SINGAPORE, June 30,
2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd
(SCG), a biotechnology company developing novel immunotherapies for
infectious diseases and their associated cancers, today announced
that U.S. Food and Drug Administration (FDA) has approved the
Investigational New Drug (IND) application to initiate Phase 1/2
clinical trial for SCG142, a novel next-generation human
papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR
T) cell therapy for patients with HPV-associated solid tumors.
"This FDA IND approval of another TCR T cell therapy candidate
generated from our proprietary GianTCRTM
platform is an important milestone for SCG. It marks the
advancement of our TCR-based therapeutic program to treat unmet
needs in different major cancer indications", said Christy Ma, Chief Executive Officer of SCG Cell
Therapy. "We are ready to commence multi-center Phase 1/2
clinical trials, assessing the potential benefits for patients via
our proprietary TCR T technology."
SCG142 is a high-avidity fully natural HPV-specific TCR armoured
with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of
SCG142 at the American Society of Gene & Cell Therapy (ASGCT)
Annual Meeting. The data indicates SCG142 had exhibited high
polyfunctional avidity. It recognized both HPV-16 and HPV-52
genotypes, with a favourable safety profile with no alloreactivity
or off-target toxicity. In addition, SCG142 demonstrated dual CD8
and CD4 TCR T cell proliferation and tumor inhibition in both
in vitro and in vivo models, indicating CD8
co-receptor independent T cell functionality, as well as promoting
long-term persistence of memory T cells.
"SCG142 is a novel and differentiated HPV-specific TCR T cell
therapy. By armoring the TCR T cells with the chimeric switch
receptor, it overcomes the hostile tumor microenvironment and
converts inhibitory effects into a co-stimulatory signal. This
process is essential for effective immunotherapy treatment of solid
tumors. With this unique next-generation design, SCG142 represents
a groundbreaking innovation that translates from our in-house
discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell
Therapy.
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About Human Papillomavirus and Cancers
Human papillomavirus (HPV) is the most common sexually
transmitted infection. Nearly all sexually active people will be
infected with HPV at some point in their lives.
Approximately half of these infections are with a
high-risk HPV type, which can lead to cancer[1]. HPV
infection accounts for more than 90% of anal and cervical cancers,
about 70% of vaginal and vulvar cancers, and 60% of penile and
oropharynx cancers. An estimated 630,000 new cancer cases and
350,000 deaths worldwide each year are resulted from HPV (related)
infection.[2]
About SCG Cell Therapy
SCG is a leading biotechnology company focusing on the
development of novel immunotherapies in infections and its
associated cancers. The company targets the most common
cancer-causing infections: helicobacter pylori, HPV, HBV and EBV,
and develops a broad and unique pipeline of TCR-based cellular
immunotherapy products against infections associated cancers. With
the proprietary GianTCRTM novel TCR screening platform
and AutocellTM fully closed and automatic cell therapy
manufacturing system, the company covers the entire value chain,
from new target research and discovery, manufacturing, and clinical
development. For more information about SCG, please visit us at
www.scgcell.com.
[1] HPV and Cancer. National
Cancer Institution. October 2023.
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[2] Basic Information about
HPV and Cancer. U.S. Centers for Disease Control and Prevention.
November 2023.
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SOURCE SCG Cell Therapy Pte Ltd