Encouraging Early Data From Next-Gen Study Puts Bristol Myers' CAR T Therapy In The Spotlight For Autoimmune Diseases

Over the weekend, Bristol Myers Squibb & Co BMY shared preliminary data from a Phase 1 study of CC-97540 (BMS-986353), a CD19-directed CAR T Cell Therapy Manufactured Using a Next-generation Process for severe, refractory autoimmune diseases.

Data were presented at the American College of Rheumatology 2024.

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CC-97540 (BMS-986353) is an investigational CD19-targeted CAR T cell therapy that expresses the CD19 CAR used in FDA-approved Breyanzi (lisocabtagene maraleucel, liso-cel) but is manufactured using the NEX-TTM process, to shorten manufacturing time, improve potency, and optimize phenotypic attributes of the CAR T cell product.

Patients received a single infusion of CC-97540 2–7 days after lymphodepleting chemotherapy (3 days fludarabine [30 mg/m2], cyclophosphamide [300 mg/m2]).

Patients were treated with 10 × 10 power 6 or 25 × 10 power 6 CAR+ T cells in the dose-escalation phase.

Results from the first patients indicate promising preliminary safety and efficacy of CC-97540 at low doses.

The data also show encouraging CAR T cell expansion and complete B cell depletion.

The abstract notes that CC-97540, a NEX-T investigational CD19 CAR T cell product, is a more potent cellular drug product than liso-cel and can be manufactured with a more rapid processing time and greater capacity.

Goldman Sachs writes that data from 15 patients across three disease indications demonstrates a robust and compelling profile thus far, a very encouraging safety profile, and a noteworthy preliminary efficacy across multiple clinically relevant domains.

The analyst writes that NEX-T has strong potential to become a key growth driver for the company. Although Goldman Sachs has not included revenue estimates yet due to its early stage, they see a possible multibillion-dollar total addressable market across various rheumatologic disease applications.

“Along with peer commercial stage CAR-T players, we see BMY as well positioned to capitalize on structural advantages,” the analyst writes.

William Blair writes, “While there are unanswered questions on the registrational path, commercial opportunity, and competitive landscape for CD19 therapies in severe autoimmune diseases, we believe this patient vignette highlights the transformative potential of CD19 CAR-T in this setting and will further drive patient interest in these programs.”

Price Action: BMY stock is up 0.63% at $56.58 at last check Monday.

Photo via Shutterstock

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