Asher Bio Announces Clinical Supply Agreement to Enable Evaluation of Etakafusp Alfa (AB248) in Combination with Rilvegostomig in a Global Phase 1b/2 Study in Non-Small Cell Lung Cancer (NSCLC)
Asher Biotherapeutics has entered into a clinical supply agreement with AstraZeneca (AZN) for a global Phase 1b/2 study. The study will evaluate the combination of Asher Bio's etakafusp alfa (AB248) with AstraZeneca's rilvegostomig as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
Under the agreement, AstraZeneca will sponsor and conduct the global study, while Asher Bio will retain full ownership of etakafusp alfa and provide it at no cost. Initial Phase 1 data for etakafusp alfa has shown promising results, demonstrating selective CD8+ T cell activation and early evidence of anti-tumor effects, including confirmed objective responses.
Asher Biotherapeutics ha stipulato un accordo per la fornitura clinica con AstraZeneca (AZN) per uno studio globale di Fase 1b/2. Lo studio valuterà la combinazione dell'etakafusp alfa (AB248) di Asher Bio con il rilvegostomig di AstraZeneca come trattamento di prima linea per il cancro del polmone non a piccole cellule (NSCLC) in fase avanzata o metastatica.
Secondo l'accordo, AstraZeneca sponsorizzerà e condurrà lo studio globale, mentre Asher Bio manterrà la piena proprietà di etakafusp alfa e lo fornirà a titolo gratuito. I dati iniziali della Fase 1 per etakafusp alfa hanno mostrato risultati promettenti, dimostrando un'attivazione selettiva delle cellule T CD8+ e prove preliminari di effetti antitumorali, compresi riscontri obiettivi confermati.
Asher Biotherapeutics ha firmado un acuerdo de suministro clínico con AstraZeneca (AZN) para un estudio global de Fase 1b/2. El estudio evaluará la combinación de etakafusp alfa (AB248) de Asher Bio con rilvegostomig de AstraZeneca como tratamiento de primera línea para el cáncer de pulmón de células no pequeñas (NSCLC) en etapa avanzada o metastásico.
En virtud del acuerdo, AstraZeneca patrocinará y llevará a cabo el estudio global, mientras que Asher Bio conservará la plena propiedad de etakafusp alfa y lo proporcionará sin costo alguno. Los datos iniciales de la Fase 1 para etakafusp alfa han mostrado resultados prometedores, demostrando una activación selectiva de células T CD8+ y evidencia temprana de efectos antitumorales, incluidos respuestas objetivas confirmadas.
Asher Biotherapeutics는 AstraZeneca (AZN)와 글로벌 Phase 1b/2 연구를 위한 임상 공급 계약을 체결했습니다. 이 연구는 Asher Bio의 etakafusp alfa (AB248)와 AstraZeneca의 rilvegostomig의 조합을 진행성 또는 전이성 비소세포 폐암(NSCLC)의 1차 치료법으로 평가할 것입니다.
계약에 따라 AstraZeneca는 글로벌 연구를 후원하고 수행하며, Asher Bio는 etakafusp alfa의 완전한 소유권을 유지하고 무상으로 제공할 것입니다. etakafusp alfa의 초기 Phase 1 데이터는 선택적인 CD8+ T 세포 활성화와 초기 항종양 효과의 증거를 포함한 유망한 결과를 보여주었습니다.
Asher Biotherapeutics a conclu un accord de fourniture clinique avec AstraZeneca (AZN) pour une étude mondiale de Phase 1b/2. L'étude évaluera la combinaison de etakafusp alfa (AB248) d'Asher Bio avec le rilvegostomig d'AstraZeneca comme traitement de première ligne pour le cancer du poumon non à petites cellules (NSCLC) avancé ou métastatique.
Dans le cadre de cet accord, AstraZeneca parrainera et mènera l'étude mondiale, tandis qu'Asher Bio conservera la pleine propriété de l'etakafusp alfa et le fournira gratuitement. Les données initiales de la Phase 1 pour l'etakafusp alfa ont montré des résultats prometteurs, démontrant une activation sélective des cellules T CD8+ et des preuves préliminaires d'effets antitumoraux, y compris des réponses objectives confirmées.
Asher Biotherapeutics hat eine klinische Liefervereinbarung mit AstraZeneca (AZN) für eine globale Phase 1b/2-Studie abgeschlossen. Die Studie wird die Kombination von Asher Bio's etakafusp alfa (AB248) mit AstraZenecas rilvegostomig als Erstlinientherapie für fortgeschrittenen oder metastasierten nicht-kleinzelligen Lungenkrebs (NSCLC) bewerten.
Im Rahmen der Vereinbarung wird AstraZeneca die globale Studie sponsern und durchführen, während Asher Bio das volle Eigentum an etakafusp alfa behält und es kostenlos bereitstellt. Erste Phase 1-Daten für etakafusp alfa haben vielversprechende Ergebnisse gezeigt und eine selektive Aktivierung der CD8+ T-Zellen sowie frühe Hinweise auf antitumorale Wirkungen, einschließlich bestätigter objektiver Reaktionen, demonstriert.
- Phase 1 clinical data shows promising results with selective CD8+ T cell activation
- Evidence of anti-tumor effects including confirmed objective responses
- Partnership with major pharmaceutical company AstraZeneca for global study
- Retention of full ownership rights to etakafusp alfa
- None.
Insights
The clinical supply agreement between Asher Bio and AstraZeneca represents a strategically calculated move in the competitive NSCLC treatment landscape. Etakafusp alfa's unique mechanism targeting CD8+ T cells, combined with rilvegostomig's dual PD-1/TIGIT blockade, could potentially create a synergistic effect in enhancing anti-tumor immune responses.
The Phase 1b/2 study structure indicates a fast-track development approach, where positive safety and early efficacy signals could accelerate the pathway to registration. First-line treatment positioning is particularly noteworthy, as success here would capture the largest available patient population segment in NSCLC.
While AstraZeneca bears the study costs, Asher Bio retains full ownership of etakafusp alfa - a favorable arrangement that preserves significant future value potential while minimizing development expenses. For AstraZeneca, this represents a low-risk opportunity to enhance their immuno-oncology portfolio in a key therapeutic area.
This agreement carries strategic significance beyond the surface-level collaboration. For AstraZeneca, it represents an efficient way to potentially strengthen their NSCLC franchise without upfront licensing costs. The structure suggests confidence in both assets, as AstraZeneca is willing to fund the trial while Asher Bio commits valuable drug supply.
The preliminary data showing "unprecedented levels of selective CD8+ T cell activation" and confirmed objective responses are particularly intriguing. Early efficacy signals in combination with AstraZeneca's bispecific antibody could position this duo as a competitive threat to established players in the first-line NSCLC space.
For investors, this validates Asher Bio's platform while preserving their full commercial rights - a important point for future valuation. The deal structure suggests potential for additional collaborations across their pipeline, which could drive further value creation.
– Clinical supply agreement with AstraZeneca for global Phase 1b/2 study to evaluate the safety and early efficacy of etakafusp alfa (AB248) in combination with rilvegostomig as a first-line treatment in patients with advanced or metastatic NSCLC –
“This exciting agreement with AstraZeneca is a reflection of the emerging clinical data from our Phase 1 study of etakafusp alfa. Initial data demonstrate a highly differentiated clinical pharmacodynamic profile with unprecedented levels of selective CD8+ T cell activation as well as initial evidence of anti-tumor effect including confirmed objective responses,” said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. “We look forward to collaborating with AstraZeneca to expand the potential impact of our lead cis-targeted immunotherapy in patients worldwide.”
As part of this agreement, AstraZeneca will sponsor and operationalize a global study to evaluate the safety and early efficacy of etakafusp alfa as a first-line treatment in combination with rilvegostomig in patients with advanced or metastatic NSCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply AstraZeneca with etakafusp alfa at no cost.
About NSCLC
NSCLC is the most common type of lung cancer, accounting for 80
About Etakafusp Alfa (AB248)
Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Asher Bio is currently evaluating etakafusp alfa in a Phase 1a/1b clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support etakafusp alfa’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, including confirmed objective responses, with a generally well-tolerated safety profile. Please refer to www.clinicaltrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial.
About Asher Bio
Asher Bio is a biotechnology company developing therapies to precisely engage specific immune cells to fight cancer and chronic viral infection. We utilize our proprietary cis-targeting platform to develop therapies engineered to overcome limitations of other immune-based treatments by selectively activating specific immune cell types with validated disease fighting functionality. Our candidates feature an antibody connected to a modified immunomodulatory protein, such as a cytokine. Our candidate design is intended to enable our candidates to selectively activate the desired immune cells and not other cells that contribute to toxicity or immune suppression. Our lead program etakafusp alfa (AB248), an IL-2 molecule specifically targeted to CD8+ effector T cells, is currently in Phase 1 trials for oncology. Our broader portfolio includes AB821, an IND-ready CD8-targeted IL-21 immunotherapy, and early-stage programs targeting CAR-T cells, myeloid cells and CD4+ T cells. Asher Bio was founded by Ivana Djuretic and Andy Yeung with support from Third Rock Ventures and is located in
1 Lung Cancer Guide | What You Need to Know | American Cancer Society
2 Lung and Bronchus Cancer — Cancer Stat Facts
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Media Contact
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Investor Contact
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Source: Asher Biotherapeutics
FAQ
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