Sana Biotechnology, IASO Bio, and Innovent Announce Strategic Collaboration and Non-Exclusive License for Clinically Validated BCMA CAR

January 11 - Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cell medicines, IASO Bio, a clinical-stage biopharmaceutical company engaged in the discovery, development, and manufacturing of innovative drugs, and Innovent Bio (HKEX: 01801, hereinafter referred to as "Innovent"), a biopharmaceutical company dedicated to the research, production, and commercialization of innovative drugs for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, jointly announced today that IASO Bio and Innovent have granted Sana non-exclusive commercial rights to their clinically validated fully human BCMA CAR construct for use in Sana's specific in vivo gene therapy and ex vivo hypoimmune cell therapy product development. IASO Bio and Innovent will receive an upfront payment from Sana and are eligible to receive potential development, regulatory milestone payments, and sales royalties totaling approximately $204 million across up to six products.

In the treatment of relapsed/refractory multiple myeloma, B-cell maturation antigen (BCMA) has been confirmed as a specific target for autologous CAR T therapy. The BCMA CAR granted to Sana Biotechnology is a key component of an autologous CAR T-cell therapy product targeting BCMA (developed by IASO Bio under the research code CT103A and by Innovent Bio under the research code IBI326). This product has demonstrated favorable clinical safety and efficacy data in China. At the recent 63rd American Society of Hematology Annual Meeting, IASO Bio and Innovent Bio jointly presented updated Phase 1/2 clinical data. The results showed that CT103A achieved an excellent overall response rate (ORR) of 94.9%, a minimal residual disease (MRD)-negative rate of 93.7%, and a complete response/stringent complete response (CR/sCR) rate of 58.2% among 79 patients with relapsed/refractory multiple myeloma. CT103A also demonstrated promising therapeutic effects in patients previously treated with BCMA CAR-T therapy, with an ORR of 76.9% among 13 subjects who had prior CAR-T treatment, 61.5% achieving very good partial response (VGPR) or better, and a CR/sCR rate of 46.2%. In February 2021, CT103A received "Breakthrough Therapy Designation" from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory multiple myeloma.

"We are delighted to collaborate with Sana. The efficacy and safety of this molecule in treating patients with relapsed/refractory multiple myeloma have been validated in the clinical trials of our fully human BCMA CAR-T co-developed with Innovent," said Dr. Wen Wang, CEO and Chief Medical Officer of IASO Bio: "We look forward to the greater potential value of CT103A being reflected in the development and commercialization of Sana's innovative products, benefiting more patients. Meanwhile, IASO Bio and Innovent will gain priority access to Sana’s next-generation cell and gene therapy products in Greater China, which is of great significance for IASO Bio to strengthen its pipeline." "Innovent is pleased that the BCMA CAR structure co-developed and clinically validated with IASO Bio has gained recognition from Sana," said Dr. Wei Xu, Vice President and Head of Cell Therapy R&D at Innovent Bio: "This licensing collaboration allows Sana to build on this foundation and develop next-generation cell therapy products using their proprietary patented technology, benefiting more patients with relapsed/refractory multiple myeloma worldwide. Innovent and IASO Bio also look forward to further cooperation with Sana in China to address more complex diseases." Dr. Terry Fry, Head of T-cell Therapies at Sana Biotechnology, stated: "We are committed to meeting patient needs, and we aim to advance multiple myeloma programs into clinical stages as early as next year. We are very pleased to obtain the clinically validated fully human BCMA CAR structure from IASO Bio and Innovent. We believe that this agreement will enable Sana to leverage its fusogen platform to significantly advance the development of our allogeneic BCMA-targeted CAR-T candidate and our in vivo CAR-T candidate." About CT103A/IBI326 (BCMA CAR-T)CT103A is an innovative product jointly developed by IASO Bio and Innovent Bio. This product uses lentivirus as a gene vector to transfect autologous T cells, and the CAR comprises a fully human scFv, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory domain, and CD3ζ activation domain. Based on rigorous screening and comprehensive in vitro and in vivo functional evaluations, CT103A has demonstrated superior efficacy data in China. In February 2021, CT103A received the "Breakthrough Therapy Designation" from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory multiple myeloma. In addition to multiple myeloma, IASO Bio is also investigating the application of CT103A in patients with autoimmune diseases.

About IASO Bio

IASO Bio is an innovative biopharmaceutical company dedicated to the development and commercialization of cell therapies and antibody drugs. With a focus on developing hematological tumor cell-based drugs and antibody therapeutics as its foundation for innovation, the company is expanding into solid tumors and autoimmune diseases. It possesses comprehensive, full-process platform capabilities from early discovery, regulatory submission, clinical development, to commercial production. These include multiple technology platforms such as a fully human antibody discovery platform, a high-throughput CAR-T drug optimization platform, a universal CAR technology platform, a manufacturing technology platform, and a clinical translational research platform. Currently, the company has 10 pipeline products at various stages of development. The most advanced product, CT103A (a fully human BCMA chimeric antigen receptor autologous T-cell injection), is in the late stage of clinical development and was granted "Breakthrough Therapy Designation" by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in February 2021. Another self-developed innovative product, CT120 (a fully human CD19/CD22 dual-target CAR-T cell injection), has entered clinical trials for indications including relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B lymphoblastic leukemia (B-ALL), and has been awarded FDA Orphan Drug Designation (ODD). Backed by a highly efficient management team, a robust product pipeline, and unique R&D and business models, IASO Bio aspires to become an influential innovator in the industry. The company aims to advance truly impactful, market-competitive innovative drugs from clinical trials to market availability, opening new therapeutic avenues and offering renewed hope to patients. For more information, please visit the company's website: www.iasobio.com or LinkedIn page: IASO Biotherapeutics (驯鹿医疗).

About Innovent Bio

"Start with trust, achieve through action." Developing high-quality biopharmaceuticals that are affordable for the general public is the ideal and goal of Innovent Bio. Founded in 2011, INNOVENT BIOLOGICS(SUZHOU)CO LTD is committed to the development, production, and commercialization of innovative drugs for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic diseases. On October 31, 2018, Innovent Bio was listed on the Main Board of the Hong Kong Stock Exchange under the stock code: 01801. Since its establishment, the company has distinguished itself among numerous biopharmaceutical companies through its innovative achievements and international operational model. It has built a product pipeline comprising 26 novel drug candidates, covering multiple disease areas including oncology, metabolic diseases, and autoimmune conditions. The company has received approval in China for six products (Sintilimab Injection, trade name: TYVYT®; Bevacizumab biosimilar, trade name: BYVASDA®; Adalimumab biosimilar, trade name: SULINNO®; Rituximab biosimilar, trade name: HALPRYZA®; Pemigatinib oral inhibitor, trade name: PEMAZYRE®; Olverembatinib tablets, trade name: CYCLOP®). The FDA has accepted the U.S. marketing application for Sintilimab. Five other drug candidates have entered Phase III or pivotal clinical trials, and an additional 15 products have entered clinical studies. Innovent Bio has assembled a top-tier team of experts in biopharmaceutical development and commercialization, including many returned overseas experts, and has established strategic partnerships with international collaborators such as Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical Co., Ltd. Innovent Bio hopes to work together with everyone to enhance the development level of China's biopharmaceutical industry to meet the public's accessibility to medicines and their aspirations for better health and quality of life. For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn page: www.linkedin.com/company/innovent-biologics/.

About Sana Biotechnology

Sana Biotechnology Focuses on Creating and Delivering Engineered Cell Medicines for PatientsSana Biotechnology is dedicated to repairing and controlling genes, replacing missing or damaged cells, and developing treatments that benefit a wide range of patients. The company has over 350 employees committed to serving patients long-term and transforming the way the world treats diseases. Sana currently has offices in Seattle, Cambridge, and South San Francisco. For more information about Sana Biotechnology, please visit sana.com/.