Vittoria’s CAR-T therapy secures clinical approval amid FDA scrutiny on sector

Vittoria Biotherapeutics will begin in-human studies of its lead chimeric antigen receptor (CAR)-T cell therapy candidate, VIPER-101, for relapsed or refractory (r/r) T cell lymphoma following investigational new drug (IND) clearance by the US Food and Drug Administration (FDA).

VIPER-101 is an autologous CD5-deleted CAR-T cell therapy designed to prevent T cells from killing each other—a limitation of existing cell therapies—while overcoming the inhibitory CD5 signalling pathway in T cells, thereby promoting the body’s antitumor response. The drug was produced using Senza5, the company’s proprietary cell therapy platform, which, as per Vittoria, improves the efficacy and safety of engineered T-cell therapies.

The University of Pennsylvania spinout is targeting a Phase I study commencement date in H1 2024 and is looking to share data in early 2025.

The IND authorisation comes at a time of caution and scrutiny for CAR-T cell immunotherapies. Last month, the FDA opened an investigation to evaluate the safety of these cell therapies after receiving reports of T cell malignancies in patients treated with BCMA-directed or CD19-directed autologous CAR-T cell immunotherapies.

Bristol Myers Squibb (BMS), Janssen, Novartis and Gilead Sciences all currently have approved therapies in this class, with the pharmaceutical giants continually looking to expand their labels.

During the review, the FDA continues to assess the approvability of CAR-T therapies. Two weeks ago before initiating the investigation, the FDA informed BMS and 2seventy bio that the agency delayed action for Abecma (idecabtagene vicleucel), a BCMA-directed fifth-line therapy FDA-approved for r/r multiple myeloma. The agency will not meet the agreed 16 December Prescription Drug User Fee Act (PDUFA) date assessing the drug in earlier lines of triple-class exposed r/r multiple myeloma. The reason for the delay was not mentioned in the announcement.

BMS was, however, awarded priority review for Breyanzi (lisocabtagene maraleucel), an approved second-line CD19-directed CAR-T for r/r large B-cell lymphoma (LBCL). The company is targeting a new indication in r/r chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and has a 14 March 2024 PDUFA date.

In August, the FDA hit Novartis, another CAR-T leader, with a letter outlining “additional significant deviations” in the manufacturing of Kymriah (tisagenlecleucel), the first FDA-approved CAR-T cell therapy. Following an initial inspection in late 2022, the FDA identified that Novartis had failed to establish appropriate procedures to ensure that cryobag containers were free of particulate matter, as required by the acceptance criteria. The FDA went on to highlight issues with subsequent responses by Novartis and requested the company to submit additional responses. GlobalData predicts that Kymriah will bring in $542m in 2023.

GlobalData is the parent company of Pharmaceutical Technology.

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