December 2025 • PharmaTimes Magazine • 6

// TREATMENTS //


Advanced therapies boost
UK’s life sciences ambitions

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The Cell and Gene Therapy Catapult (CGT Catapult) has highlighted the vital role of advanced therapies in supporting the UK Government’s goal of becoming a top three global life sciences economy by 2035.

In its latest annual review, CGT Catapult outlines how it is driving progress in the cell and gene therapy industry, enhancing both economic productivity and patient outcomes.

Over the last financial year, the organisation collaborated with 70 companies, 60% of which were UK-based SMEs. These companies collectively raised more than £177m.
Patient access to innovative treatments is also on the rise. As of April, 17 therapies had been approved and reimbursed for use.

In 2024, 9.5% of global advanced therapy clinical trials included UK representation, with nine CGT Catapult-supported companies conducting trials domestically.

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “Many thanks to our collaborators in industry, healthcare and Government who we have worked with over the past year. Working together, we have delivered partnerships that supported industry growth, and helped ensure the UK maintains its position as a global leader in advanced therapies.”

He added: “The advanced therapies sector is crucial to driving forward the Government’s mission of sustainable economic growth and improved health.”


Sonoma Biotherapeutics reports promising data for rheumatoid arthritis therapy

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Sonoma Biotherapeutics has announced positive interim results from its ongoing phase 1 Regulate-RA trial evaluating SBT-77-7101 in patients with refractory rheumatoid arthritis (RA).

The data was presented at the 2025 American College of Rheumatology (ACR) Convergence in Chicago.

Jeff Bluestone, Chief Executive Officer and President, said: “We are very encouraged by these positive interim results from a first-in-human study of our proprietary programme SBT-77-7101 in patients with refractory rheumatoid arthritis (RA), a severe form of RA that persists despite treatment with multiple conventional, biologic and targeted synthetic therapies.”

He added: “The study is providing clinical and mechanistic evidence of therapeutic activity alongside emerging signs of durability and a favourable safety profile. We look forward to completion of the ongoing dose escalation of SBT-77-7101 and its advancement into the dose expansion phase.”

The trial is assessing three ascending doses of SBT-77-7101 in six participants across two cohorts. No dose-limiting toxicities, cytokine release syndrome or neurotoxicity were observed. By week 4, 67% of participants saw a 50% or greater reduction in swollen and tender joint counts. Additionally, 83% showed improvements in DAS28-CRP and CDAI scores.

Participants in the higher-dose cohort experienced deeper and more consistent responses, with one showing a durable effect through week 24. CAR+ Tregs were detected in both synovial tissue and blood, indicating systemic and local activity.

Joe Arron, Chief Scientific Officer, stated: “It is gratifying to see the preliminary safety, PK/PD and efficacy data in the phase 1 REGULATE-RA clinical trial, as it validates the potential for antigen-directed Tregs to treat autoimmunity, even in highly refractory patients with high levels of baseline disease.”