Cell therapy weekly: acquisition to advance CAR-T therapy for multiple myeloma
This week: Gilead Sciences (CA, USA) announced its acquisition of Arcellx (CA, USA) to advance the development of anito-cel, a promising CAR-T therapy for multiple myeloma. Plus, A2 Biotherapeutics (CA, USA) dosed the first patient in its EVEREST-2 study, showcasing progress in its next-generation CAR T therapy enhanced with a membrane-tethered IL-12 booster, and BreezeBio (CA, USA) secured US$60 million in Series B financing to drive the development of its immune modulation therapy, BRZ-101, and expand its NanoGalaxy delivery platform.
The news highlights:
- Acquisition to advance CAR-T therapy for multiple myeloma
- First patient dosed in study of next-generation CAR-T therapy with IL-12 booster
- US$60 million secured to develop mRNA-based immune modulation therapy
Acquisition to advance CAR-T therapy for multiple myeloma
Gilead Sciences announced its acquisition of Arcellx in a deal, valued at $7.8 billion. This acquisition builds on the existing partnership between Kite, a Gilead company, and Arcellx to co-develop anito-cel, a BCMA-directed CAR-T therapy for relapsed or refractory multiple myeloma. Anito-cel has shown promising clinical results, offering durable responses and manageable safety profiles, addressing challenges in current CAR-T therapies.
“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” said Daniel O’Day, Chairman and CEO of Gilead Sciences. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy. In addition, the anito-cel D-domain BCMA binder could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation.”
Arcellx’s proprietary D-Domain CAR technology platform also holds potential for next-generation therapies, enhancing specificity and binding affinity. The FDA has accepted the Biologics License Application for anito-cel, with a decision expected by December 2026. The transaction, approved by both companies’ boards, is set to close in the second quarter of 2026, pending regulatory approvals and shareholder agreements.
First patient dosed in study of next-generation CAR-T therapy with IL-12 booster
A2 Biotherapeutics has dosed the first patient in its EVEREST-2 study, evaluating A2B543, a novel CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster. A2B543 is built on A2 Bio’s proprietary Tmod™ platform, which selectively targets tumor cells while sparing healthy tissue. The IL-12 booster is designed to activate only when the CAR T-cell engages a tumor antigen, improving the therapy’s potency and persistence in the challenging solid tumor microenvironment while minimizing systemic toxicity.
“Dosing the first patient with A2B543 is a significant step forward in the evolution of the Tmod™ platform,” said John Welch, chief medical officer of A2 Bio. “While systemic IL-12 induces a potent antitumor immune response, its use has been limited by severe toxicity. With A2B543, we are arming our Tmod™ cells with a membrane-tethered, inducible IL-12 component. This design allows us to localize the impact of IL-12 to the tumor microenvironment, boosting the persistence and potency of Tmod™ without the systemic side effects.”
US$60 million secured to develop mRNA-based immune modulation therapy
BreezeBio, formerly known as GenEdit, has secured US$60 million in Series B financing to advance its therapeutic programs and expand its NanoGalaxy delivery platform. The funding will support the development of its lead candidate, BRZ-101, a novel immune modulation therapy aimed at restoring tolerance in type 1 diabetes.
BRZ-101 uses mRNA to deliver autoantigens and tolerogenic co-factors to antigen-presenting cells, which then induce antigen-specific regulatory T cells (Tregs). These Tregs precisely block autoimmune responses without impairing overall immune function. Preclinical studies have shown BRZ-101 to be effective in inducing immune tolerance in multiple autoimmune disease models, including the NOD mouse model of diabetes, and it has demonstrated safety in mice and non-human primates. The therapy is now progressing into IND-enabling studies.
“Now that we can deliver genetic payloads to the right cells with precision, we are building genetic medicines designed to make a real difference for patients,” said Kunwoo (Ryan) Lee, CEO of BreezeBio. “We’ve completed our transition from a delivery platform to a therapeutics company, and this financing allows us to advance our first internal programs toward the clinic while continuing to expand the reach of NanoGalaxy.”