ASCO's blockbuster CAR-T therapy has a total remission rate of 80%, and Baiji Gene brings new AML clinical trial data

Recent popular reports from Yimaike ★ Invitation to the event2021 Oncolytic Virus Drug Development Forum is about to open in Shanghai ★ The financing has reached hundreds of millions in half a year, and the oncolytic virus has entered the fast laneYimai New Observation June 6, 2021 / Yimaike News News/--Guangzhou Baiji Gene Technology Co.
, Ltd.
("Baiji Gene" for short), an innovative biopharmaceutical company dedicated to the development of high-efficiency and inclusive cell therapy for cancer treatment.
(ASCO) Oral report at the annual meeting: The results of a multi-center, mid-term clinical study on the treatment of relapsed/refractory acute myeloid leukemia in children with CAR-T, the target of CLL1
.

Public information shows that the incidence of childhood leukemia (under 15 years of age) in China is about 4-5 per 100,000; if it expands to under 18 years of age, about 15,000 new cases occur each year, mainly in childhood acute leukemia
.

Among them, the incidence of childhood acute myeloid leukemia (cAML) is second only to childhood acute lymphoblastic leukemia (cALL), accounting for about 15% to 20% of childhood acute leukemia (cAL), but it accounts for the deaths due to childhood acute leukemia More than 50%
.

"Research on the treatment of acute myeloid leukemia (cAML) is a worldwide problem.
As one of the potential targets for drug development, CLL1 is abnormally highly expressed on childhood AML cells and leukemia stem cells LSCs, but it is almost not expressed on LSCs.
Normal hematopoietic cells
.

” said Dr.
Luo Min, CEO and Chief Technology Officer of Baiji Gene: “As a revolutionary new method of cancer treatment, CAR-T drugs have shown excellent success rate and safety in the treatment of acute lymphoblastic leukemia.
We It is hoped that the advantages of CAR-T drugs will continue to be used in the treatment of acute myeloid leukemia, so as to benefit more patients with acute myeloid leukemia
.

Therefore, as an innovation-driven R&D company, we took the lead in developing Anti-CLL1 CAR-T drug candidates in the industry
.

"Anti-CLL1 CAR-T drug candidate is a cell therapy product that is independently developed by Baiji Gene and has core patented technology to precisely target CLL1.
This candidate product is undergoing a phase I clinical trial (ChiCTR1900027684) initiated by the investigator.
Evaluation is mainly used to evaluate the safety and effectiveness of the drug
.

Preliminary test results show that it has excellent clinical therapeutic potential
.

From October 2019 to January 2021, the study enrolled 11 patients with relapsed/refractory disease Children with acute myeloid leukemia, after undergoing cyclophosphamide/fludarabine myeloid clearing, the patients received 0.
3~1x106 cells/kg body weight, a single dose of Anti-CLL1 CAR-T cells, respectively, the highest dose level It was 1×106 cells/kg body weight
.
The
results showed that the median peak time of Anti-CLL1 CAR-T cell expansion in vivo was 8 days, indicating that CAR-T cells expanded rapidly and efficiently in children
.
The
overall response rate (ORR) ) As high as 81.
8% (9/11), the total disease control rate (DCR) is as high as 90.
9% (10/11), 10 out of 11 patients fully responded to Anti-CLL1 CAR-T cell therapy, CLL1 positive AML Cancer cells were eliminated within one month
.

Among them, 5 patients (n=5) achieved excellent complete remission of CR and minimal residual disease negative MRD-, and 3 patients (n=3) achieved complete remission of CR and minimal residual disease Positive MRD+, 1 patient (n=1) achieved PR, 1 patient (n=1) showed SD (with CLL1-negative AML cells)
.

The data of all response groups showed that Anti-CLL1 CAR-T drug candidates are fast and efficient , Precise and thorough treatment of AML
.

Among the 11 infused patients, grade 3-4 hematological adverse events were observed before and during CAR-T cell infusion, but no Anti-CLL1 CAR-T dose-limiting toxicity was observed
.

At the same time, a grade 1-3 cytokine release syndrome was observed, but there were no fatal incidents
.

After the guided intervention treatment, all the above-mentioned adverse reactions were resolved
.

The study will continue to evaluate the effectiveness and safety of Anti-CLL1CAR-T in the treatment of patients and the long-term prognosis of patients who fail to undergo bone marrow transplantation
.

The researcher initiated the clinical study (IIT) co-lead investigator, Director Zhang Hui of Guangzhou Women’s and Children’s Medical Center, said: “We are very pleased to see that Baiji Gene Anti-CLL1CAR-T drug candidates show fast, efficient, Accurate and safe AML treatment effect, 10/11 patients responded positively to Anti-CLL1 CAR-T cell therapy within one month
.

For patients showing MRD + with CLL1-negative AML blasts, combined with azacitidine chemotherapy HSCT may help these patients achieve complete remission in a stricter sense
.

In short, these preliminary results show that anti-CLL1 CAR-T cells are well tolerated for the treatment of children with R/R-AML and will be one of the excellent candidate therapies One"
.

 2021 American Society of Clinical Oncology (ASCO) Annual Meeting Abstract 10000: The efficacy and safety of anti-CLL1 based CAR-T cells in children with relapsed or refractory acute myeloid leukemia: A multicenter interim analysis.
Anti-CLL1 CAR-T cells in children with relapsed treatment Efficacy and safety of sexual or refractory acute myeloid leukemia: a multicenter, interim analysis
.

Poster release date: June 4, 2021 About Baiji Gene Guangzhou Bio-gene Technology Co.
, Ltd was established in 2015 and is a subsidiary of Hedy Group
.

The company is committed to developing the world's leading cell therapy drugs for the treatment of hematopoietic malignancies including leukemia and lymphoma, as well as a variety of solid tumors
.

The company has applied for 32 patents on core technologies such as the structural sequence and preparation method of a new generation of CAR-T cell therapy products, including 6 PCT patents and more than 10 authorized invention patents, establishing a strong intellectual property barrier
.

At present, the autologous CAR-T product for AML has shown excellent efficacy and safety in more than 10 patients in the multi-center IIT study; the universal cell therapy product based on γδT solves the problem of expansion and infection.
In animal experiments It has the same curative effect as autologous CD19 CAR-T
.

In terms of solid tumors, the company's CAR-T products for skin tumors and gastrointestinal tumors have begun IIT research
.

The company currently has a stable clinical cooperation with more than ten Class-A hospitals across the country.
At the same time, the company's main investor Qixi Group plans to build 20 specialized tumor hospitals across the country in the next five years, which will have a unique advantage in future market promotion
.

To learn more about Baiji Gene, please visit https:// Reference materials: 1.
Hui Zhang, Chaoke Bu, Zhiyong Peng, min luo, Chunfu Li; GuangzhouWomen and Children's Medical Center, Guangzhou, China; Nanfang -ChunfuChildren's Institute of Hematology and Oncology, Dongguan, China; GuangzhouBio-Gene Co.
, Ltd.
, Guangzhou, China.
The efficacy and safety of anti-CLL1 based CAR-T cells in children with relapsed or refractory acutemyeloid leukemia: A multicenter interim analysis .
2021 ASCO Annual Meeting,Abstract #10000.
2.
WillierS, et al.
CLEC12A and CD33 coexpression as a preferential target for pediatricAML combinatorial immunotherapy.
Blood.
2021 Feb 25;137(8):1037-1049.
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