Innovative Fully Human BCMA CAR-T Therapy IBI326 (CT103A) Demonstrates High Efficacy and Favorable Safety in Relapsed/Refractory Multiple Myeloma: Updated Phase I Results to Be Presented at EHA 2021

SAN FRANCISCO and SUZHOU, China, June 8, 2021 /PRNewswire/ -- Innovent Biologics (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for the treatment of major diseases such as cancer, metabolic diseases, and autoimmune diseases, and IASO Bio jointly announced that the latest results from the Phase I clinical study of IBI326 (Innovent development code: IB1326; IASO Bio development code: CT103A) for the treatment of relapsed/refractory multiple myeloma (R/R MM) will be presented in an oral session at the 2021 European Hematology Association (EHA) Virtual Congress. The presentation will further demonstrate the safety, efficacy, and long-term in vivo persistence of IBI326.

IBI326 is a fully human BCMA CAR-T cell therapy jointly developed by Innovent Bio and IASO Bio, and has now officially entered pivotal Phase II registration clinical trials. In February this year, IBI326 was granted "Breakthrough Therapy" designation by the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) for the indication of relapsed/refractory multiple myeloma.

Professor Li Chunrui from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology will deliver an oral presentation at the EHA Congress on clinical data from 35 subjects with relapsed/refractory multiple myeloma treated with IBI326 at dose cohorts of 1.0 × 10^6/kg, 3.0 × 10^6/kg, and 6.0 × 10^6/kg, respectively. Through exploration across the two phases of dose escalation and dose expansion, the 1.0 × 10^6/kg dose was determined asIIRecommended dose for the phase study. The median age of the 35 subjects was 54 (27–72) years. Among them, 8 subjects had extramedullary lesions, 1 had plasma cell leukemia, the median number of prior lines of therapy was 4 (3–12), 10 subjects had previously undergone autologous hematopoietic stem cell transplantation, and 10 had previously received non-humanized CAR-T therapy. As of May 1, 2021, the median follow-up time for the 35 subjects was 291 (21–954) days.

At the 61st American Society of Hematology (ASH) Annual Meeting held in 2019, Innovent Bio and IASO Bio jointly presented an oral report on clinical data from a study of their co-developed fully human BCMA CAR-T therapy for relapsed/refractory multiple myeloma (Abstract #582). The data demonstrated that IBI326 exhibits a favorable safety profile, excellent efficacy, and durable persistence. Notably, the study also enrolled four patients who had relapsed after prior murine BCMA CAR-T therapy, and the results indicate that IBI326 can provide an effective treatment option for patients who relapse following murine CAR-T therapy.

In June 2021, the preliminary results of a clinical study evaluating the efficacy and safety of IBI326 in the treatment of relapsed/refractory multiple myeloma were officially published in *Blood*, a top-tier academic journal in hematology: "A Phase 1 Study of a Novel Fully Human BCMA-targeting CAR (CT103A) in Patients with Relapsed/Refractory Multiple Myeloma". The study highlighted the unique advantage of IBI326's long-term in vivo persistence and the authors' exploration of the prospects for disease retreatment, which garnered significant attention from *Blood* and led to its selection as a featured clinical research article. Concurrently, it received a highlight commentary from an authoritative expert at the UCL Cancer Institute titled "BCMA CARs in multiple myeloma: room for more?" (DOI 10.1182/blood.2021010833).

Dr. Hui Zhou, Senior Vice President of Clinical Development at Innovent Bio, stated: “We are pleased to see that the outstanding clinical data for IBI326 (development code CT103A by IASO Bio) has received strong recognition at the European Hematology Association (EHA) Annual Congress. Notably, it continues to deliver substantial clinical benefits even for subjects who have previously failed non-human-derived CAR-T therapy, offering a superior treatment option for patients with relapsed/refractory multiple myeloma. We look forward to the early commercial launch of this cell therapy to benefit patients.”

Dr. Wen Wang, CEO of IASO Bio, stated: "I am very pleased to see our high-quality clinical data at a top international conference --Presented at the European Hematology Association (EHA) Annual Meeting, this marks the only oral presentation on a BCMA CAR-T therapy from China at this year’s EHA congress. The updated data further corroborate the efficacy and distinct clinical profile of CT103A in the treatment of relapsed/refractory multiple myeloma. Notably, the presented dataset included 8 patients with extramedullary lesions and 10 patients who had failed prior non-humanized CAR-T therapy, with all subjects demonstrating clinical benefit. The IASO Bio team will continue to leverage innovative clinical development strategies to further substantiate the advantages of CT103A. We also greatly anticipate Professor Li Chunrui’s oral presentation at this EHA congress from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.”

Report Details:

Abstract: S194 Study results of a novel fully human BCMA CAR-T cell therapy, CT103A, for the treatment of relapsed/refractory multiple myeloma
Format: Oral Presentation
Symposium Theme: T cell re-directing therapies in relapsed/refractory multiple myeloma

About Multiple Myeloma

Multiple myeloma (MM) is one of the most common hematologic malignancies, a malignant disease characterized by the abnormal clonal proliferation of plasma cells. For treatment-naïve patients with multiple myeloma, commonly used first-line therapeutic agents include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. For the majority of patients, standard first-line therapy can achieve disease stability for 3 to 5 years; however, a small subset of patients exhibits primary resistance upon initial treatment, resulting in inadequate disease control. Even among most newly diagnosed patients who respond to initial therapy, the disease will inevitably progress to a relapsed or refractory stage following the period of stability. Consequently, significant unmet clinical needs remain for patients with relapsed/refractory multiple myeloma.

About IBI326 (BCMA CAR-T)

IBI326 is an innovative product jointly developed by Innovent Bio and IASO Bio. This product utilizes a lentiviral vector to transduce autologous T cells. The CAR construct comprises a fully human scFv, a CD8α hinge and transmembrane domain, a 4-1BB costimulatory domain, and a CD3ζ activation domain. Following rigorous screening and comprehensive in vitro and in vivo functional evaluations, the IBI326 CAR-T product demonstrates potent and rapid efficacy with outstanding durability. In February 2021, IBI326 was granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) for the treatment of relapsed or refractory multiple myeloma.

# About Innovent Bio

“Rooted in Trust, Realized through Action.” Developing high-quality biologics that are affordable to patients is the vision and goal of Innovent Bio. Founded in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases, including oncology, autoimmune diseases, and metabolic disorders. On October 31, 2018, Innovent Biologics was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with the stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies through its innovative achievements and internationalized operational model. It has established a product pipeline comprising 24 new drug candidates, covering multiple therapeutic areas such as oncology, metabolic diseases, and autoimmune diseases, among which six have been selected for the national "Major New Drug Development" special program. The company currently has four products (Sintilimab Injection, trade name: Daboshu^®, English Trademark: TYVYT^®; bevacizumab biosimilar, trade name: Byvasda^®, English Trademark: BYVASDA^®; Adalimumab biosimilar, brand name: Sulixin^®, English trademark: SULINNO^®; Rituximab biosimilar, brand name: Byvasda^®, English trademark: HALPRYZA^®) approved for marketing by the NMPA, among which the U.S. marketing application for sintilimab has been accepted by the FDA. Six products have entered Phase III or pivotal clinical trials, and an additional 14 products have entered clinical trials. Sintilimab was successfully included in the National Reimbursement Drug List in November 2019, becoming the first PD-1 inhibitor in China, and the only one that year, to be included in the national medical insurance catalog.

Innovent Bio has assembled a high-caliber talent team for biologics development and industrialization at an internationally advanced level, comprising numerous experts with overseas backgrounds, and has established strategic partnerships with international collaborators such as Eli Lilly (US), Adimab, Incyte, MD Anderson Cancer Center, and Hanmi (South Korea). Innovent Bio aims to work alongside all stakeholders to elevate China's biopharmaceutical industry, thereby improving drug accessibility for the public and fulfilling people's aspirations for health and well-being. For more details, please visit the company website:www.innoventbio.com。

About IASO Bio

IASO Bio is an innovative biopharmaceutical company focused on the development and commercialization of cell therapies and antibody drugs. Founded in 2017, the company has assembled an international management team with extensive experience in new drug R&D, clinical research, and commercialization. With the development of cell therapies and antibody drugs for hematologic malignancies as the cornerstone of its innovation, IASO Bio is expanding into solid tumors and autoimmune diseases. The company possesses comprehensive end-to-end platform capabilities spanning early discovery, regulatory submission, clinical development, and commercial manufacturing, supported by five major technology platforms: a fully human antibody discovery platform, a high-throughput CAR-T optimization platform, a universal CAR technology platform, a manufacturing technology platform, and a clinical translational research platform. Currently, 10 pipeline candidates are under development at various stages. The most advanced product, CT103A (a fully human BCMA CAR autologous T-cell injection), has reached the late-stage clinical development phase and was granted “Breakthrough Therapy” designation by the Center for Drug Evaluation (CDE) in February 2021.

Driven by a management team with strong execution capabilities, an extensive product pipeline, and distinctive innovative R&D and business models, IASO Bio aspires to become the most influential innovative pharmaceutical company in the industry. We are committed to advancing innovative drugs that truly address unmet clinical needs and possess strong market competitiveness from clinical development through to commercialization, opening new therapeutic pathways for patients and bringing new hope. For more details, please visit the company website:www.iasobio.com。

Forward-Looking Statements

The information contained in this announcement may include certain forward-looking statements. These statements are inherently subject to significant risks and uncertainties. Statements containing words such as "anticipate," "believe," "predict," "expect," "intend," and other similar terms that relate to the Company constitute forward-looking statements. The Company assumes no obligation to continuously update these forward-looking statements.

These forward-looking statements are based on the current views, assumptions, expectations, estimates, forecasts, and understanding of the Company's management regarding future events at the time such statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond the Company's control and difficult to predict. Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal, and social conditions, actual results may differ materially from the information contained in these forward-looking statements.

The Company, its directors, and its employees and agents shall not assume (a) any obligation to correct or update the forward-looking statements contained on this website; and (b) any liability arising from any forward-looking statements failing to materialize or becoming inaccurate.