The U.S. FDA grants Janssen the BCMA/CD dual anti-breakthrough therapy designation medical Maimeng broke

Recent popular reports by Yimike ★ The article elaborates: CAR-T production whole-process solution combing ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? MedClub New Observation June 3, 2021/MedClub News/--Recently, Janssen, a subsidiary of Johnson & Johnson, announced that the FDA has granted its bispecific antibody teclistamab breakthrough therapy designation.
It is currently being evaluated in phase II clinical trials for the treatment of patients with relapsed/refractory multiple myeloma.

Prior to this, the European Commission and the US Food and Drug Administration respectively granted teclistamab orphan drug designation in 2020.

In January 2021, teclistamab was granted PRIME (Priority Medicine) designation by the European Medicines Agency (EMA).

teclistamab is a ready-made T cell redirecting bispecific antibody against B cell maturation antigen (BCMA) and CD3 receptor.
BCMA is the most selectively expressed receptor on the MM cell line, and its expression level is in multiple myeloma As the disease progresses gradually, Teclistamab can redirect CD3-positive T cells to the vicinity of multiple myeloma cells expressing BCMA and activate immune function against tumor cells.

The latest clinical results published by ASH showed that among patients treated with subcutaneous teclistamab in the phase II clinical trial, the overall response rate (ORR) reached 73% (n=16/22), and the patients who achieved partial response (PR) were 55%, and 23% of patients achieved complete remission (CR) in a strict sense.

At a median follow-up time of 3.
9 months, 95% (n=15/16) patients had no disease progression after remission, and the cellular response deepened over time.

At a median follow-up time of 6.
1 months, the total remission rate of patients receiving the recommended dose in the phase II clinical trial reached 65%, and 40% of the patients achieved complete remission, and the median duration of remission had not yet been reached.

▲ Dr.
Peterna Lebwitz, Head of Global Oncology, Janssen R&D Department (Picture of Janssen Source: Johnson & Johnson) "We are very pleased that our new bispecific antibody teclistamab has obtained breakthrough therapy and PRIME designation.

" Peterna Lebwitz , Head of Global Oncology, Janssen R&D Department Dr.
Lebowitz said, “This project demonstrates our commitment to advancing scientific development for patients with multiple myeloma.
It is based on our strong product portfolio in this disease.

” The field of myeloma has been deeply cultivated for a long time, and this is also its first therapeutic area in the direction of hematological tumors.
In 2019, Janssen released the combination of daratumumab to treat the relapse of resistance to lenalidomide and proteasome inhibitor (PI) Patients with multiple myeloma.

In 2020, Janssen and Legend Bio jointly developed the BCMA antigen-targeted CAR-T therapy Cilta-cel.

This CAR-T therapy has also received the breakthrough therapy designation granted by the FDA.

Janssen's research in the field of cellular immunotherapy has given more options for the treatment of multiple myeloma.

Current status of bispecific antibodies at home and abroad Bispecific antibodies are one of the hottest fields in current medical research and development.

As of today, a total of four bispecific antibodies have been approved for marketing worldwide, including Trion Pharma’s Catumaxomab (Catumaxomab) targeting CD3 and EpCAM, and Amgen’s Blinatumomab (Blinatumomab) targeting CD3 and CD19.
), Roche targeted FIX and FX Emicizumab (Emicizumab), and Johnson & Johnson's Janssen EGFR/cMET double antibody Rybrevant (amivantamab-vmjw).

Among them, Trion Pharma's catumaxomab was officially withdrawn from the market in June 2017 due to the miserable market sales situation.
Therefore, there are currently three bispecific antibody drugs on the market.

 Focusing on the domestic market, the era of dual-antibiotics is approaching.
Domestic biopharmaceutical companies have high expectations for dual-antibiotic drugs.
They tend to enter the wave of research and development of innovative dual-antibiotic drugs through investment, mergers and acquisitions, and license in, and promote the development of the industry with the power of capital.
Deeply participate in the research and development of dual-antibody drugs.

Related companies include CSPC, Yifan Pharmaceutical, Saisheng Pharmaceutical, Buchang Pharmaceutical, etc.

 How to break through the technical barriers of domestic dual-resistant products and move towards market-oriented industrialization still requires continuous exploration in the industry.
The domestic hot target track is crowded, but differentiated innovation is gradually emerging.

We have reason to believe that with continuous breakthroughs in concepts and technologies, the field of double antibodies will bring more surprises to future disease treatments.

Reference: https:// -multiple-myeloma/YiMike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights of bio-innovative drugs.
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