SINGAPORE, July 16, 2024 /PRNewswire/ -- Biosyngen, a
leading biotechnology company focused on the development of
innovative cell therapies, recently announced that the Center for
Drug Evaluation (CDE) of the National Medical Products
Administration (NMPA) in China has
approved the initiation of a pivotal Phase ll clinical trial
evaluating BRG01, the company's autologous Epstein-Barr virus (EBV)
specific chimeric antigen receptor T-cell (CAR-T) therapy, for the
treatment of patients with recurrent or metastatic EBV-positive
nasopharyngeal carcinoma. BRG01 is the world's first CAR-T
therapy for solid tumor to obtain clinical trial approvals from
China and the U.S. and to advance
to a pivotal Phase ll clinical trial, representing a
significant milestone in the field of cell-based immuno-therapies
for solid cancers.
"The approval of the Phase ll clinical trial for BRG01 is a
testament to the robust preclinical data and strong early clinical
results observed with this innovative therapy" said Professor
Zhang Li, Director of the Phase l
Ward at the Sun Yat-Sen University Cancer Center and Deputy
Director of the Lung Cancer Research Institute at Sun Yat-sen
University, who is serving as the principal investigator for the
BRG01 clinical trial. "BRG01 has the potential to be a
first-in-class T-cell therapy for EBV-positive tumors, and we are
confident in its ability to deliver meaningful clinical benefits to
patients with this difficult-to-treat malignancy."
The Phase l clinical trial of BRG01 in China and the U.S. has completed patient
enrollment in January this year. All participants have received
BRG01 infusion as part of this registered clinical trial. The Phase
l study has successfully completed assessments of dose-limiting
toxicity (DLT) and preliminary efficacy in nine
patients with advanced nasopharyngeal carcinoma who had
previously been treated with at least one immune checkpoint
inhibitor, such as a PD-1antibody.
Initial data from the study have demonstrated excellent safety
and encouraging signs of clinical activity, with 75% of
high-dose patients experiencing local tumor shrinkage and reduced
metabolic activity on PET-CT scans, and some patients achieving
complete remission of their tumor lesions. Additionally,
BRG01 has shown potent anti-EBV activity, with significant
reductions in peripheral blood EBV viral load observed following
treatment.
These findings underscore BRG01's potential in tumor therapy and
highlight its dual benefits in antiviral treatment, establishing a
robust foundation for future clinical applications. These results
are likely pivotal in the CDE's decision to advance BRG01 to phase
II clinical trials.
BRG01 is an autologous T cell immunotherapy product that has
been engineered to express chimeric receptors targeting the
Epstein-Barr virus (EBV) antigen on the surface of T cells. This
innovative therapy represents a new generation of CAR-T cell
treatment specifically designed to target EBV. BRG01 received phase
I clinical trial approval from the CDE in China in December
2022 and from the FDA in the
United States in February
2023. Subsequently, it was granted orphan drug designation
(ODD) and fast track designation (FTD) by the FDA in June and
July 2023, respectively.
At the annual Meeting of the American Society of Gene and Cell
Therapy (ASGCT) in May, Biosyngen presented preclinical research on
the therapy, and the data was published as an original study in
Frontiers in lmmunology. In addition, at the Gordon Research
Conference (GRC) on Nasopharyngeal Carcinoma held in Switzerland in early June this year,
Biosyngen's scientist and pipeline inventor, Chair of Translational
Immuno-Oncology at the University of Cologne, Professor Renata Stripecke also
presented the results of preclinical research and the latest
clinical data of this therapy.
The development of cell therapy drugs for hematological
malignancies has seen substantial progress, yet advancements in
solid tumor treatments have lagged behind. The FDA's
accelerated approval of lovance's tumor-infiltrating lymphocyte
(TlL) therapy, lifileucel, for the treatment of advanced melanoma
in February represents a significant milestone in the
commercialization of solid tumor cell therapies. This milestone has
bolstered confidence among companies engaged in the development of
cell therapies for solid tumors. However, overcoming the challenges
posed by solid tumors requires a unique and comprehensive approach
from the outset. This approach must encompass considerations
regarding technology, target selection, and indication, ensuring
satisfaction of clinical needs and druggability of the therapeutic
interventions.
As one of the most common head and neck tumors, nasopharyngeal
carcinoma - an epithelial carcinoma arising from the nasopharyngeal
mucosal lining, is closely related to EBV infection. According to
WHO, an estimated number of 133,000 new cases of nasopharyngeal
carcinoma worldwide was reported in 2020; 50% of which was
diagnosed in China. South China provinces such as Guangdong and Guangxi provinces make up for more than 60% of
nasopharyngeal carcinoma patient population in China. Though existing practice such as immune
checkpoint inhibitor has been applied in second-line treatment
of nasopharyngeal carcinoma, overall response rates were
generally below 30%. In another words, more than 70% patients did
not benefit from existing therapy. Therefore, it is imperative
to explore new approaches to improve efficacy and satisfy unmet
medical needs.
The emergence and progression of nasopharyngeal carcinoma are
closely associated with Epstein-Barr virus (EBV) infection. EBV has
infected about 95% of population worldwide. It has been listed as
Group 1 carcinogen ("Carcinogenic to humans") by World Health
Organization (WHO) and proved to be associated with a range of
diseases including nasopharyngeal carcinoma, EBV-positive gastric
cancers, lymphoma and lymphoproliferative diseases. Research
indicates that tumor cells in nasopharyngeal carcinoma frequently
exhibit EBV antigen expression, and EBV-positive tumor cells
display target proteins for CD4+T cells and CD8+T cells,
facilitating the infiltration of EBV-targeting CAR T cells into
tumor tissue to exert a cytotoxic effect.
Leveraging this specific EBV target, CAR T-cell therapy
developed by Biosyngen is also being explored for treating
EBV-positive lymphoma. In April
2023, BRG01 obtained approval from the Drug Evaluation
Center (CDE) and the Food and Drug Administration (FDA) for
clinical trials in this new indication, with Phase I clinical
studies currently ongoing.
Biosyngen has evolved into a biotechnology company
specializing in three major cell therapies for solid tumors and
hematologic malignancies, including CAR-T, TCR-T, and TIL. The
company's therapies utilizing these strategies have all been
granted approvals for clinical trials, with its TCR-T and TIL
therapies targeting various solid tumors such as lung and liver
cancer.
"The approval of BRG01 for a pivotal Phase ll clinical
trial is a major milestone for Biosyngen and underscores our
commitment to developing innovative cell therapies to address
significant unmet needs in solid tumors," said Dr. Michelle Chen, Co-Founder and CEO of
Biosyngen. "We plan to continue investing in research and
development to expedite the clinical progress and market
availability of BRG01, offering more effective treatment options
for patients worldwide."
With Biosyngen's efficient operations and rapid research
outcomes, there is optimism for significant advancements in solid
tumor cell therapies within a shorter timeframe, potentially
bringing new treatment possibilities and hope to patients.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/biosyngens-brg01-enters-phase-ii-clinical-trial-a-first-in-kind-autologous-ebv-specific-car-t-therapy-for-solid-tumors-on-recurrentmetastatic-nasopharyngeal-carcinoma-302197994.html
SOURCE Biosyngen