Latest R&D Progress of Multiple Therapeutics from JW Therapeutics and BioNTech

Recently, WuXi AppTec announced that it will release the latest clinical research data for the CAR-T product BeiNuoDa. In addition, BioNTech released its financial report for the first quarter of 2022. Beyond further developing the COVID-19 vaccine, BioNTech also introduced advancements in R&D for other infectious diseases and oncology, including four infectious disease vaccines entering clinical trials and sixteen cancer projects currently in clinical development.

JW Therapeutics:CAR-T Cell Therapy Product Relmacabtagene Autoleucel Injection

JW Therapeutics announced that it will present multiple latest clinical research data of its CAR-T cell therapy product Relma-cel Injection (trade name: Bynoda) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in the form of a poster presentation and online publication, includingThe Multicenter Phase 2 RELAIANCE Clinical Study of Relmacabtagene Autoleucel in Chinese Patients with Refractory/Relapsed Diffuse Large B-Cell LymphomaPreliminary Efficacy and Safety Results of the Phase 1, Open-Label, Single-Arm, Multicenter Study of Relma-cel as Second-Line Treatment in Chinese Patients with Primary Refractory Diffuse Large B-Cell LymphomaTwo-Year Survival Follow-Up Data Update from the Phase 1 Study of Relmacabtagene Autoleucel in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.

Relmacabtagene Autoleucel Injection is an autologous CAR-T cell immunotherapy product targeting CD19 developed by WuXi Jumo based on the CAR-T cell process platform of Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). The product was approved by China's National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This is the first product launched by WuXi Jumo and also the first CAR-T product approved as a Class 1 biologic in China.

Currently, JW Therapeutics continues to explore the use of Relmacabtagene Autoleucel Injection for treating more disease indications. Recently, a new indication application for this product has been granted priority review by the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two lines of systemic therapy. Additionally, the application for Relmacabtagene Autoleucel Injection for treating adult patients with relapsed or refractory mantle cell lymphoma who have undergone at least two lines of therapy has also been designated as a breakthrough therapy by the CDE.

BioNTech:Four infectious disease vaccines to enter clinical trials and sixteen cancer projects in clinical development

The mRNA technology-based influenza vaccine jointly developed by BioNTech and Pfizer is currently being tested in Phase 1 clinical trials, and a clinical study to evaluate a self-amplifying RNA (self-amplifying RNA) candidate vaccine is expected to be launched.Candidate vaccines for shingles, malaria, tuberculosis, and type 2 herpes virus based on mRNA are expected to enter the first human clinical trials in the second half of the year.

The company’s clinical pipeline includes 16 candidate therapies currently being evaluated in 20 clinical trials, five of which are randomized Phase 2 clinical trials. The combination therapy BNT211, consisting of the company's CLDN-6-targeted CAR-T therapy and an mRNA vaccine expressing CLDN6, achieved positive results in a Phase 1/2 clinical trial. These results were recently presented at the AACR conference. Among the 16 treated patients, the overall response rate was 43%, and the disease control rate was 86%. All patients demonstrated robust CAR-T cell engraftment.

Among the four testicular cancer patients treated with high-dose CAR-T therapy, three achieved objective responses, with one patient later achieving complete remission during follow-up.

The company's personalized cancer vaccine, autogene cevumeran, has entered Phase 2 clinical trials as an adjuvant therapy to treat patients with stage II/III colorectal cancer who are circulating tumor DNA positive after surgery. Two cancer vaccines expressing shared tumor antigens, BNT111 and BNT113, are also being evaluated in Phase 2 clinical trials.

In addition, the company's R&D projects using mRNA-encoded therapeutic antibodies will also enter the clinical stage, where BNT141 encodes an antibody targeting Claudin-18.2, and BNT142 encodes a bispecific antibody targeting CLDN6 and CD3.

Editor: Qijin

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