On February 13, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio) reported that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has formally granted Orphan Drug Designation (ODD) to their co-developed fully-human B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy (Innovent: IBI326, IASO Bio: CT103A) for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM) (Press release, Innovent Biologics, FEB 13, 2022, View Source [SID1234608052]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ODD will accelerate drug development and registration action in the United States. IBI326 will be eligible for certain development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a seven-year U.S. market exclusivity granted upon product approval. In February 2021, IBI326 was granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of R/R MM.

"This ODD of IBI326 is a milestone recognizing our effort to develop a novel anti-BCMA CAR with better efficacy and persistence," said Dr. Hui Zhou, Senior Vice President of Innovent, "It underscores the importance of bringing this therapeutic option to patients with multiple myeloma, and strongly motivates us to expedite the clinical development of IBI326. We hope to launch IBI326 as soon as possible which will bring hope to patients with multiple myeloma."

"FDA approval of ODD to CT103A is of great significance to patients with multiple myeloma and represents the FDA’s recognition of CT103A and the clinical data provided by IASO Bio", said Dr. Wen Wang, Chief Executive Officer and Chief Medical Officer of IASO Bio. "Currently, our team is advancing the clinical development of CT103A to the four dimensions of strategy including frontline therapy, combination therapies, indication expansion, and ex-China development. We are looking forward to the launch of CT103A both in China and US as soon as possible to offer living-saving treatment option to more patients."

About Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of newly-diagnosed all cancer cases, and more than 2% of cancer-related deaths.

According to Frost & Sullivan:

The number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020, and is expected to increase to 37,800 by 2025. The total number of patients diagnosed with MM in the United States increased from 132,200 in 2016 to 144,900 in 2020, and is expected to rise to 162,300 by 2025.
The number of new MM cases in China rose from 18,900 in 2016 to 21,100 in 2020, and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020, and is expected to rise to 182,200 by 2025.
About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by IASO Bio and Innovent. Previous studies indicate subjects with relapsed/refractory multiple myeloma (R/R MM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent. In February 2021, IBI326 was granted "Breakthrough Therapy Designation" by the NMPA for the treatment of relapsed/refractory multiple myeloma. In February 2022, IBI326 was granted "Orphan Drug Designation" by the FDA for the treatment of relapsed/refractory multiple myeloma.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 29 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection), Pemazyre (pemigatinib oral inhibitor) and Olverematinib (BCR TKI) – officially approved for marketing in China, 5 assets in Phase 3 or pivotal clinical trials, and an additional 18 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:
TYVYT (sintilimab injection) is not an approved product in the United States.

BYVASDA (bevacizumab biosimilar injection), SULINNO, and HALPRYZA (rituximab biosimilar injection) are not approved products in the United States.

TYVYT (sintilimab injection, Innovent)
BYVASDA (bevacizumab biosimilar injection, Innovent)
HALPRYZA (rituximab biosimilar injection, Innovent)
SULINNO (adalimumab biosimilar injection, Innovent)
Pemazyre (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Disclaimer:

This indication is still under clinical study, which hasn’t been approved in China or the U.S.
Innovent does not recommend any off-label usage.
For medical and healthcare professionals only.