A recent announcement by Intellia Therapeutics and Kyverna Therapeutics showcased very promising research into a Car-T therapy focused on autoimmune disorders. The exclusive agreement between the two companies to both develop and then later commercialize a carefully-developed allogeneic CD19 chimeric Antigen Receptor (CAR) T-cell therapy which is aimed at treating a number of B cell-mediated autoimmune diseases. The partnership is focused on licensing and collaboration, with Kyverna being given access to the proprietary ex vivo CRISPR/Cas9-based allogeneic platform developed by Intellia so that the team can create KYV-201, which is a next-generation Car-T CD19 investigational option.
With the exclusive global license to its novel anti-CD19 clinical-stage Car-T construct, it can develop both tautologous and allogeneic Car-T therapy treatments. This allows them to combine fully-human anti-CD19 Car-T therapy with costimulatory domains. This improves clinical tolerability while reducing cytokine release to improve outcomes. With the partnership with Intellia, Kyverna will be able to create further development in this construct using an allergenic setting, so that specific autoimmune diseases can be targeted.
To balance the partnership, Intellia will be able to gain equity interest in Kyverna, in addition to the financial investment that they make. Intellia may also gain future payments as particular developmental and commercialization milestones are reached. If Intellia decides to co-develop and -commercialize the KYV-201 end product within the U.S., the company will need to pay an opt-in fee as well as split the total development expenses and sales revenues within the country by 50%.
It’s expected that Kyverna will be funding and leading both the preclinical and clinical studies for KYV-201 while retaining all rights outside the United States, while Intellia will also receive low- to mid-single-digit royalties across the entire scope of the project, with the company receiving licensing for KYV-201 from the quasi-public National Institutes of Health.
“We have been planning from the start for autologous and allogeneic applications of the differentiated CD19 CAR we licensed from the NIH, and the collaboration with Intellia will enable us to move forward with our plans for KYV-201, our allogeneic program,” Kyverna President and CEO Dominic Borie, MD, Ph.D. mentioned in a recent Biospace interview.
“Both programs will be resourced appropriately and we are preparing to enter the clinic in the first half of 2022 with our autologous fully human CD19 CAR, KYV-101. We’ve worked hard to get to this point, and are excited about what the future holds as we work to bring transformative therapies to autoimmune patients,” Borie continued, summarizing the end goals of the partnership.
Currently, Intellia’s ex vivo programs are using CRISPR technology to create genetic therapies by using genetically-engineered human cells to treat cancers as well as a range of different autoimmune diseases. By using intravenously-administered CRISPR as a Car-T therapy, the company’s in vivo programs are able to perform extremely precise editing of genes that are causing disease in very specifically-targeted tissue locations. It’s expected that this partnership between Kyverna and Intellia will help the medical community to more rapidly develop more effective, safer and accessible therapies for a wide range of diseases.