Over the weekend, Bristol Myers Squibb & Co BMY shared preliminary knowledge from a Part 1 examine of CC-97540 (BMS-986353), a CD19-directed CAR T Cell Remedy Manufactured Utilizing a Subsequent-generation Course of for extreme, refractory autoimmune illnesses.
Knowledge have been introduced on the American School of Rheumatology 2024.
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CC-97540 (BMS-986353) is an investigational CD19-targeted CAR T cell remedy that expresses the CD19 CAR utilized in FDA-approved Breyanzi (lisocabtagene maraleucel, liso-cel) however is manufactured utilizing the NEX-TTM course of, to shorten manufacturing time, enhance efficiency, and optimize phenotypic attributes of the CAR T cell product.
Sufferers obtained a single infusion of CC-97540 2–7 days after lymphodepleting chemotherapy (3 days fludarabine [30 mg/m2], cyclophosphamide [300 mg/m2]).
Sufferers have been handled with 10 × 10 energy 6 or 25 × 10 energy 6 CAR+ T cells within the dose-escalation section.
Outcomes from the primary sufferers point out promising preliminary security and efficacy of CC-97540 at low doses.
The info additionally present encouraging CAR T cell growth and full B cell depletion.
The summary notes that CC-97540, a NEX-T investigational CD19 CAR T cell product, is a stronger mobile drug product than liso-cel and will be manufactured with a extra fast processing time and larger capability.
Goldman Sachs writes that knowledge from 15 sufferers throughout three illness indications demonstrates a strong and compelling profile to this point, a really encouraging security profile, and a noteworthy preliminary efficacy throughout a number of clinically related domains.
The analyst writes that NEX-T has robust potential to develop into a key development driver for the corporate. Though Goldman Sachs has not included income estimates but as a consequence of its early stage, they see a doable multibillion-dollar complete addressable market throughout numerous rheumatologic illness functions.
“Together with peer industrial stage CAR-T gamers, we see BMY as effectively positioned to capitalize on structural benefits,” the analyst writes.
William Blair writes, “Whereas there are unanswered questions on the registrational path, industrial alternative, and aggressive panorama for CD19 therapies in extreme autoimmune illnesses, we imagine this affected person vignette highlights the transformative potential of CD19 CAR-T on this setting and can additional drive affected person curiosity in these packages.”
Worth Motion: BMY inventory is up 0.63% at $56.58 ultimately examine Monday.
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