Tuesday, July 16, 2024

FDA Fast-Tracks Prostate Cancer Treatment 225Ac-FL-020 by Full-Life Technologies

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The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Full-Life Technologies’ 225Ac-FL-020 for treating metastatic castration-resistant prostate cancer (mCRPC). This designation aims to expedite the development and regulatory review of treatments for serious conditions with unmet medical needs. The lead radiopharmaceutical, 225Ac-FL-020, targets prostate-specific membrane antigen (PSMA) and uses alpha-radiotherapy to specifically attack cancer cells while minimizing damage to healthy tissues.

In preclinical models, radiolabelled FL-020 showed a promising in vivo biodistribution profile. This included high and sustained tumor uptake and rapid systemic clearance, demonstrating strong anti-tumor activity in LNCaP xenograft mice and a favorable safety profile. These encouraging results have laid a solid foundation for the next stages of clinical development. In May this year, Full-Life obtained clearance for an investigational new drug (IND) application from the FDA to commence clinical trials of 225Ac-FL-020. This approval is a crucial step towards bringing this innovative treatment to patients in need. The Phase I clinical trial will assess the safety, tolerability, and anti-tumor activity of 225Ac-FL-020, both in the US and globally.

Full-Life’s Chief Medical Officer Steffen Heeger emphasized the significance of the FDA fast-track designation, stating that it underscores the critical need for innovative and effective treatments for prostate cancer. Heeger noted that this designation allows for closer collaboration with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients. This close collaboration is expected to streamline the development and approval process, bringing hope to patients with limited treatment options.

Full-Life Secures $63.3 Million to Advance Prostate Cancer Treatment with FDA Fast-Track Designation

The company’s commitment to advancing this treatment is further supported by a significant financial investment. In January this year, Full-Life secured $63.3 million in financing, which included $47.3 million raised in a Series B funding round and $16 million through loan facilities. This investment is aimed at progressing the development of Full-Life’s radiopharmaceutical pipeline, enhancing manufacturing expertise, and streamlining the UniRDC discovery platform.

The fast-track designation by the FDA highlights the importance of expediting the development of treatments for serious conditions like prostate cancer. Full-Life’s innovative approach using alpha-radiotherapy targets cancer cells more precisely, reducing collateral damage to healthy tissues. This precision is critical in treating cancers such as prostate cancer, where current treatment options are limited and often come with significant side effects.

The upcoming clinical trials will be pivotal in determining the effectiveness and safety of 225Ac-FL-020 in humans. The trials aim to provide comprehensive data on how well the treatment works, its safety profile, and how it can be integrated into current cancer treatment protocols. The results of these trials could potentially change the standard of care for mCRPC patients, offering a new, effective treatment option.

Prostate Cancer

Full-Life Boosts Radiopharmaceutical Pipeline and Advances Prostate Cancer Treatment

The substantial funding secured by Full-Life is a testament to the potential of their radiopharmaceutical pipeline. The $63.3 million investment will not only support the clinical trials for 225Ac-FL-020 but also enhance the company’s manufacturing capabilities and streamline its discovery platform. This comprehensive approach ensures that Full-Life is well-prepared to meet the challenges of developing and commercializing a new prostate cancer treatment.

The financial backing also reflects investor confidence in Full-Life’s innovative approach and the potential impact of their treatments. The successful development and approval of 225Ac-FL-020 could pave the way for future advancements in radiopharmaceuticals, benefiting patients with various types of cancer beyond prostate cancer. The FDA fast-track designation for Full-Life Technologies’ 225Ac-FL-020 represents a significant milestone in the treatment of metastatic castration-resistant prostate cancer. This innovative radiopharmaceutical has shown promising preclinical results, and the upcoming clinical trials will be crucial in determining its effectiveness and safety in humans.

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The substantial financial investment secured by Full-Life underscores the potential of their pipeline and their commitment to advancing cancer treatment. As clinical development progresses, 225Ac-FL-020 holds the promise of offering a new, effective treatment option for patients with prostate cancer, ultimately improving patient outcomes and advancing the field of oncology.

 

Resource: Full Life Technologies, July 03, 2024

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