Asher Bio Announces Clinical Trial Collaboration and Supply Agreement on Etakafusp Alfa (AB248) in Combination with Bispecific T-cell Engager in Patients with Small Cell Lung Cancer
Asher Biotherapeutics has entered into a clinical trial collaboration and supply agreement with Amgen (NASDAQ:AMGN) to evaluate the combination of etakafusp alfa (AB248) with IMDELLTRA® (tarlatamab) in patients with extensive-stage small cell lung cancer (ES-SCLC).
The collaboration will focus on testing Asher Bio's CD8+ T cell targeted interleukin-2 immunotherapy alongside Amgen's DLL3-targeting Bispecific T-cell Engager therapy. Amgen will sponsor and conduct a global Phase 1b study to evaluate the safety and early efficacy of the combination therapy. Asher Bio will maintain full ownership of etakafusp alfa and provide it to Amgen at no cost.
Asher Biotherapeutics ha siglato un accordo di collaborazione per trial clinici e fornitura con Amgen (NASDAQ:AMGN) per valutare la combinazione di etakafusp alfa (AB248) con IMDELLTRA® (tarlatamab) in pazienti affetti da cancro polmonare a piccole cellule in stadio avanzato (ES-SCLC).
La collaborazione si concentrerà sul testare l'immunoterapia con interleuchina-2 mirata alle cellule T CD8+ di Asher Bio insieme alla terapia Bispecific T-cell Engager di Amgen, che mira a DLL3. Amgen sponsorizzerà e condurrà uno studio globale di Fase 1b per valutare la sicurezza e l'efficacia iniziale della terapia combinata. Asher Bio manterrà il pieno possesso di etakafusp alfa e lo fornirà ad Amgen senza alcun costo.
Asher Biotherapeutics ha entrado en un acuerdo de colaboración para ensayos clínicos y suministro con Amgen (NASDAQ:AMGN) para evaluar la combinación de etakafusp alfa (AB248) con IMDELLTRA® (tarlatamab) en pacientes con cáncer de pulmón de células pequeñas en etapa extensa (ES-SCLC).
La colaboración se centrará en probar la inmunoterapia con interleucina-2 dirigida a células T CD8+ de Asher Bio junto con la terapia Bispecific T-cell Engager de Amgen, que está dirigida a DLL3. Amgen patrocinará y llevará a cabo un estudio global de Fase 1b para evaluar la seguridad y la eficacia temprana de la terapia combinada. Asher Bio mantendrá la plena propiedad de etakafusp alfa y lo proporcionará a Amgen sin costo alguno.
Asher Biotherapeutics는 Amgen (NASDAQ:AMGN)과의 임상 시험 협력 및 공급 계약을 체결하여 광범위한 단계의 소세포 폐암(ES-SCLC) 환자에서 etakafusp alfa (AB248)와 IMDELLTRA® (tarlatamab)의 조합을 평가합니다.
이 협력은 Asher Bio의 CD8+ T 세포 표적 IL-2 면역 요법과 Amgen의 DLL3을 표적하는 Bispecific T-cell Engager 요법을 테스트하는 데 중점을 두고 있습니다. Amgen은 이 조합 요법의 안전성과 초기 효능을 평가하기 위해 글로벌 1b상 연구를 후원하고 수행합니다. Asher Bio는 etakafusp alfa에 대한 완전한 소유권을 유지하며 이를 Amgen에 비용 없이 제공합니다.
Asher Biotherapeutics a signé un accord de collaboration pour des essais cliniques et de fourniture avec Amgen (NASDAQ:AMGN) afin d'évaluer la combinaison d'etakafusp alfa (AB248) avec IMDELLTRA® (tarlatamab) chez des patients atteints de cancer du poumon à petites cellules à un stade avancé (ES-SCLC).
La collaboration se concentrera sur l'essai de l'immunothérapie interleukine-2 ciblant les cellules T CD8+ d'Asher Bio, ainsi que sur la thérapie Bispecific T-cell Engager d'Amgen, qui cible DLL3. Amgen parrainera et réalisera une étude mondiale de phase 1b pour évaluer la sécurité et l'efficacité précoce de la thérapie combinée. Asher Bio conservera l'entière propriété d'etakafusp alfa et le fournira à Amgen sans frais.
Asher Biotherapeutics hat eine Vereinbarung über eine klinische Studienzusammenarbeit und Lieferung mit Amgen (NASDAQ:AMGN) getroffen, um die Kombination von etakafusp alfa (AB248) mit IMDELLTRA® (tarlatamab) bei Patienten mit ausgedehntem kleinen Zell-Lungenkrebs (ES-SCLC) zu bewerten.
Die Zusammenarbeit konzentriert sich auf die Prüfung der CD8+ T-Zell-gesteuerten Interleukin-2-Immuntherapie von Asher Bio zusammen mit der DLL3-gezielten Bispezifischen T-Zell-Engager-Therapie von Amgen. Amgen wird eine globale Phase 1b-Studie sponsern und durchführen, um die Sicherheit und frühe Wirksamkeit der Kombinationstherapie zu bewerten. Asher Bio wird das volle Eigentum an etakafusp alfa behalten und es Amgen kostenfrei zur Verfügung stellen.
- Strategic partnership with major pharmaceutical company Amgen
- Amgen to sponsor and conduct global Phase 1b study
- Asher Bio retains full ownership of etakafusp alfa
- None.
Insights
This collaboration agreement represents a strategic opportunity to evaluate a potentially synergistic combination therapy in extensive-stage small cell lung cancer (ES-SCLC). The pairing of etakafusp alfa's CD8+ T cell-targeted IL-2 mechanism with IMDELLTRA's BiTE platform could enhance anti-tumor immune responses through complementary pathways. IMDELLTRA recently received FDA approval and demonstrated a
The scientific rationale is compelling - etakafusp alfa's selective CD8+ T cell expansion could potentially overcome T cell exhaustion that often limits BiTE efficacy. For Amgen, this represents a low-risk way to potentially enhance IMDELLTRA's clinical profile in a difficult-to-treat indication. The deal structure, with Amgen running the trial while Asher Bio retains full ownership of etakafusp alfa, suggests this is primarily an exploratory collaboration rather than a precursor to a larger partnership.
In simple terms: Think of IMDELLTRA as a GPS that guides immune cells to cancer cells, while etakafusp alfa acts like an energy drink that makes these immune cells stronger and more effective at fighting the cancer. Together, they might work better than either one alone.
This collaboration agreement exemplifies a capital-efficient deal structure that benefits both parties. For Amgen, securing access to a potentially complementary asset without upfront payments reduces financial risk while exploring IMDELLTRA's combination potential. For Asher Bio, leveraging Amgen's clinical trial infrastructure and expertise while maintaining full ownership of etakafusp alfa preserves future strategic optionality.
The deal's structure suggests Amgen's primary interest is in enhancing IMDELLTRA's competitive position in the SCLC market rather than acquiring rights to etakafusp alfa. This type of collaboration is increasingly common among biotech companies looking to maximize the value of their assets while preserving capital. If the combination shows promise, it could lead to a more substantial partnership or increase Asher Bio's attractiveness as an acquisition target.
“This clinical trial collaboration and supply agreement with Amgen allows us to further expand on the Phase 1 results for etakafusp alfa in a new combination with IMDELLTRA® in a global Phase 1b study in ES-SCLC,” said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. “Based on emerging data to date, we believe etakafusp alfa has the potential to improve the efficacy of T cell engagers (TCEs) by selectively expanding the CD8+ T cell population, improving effector function, tumor infiltration and reversing TCE-induced T cell desensitization. We look forward to collaborating with Amgen to assess the potential for the novel combination to improve outcomes for patients with ES-SCLC.”
As part of this collaboration agreement, Amgen will sponsor and operationalize a global Phase 1b study to evaluate the safety and early efficacy of etakafusp alfa in combination with IMDELLTRA® in patients with ES-SCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply Amgen with etakafusp alfa at no cost.
About SCLC
SCLC is one of the most aggressive and devastating solid tumor malignancies, with a median survival of approximately 12 months following initial therapy and a
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 which are the immune cells that drive anti-tumor efficacy, 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 American Cancer Society. Lung Cancer Survival Rates.
2 Paz-Ares L, Chen Y, Reinmuth N, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from
3 Liu SV, Reck M, Mansfield AS, et al. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021;39:619-630.
4 Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654.
5 Von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17(2):658-67.
6 Von Pawel J, Jotte R, Spigel DR, et al. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014;32(35):4012-9.
7 Coutinho AD, Shah M, Lunacsek OE, et al. Real-world treatment patterns and outcomes of patients with small cell lung cancer progression after 2 lines of therapy. Lung Cancer. 2019;127:53-58.
8 Borghaei H, Pundole X, Anderson E, et al. Treatment patterns and outcomes in recent US clinical practice for SCLC patients after two prior lines of therapy. Presentation at World Conference on Lung Cancer 2023. September 9-12, 2023;
9 Oronsky B, Abrouk N, Caroen S, et al. A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC). J Cancer. 2022;13:2945-2953.
10 World Health Organization. Lung. 2020.
11 Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14:549-561.
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Source: Asher Biotherapeutics
FAQ
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