biopharmaapac.com Open in urlscan Pro
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Form analysis
5 forms found in the DOM

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---

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---

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---

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 * LifeScience
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 * CARsgen Therapeutics Receives NMPA Approval for Breakthrough Multiple Myeloma
   CAR T-Cell Therapy

CARSGEN THERAPEUTICS RECEIVES NMPA APPROVAL FOR BREAKTHROUGH MULTIPLE MYELOMA
CAR T-CELL THERAPY

04 March 2024 | Monday | News



--------------------------------------------------------------------------------

Zevorcabtagene autoleucel, a novel autologous CAR-T product, gains regulatory
green light in China for patients with advanced multiple myeloma, promising a
new era of treatment options.

Image Source : Public Domain

CARsgen Therapeutics, a company focused on innovative CAR T-cell therapies for
the treatment of hematologic malignancies and solid tumors, announces that
today the National Medical Products Administration ("NMPA") of China has
approved the New Drug Application ("NDA") for zevorcabtagene autoleucel (R&D
code: CT053, an autologous CAR-T product candidate against BCMA), for the
treatment of adult patients with relapsed or refractory multiple myeloma who
have previously progressed after at least 3 lines of therapy (including a
proteasome inhibitor and immunomodulator agent).

 

Zevorcabtagene autoleucel is an autologous BCMA-targeted CAR T-cell product,
generated by transducing T cells with a lentivirus encoding a CAR comprising a
fully human BCMA-specific single chain variable fragment ("scFv"), the human
CD8α hinge domain, CD8α transmembrane domain, 4-1 BB co-stimulatory domain and
CD3ζ activation domain. The proprietary novel fully-human scFv has high binding
affinity and stability.

The approval of zevorcabtagene autoleucel is based on an open-label, single arm,
multi-center Phase II clinical trial (LUMMICAR STUDY 1, NCT03975907) conducted
in China. The trial results were released at the 2022 Annual Meeting of the
American Society of Hematology ("ASH"), and zevorcabtagene autoleucel
demonstrated encouraging efficacy and a favorable safety profile.

Multiple myeloma is an incurable malignant plasma cell disorder that accounts
for approximately 10% of all hematological cancers.[1] With China's ageing
population coupled with an increase in life expectancy, the number of patients
with multiple myeloma is expected to expand. Frost & Sullivan forecasts that the
prevalence of multiple myeloma in China in 2023 is approximately 153,000 per
annum, and the number of new cases would be 23,200 per annum. It is estimated
that the prevalence of multiple myeloma in China is expected to grow to 266,300
by 2030.[2]

Prof. Wenming Chen, the principal investigator of the LUMMICAR STUDY 1, Director
of Hematology Department, Beijing Chao-Yang Hospital, Capital Medical
University, said, "In the realm of traditional treatments, the prognosis for
patients dealing with relapsed or refractory multiple myeloma remains notably
grim, given the limitations of available therapeutic alternatives. These
individuals confront substantial unmet clinical needs, necessitating an
expeditious adoption of an effective, safe, and convenient treatment modalities.
The approval of zevorcabtagene autoleucel not only expands the array of choices
available to clinical practitioners but also brings new hope to patients."

Prof. Chengcheng Fu, the principal investigator of the LUMMICAR STUDY 1,
Director of Hematology Department, the First Affiliated Hospital of Soochow
University, said, "Based on the published results of the LUMMICAR-1 study,
zevorcabtagene autoleucel has demonstrated profound and enduring therapeutic
efficacy in patients with relapsed or refractory multiple myeloma, exhibiting
overall favorable tolerability. We are pleased to witness the regulatory
approval and market launch of zevorcabtagene autoleucel. We look forward to its
potential to benefit a larger number of individuals, aiding them in achieving
high-quality, long-term survival."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and
Chief Scientific Officer of CARsgen Therapeutics, said, "This year marks the
tenth anniversary of CARsgen, and I am delighted to announce the NDA approval of
zevorcabtagene autoleucel. This achievement stands as a significant milestone in
the company's development and serves as a testament to the unwavering dedication
of our team. I would like to express heartfelt gratitude to our team members,
investigators, patients, and the broader community for their support and trust.
We look forward to zevorcabtagene autoleucel bringing renewed hope to adult
patients with relapsed or refractory multiple myeloma, thereby improving their
survival. Guided by the vision of 'Making Cancer Curable,' we remain committed
to exploring new technologies, expanding our product pipeline with global rights
to address the major challenges of CAR T-cell therapies, and bringing innovative
and differentiated cell therapies to cancer patients worldwide."



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