On October 11, 2022 IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines and Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, reported that the companies entered into an agreement pursuant to which Cabaletta obtained from IASO Bio an exclusive, worldwide license to develop, manufacture and commercialize a clinically validated fully-human CD19 binder for use in product that is designed to modify T cells in treatment of autoimmune diseases (Press release, IASO BioMed, OCT 11, 2022, View Source [SID1234621896]). IASO Bio is entitled to receive up to approximately $162 million in aggregate payments, including an upfront payment and potential development and sales milestone payments across up to two products, as well as royalties. IASO Bio has the right of first negotiation to develop and commercialize Cabaletta’s products using the licensed sequence in the Greater China region.
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Clinically, CD19-targeted chimeric antigen receptor (CAR)-T cell therapies have been shown to induce deep and durable B cell depletion resulting in efficacy in treating B-cell malignancies, supporting the promise of this transformative approach in patients with B cell-mediated autoimmune diseases. Existing approaches to address such diseases are often limited by either modest effects, leading to resistant and uncontrolled disease, or significant treatment-related morbidity and mortality.
"Our collaboration with IASO Bio allows Cabaletta to utilize a CD19 binder in CABA-201, our newly designed, CD19-targeting CAR T product candidate. The CD19 binder has been clinically evaluated with safety data that we believe support clinical development in patients with autoimmune diseases," said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. "We are excited to progress CABA-201 forward in our effort to develop therapies that deliver deep, durable and potentially curative responses for patients with autoimmune diseases."
"We are very pleased to enter a collaboration with Cabaletta," said Wen (Maxwell) Wang, M.D., Ph.D., CEO of IASO Bio. "The potential of our fully-human CD19 sequence generated by our own fully human antibody discovery platform to provide durable response and superior safety for cancer patients has been validated in clinical trials of our in-house developed fully human CD19/CD22 dual-targeted CAR T-cell therapy CT120 that has been evaluated in approximately 20 patients with promising tolerability data to date. CT120 has obtained two IND clearance for non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL) in China, and FDA Orphan Drug Designation (ODD) for ALL. The company retains the global rights of CT120 and is advancing its development in China. We are excited to help maximize the value of CD19 sequence with Cabaletta to potentially benefit patients with a broad range of autoimmune diseases."