Allogeneic CAR T Produces Durable Responses in Kidney Cancer
An off-the-shelf CAR T-cell therapy has produced durable responses in a Phase 1 study involving patients with advanced renal cell carcinoma.
ALLO-316 is an allogeneic CAR T therapy designed to target CD70, which is expressed at high levels in some renal cell carcinomas. In the Phase 1b portion of the TRAVERSE study, 20 patients received the therapy after standard lymphodepletion. All had disease resistant to immune checkpoint inhibitors and at least one tyrosine kinase inhibitor.
The confirmed response rate was 25 percent across the treated Phase 1b group and 31 percent among the 16 patients whose tumors had high CD70 expression. Responses lasted between eight and more than 18 months, and all responding patients remained progression-free at the time of analysis.
ALLO-316 incorporates Allogene Therapeutics’ Dagger technology, which is designed to reduce rejection by targeting CD70-positive host T cells as well as tumor cells. The therapy showed expansion, persistence, and evidence of tumor infiltration following standard lymphodepletion. Source
FDA Clears CD22-Directed In Vivo CAR T Trial
The FDA has cleared Umoja Biopharma’s investigational new drug application for UB-VV400, allowing the company to begin a US Phase 1/2 study of its CD22-directed in vivo CAR T-cell therapy.
UB-VV400 uses Umoja’s VivoVec lentiviral delivery platform to generate CAR T cells inside the patient rather than through ex vivo collection and manufacturing. The candidate is being developed for adults with relapsed or refractory B-cell malignancies, including patients whose disease has progressed after a previous CAR T therapy.
The open-label VIBRANT-1 study will evaluate UB-VV400 in combination with rapamycin, assessing safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The first patient is expected to be treated in the third quarter of 2026.
Umoja is also evaluating the candidate in an investigator-initiated study in China, with initial clinical data expected later this year. Source
In Vivo CAR T Enters Autoimmune Disease Trial
Tempest Therapeutics and Hebei Senlang Biotechnology are preparing a first-in-human study of an in vivo CAR T-cell therapy designed to reset the B-cell compartment in neurological autoimmune diseases.
TPST-4003 uses CD7-targeted lipid nanoparticles to deliver mRNA encoding a dual-target CD19/BCMA CAR. The approach is intended to generate CAR-expressing T and natural killer cells inside the body and eliminate a broader range of B-cell populations than CD19 targeting alone.
Senlang will conduct an investigator-initiated study in China involving approximately 10 patients with myasthenia gravis or multiple sclerosis. The trial will assess safety, CAR-positive immune-cell generation, cellular kinetics, and the depth and duration of B-cell depletion. First dosing is expected in the fourth quarter of 2026.
The agreement also gives Senlang an exclusive option to negotiate a license for TPST-4003 in China. Source
Repligen to Acquire BioLife Solutions for $1.5 Billion
Repligen has agreed to acquire BioLife Solutions in a cash-and-stock transaction valued at approximately $1.5 billion, expanding its presence in cell therapy manufacturing.
BioLife supplies biopreservation media and other cell-processing products used to maintain biological materials during collection, storage, and distribution. Its CryoStor media are used in 18 approved therapies and in many commercially sponsored cell therapy trials in the US.
Under the agreement, BioLife shareholders will receive $11.25 in cash and 0.1442 Repligen shares for each BioLife share. The transaction is expected to close in the fourth quarter of 2026, subject to regulatory and shareholder approvals.
Repligen said the acquisition would add a recurring consumables business to its existing portfolio of filtration, fluid-management, chromatography, and process-analytics technologies. Source
United Therapeutics Acquires Thymmune
United Therapeutics has acquired Thymmune Therapeutics for $140 million upfront, with former shareholders eligible for up to a further $160 million tied to clinical and regulatory milestones.
Thymmune is developing regenerative thymic cell therapies derived from induced pluripotent stem cells. Its lead preclinical candidate, THY-100, is intended to create a functional neo-thymus inside the body and restore T-cell development in infants with congenital athymia.
United Therapeutics plans to explore the platform’s wider potential in transplant tolerance, autoimmune disease, and other conditions associated with impaired immune function. The acquisition also complements the company’s organ-manufacturing and immunomodulation programs. Source
Zemcelpro Early Access Expands to Three Markets
Cordex Biologics has granted FarmaMondo distribution rights for Zemcelpro in Argentina, Hong Kong, and Singapore.
Zemcelpro is a cord blood-derived hematopoietic stem cell transplantation product containing UM171-expanded CD34-positive cells and unexpanded CD34-negative cells from the same cord blood unit. It holds conditional European authorization for adults with hematological malignancies who require an allogeneic transplant but lack a suitable donor.
FarmaMondo will support access through the relevant early access pathways in the three territories. Cordex is also pursuing regulatory filings in the US, Canada, UK, and Switzerland. Source
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