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In order to further improve the diagnosis and treatment of hematological tumors, the 25th National Clinical Oncology Conference and 2022 CSCO Annual Conference, co-hosted by the Chinese Society of Clinical Oncology (CSCO) and Beijing Heesco Clinical Oncology Research Foundation, were held
from November 5 to 12, 2022 。 The 7th Anti-leukemia & Lymphoma International Summit Forum and CSCO Leukemia & Lymphoma Expert Committee Tour - Harbin Station was also held at the same time, the conference report was selected as the most cutting-edge theme report and the most influential clinical research related to leukemia and lymphoma, and invited many experts in the field of blood to discuss the frontier progress
of leukemia and lymphoma.
The highlights are now compiled below for the readers!
The conference report session was grandly opened
At the beginning of the conference, under the chairmanship of Professor Ma Jun of Harbin Institute of Hematology and Oncology, Professor Ma Jun said that this conference brought together many well-known scholars, entrepreneurs and experts from related institutions to share a number of cutting-edge advances
in the field of hematology, including CAR-T cell therapy.
At the moment of the epidemic, only the combination of medical administration, medicine and doctor-patient can ultimately achieve higher clinical cure
for tumor patients.
the cohesive force, the source of the future - the innovation road of Hejilensai cell injection
After the speeches of the experts, the report of the conference officially set sail
.
Professor Zhou Daobin of Peking Union Medical College Hospital said in the chairmanship that Heyuan Biotech is a new generation of biopharmaceutical company driven by cell and gene innovation technology, and its self-developed core product CD19 CAR-T product Hergilencel has achieved encouraging results in acute lymphoblastic leukemia (ALL).
。
Professor Wang Jianxiang, Director of the National Clinical Research Center for Hematology, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), shared the innovation path
of Hejilencel cell injection.
Figure 2 Moderated by Professor Zhou Daobin
Figure 3 Professor Wang Jianxiang gave a wonderful speech
1.
The first R&D of CD19 CAR-T drugs with China's independent intellectual property rights
As a new "live" drug, CAR-T cell therapy drugs have different R&D paths from drug exploration, pharmaceutical research, preclinical research, clinical research to approval and marketing
.
Since 2017, the FDA has approved six CAR-T drugs for the treatment of ALL, non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) indications; China has approved two imported CAR-T drugs for the treatment of large B-cell lymphoma, but no CAR-T products for ALL have been approved
.
At present, China's first targeted CD19 CAR-T drug for the treatment of ALL and independent intellectual property rights, Hergilencel, is about to submit a new drug application
for marketing.
Fig.
4 Clinical progress of CAR-T cell therapy
Hergilencel developed HI19α antibody derived from CD19, which has stronger specificity and affinity, and is applied to CAR-T therapy
after a series of technical translations by researchers.
In both in vivo and in vitro experiments conducted in preclinical studies, Hergilencel has been shown to significantly kill leukemia cells
.
Based on its encouraging efficacy in investigator-initiated clinical studies (IIT), Hergilencel has been approved for adult relapsed or refractory (r/r) B-ALL and r/r B-NHL, and pediatric B-ALL, and in 2020 and 2022, it has been certified as a "breakthrough therapy drug" in China and an FDA as an orphan drug
。 In October 2022, the pivotal Phase II registration clinical study in adults r/r B-ALL reached the primary endpoint, and detailed data will be presented orally at the 2022 ASH Annual Meeting (abstract number 660).
Figure 5 Development history of Herkilens
2.
Hökilensel's clinical research and development plan
Herkilencel has achieved remarkable results in various researches, and plans to conduct further clinical research
in the field of hematological oncology at home and abroad in the future.
In China, the study of Hergilencel for the treatment of R/R B-ALL in adults has been completed, and a new drug application (NDA) submission is planned for the fourth quarter of this year
.
At the same time, the team will initiate a clinical trial of r/r B-ALL registration in children, and hopes to use it on the basis of previous studies to treat more frontline patients with B-ALL
who are positive for minimal residual disease (MRD).
In addition, a Phase II registration clinical study for r/r B-NHL is currently underway and an NDA submission
is expected in 2023.
In the ongoing IIT study, the use of Hergilencel for non-tumor diseases such as autoimmune diseases/systemic lupus erythematosus is also being
explored.
At the same time, in the U.
S.
FDA, Hergilencel is also preparing a clinical trial application (IND)
for adult r/r B-ALL.
Figure 6 Hergilencel clinical development plan
Third, the preliminary data of the Hergilencel clinical study
About 50%-60% of adult ALL patients will relapse or refractory to treatment, the prognosis of this part of patients is very poor, although new drugs have been approved for marketing in recent years, but the prognosis improvement is not significant, the overall survival is not significantly improved, only 4~7.
7 months
.
According to domestic and international guidelines, the participation of r/r B-ALL patients in clinical trials is still the main recommendation
.
At present, the FDA has approved cell therapy products, including Tisagenlecleucel for children and young adults 25 years of age and younger adults r/r B-ALL and Brexucabtagene autoleucel for adult r/r B-ALL, and there are no CAR-T cell drugs targeting CD19 for the treatment of B-ALL in China
.
As the first self-developed new CAR-T therapeutic drug in China, Hergilencel has achieved significant efficacy
in its related clinical research.
In its phase II pivotal registration clinical study, a total of 53 adult patients with r/r B-ALL were enrolled, of which 36 patients were eligible for decontamination and received Hergilencel
.
After enrollment, 0.
5×108 CAR-positive T cells were reinfused, and the ORR reached 86.
1% within 3 months, and 100% of ORR patients were
MRD-negative.
ORR was 65.
6% at 3 months, 90.
5% of ORR patients were MRD negative, and patients with ORR at 3 months showed a trend
towards sustained remission.
More detailed and comprehensive data from the pivotal clinical study of Hergilencel in adults with r/r B-ALL will be presented in an oral presentation at the 2022 ASH Annual Meeting (abstract number 660).
Fig.
7 Results of phase II study of R/R B-ALL in adults treated with hergilencel
The 5-year overall survival (OS) rate of newly diagnosed children with B-ALL in pediatric leukemia patients is 89%, but 20% of children face relapse after initial treatment, and with the increase of the number of treatment lines, the prognosis of children B-ALL is worse, and effective treatment is
urgently needed.
From August 2017 to July 2020, a total of 30 children/adolescents (< 18 years old) B-ALL patients received cell infusion therapy in Hökilencel-related IIT
.
Among the 12 patients refractory to bone marrow recurrence, 10 obtained CR or CRi with an ORR of 83.
3%, of which 7 were MRD negative; Among the 5 MRD-positive patients, 3 MRD turned negative; 13 patients with simple extramedullary recurrence and 12 patients with CR.
As of August 4, 2022, the median OS of 30 pediatric/adolescent patients, including those who did not receive transplant and those who received transplantation, did not achieve median OS, and there was no significant difference in OS between transplanted and non-transplanted patients (P>0.
05), indicating that Hergilencel had a significant effect on both adult and pediatric patients with B-ALL and showed a long-term survival benefit
.
Fig.
8 Early IIT results of Hergilencel treatment for children/adolescents with B-ALL
At the same time, in order to better apply the clinical practice after the launch of Herkilencel, the R&D team specially formulated a full-process management plan for CAR-T treatment, including patient screening, CAR-T preparation, treatment, condition monitoring and other aspects
.
It is expected that after the launch of Herkilencel, it can bring hope
to more patients.
Expert discussion
Subsequently, under the chairmanship of Dr.
Lulu Lv, CEO of Heyuan Biologics, Professor Liu Daihong of the General Hospital of the People's Liberation Army Chinese and Professor Li Wenyu of Guangdong Provincial People's Hospital had a heated discussion.
Professor Liu pointed out that at present, there is a lack of effective treatment for adult r/r B-ALL, and the efficacy and safety of Hergilencel, as the first CD19 CAR-T with independent intellectual property rights in China, is currently in the II clinical study of adult r/r B-ALL patients is very encouraging
.
Professor Lee added that the ORR of 65.
6% at 3 months of Hergilensa was encouraging
.
At present, the price of international CAR-T products is still very expensive, and we look forward to our domestic self-developed Hergilensai being approved to enter the clinic as soon as possible, improve the accessibility of CAR-T therapy in China, and solve the clinical needs
of Chinese patients.
Figure 9 Wonderful comments by Professor Liu Daihong (left) and Professor Li Wenyu (right).
Dr.
Lu concluded that as the first CAR-T product with independent intellectual property rights for the treatment of adult r/r B-ALL, Hergilencel has entered the new drug application stage, and is also exploring the indications for front-line treatment and pediatric B-ALL, and plans to support the development of new drugs in the United States through key clinical research data in China, in order to bring benefits
to more leukemia patients.
Figure 10 Dr.
Lulu Lu's wonderful summary
Editors: San Yue, Su Meng
Reviewer: Sanyue
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