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Genscript Biotech Corporation
金斯瑞生 物科 技 股份 有限 公 司 *
(Incorporated in the Cayman Islands with limited liability)
(Stock code: 1548)
VOLUNTARY ANNOUNCEMENT
RESEARCH AND DEVELOPMENT UPDATE
Reference is made to the voluntary announcements of Genscript Biotech Corporation (the "Company" , together with its subsidiaries, the "Group" ) dated 28 October 2016, 14 May 2017, 6 June 2017, 19 September 2017, 1 November 2018, 4 December 2018, 4 April 2019, 16 April 2019 and 28 August 2019. The board (the "Board" ) of directors (the "Directors" ) of the Company is pleased to announce that Legend Biotech Corporation, a subsidiary of the Company, will present key clinical development of LCAR-B38M and JNJ-68284528(JNJ-4528) at the American Society of Hematology ( "ASH" ) meeting on December 7, 2019 and December 9, 2019, including the long term follow-up clinical development of the LEGEND-2 study in China, as well as the initial data from CARTITUDE-1 study in the United States which builds upon the first-in-humanLEGEND-2 study.
LCAR-B38M and JNJ-68284528(JNJ-4528) are investigational B-cell maturation antigen ( "BCMA" ) chimeric antigen receptor T-cell ( "CAR-T" ) therapy being studied in relapsed and/ or refractory multiple myeloma ( "RRMM" ). Abstracts of the data from the above studies will be presented during the following dates and times. Updated data for CARTITUDE-1 study will be presented during the oral presentations.
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Date, Time and | ||||
Study | Abstract#/Title | Presenting Author | ||
CARTITUDE-1 | ABSTRACT #577: Results from | Oral Presentation | ||
(MMY2001, | CARTITUDE-1: a Phase 1b/2 | Monday, December 9, 7:00 | ||
NCT03548207), | study of JNJ-4528, a CAR-T cell | am | ||
United States | therapy directed against BCMA, | Presented by D Madduri | ||
in patients with RRMM | ||||
ABSTRACT #928: | Oral Presentation | |||
Translational analysis from | Monday, December 9, 7:00 | |||
CARTITUDE-1, an ongoing | pm | |||
Phase 1b/2 study of JNJ-4528 | Presented by E Zudaire | |||
BCMA-targetedCAR-T cell | ||||
therapy in RRMM, indicates | ||||
preferential expansion of CD8+ | ||||
T Cell central memory cell | ||||
subset | ||||
LEGEND-2 | ABSTRACT #579: Long-term | Oral Presentation | ||
(NCT03090659), China | follow-up of a Phase 1, first- | Monday, December | 9, | 7:30 |
in-humanopen-label study of | am | |||
LCAR-B38M, a structurally | Presented by BY Wang | |||
differentiated CAR-T cell | ||||
therapy targeting BCMA, in | ||||
patients with RRMM | ||||
ABSTRACT #1858: Updated | Poster Presentation | |||
Phase 1 results of a first-in- | Saturday, December | 7, | 5:30 | |
human open-label study of | pm | |||
LCAR-B38M, a structurally | Presented by LJ Chen | |||
differentiated CAR-T cell | ||||
therapy targeting BCMA | ||||
In February 2019, Office of Orphan Product Development from the Food and Drug Administration of the United States granted the Orphan Drug Designation for JNJ-4528(JNJ-4528)/LCAR-B38M. On April 3, 2019, the European Medicines Agency ( "EMA" ) granted a "PRIority MEdicines" ( "PRIME" ) designation to Janssen-Cilag International N.V. for JNJ-4528 which was supported by results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) and the Phase 1/2 LEGEND-2 study (NCT03090659) evaluating LCAR-B38M in RRMM. For details, please refer to the voluntary announcement of the Company dated April 4, 2019 and the annual report of year 2018 of the Company dated April 15, 2019.
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About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm,open-label Phase 1/2 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M for the treatment of relapsed or refractory multiple myeloma.
About CARTITUDE-1
In the United States, JNJ-4528 is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy or are double refractory to a proteinase inhibitor ( "PI" ) and immunomodulatory drug ( "IMiD" ), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.
Shareholders and potential investors of the Company are advised to pay attention to investment risks and exercise caution when they deal or contemplate dealing in the securities of the Company.
By order of the Board
Genscript Biotech Corporation
Zhang Fangliang
Chairman and Chief Executive Officer
Hong Kong, 7 November 2019
As at the date of this announcement, the executive Directors are Dr. Zhang Fangliang, Ms. Wang Ye and Mr. Meng Jiange; the non-executive Directors are Dr. Wang Luquan, Mr. Pan Yuexin and Ms. Wang Jiafen; and the independent non-executive Directors are Mr. Guo Hongxin, Mr. Dai Zumian and Mr. Pan Jiuan.
- For identification purposes only
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GenScript Biotech Corporation published this content on 07 November 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 November 2019 22:19:06 UTC