BMS and Prime announce $3.5bn T cell therapy deal

Ex vivo gene therapy offers a potential one-time, curative solution for a host of genetic diseases. 

Bristol Myers Squibb (BMS) has entered into a significant research and licensing agreement with Prime Medicine to advance the development of ex vivo T cell therapies. The collaboration, announced on September 30, outlines Massachusetts-based Prime Medicine's responsibility to design gene editing reagents using its proprietary PASSIGE technology. These reagents will then be utilized by BMS to develop ex vivo T cell therapies.

As part of the agreement, Prime Medicine will receive an upfront payment of $55 million and an additional $55 million as an equity investment from BMS. Moreover, Prime Medicine stands to gain over $3.5 billion through milestone payments. These include up to $1.4 billion tied to developmental milestones and more than $2.1 billion linked to commercialization. Future sales will also entitle Prime to royalties, further incentivizing their innovative work.

The PASSIGE platform, which stands for Prime Assisted Site-Specific Integrase Gene Editing, is a sophisticated technology that combines prime editing with integrase or other site-specific recombinase. This method is designed to allow for the stable insertion and expression of genetic material in the genome of extracted cells without the use of viral components or causing double-strand DNA breaks. The result is precise genetic modification that avoids off-target edits, making it a promising tool in gene therapy.

Prime Medicine's leading candidate, PM-359, is currently undergoing a Phase I/II clinical trial for the treatment of chronic granulomatous disease (CGD). This open-label, single-arm trial (NCT06559176) aims to establish the therapy’s efficacy and safety. In January 2024, PM-359 was granted orphan drug designation, and an Investigational New Drug (IND) application was approved by the US Food and Drug Administration (FDA) in April.

In May 2024, Prime Medicine disclosed preclinical data revealing that PM-359 successfully corrected CGD-causative mutations in over 75% of patients' CD34-positive cells. Importantly, these corrections occurred without any off-target edits post-engraftment, highlighting the precision and potential of the therapy.

Prime Medicine, established in 2021 with $315 million in Series A and B financing, has seen fluctuations in its stock value since going public in October 2022. Despite a general decline, the announcement of the deal with BMS resulted in a significant 22% increase in the company’s share price, which opened at $4.23 on September 30. Currently, Prime Medicine's market capitalization stands at $464.5 million.

On the same day as the BMS deal announcement, Prime Medicine also revealed a strategically focused pipeline. This new direction involves prioritizing their candidate for Wilson’s disease, with plans to submit an IND and possibly a clinical trial application (CTA) by the first half of 2026. Additionally, data from the ongoing Phase I/II trial of PM-359 is expected to be released in 2025, offering further insights into the therapy's potential.

By advancing these innovative therapies and leveraging strategic partnerships, Prime Medicine and Bristol Myers Squibb are at the forefront of translating cutting-edge genetic research into viable treatments for serious genetic conditions.

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