Suzhou, China, Palo Alto, California, USA May 20, 2021/PRNewswire/-Genxi Biotechnology Group (NASDAQ: GRCL;; Genxi Bio, a global clinical biopharmaceutical company dedicated to developing efficient and economical cell therapy for cancer treatment, announced today that it will publish the latest clinical research results of a multi-center, first-time human trial on GC012F in the treatment of relapsed/refractory multiple myeloma during the annual meeting of American Society of Clinical Oncology (ASCO) in 2021 and the conference of European Hematology Association (EHA) in 2021.
GC012F is a BCMA/CD19 dual-target autologous CAR-T cell therapy developed based on the patented technology platform of Genxi Bio-FasTCAR, which has the advantage of "production can be completed the next day". At present, the candidate product is being evaluated in a phase I clinical trial initiated by researchers.
- By January 12, 2021, 19 patients with multiple myeloma were enrolled in the three dose groups of this study, of which the highest dose level was 3×10.fiveCells/kg body weight, all the above patients meet the criteria of recurrence/refractory after multiple rounds of treatment. Subsequent patients (after the release of data at the ASH annual meeting in 2020) received the highest dose level of treatment.
- The early objective remission rate (ORR) was as high as 94.7%(18/19), and all the responses showed that excellent partial remission (VGPR) and even complete remission (SCR) were obtained. The data of all dose groups showed a rapid, in-depth and lasting therapeutic effect.
- All patients (n=9) who received treatment in the highest dose group achieved negative minimal residual lesions-complete remission (MRD- sCR) in a strict sense.
- Of the 19 patients, 18 (94.7%) belonged to the high-risk patients defined in mSMART 3.0 guidelines, and the median number of previous treatment lines was 5.
- 94.7%(18/19) patients have been exposed to PI, IMiD and at least the third treatment scheme, including anti-CD38 targeted therapy.
- The safety of GC012F is consistent with the previous observation results, and the main symptom is low-grade cytokine release syndrome (CRS)(84% patients are grade 1/2; 11% (n=2) patients were grade 3), and there was no grade 4 or 5 CRS;. No immune effector cell-related neurotoxicity (ICANS) was observed in 19 patients. Adverse events (TEAEs) occurred during treatment were mainly manifested as decrease of blood cell count and increase of AST. All TEAEs were relieved after standard treatment.
- The study will continue to evaluate the effectiveness and safety of GC012F in the treatment of patients.
"I am glad to see the mutual evidence between the follow-up of the initial patients and the treatment effect of the subsequent patients, which not only confirms the research results announced at the annual meeting of ASH last year, but also further clarifies the excellent safety and effectiveness of GC012F dual-targeted autologous CAR-T cell therapy, including for high-risk patients."Chief Medical Officer of Genxi BiologydoctorIt said: "High-risk patients are usually extremely difficult to treat, but all patients in the highest dose group in this study have reached the MRD negative sCR state and maintained a deep response for six months or even longer after receiving GC012F infusion. The above exciting research data bring brand-new hope to high-risk patients (including those who do not respond to the standard treatment plan). Next, we plan to promote this research on a global scale, including promoting it as a more preferred treatment option. I look forward to sharing more developments with you in the near future. "
GC012FClinical research initiated by researchers (IIT) Co-principal researcher, Professor Du Fu of shanghai changzheng hospital."Multiple myeloma (MM) is a malignant blood tumor that is extremely difficult to treat. There are about 750,000 patients with multiple myeloma worldwide.[1]There are about 160,000 new patients every year.[2]And it is on the rise year by year. Among them, high-risk patients account for 20%-30%.[3]The prognosis is usually poor, accompanied by higher risk of early recurrence, shorter progression-free survival and overall survival. This time, we are pleased to see that the BCMA/CD19 dual-target autologous CAR-T cell therapy GC012F of Genxi Bio has shown excellent effectiveness and safety for the long-term follow-up results of patients with relapsed/refractory multiple myeloma. And thanks to the advantages of FasTCAR platform, the waiting time of clinical treatment has been significantly shortened, and the hope of life has been ignited for more patients. "
GC012FClinical research initiated by researchers (IIT) Co-principal researcher, Professor Fu Weijun of shanghai changzheng hospital.Said: "I am very happy to see that after we announced the first human trial data of GC012F in the form of oral report at the ASH meeting last year, this research has made positive progress again, and the previous results have been further verified; This also allows us to see the good application prospects of Ganxi Bio-FasTCAR platform and Dual CAR technology. With the deepening of research, the clinical benefits of this innovative BCMA/CD19 dual-targeted autologous CAR-T cell therapy for patients with multiple myeloma, especially high-risk patients, are constantly emerging. It is expected that this research will continue to achieve more results and strive to meet the urgent treatment needs of patients with recurrent/refractory multiple myeloma as soon as possible. "
Details of the electronic poster are as follows:
2021American Society of Clinical Oncology (ASCO) annual meeting
abstract8014:Long-term follow-up results of the first multicenter human trial of BCMA/CD19 dual-target CAR-T cell therapy GC012F for patients with relapsed or refractory multiple myeloma based on FasTCAR platform.
Poster release date:June 4, 2021
2021European hematology association (EHA2021) conference
abstractEP962:Long-term follow-up results of the first multicenter human trial of BCMA/CD19 dual-target CAR-T cell therapy GC012F for patients with relapsed or refractory multiple myeloma based on FasTCAR platform.
Poster release date:June 11th, 2021
About multiple myeloma
Multiple myeloma (MM) is the third most common malignant hematological tumor in the United States. Its tumor cells originated from bone marrow plasma cells, an immune cell responsible for secreting anti-infective antibodies. About 160,000 patients worldwide are diagnosed with multiple myeloma every year; In 2020, the United States is expected to have more than 32,000 confirmed patients. In recent years, although many progress has been made in the treatment of multiple myeloma, the clinical treatment effect is still unsatisfactory. International Myeloma Working Group (IMWG) and the consensus guidelines of Mayo ST Rating for Myeloma and Risk-Adapted Therapy (MSMART) classify patients with specific cytogenetic abnormalities or other abnormalities as high-risk patients, and this group accounts for 20-30% of all patients with multiple myeloma. High-risk patients with high risk of early recurrence, progression-free survival and short overall survival are considered as the most difficult patients with multiple myeloma, and usually have poor prognosis.
aboutGC012F
GC012F is a candidate product for dual-target autologous CAR-T therapy based on FasTCAR platform. At present, the candidate product is evaluating its safety and effectiveness in the treatment of multiple myeloma in a multi-center and phase I clinical trial initiated by researchers, covering many research centers in China. GC012F brings rapid, in-depth and lasting therapeutic effects to patients with multiple myeloma by simultaneously targeting the malignant plasma cell site expressing BCMA and the early progenitor cell site expressing CD19.
aboutFasTCAR
FasTCAR is a technology platform with intellectual property rights of Genxi Bio, aiming at developing high-quality autologous CAR-T cell therapy. Preclinical studies show that the phenotype of CAR-T cells produced by FasTCAR technology platform is younger, the degree of depletion is lower, and the amplification ability, persistence, bone marrow migration ability and tumor cell clearance activity are enhanced. With the advantage of "completing production the next day", FasTCAR platform technology can greatly improve cell production efficiency, thus significantly reducing production costs and enabling cell therapy to benefit more cancer patients.
About genxi creatures
Genxi Biotechnology Group (Genxi Bio for short) is a global clinical biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapy. Using its pioneering FasTCAR and TruUCAR technology platforms, Genxi Bio is developing a number of rich clinical cancer treatment product pipelines, both autologous and allogeneic. These products are expected to overcome the persistent major industry challenges of traditional CAR-T therapy, including long production time, poor production quality, high treatment cost and lack of effective treatment for solid tumors. To learn more about Genxi Bio, please visit www.gracellbio.com/ Concern LinkedIn account @GracellBio.
Warning statement about forward-looking statements
The statement in the press release about future expectations, plans, prospects and other non-historical facts may contain a "forward-looking statement" as defined in the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the expected transaction and completion time of this offering. These statements may, but do not necessarily, contain the following words and corresponding negative forms or similar words: purpose, expectation, belief, estimation, prediction, plan, possibility, prospect, plan, potential, conjecture, formulation, seeking, possibility, should and will. Due to various important factors, the actual results may be significantly different from the forward-looking statements, and there is no guarantee that any forward-looking statements will be realized. These important factors include the factors mentioned in the Risk Factors section of Genxi Bio’s recent annual report in Form 20-F, and the discussion on potential risks, uncertainties and other important factors in Genxi Bio’s subsequent report to the US Securities Regulatory Commission after the session. Any forward-looking statements in this statement only reflect the current expectations, and Genxi Bio has no responsibility to publicly update or review any forward-looking statements, whether based on new information, future events or other reasons. Readers are requested not to rely on forward-looking statements after the publication date of this press release.
Media contact
marvin.tang@gracellbio.com
Investor contact
gracie.tong@gracellbio.com