An innovative PET tracer for brain tumor diagnosis, with BIC potential

If you are interested in this asset or need more information, please contact DrugTimes BD Team at BD@drugtimes.cn or visit our website at https://www.drugtimes.cn

Executive Summary

In the quest for more effective diagnostic tools in oncology, particularly for brain tumors, an innovative Positron Emission Tomography (PET) tracer has emerged, demonstrating significant potential as a Best-in-Class (BIC) candidate. This novel bis-boron boramino acid PET tracer, developed globally to target the L-type amino acid transporter 1 (LAT1), shows promise in addressing the limitations of existing PET tracers, especially 18F-FDG, which is widely used in clinical settings but has known limitations in brain cancer imaging.

Introduction

Brain tumors present a significant challenge in cancer diagnostics due to their complex nature and the need for precise imaging to guide treatment decisions. The current standard, 18F-FDG, while valuable in many oncological applications, falls short in differentiating brain tumors from surrounding tissue, particularly in the context of radiation necrosis post-treatment. This has led to a search for more effective PET tracers that can provide clearer images and more accurate diagnoses.

The Innovative PET Tracer

The new PET tracer, [18F]BF3-BPA, stands out for its ability to significantly lower background activity and increase tumor-to-background ratio (TBR) compared to existing amino acid PET tracers. This promising theranostic agent not only enhances PET imaging for diagnosis but also holds potential for Boron Neutron Capture Therapy (BNCT) treatment.

Mechanism of Action

As an amino acid analog, [18F]BF3-BPA is specifically taken up by tumors through LAT1, which is highly expressed in solid tumors, including brain tumors, with low background uptake in normal tissues. This targeted approach results in a higher tumor-to-normal brain uptake ratio, making it an excellent PET tracer for cancer diagnosis and localization.

Development Progress

– The tracer received Investigational New Drug (IND) approval from China NMPA in August 2023 and from the US FDA in September 2023.
– Phase 1 studies have been completed, demonstrating safety and tolerability in healthy volunteers.
– An exploratory clinical study (IIT, Phase 2) is ongoing for patients with clinically suspected glioma, with plans for a brain metastases cohort.
– A pivotal Phase 3 study is expected to initiate in Q1 2026.

Pharmacology and Pharmacokinetics

Preclinical studies have shown [18F]BF3-BPA to have excellent target ability and visualization, significantly outperforming 18F-FDG in both U87MG orthotopic xenograft mouse models and Lewis lung cancer brain metastatic models. The tracer also exhibits a favorable tissue distribution profile, with low levels of radioactive components found in the brain, aligning with the low background observed in preclinical studies.

Clinical Development

The primary endpoint of the clinical studies includes the identification of the recommended phase 2 dose (RP2D), assessing efficacy in terms of diagnostic performance, and positive-predictive value for the diagnosis of tumor lesions.

Summary

With a global rights framework and flexibility for various business models, including exclusive licensing or co-development, the developer is open to partnerships for regional or global rights. Manufacturing tech-transfer is also available, making this an attractive opportunity for potential licensing partners looking to innovate in the field of brain tumor diagnostics.

Conclusion

The [18F]BF3-BPA PET tracer represents a significant advancement in the diagnostic landscape of brain tumors. Its innovative mechanism and promising preclinical and clinical data position it as a potential BIC product, offering a new horizon for patients and healthcare providers in the quest for more accurate and effective diagnostic tools.

If you are interested in this asset or need more information, please contact DrugTimes BD Team at BD@drugtimes.cn or visit our website at https://www.drugtimes.cn.

发布者:DrugTimes001,转载请首先联系contact@drugtimes.cn获得授权

(0)
打赏 为好文打赏 支持药时代 共创新未来! 为好文打赏 支持药时代 共创新未来!
上一篇 2024年12月23日 13:38
下一篇 2024年12月23日 17:52

相关推荐

公众号
公众号
分享本页
返回顶部