Akeso's Innovative Approach to Pancreatic Cancer: First Patient Dosed in Phase II Study

Introduction

In a landmark advancement in cancer therapy, Akeso Inc. has announced that they have successfully dosed the first patient in their registrational Phase II study, known as AK130-202. This significant step involves the evaluation of the promising drug AK130, which is a bifunctional antibody fusion protein that targets both TIGIT and TGF-β, in combination with ivonescimab, a bispecific antibody that concurrently honors PD-1 and VEGF pathways. This unique approach aims to tackle advanced pancreatic cancer cases that have not responded to prior treatments.

The Study Overview

The AK130-202 study is designed to evaluate the safety and effectiveness of AK130, particularly for patients who have exhausted two previous systemic therapies. Akeso’s innovative therapy sets itself apart as the world’s first and only registrationally developed TIGIT/TGF-β bifunctional antibody. By utilizing a groundbreaking strategy referred to as 'IO2.0 + IO2.0' combinations, Akeso aims to solidify its foothold in the rapidly evolving landscape of immuno-oncology therapies.

Role of AK130

So, what exactly is AK130? It is an entirely independently developed bifunctional antibody from Akeso that combines an anti-TIGIT monoclonal antibody with the extracellular domain of the human TGF-β receptor II. TIGIT acts as a crucial checkpoint in immune regulation. When blocked, it can alleviate the suppression of tumor-infiltrating CD8+ T cells and natural killer (NK) cells, ultimately leading to improved anti-tumor activity. TGF-β signaling, on the other hand, is notorious for promoting immunosuppression. By inhibiting both pathways, AK130 aims to activate T-cell responses while mitigating the immunosuppressive influence of regulatory T cells (Tregs).

Therapeutic Potential

The holistic dual blockade of both the PD-1/VEGF and TIGIT/TGF-β pathways is backed by preclinical studies, suggesting a synergistic therapeutic potential. This combination approach is expected to remodel the tumor immune microenvironment significantly and amplify anti-tumor immune responses. Akeso has previously observed robust efficacy with ivonescimab monotherapy in first-line pancreatic cancer, and the strategic amalgamation with AK130 is anticipated to enhance therapeutic outcomes in this challenging malignancy.

Clinical Development Pipeline

Akeso has established itself as a leader in the oncology field, credited with a pipeline that encompasses nine self-developed bispecific antibodies or antibody-drug conjugates at various stages of clinical development or regulatory approval. Utilizing a proprietary bispecific antibody technology platform, Akeso is also navigating multiple advanced combination therapy research programs that include both commercially approved and innovative candidates like AK130 and AK146D1, a Trop2/Nectin4 bispecific ADC.

Conclusion

The commencement of the AK130-202 study marks a notable milestone in Akeso’s unwavering commitment to pushing the boundaries of oncology treatment and innovation. While challenges in regulatory approval and market competition persist, Akeso remains steadfast in its mission to provide effective and affordable therapeutic solutions for patients battling cancer worldwide. Given the promising developments, the future looks encouraging for advanced pancreatic cancer treatment as Akeso continues its journey of biomedical innovation.

For more detailed information about Akeso’s approaches and advancements, visit their official website at Akeso Bio.