C-CAR088

ROCKVILLE, Md., May 2, 2023 /PRNewswire/ -- Cellular Biomedicine Group Inc. (CBMG or the Company), a clinical-stage biopharmaceutical company focused on discovery and development of innovative cellular therapies for cancer and autoimmune diseases, today announced that the Company has entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen) for C-CAR039, an anti-CD19 & CD20 bi-specific chimeric antigen receptor T-cell (CAR-T) therapy, and C-CAR066, an anti-CD20 CAR-T, which have been studied for the treatment of Non-Hodgkin Lymphoma (NHL). Continue Reading The U.S. Food and Drug Administration (FDA) has granted C-CAR039 Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed/refractory Diffuse Large B-cell Lymphoma (r/r DLBCL). Furthermore, C-CAR039 has also received Orphan Drug designation from the FDA for the treatment of Follicular lymphoma (FL). Both C-CAR039 and C-CAR066 have received FDA Investigational New Drug application clearance. "We feel privileged to work with Janssen to advance the promise of our innovative medicines." Tweet this Under the terms of the agreement, Janssen will receive an exclusive license to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China, and the parties will negotiate an option for Janssen to develop the China territory subject to certain deadlines before the Company files the Biologics License Application (BLA) application in China. CBMG will transfer IND and studies for C-CAR039 (NCT05421663) and C-CAR066 (NCT05784441) to Janssen and will supply the initial clinical trial materials comprised of viral vector and plasmid, as well as assist Janssen on the technology transfer. CBMG will receive a $245 million upfront payment and milestone payments upon certain clinical development, regulatory filing, commercialization and sales achievements. After commercialization CBMG will also receive royalties on Janssen net sales. The transaction is subject to customary closing conditions and antitrust clearance. "We are very excited to announce the C-CAR039 and C-CAR066 CAR-T collaboration and license agreement with Janssen to develop and commercialize our novel CAR-T therapies," said Tony (Bizuo) Liu, Chairman and CEO of CBMG. "The updated clinical data for both C-CAR039 and C-CAR066 continue to support the view that both CAR-T assets have the potential to be best in disease and best in class in r/r NHL to address significant unmet medical needs globally. We are thrilled that through this collaboration we will be able to expand the potential of these promising NHL drug candidates in the hope of helping patients worldwide. We feel privileged to work with Janssen to advance the promise of our innovative medicines." About Non-Hodgins's lymphoma Non-Hodgins's lymphoma is the most common hematological malignancy worldwide. NHL ranked as the 5th to 9th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.1 Diffuse large B-cell lymphoma is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.2,3 About CBMG Cellular Biomedicine Group Inc. (CBMG) develops proprietary cell therapies for the treatment of cancerous and autoimmune diseases. CBMG operates state-of-the-art research and GMP facility in Rockville Maryland and partners with its affiliate in Shanghai to augment its global research and development capabilities. CBMG and its affiliate conduct multiple clinical studies comprised of C-CAR039 Phase 1b trial, C-CAR066 targeting treatment for r/r NHL, C-CAR088, an autologous anti-B cell maturation antigen (BCMA) CAR-T for r/r Myeloma (MM), C-CAR031, an autologous armored anti-GPC3 CAR-T for Hepatocellular carcinoma (HCC), C-TIL051, an autologous tumor-infiltrating lymphocytes (TIL) therapy for non-small cell lung cancer (NSCLC); and continue to discover and develop multiple novel T cell therapies for solid tumor and for orphan autoimmune diseases. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, CBMG does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. References Mafra A, Laversanne M, Gospodarowicz M, Klinger P, De Paula Silva N, Piñeros M, Steliarova-Foucher E, Bray F, Znaor A. Global patterns of non-Hodgkin lymphoma in 2020. Int J Cancer. 2022 Nov 1;151(9):1474-1481. doi: 10.1002/ijc.34163. Epub 2022 Jul 2. PMID: 35695282. Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808. Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70. Company Contact: Sarah Kelly Communications & Investor Relations CBMG Phone: +1 240-616-4899 Email: sarah.kelly@cellbiomedgroup.com SOURCE Cellular Biomedicine Group

Promising anti-tumor activity reported for C-CAR031, a novel Glypican 3 (GPC3)-targeting cell therapy designed by AstraZeneca SHANGHAI, April 17, 2023 /PRNewswire/ -- Shanghai Cellular Biopharmaceutical Group Ltd. (the Company, or Shanghai Cellular Bio), a company engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today presented data from the First-in-Human (FIH) Phase I trial evaluating C-CAR031 at the 2023 American Association for Cancer Research (AACR) Annual Meeting. Continue Reading Early results indicate that C-CAR031 is well tolerated with promising anti-tumor activity seen and objective responses in several patients to date, including 3 patients with confirmed partial responses, 2 with stable disease and 1 with progressive disease per both RECIST v1.1 and mRECIST criteria. The clinical responses of the patients who achieved partial responses are ongoing up to the data cutoff date. Early results indicate that C-CAR031 is well tolerated with promising anti-tumor activity Tweet this C-CAR031 is an autologous GPC3-directed second generation armored CAR-T with affinity-tuned single-chain variable fragment (scFv) to enhance its safety profile, based on a novel cell therapy designed by AstraZeneca (LSE/STO/Nasdaq:AZN) using their TGFβRII dominant negative armoring discovery platform. To investigate the feasibility, safety and initial efficacy of C-CAR301 in hepatocellular carcinoma (HCC), Shanghai Cellular Bio is currently conducting a Phase I FIH clinical study (NCT05155189) in advanced HCC in The First Affiliated Hospital, Zhejiang University School of Medicine in Hangzhou, China. Methods: This FIH, open-label dose escalation trial employs an accelerated dose titration plus i3+3 design. Histologically confirmed GPC3+ advanced HCC patients (pts) who failed systemic treatments received a single-dose i.v. infusion of C-CAR031 following standard lymphodepletion. The primary objective was to assess the safety and tolerability. Adverse events (AEs) were graded using CTCAE 5.0, and cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria. Results: As of March 2nd, 2023, seven patients received two dose levels (DL1, n=1; DL2, n=6) of C-CAR031. The median number of prior lines of therapies was 4 (range 1-6). The median follow-up was 77 (67-213) days. Seven patients with ≥28 days' follow-up were eligible for safety evaluation. Good safety profile was observed at explored dose levels. 86% (6/7) patients experienced Gr1/2 CRS; no Dose Limiting Toxicities (DLT) or ICANS was observed. The ≥Gr3 non-hematologic product-related AE included transient Gr3 AST elevation (2/7, 28%), hypokalemia (1/7, 14%), and abdominal pain (1/7,14%). 5/6 (83%) patients at DL2 showed tumor shrinkage post C-CAR031 treatment (median -41.4% range -3.4%~ - 94.4%). Best clinical responses at DL2 included 3 confirmed PR, 2 SD and 1 PD per both RECIST v1.1 and mRECIST. The clinical responses of the patients who achieved PR are ongoing up to the cutoff date. C-CAR031 showed a robust cellular kinetic profile. CAR-T cells were detectable in blood of all patients in the last follow-up. Conclusion: In this FIH study, C-CAR031 is well tolerated and shows promising anti-tumor activity. Enrollment is ongoing to confirm initial results. About Shanghai Cellular Biopharmaceutical Group Ltd Shanghai Cellular Biopharmaceutical Group Ltd develops proprietary cell therapies for the treatment of cancerous diseases and autoimmune diseases, and operates state-of-the-art research and GMP facility in Shanghai, China. Shanghai Cellular Bio partners with its affiliate in Maryland to augment its global research and development capabilities. Shanghai Cellular Bio and its affiliate conduct multiple clinical studies comprised of C-CAR039 Phase 1b trial, C-CAR066 targeting treatment for r/r NHL, C-CAR088, an autologous anti-B cell maturation antigen (BCMA) CAR-T for r/r myeloma (MM), C-CAR031, an autologous armored anti-GPC3 CAR-T for Hepatocellular carcinoma (HCC), C-TIL051, an autologous tumor-infiltrating lymphocytes (TIL) therapy for non-small cell lung cancer (NSCLC); and continue to discover and develop multiple novel T cell therapies for solid tumor and for orphan autoimmune diseases. Company Contact: Sarah Kelly Communications & Investor Relations Shanghai Cellular Biopharmaceutical Group Ltd. Phone: +86 21 5406 9990 Email: [email protected] SOURCE Shanghai Cellular Biopharmaceutical Group Ltd.