Instil Bio Announces U.S. F.D.A. Clearance of Investigational New Drug (IND) Application for AXN-2510, a PD-L1xVEGF Bispecific Antibody, for a Phase 1 Trial in Relapsed/Refractory Solid Tumors
Instil Bio (NASDAQ: TIL) has received FDA clearance for its Investigational New Drug (IND) application for AXN-2510, a PD-L1xVEGF bispecific antibody. The company plans to initiate a Phase 1 trial for relapsed/refractory solid tumors by the end of 2025.
The Phase 1 trial will evaluate safety, efficacy, pharmacokinetics, and pharmacodynamics of AXN-2510 as monotherapy. Additionally, ImmuneOnco is expected to share initial safety and efficacy results from an ongoing Phase 2 study of AXN-2510 combined with chemotherapy in first-line NSCLC in China during the second half of 2025.
Instil Bio (NASDAQ: TIL) ha ottenuto l'autorizzazione dalla FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) per AXN-2510, un anticorpo bispecifico PD-L1xVEGF. L'azienda prevede di avviare una fase 1 di sperimentazione per tumori solidi recidivanti/refrattari entro la fine del 2025.
La fase 1 valuterà la sicurezza, efficacia, farmacocinetica e farmacodinamica di AXN-2510 come monoterapia. Inoltre, ImmuneOnco dovrebbe condividere i primi risultati di sicurezza ed efficacia da uno studio in corso di fase 2 su AXN-2510 in combinazione con chemioterapia nel trattamento di prima linea del NSCLC in Cina nella seconda metà del 2025.
Instil Bio (NASDAQ: TIL) ha recibido la aprobación de la FDA para su solicitud de Nuevo Fármaco en Investigación (IND) para AXN-2510, un anticuerpo bispecífico PD-L1xVEGF. La compañía planea iniciar un ensayo de fase 1 para tumores sólidos en recaída/refractarios antes de finales de 2025.
El ensayo de fase 1 evaluará la seguridad, eficacia, farmacocinética y farmacodinámica de AXN-2510 como monoterapia. Además, se espera que ImmuneOnco comparta los primeros resultados de seguridad y eficacia de un estudio en curso de fase 2 de AXN-2510 combinado con quimioterapia en primera línea para NSCLC en China durante la segunda mitad de 2025.
Instil Bio (NASDAQ: TIL)가 PD-L1xVEGF 이중특이항체인 AXN-2510에 대한 임상시험신약(IND) 신청에 대해 FDA 승인을 받았습니다. 회사는 2025년 말까지 재발/불응성 고형암을 대상으로 하는 1상 시험을 시작할 계획입니다.
1상 시험에서는 AXN-2510 단독요법의 안전성, 유효성, 약동학 및 약력학을 평가할 예정입니다. 또한 ImmuneOnco는 2025년 하반기에 중국에서 진행 중인 AXN-2510과 화학요법 병용의 1차 NSCLC 대상 2상 연구의 초기 안전성 및 유효성 결과를 공유할 것으로 기대됩니다.
Instil Bio (NASDAQ : TIL) a obtenu l'autorisation de la FDA pour sa demande de médicament expérimental (IND) concernant AXN-2510, un anticorps bispécifique PD-L1xVEGF. La société prévoit de lancer un essai de phase 1 pour les tumeurs solides en rechute/réfractaires d'ici la fin de l'année 2025.
L'essai de phase 1 évaluera la sûreté, l'efficacité, la pharmacocinétique et la pharmacodynamie d'AXN-2510 en monothérapie. De plus, ImmuneOnco devrait partager les premiers résultats de sécurité et d'efficacité d'une étude de phase 2 en cours combinant AXN-2510 avec une chimiothérapie en première ligne du NSCLC en Chine au cours du second semestre 2025.
Instil Bio (NASDAQ: TIL) hat die FDA-Zulassung für seinen Antrag auf ein Investigational New Drug (IND) für AXN-2510, einen PD-L1xVEGF bispezifischen Antikörper, erhalten. Das Unternehmen plant, bis Ende 2025 eine Phase-1-Studie bei rezidivierenden/refraktären soliden Tumoren zu starten.
Die Phase-1-Studie wird die Sicherheit, Wirksamkeit, Pharmakokinetik und Pharmakodynamik von AXN-2510 als Monotherapie untersuchen. Darüber hinaus wird erwartet, dass ImmuneOnco in der zweiten Hälfte des Jahres 2025 erste Sicherheits- und Wirksamkeitsergebnisse aus einer laufenden Phase-2-Studie mit AXN-2510 in Kombination mit Chemotherapie bei Erstlinientherapie von NSCLC in China vorstellt.
- FDA clearance received for AXN-2510 IND application
- Phase 1 trial initiation planned for end of 2025
- Concurrent Phase 2 study results expected in H2 2025
- Expansion into global clinical development
- Early-stage development with no efficacy data yet
- Results from ongoing trials not available until late 2025
US phase 1 trial of ‘2510 is expected to be initiated before the end of 2025
Anticipate ImmuneOnco sharing initial safety and efficacy results from phase 2 trial of ‘2510 + chemo in 1L NSCLC in the second half of 2025
DALLAS, July 02, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced the clearance of an Investigational New Drug (IND) application for AXN-2510 (“’2510”) by the U.S. Food and Drug Administration.
Instil expects to initiate a phase 1 trial of ‘2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of ‘2510 in patients with solid tumors. Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of ‘2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco.
“We are pleased to announce the clearance of the ‘2510 IND by the FDA,” said Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil. “Evaluating ‘2510 in a global population will be a critical milestone in the clinical development of ‘2510.”
About Instil Bio
Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil's lead asset, AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. For more information, visit www.instilbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words (and variations of words) such as "anticipates," "believes," "could,” expects," "exploring," "future," "intends," "may," "plans," "potential," "projects," "will," “target,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding Instil's expectations with respect to the therapeutic potential of AXN-2510, the clinical development of AXN-2510, patient enrollment and clinical trials and the timing, scope and design thereof, and the availability and timing of data from clinical trials. Forward-looking statements are based on Instil management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with in-licensing product candidates and clinical trial collaborations; the costly and time-consuming product development process and the uncertainty of clinical success; the risks inherent in relying on collaborators and other third parties, including for manufacturing and clinical trial operation; the risks and uncertainties related to successfully initiating, enrolling, completing and reporting data from clinical studies, as well as the risks that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials and that Instil's product candidates may otherwise not be effective treatments in their planned indications; risks related to macroeconomic conditions, including as a result of international conflicts, U.S.-China trade and political tensions, interest rates, inflation, and other factors, which could materially and adversely affect Instil's business and operations; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process for product candidates across multiple indications and multiple regulatory authorities; the impact of product candidates that may compete with those developed by Instil; the sufficiency of Instil's cash resources; and other risks and uncertainties affecting Instil and its plans and development programs, including those discussed in the section titled "Risk Factors" in Instil's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC, as well as Instil's other filings with the SEC. Additional information will be made available in other filings that Instil makes from time to time with the SEC. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as the date hereof, and Instil disclaims any obligation to update these statements except as may be required by law.
Contacts:
Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com
FAQ
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