Clade is combining this expertise with its proprietary immune “cloaking” of human iPSCs and their adult derivatives, novel universal targeting, and cellular enhancements to enable the development of true “off-the-shelf” cell therapies. Clade has unparalleled expertise in generating adult human T cells, Treg cells and B cells derived from induced pluripotent stem cells (iPSCs). Our pipeline of novel, distinctive g/d TCRs has the potential to make a significant impact to the lives of patients with solid tumors, and this strategic transaction with Clade Therapeutics represents a major step towards bringing our novel g/d TCRs to the clinic in an off-the-shelf platform.”Ĭlade Therapeutics’ mission is to discover and deliver next generation cell medicines to improve the lives of patients in need.Ĭlade Therapeutics is shifting the paradigm of cell medicine by establishing a robust cellular platform with stem-cell derived immune cells for treatment of cancer and autoimmune diseases. Marcel Zwaal, Chief Executive Officer of Gadeta said, “Today, we are pleased to announce a significant milestone in the journey of Gadeta. This acquisition reaffirms our belief that Clade’s engineerable platform provides the right ‘chassis’ for integrating compelling innovations coming out of the autologous cell therapy ecosystem.” Clade’s pipeline programs are focused on replicating the benefits of the autologous cell therapy products, while addressing their profound limitations – inconsistent quality, challenging patient logistics, and lack of scalability. Jim Glasheen, Ph.D., President and Chief Business Offer of Clade Therapeutics added, “Gadeta has generated compelling in-vitro and in-vivo data over the last few years with its lead gamma/delta (g/d) TCRs in solid tumor indications and we’re excited to integrate this novel targeting into Clade’s solid tumor programs. This integration seamlessly complements Clade’s existing platform and commitment to developing engineerable, off-the-shelf, scalable, and consistent cell medicines.” The acquisition of Gadeta represents a strategic move to integrate a third element to our platform: ‘Universal Targeting’. “Our technology platform consists of both a ‘Cell Foundry’ that enables the generation of adult immune cells including both CD8+ and CD4+ T Cells, as well as a ‘Cloaking Engine’ that ensures best-in-class and tuned protection from both the cellular and humoral wings of a host’s immune system. “Clade is at the forefront of broadening the impact of cell therapy by establishing a more robust cellular platform with stem-cell derived immune cells,” said Chad Cowan, Ph.D., Chief Executive Officer of Clade Therapeutics. Gadeta shareholders will receive upfront and downstream economics. Under the terms of the acquisition agreement, Clade has acquired all outstanding shares of Gadeta, making it a wholly owned subsidiary of Clade. The integration of Gadeta’s g/d TCR targeting technology is complementary to Clade’s cellular platform technology and will enhance the development of engineerable, off-the-shelf, scalable, and consistent stem-cell based medicines. Neumann said Tecartus’ safety profile here was comparable to prior experience and the side effects were mostly manageable and acceptable for this heavily pretreated patient population.The acquisition will provide Clade with preclinical cell therapy programs, g/d TCR discovery engine and a suite of cell enhancement to improve anti-tumor activity of cell therapies. Two patients’ deaths were linked to the treatment, including one brain herniation and one septic shock. In ZUMA-3, 24% of patients experienced immune overreaction at grade 3 or above and 25% had neurologic events at those levels. The current data were calculated after a median follow-up of 16.4 months.ĬAR-T therapies are known to come with the dangerous side effect of cytokine release syndrome, and Tecartus is no exception. Patients still need to be followed longer to produce long-term response data, he noted during an interview ahead of the presentation. Among 25 ZUMA-3 patients who had previously received Blincyto, the complete remission rate for Tecartus stood at 60%.įrank Neumann, M.D., Ph.D., Kite’s newly-minted global head of clinical development, labeled the showing as “outstanding” for the ALL field. Previous research has linked prior use of Amgen’s CD3-CD19 bispecific T-cell engager Blincyto to a reduced response to a CD19-directed CAR-T. RELATED: Gilead's Kite bags second CAR-T okay with Tecartus nod in mantle cell lymphoma Tecartus achieved the results in a heavily pretreated population 47% of patients had previously tried but failed at least three other therapies before the CAR-T. An approval would expand the use of Tecartus from its current label in relapsed or refractory mantle cell lymphoma. With that data, the FDA has put Kite’s filing for Tecartus in ALL under priority review, with a target decision date set for October 1.

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