Performance Highlights Quick Facts
CT053 completed the enrollment of China's key phase II clinical trial, and plans to submit NDA in China in the third quarter of 2022 CT041 initiates China's confirmatory phase II clinical trial CT041 was awarded "Regenerative Medicine Advanced Therapy" (RMAT) by FDA CT041 Chinese investigator-initiated trial Published the data in "Nature Medicine" Continue to develop innovative CAR-T technology, deploy next-generation pipeline candidate products The US CGMP production plant has started operation, and in the second half of the year, it will support North American clinical trials.
Looking back on the first half of 2022, although the epidemic has brought some challenges, Keji Pharmaceutical has made significant progress in the clinical development of pipeline products, technological innovation and business operations in China and the United States
Keji Pharmaceutical Product Pipeline Diagram
CT053 is an upgraded, fully human anti-BCMA autologous CAR-T cell product candidate for the treatment of relapsed/refractory multiple myeloma (R/R MM)
CT053 was granted regenerative medicine advanced therapy (RMAT) and orphan drug designation by the US FDA in 2019 for the treatment of R/R MM, and was granted priority medicine (PRIME) by the European Medicines Agency (EMA) in 2019 for the treatment of R/R MM Qualified and obtained orphan drug product designation in 2020, and obtained breakthrough therapy designation from the State Food and Drug Administration in 2020 for the treatment of R/R MM
Keji has completed patient enrollment in China's pivotal Phase II trial (LUMMICAR STUDY 1) and plans to submit a New Drug Application (NDA) to the State Food and Drug Administration in the third quarter of 2022
Results of the CT053 Chinese Investigator-Initiated Trial (IIT) will be published in the journal Haematologica in 2022
CT041 is a potentially first-in-class autologous CAR-T cell product candidate targeting the Claudin18.
CT041 was granted orphan drug designation by the US FDA in 2020 for the treatment of GC/GEJ and orphan drug product designation by the EMA in 2021 for the treatment of advanced gastric cancer
As of the announcement date, CT041 is the world's first and only CAR-T cell product candidate for the treatment of solid tumors that has entered a confirmatory Phase II clinical trial
Keji's ongoing trials include a Phase 1b/2 clinical trial in advanced GC/GEJ and PC in North America (CT041-ST-02, NCT04404595), and a Phase Ib trial in advanced GC/GEJ and PC in China Phase II clinical trial and a confirmatory Phase II clinical trial for advanced GC/GEJ (CT041-ST-01, NCT04581473) and IIT
Results of the Phase 1b study of CT041 in the United States (NCT04404595) and the Phase Ib/II study in China (NCT04581473) were presented as a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022
AB011 is a humanized monoclonal antibody product candidate targeting CLDN18.
Keji is conducting a Phase I clinical trial of AB011 in China for the treatment of CLDN18.
Continue to promote CAR-T technological innovation and overcome major challenges in the industry
Keji has established a comprehensive R&D platform covering the entire CAR-T development cycle, including target discovery, antibody development, vector design, manufacturing, quality assurance, and quality control
Keji continues to devote itself to promoting CAR-T technological innovation to overcome major challenges in the industry
The company's four strategic pillars include:
(1) Efficacy: In order to improve the efficacy of the treatment of solid tumors, Keji continues to develop next-generation CAR-T technologies, such as CycloCAR®
CycloCAR® features the co-expression of cytokine IL-7 and chemokine CCL21 in CAR-T cells, which is expected to produce higher clinical efficacy and reduce lymphatic-clearing chemotherapy pretreatment
(2) Safety: To improve the applicability of adoptive cell therapy, Keji has developed sFv-ε-based T cell therapy, which consists of GPC3-targeted scFv and CD3ε subunits composed of pan-T cell receptors (TCRs) The complex provides the power to form functional TCR complexes with other TCR subunits, redirecting T cells to kill tumor cells in an MHC-independent manner
(3) Patient accessibility: Keji is developing an allogeneic CAR-T cell product candidate using THANK-uCAR® technology
The company believes that this technology is expected to promote the proliferation, persistence and efficacy of CAR-T cells
The company believes that the successful application of THANK-uCAR® technology will significantly reduce the cost of CAR-T cell therapy and improve patient accessibility
(4) Target availability: Keji developed the LADAR® technology (Local Action Driven by Artificial Receptors), in which the artificial receptors are triggered by LADAR® ligands to induce transcription of target genes
Through the LADAR® artificial receptor, anti-tumor CAR transcription is triggered only when LADAR® binds to the LADAR® ligand, allowing precise control of when and under what circumstances immune cells act on cancer cells
At present, the above technologies are all independently developed, with global rights and interests, and can be used individually or in combination to upgrade Keji's existing product candidates and generate future pipeline candidates
As of June 30, 2022, Keji has more than 300 patents, of which 70 are authorized patents worldwide (including China, the United States, Europe and Japan)
Compared with the end of 2021, 7 authorized patents and 21 patent applications have been added
Vertically integrated production capacity to support global clinical trials
Keji has established autonomous, vertically integrated production capabilities, including plasmid production, lentiviral vector production, and CAR-T cell production
The company continues to expand global production capacity in China and the United States to support clinical trials and subsequent commercialization of pipeline products
Utilizing the company's clinical production facility in Xuhui District, Shanghai, and commercial GMP production facility in Jinshan District, Shanghai, the company is able to independently manufacture CAR-T cells to support clinical trials in China and lentiviral vectors to support clinical trials worldwide test
This year, the company made significant progress in expanding the company's production capacity outside of China by launching a CGMP manufacturing facility in the Research Triangle Park (RTP) in Durham, North Carolina, USA
The factory has successfully passed the official inspection and has obtained a compliance certificate issued by the Durham City and County Inspection Bureau.
After RMAT consultation with the FDA, the commissioning, qualification and verification of the RTP production factory has been started
At the same time, Keji has been carrying out technology transfer to the RTP production plant and promoting the clinical production of CT041 and CT053 products
Senior executives join to strengthen the leadership team
As of June 30, 2022, Keji had 601 employees
The company has also strengthened its leadership team by hiring Dr.
Raffaele Baffa as Chief Medical Officer of Keji Pharmaceuticals and Mr.
Richard Daly as President of CARsgen Therapeutics Corporation, a US subsidiary of Keji Pharmaceuticals
Source: Keji Pharmaceutical Holdings Co.