EMA recommended use of Breyanzi CAR-T therapy in patients with DLBCL

Treatment with Breyanzi will be restricted to patients whose cancer has come back or who have not responded to two or more lines of systemic therapy. The EMA pointed to clinical trial data showing around 50% to 60% of patients achieve a long-term response and will be cured of the disease with standard of care. However, treating relapsed or refractory patients remains a challenge and requires alternative options. Breyanzi was reviewed as an advanced therapy medicinal product (ATMP) and the European regulators considered the benefits as well as potentially severe side effects. The therapy can cause cytokine release syndrome, a systemic response to the activation and proliferation of the CAR T cells, causing high fever and flu-like symptoms, infections and encephalopathy. Breyanzi was originally developed by Celgene and its Juno Therapeutics cell therapy unit before the merger with New York-based BMS in late 2019. FDA approved Breyanzi early last year in LBCL, an indication tackled by rival CD19-targeting CAR T therapies from Gilead’s Kite unit and Novartis.

DEALS AND FINANCING

CAR-T developer Arcellx is aiming for NASDAQ listing

Clinical-stage CAR-T developer Arcellx is hoping to test the public markets with a NASDAQ listing, according to a new regulatory filing. Backed by a syndicate including New Enterprise Associates, S.R. One and Novo Holdings A/S, the biotech reported in December a 100% overall response rate among 19 patients in a Phase 1 trial of its CART-ddBCMA product to treat multiple myeloma. BofA Securities, SVB Leerink, Barclays and William Blair are underwriters.
Carisma inks deal with Moderna on CAR-M for oncology
A multiyear deal with Carisma Therapeutics announced brings the mRNA and LNP technologies of Moderna into a less explored corner of the immune cell therapy space: in vivo-engineered CAR monocytes. In November, Carisma presented the first clinical evidence that a CAR macrophage may drive changes in the tumor microenvironment, though it remains unclear whether the modality can compete with CAR T cells. Moderna will provide research funding to support preclinical development by the partner and will assume responsibility for clinical development and commercialization of any products resulting from the collaborations. Moderna will pay Carisma $45 million cash up front and invest in a $35 million convertible note for the option to nominate up to 12 targets for development and commercialization. Carisma is eligible to receive undisclosed development, regulatory, and commercial milestone payments, plus royalties on net sales.

Kyverna’s autoimmune cell therapies get lift from $85 million series B

Kyverna Therapeutics’  Northpond Ventures-led $85 million series B round will fund a Phase 2 study of the company’s autologous anti-CD19 CAR T cell therapy, which is optimized for B cell-driven autoimmune diseases such as lupus nephritis, systemic sclerosis, and inflammatory myopathies. The funds will also support development of an allogeneic version of the therapy, KYV-201, and the company's preclinical synthetic Treg platform. Kyverna gained access to the autoimmunity-optimized CD19 CAR construct and allogeneic gene editing technology behind its two lead programs via a pair of deals announced this month. The CAR construct from NIH aims to lower the risk of neurotoxicity, while the Intellia Therapeutics gene editing partnership takes the technology off the shelf. Founding investors Westlake Village BioPartners, Vida Ventures and Gilead Sciences, and new investors RTW Investments, CAM Capital, Insight Partners, HealthCor, LYFE Capital, Intellia, Argentum Peak, Hudson Bay Capital, and jVen Capital participated in the round.