CD20 CAR-T therapy ORR reaches 100%, and CAR-T at home and abroad may usher in a wave of listing

October 31, 2022 /eMedClub News/--Bio, a biopharmaceutical company, recently announced the latest Phase 1/2 clinical trial of its CD20-targeted CAR-T therapy MB-106 for the treatment of multiple hematological tumors, the results of which will be presented at the 11th International Symposium on Waldenstrom Macroglobulinemia
。 MB-106 is a fully human, third-generation, CD20-targeted CAR-T cell therapy containing 4-1BB and CD28 co-stimulatory domains, and its modified IgG1 spacer eliminates FcR binding
.
The product was developed in collaboration with Mustang and Fred Hutchinson Cancer Center for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphoblastic leukemia (CLL).

The clinical data published by Mustang include Fahrenheit macroglobulinemia (WM) cohort and trial data
for the entire cohort.
Fahrenheit macroglobulinemia, a rare non-Hodgkin lymphoma (NHL) characterized by clonal IgM in blood, is a rare disease with an annual incidence of about 3 parts per million, and about 1400 new cases are diagnosed in the United States each year, with a median age of 70 years
at diagnosis.
In June of this year, the product was granted orphan drug designation by the FDA for the treatment of WM.

Data as of September 2022, clinical results show:

Both patients with WM had 100% ORR and CR;

In a variety of hematological tumors, including B-NHL, CLL, follicular lymphoma , diffuse large B-cell lymphoma, the observed overall response rate (ORR) was 96% (27/28) and the complete response rate (CR) was 75% (21/28).

12 patients had complete remissions over 12 months; 4 patients had a complete response for more than two years, with a maximum complete response time of 33 months;

Patients who had previously received CD 19 CAR-T cell therapy relapsed remission;

MB-106 demonstrated a favorable safety profile during treatment, and no patients developed grade 3 or higher cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome
.

Overall, MB-106 has shown good efficacy and controllable safety in the treatment of a variety of hematological tumors, especially in the WM cohort, and is expected to become a potential clinical treatment for
a variety of hematological tumors.
However, the trial has limited patient participation, and large multicenter clinical trials are necessary to further verify its efficacy and safety
.

Recent progress of the domestic CAR-T track

Mustang Bio's CAR-T has shown good efficacy and safety, and is one step closer to commercialization, and recent domestic companies have also made good progress on the CAR-T track.

(If there are any incomplete, please add
them.
) ）

Recently, the Phase 1 study results of C-CAR088, a novel second-generation CAR-T cell targeting BCMA, in patients with relapsed or refractory multiple myeloma (R/R MM), were published in the Journal for ImmunoTherapy of Cancer
.
The results showed that among the 28 evaluable patients, C-CAR088 demonstrated high antitumor activity and an ORR (objective response rate) of 96.
4%, making it a promising treatment option
for R/R MM.

On October 9, 2022, the official website of China's National Medical Products Administration (NMPA) showed that JW Therapeutics' CD19 CAR-T cell immunotherapy product Carteyda ® (relma-cel injection) has been officially approved for the treatment of patients with relapsed or refractory follicular lymphoma (r/r FL), which is the second indication approved for the product
.

On October 11, Heyuan Biotech and the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) jointly announced that the CAR-T product Herquilency injection (proposed) targeting CD19 has reached the primary research endpoint
in a key clinical study in the treatment of adult relapsed or refractory acute B-lymphoblastic leukemia (r/r B-ALL).
The results of the study showed that Herquhilenca injection showed excellent clinical efficacy and good
safety in the treatment of adult patients with r/r B-ALL.
According to Dr.
Lulu Lulu, CEO of Heyuan Biologics, the company will officially submit a marketing application
for the drug to CDE in the near future.

On October 11, Reindeer Bio, together with Cabaletta Bio, a clinical-stage biotechnology company dedicated to the development and commercialization of the first targeted cell therapy for patients with autoimmune diseases, announced that Reindeer Biologics has granted Cabaletta the exclusive global development, manufacturing and commercialization rights to develop its clinically validated fully human CD19 sequence for Cabaletta in the development of modified T cells in the field of autoimmune diseases
。

On October 13, according to the latest announcement on the official website of CDE, the clinical trial application (IND) of autologous Anti-CLL1 CAR-T injection of Guangzhou Baiji Gene Technology Co.
, Ltd.
(hereinafter referred to as "Baiji Gene") has been accepted
.

On October 18, Keji Pharmaceutical announced that China's National Medical Products Administration (NMPA) has accepted the new drug marketing application (R&D code: CT053)
of Zevoki Olencel injection.
Zevoki Olencel Injection is a fully human anti-autologous-targeting BCMA CAR-T cell candidate intended for the treatment of relapsed/refractory multiple myeloma
.
It is worth mentioning that the drug has just been included in the priority review
by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.

Recently, the Journal of Clinical Oncology published preliminary efficacy and safety results from the 18-month follow-up of the legendary biological CARTIFAN-1 study, which is a pivotal phase II study
of BCMA-targeted CAR-T therapy cilta-cel in the treatment of Chinese patients with relapsed/refractory multiple myeloma (RRMM) who have previously received ≥ 3rd line therapy 。 The results showed that patients had early, deep and durable remission with a manageable safety profile, with an ORR (objective response rate) of 89.
6%.

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On October 25, the US FDA announced that the US FDA has granted its self-developed autologous GPRC5D targeted CAR-T product OriCAR-017 orphan drug designation for the treatment of relapsed/refractory multiple myeloma
.

On October 25, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Fosun Kate's Aquilenxel injection submitted a new indication marketing application and was accepted
.
According to Fosun Kate's press release, this application is intended for the second-line treatment of adult patients with large B-cell lymphoma, and has been included in the priority review
by CDE a few days ago.
At present, the application for marketing registration of this new indication has officially entered the review stage
.

In general, with the advancement of clinical practice and the change of technology, the domestic CAR-T industry is in a period of
accelerated development.

Resources:

1.
Official website of each company

2.
com/article/releases/ mustang-bio-announces-phase-1-2-clinical-trial-data-of-mb-106-a-first-in-class-cd20-targeted-autologous-car-t-cell-therapy-to-be-presented-at-11th-international-workshop-for-waldenstrom-s-macroglobulinemia /?keywords=CELL