Manufacturing and control of an innovative new drug category: nanofilament immunotherapy

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Project of $ 599,322 over 2 years

• Supported by CQDM through:
  Ministère de l’Économie, de l’Innovation et de l’Énergie du Québec (MEIE)
• And by co-funding partner:
  – TATUM bioscience

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Challenge:

TATUM bioscience is developing an innovative cancer treatment—nanofilament immunotherapy—using nanofilaments produced by a specially modified strain of E. coli. Among these nanofilaments, the TAT003 candidate exhibits particularly promising biological activity for the treatment of various types of cancer. Building on the exceptional results obtained to date with this candidate and the significant potential of its technology, TATUM has proactively undertaken optimization efforts to continue increasing yield and improving long-term stability. To effectively prepare for the next stages of its clinical development and accelerate market launch, TATUM is currently dedicating a significant portion of its resources to optimizing production yields, improving the molecule’s long-term stability, and adjusting its purification process to ensure compliance with pharmaceutical manufacturing requirements and future regulatory steps. Addressing these technical challenges is essential to advancing this treatment toward clinical application.

Solution:

To overcome these challenges, TATUM has assembled a team of partners with complementary expertise. CNETE will optimize the fermentation process and the methods for separating and concentrating TAT003 nanofilaments to meet the target criteria. CERASP will develop methods to improve the product’s long-term stability. CERASP will initially use preparations provided by TATUM to screen for excipients compatible with TAT003 and develop specialized formulations for intratumoral injection. CERASP will then use CNETE’s equipment to finalize the formulation and conduct long-term stability testing of the product in frozen or lyophilized form. Finally, the entire team will monitor progress using specialized analytical tools and ensure that the process complies with GMP standards for clinical-grade production. To accelerate the clinical and industrial development of its therapeutic nanofilament technology while reducing costs, TATUM has established strategic collaboration agreements with partners possessing high-level complementary expertise and industry-standard infrastructure. This approach will enable the company to rapidly establish a robust, scalable production platform that meets pharmaceutical and regulatory requirements. As part of this project, it has therefore partnered with two research centers renowned for their highly complementary expertise: CNETE and CERASP. CNETE will contribute to optimizing the fermentation, separation, and concentration processes for TAT003 nanofilaments in order to improve production performance and support the development of a scalable bioprocess. In parallel, CERASP will develop specialized formulations aimed at improving the product’s long-term stability as well as its compatibility with intratumoral administration, including frozen or lyophilized formulations tailored to clinical needs. The entire project will rely on advanced analytical tools and an approach aligned with GMP standards, enabling TATUM to reduce development timelines and effectively prepare for the future commercial production of its technology.

Expected Achievements /Impacts:

This project will enable TATUM to advance the clinical and commercial development of its flagship compound, TAT003, while establishing the technological foundations necessary for the rapid commercialization of future therapeutic nanofilaments. The work carried out will lead to the development of a robust, scalable manufacturing platform that meets the requirements of the biopharmaceutical industry. The optimization of production, purification, and formulation processes will help reduce manufacturing costs, accelerate regulatory milestones, and strengthen TATUM’s ability to efficiently develop new therapeutic candidates based on its nanofilament technology. This approach will position the company favorably with industrial partners and investors.