi-Le). La nuova designazione riguarda il trattamento del cancro al seno avanzato o metastatico in pazienti con malattia HER2 bassa o negativa, inclusi quelli con cancro al seno triplo negativo (TNBC), che hanno ricevuto precedenti trattamenti con ADC inibitori della topoisomerasi-1.
Questo si aggiunge alla precedente designazione Fast Track per il trattamento di pazienti adulti con TNBC ricorrente avanzato o metastatico. Il programma Fast Track della FDA potrebbe consentire vantaggi come comunicazioni più frequenti con la FDA e potenziale approvazione accelerata. L'azienda sta anche annunciando i dati iniziali della fase 1 degli studi clinici per Emi-Le, con i risultati che saranno discussi in una conferenza telefonica separata.
Mersana Therapeutics (NASDAQ: MRSN) anunció que la FDA otorgó una designación adicional de Fast Track a XMT-1660, ahora llamado emiltatug ledadotin (Emi-Le). La nueva designación abarca el tratamiento del cáncer de mama avanzado o metastásico en pacientes con enfermedad HER2 baja o negativa, incluidos aquellos con cáncer de mama triple negativo (TNBC), que han recibido tratamiento previo con ADC inhibidores de la topoisomerasa-1.
Esto se suma a la designación Fast Track anterior para el tratamiento de pacientes adultos con TNBC recurrente avanzado o metastásico. El programa Fast Track de la FDA podría permitir beneficios como comunicaciones más frecuentes con la FDA y una posible aprobación acelerada. La compañía también está anunciando los datos clínicos iniciales de la fase 1 para Emi-Le, cuyos resultados se discutirán en una conferencia telefónica separada.
Mersana Therapeutics (NASDAQ: MRSN)는 FDA가 XMT-1660, 현재 emiltatug ledadotin (Emi-Le)로 명명된 제품에 대해 추가적인 패스트 트랙 지정을 부여했다고 발표했습니다. 새로운 지명은 HER2 저수준 또는 HER2 음성 질병의 환자, 즉 이전에 톱이성효소-1 억제제 ADC 치료를 받은 삼중 음성 유방암(TNBC) 환자에 대한 고급 또는 전이성 유방암 치료를 포함합니다.
이것은 전이성 TNBC 성인 환자 치료를 위한 이전의 패스트 트랙 지명에 추가되는 것입니다. FDA의 패스트 트랙 프로그램은 더 빈번한 FDA 커뮤니케이션 및 가속 승인 가능성과 같은 이점을 제공할 수 있습니다. 회사는 또한 Emi-Le의 초기 1상 임상 데이터를 발표하고 있으며, 결과는 별도의 컨퍼런스 콜에서 논의될 예정입니다.
Mersana Therapeutics (NASDAQ: MRSN) a annoncé que la FDA a accordé une désignation Fast Track supplémentaire à XMT-1660, maintenant nommé emiltatug ledadotin (Emi-Le). La nouvelle désignation concerne le traitement du cancer du sein avancé ou métastatique chez des patients présentant une maladie HER2 faible ou négative, y compris le cancer du sein triple négatif (TNBC), ayant reçu un traitement préalable avec un ADC inhibiteur de la topoisomérase-1.
Cela s'ajoute à la précédente désignation Fast Track pour le traitement des patients adultes atteints de TNBC récurrent avancé ou métastatique. Le programme Fast Track de la FDA pourrait offrir des avantages tels que des communications plus fréquentes avec la FDA et une approbation accélérée potentielle. L'entreprise annonce également les premières données cliniques de la phase 1 pour Emi-Le, dont les résultats seront discutés lors d'une conférence téléphonique séparée.
Mersana Therapeutics (NASDAQ: MRSN) gab bekannt, dass die FDA eine zusätzliche Fast Track-Zertifizierung für XMT-1660, jetzt emiltatug ledadotin (Emi-Le) genannt, erteilt hat. Die neue Zertifizierung bezieht sich auf die Behandlung von fortgeschrittenem oder metastatischem Brustkrebs bei Patienten mit HER2 niedrig oder HER2-negativer Erkrankung, einschließlich dreifach negativem Brustkrebs (TNBC), die zuvor eine Behandlung mit Topoisomerase-1-Inhibitor-ADC erhalten haben.
Dies ergänzt die frühere Fast Track-Zertifizierung für die Behandlung erwachsener Patienten mit fortgeschrittenem oder metastasierendem rezidivierenden TNBC. Das Fast Track-Programm der FDA könnte Vorteile wie häufigere Kommunikationsmöglichkeiten mit der FDA und potenzielle beschleunigte Genehmigungen ermöglichen. Das Unternehmen kündigt auch erste klinische Daten der Phase 1 für Emi-Le an, deren Ergebnisse in einer separaten Telefonkonferenz erörtert werden.
- Received additional FDA Fast Track designation for XMT-1660 (Emi-Le)
- Expanded potential treatment scope to include HER2 low/negative breast cancer
- Eligibility for accelerated approval and priority review processes
- None.
Insights
The FDA Fast Track designation for Emi-Le (XMT-1660) in advanced breast cancer represents a critical regulatory milestone. The expanded designation now covers HER2-low and HER2-negative breast cancers, including the notoriously difficult-to-treat triple-negative breast cancer (TNBC). This broadens the drug's potential market significantly beyond its initial Fast Track designation for TNBC alone.
The timing is particularly strategic as it positions Emi-Le to address an emerging treatment gap. With topoisomerase-1 inhibitor ADCs becoming standard first-line therapy, there's a growing population of patients who progress and need subsequent treatment options. This represents a substantial commercial opportunity in a market with effective alternatives.
The Fast Track benefits could accelerate Emi-Le's path to market through more frequent FDA interactions and potential eligibility for expedited programs like Accelerated Approval. For a company with
The therapeutic positioning of Emi-Le is particularly noteworthy from a clinical perspective. The drug targets B7-H4, a novel pathway distinct from current ADC approaches, potentially offering a new mechanism of action for patients who've progressed on existing therapies. The inclusion of both hormone-receptor positive and TNBC patients who've received prior topoisomerase-1 inhibitor ADCs addresses a critical unmet need in breast cancer treatment.
The strategic focus on post-topoisomerase-1 inhibitor ADC treatment is especially relevant given the increasing adoption of drugs like Enhertu and Trodelvy in these populations. The growing evidence of difficult-to-treat disease after these therapies creates an urgent need for effective subsequent lines of treatment, which Emi-Le could potentially fulfill.
Conference call to discuss positive initial Phase 1 clinical data today at 8:30 a.m. ET
CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the U.S. Food and Drug Administration (FDA) recently granted an additional Fast Track designation to XMT-1660. The company also announced that the World Health Organization has approved emiltatug ledadotin (abbreviated as Emi-Le) as XMT-1660’s international nonproprietary name (INN).
The new Fast Track designation is for the treatment of advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including triple-negative breast cancer (TNBC), who have received a prior topoisomerase-1 inhibitor ADC. Additionally, hormone-receptor positive patients should also have received or be ineligible for endocrine therapy. The FDA previously granted Fast Track designation to Emi-Le for the treatment of adult patients with advanced or metastatic recurrent TNBC.
“Topoisomerase-1 inhibitor ADCs are rapidly becoming the standard of care for metastatic TNBC and hormone-receptor positive breast cancer, and an increasing amount of research shows that these patients are exceedingly difficult to treat thereafter,” said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. “This growing population is a primary focus for us as we advance the development of Emi-Le. We are excited to announce this additional Fast Track designation and the initial clinical data from our ongoing Phase 1 clinical trial that were press released separately this morning.”
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A product candidate granted Fast Track designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application (BLA) by the FDA.
Conference Call Information
Mersana will host a conference call today at 8:30 a.m. ET to discuss the initial clinical data from its Phase 1 clinical trial of Emi-Le. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast that includes the data presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes Emi-Le (emiltatug ledadotin; XMT-1660), a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.
Forward-Looking Statements
This press release contains “forward-looking” statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, those concerning Mersana’s areas of focus; the continued development and therapeutic potential of Mersana’s product candidates, including Emi-Le (XMT-1660); Mersana’s anticipated disclosure of initial clinical trial data from its Phase 1 clinical trial of Emi-Le; and the potential advantages of Fast Track Designation. Mersana may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, uncertainties inherent in research and development and clinical development of Mersana’s product candidates, including Emi-Le; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that the receipt of Fast Track designation for Emi-Le may not result in a faster development or regulatory review or approval process compared to products considered for approval under conventional FDA procedures the risk that the FDA may later decide that Emi-Le no longer meets the conditions for Fast Track designation or decide that the time period for FDA review or approval will not be shortened; the risk that Mersana may not realize the intended benefits of its platforms, technology and collaborations; and other important factors, any of which could cause Mersana’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Mersana’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024, as well as in other filings Mersana may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mersana expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Contact:
Jason Fredette
617-498-0020
jason.fredette@mersana.com
FAQ
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