Gilead gives Arcellx $285 million to extend agreement for BCMA cell treatment

Gilead Sciences subsidiary, Kite Pharma, is allocating $285 million towards advancing its pursuit of BCMA through a strategic collaboration with Arcellx. In exchange for this substantial investment, $200 million of which will be directly infused into Arcellx, Kite gains exclusive rights to an early-phase BCMA CAR-T candidate. This agreement also marks an expansion of their existing mid-phase cell therapy collaboration, now encompassing lymphomas.

Earlier this year, Kite had initially invested $225 million in a partnership with Arcellx to co-develop the BCMA-directed CAR-T drug candidate CART-ddBCMA. This deal, inclusive of up to $335 million in clinical milestones and triple that in regulatory and commercial achievements, granted Kite the option to negotiate licensing agreements for additional autologous CAR-T cell candidates—a provision that Kite has now exercised.

Under the expanded collaboration, Gilead’s cell therapy arm secures rights to ACLX-001, an early-phase BCMA-targeted CAR-T cell therapy designed by Arcellx. This therapy allows physicians to manipulate its activity in vivo through the administration of soluble protein adapters, offering a unique approach to activation, silencing, and reprogramming.

Arcellx’s innovative ARC-SparX platform, utilized in ACLX-001, ensures T cells are directed to the target only when the protein binds to the receptor. This mechanism provides physicians with the ability to modulate T cell efficacy by adjusting the protein dose and redirecting cells to alternative targets, potentially addressing challenges in controlling CAR-T cell therapies.

The differentiation of ACLX-001 from the more advanced CART-ddBCMA is notable. The FDA had briefly placed a phase 2 clinical trial of CART-ddBCMA on partial hold earlier in the year following a patient death, though Arcellx resolved the situation by August. Despite this incident, Kite remains committed to the asset, having exercised its option on ACLX-001

Entering a competitive landscape, Arcellx faces a market with several BCMA-directed drugs already available for multiple myeloma. Pfizer’s Elrexfio and Johnson & Johnson’s Tecvayli, both bispecific antibodies engaging T cells to target BCMA-expressing cancer cells, received FDA approval in August.

The $200 million investment by Kite in Arcellx secures Gilead a 13% stake in the company. A standstill agreement prevents Gilead from acquiring beneficial ownership beyond a specified percentage. This infusion is anticipated to extend Arcellx’s cash runway into 2027. Additionally, Kite is making an $85 million payment to Arcellx, with potential milestone payments in the future. Cindy Perettie, Executive Vice President of Kite, emphasized the strategic significance of deepening the partnership to advance multiple myeloma and explore opportunities in lymphoma.

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