NANJING, China, July 7, 2022
/PRNewswire/ -- SunHo BioPharmaceutical Co., Ltd. ("SunHo"), a
clinical-stage leading biopharma in immunocytokines with full-set
of capabilities from discovery to commercialization, announced that
IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10
immunocytokine), two first-in-class immunocytokines developed
in-house for the treatment of locally-advanced or metastatic
malignant tumors have entered Phase 1/2 clinical trials. The first
patient has been dosed respectively in June.
"We are excited for achieving this important milestone, which
also marked the first step to what we hope will ultimately allow us
to bring an innovative cancer immunotherapy to patients who
otherwise do not respond to or become relapsed/refractory of
current therapies", said Dr. Liusong Yin, the Executive President
and Chief Science Officer of SunHo, "We focus on innovative
immunocytokines to build the next leading global biopharma of
immunotherapy, and to bring perceivable benefits and affordable
medicine to patients worldwide, by innovation and
collaboration."
About IAP0971
IAP0971 is the world's first PD1-IL15 immunocytokine receiving
IND approval from both FDA and NMPA. It was developed by SunHo
based on their own proprietary and patented AICTM (Armed
ImmunoCytokine) platform.
SunHo designed IAP0971 based on the deep understanding of the
tumor microenvironment and limitations of current immunotherapy. On
the one hand, IL15/IL15Rα complex in IAP0971 specifically binds to
the IL2/15Rβ and IL2/15Rγ expressed on T cells and NK cells and
promotes the proliferation and activation of T cells and NK cells,
without activation of Treg cells or inducing apoptosis of activated
T cells which are common side effects of IL2-based therapies. On
the other hand, the expression of PD1 on CD8+ T cells in tumor
microenvironment is much higher than that in peripheral blood and
peripheral lymphoid organs, so that anti-PD1 antibody in IAP0971
can specifically target IL15 into the tumor immune
microenvironment, to recruit, activate and reinvigorate immune
cells, and achieve a much-enhanced anti-tumor immunity. IAP0971
fuses the anti-PD1 antibody and IL15 cytokine, acts in the same
location and on the same cells at the same time showing great
cis-synergy, which will further improve the effectiveness and
therapeutic window of IAP0971.
The indications of IAP0971 include lung cancer, cervical cancer,
head and neck squamous cell carcinoma, liver cancer, lymphoma, and
other locally-advanced or metastatic malignant tumors.
About IAE0972
IAE0972 is the world's first EGFR-IL10 immunocytokine receiving
IND approval from both FDA and NMPA. It was also developed by SunHo
based on their own proprietary and patented AICTM (Armed
ImmunoCytokine) platform.
IAE0972 was designed to solve the problems of immune cell
exhaustion in current immunotherapy, and to lift the limitations of
current EGFR-based monoclonal antibodies. IL10 in IAE0972 is a
potent activator of antigen-specific CD8+ T cells in the tumor
microenvironment and can restore the tumor-killing activity of
tumor-infiltrating lymphocytes by restoring the oxidative
phosphorylation metabolism of Terminally Exhausted T cells.
Anti-EGFR antibody can specifically enrich IAE0972 in tumor
microenvironment, so that IL10 can reinvigorate antigen specific
CD8+ T cells and facilitate its proliferation, while preserving the
tumor cell proliferation inhibition activities of EGFR antibody.
Relying on the synergy of EGFR antibody and IL10 cytokine, IAE0972
can effectively and specifically activate the immune system to kill
EGFR-positive tumor cells, solving the drug resistance, high skin
toxicities, and other clinical problems of existing drugs.
The indications of IAE0972 include colorectal cancer, head and
neck squamous cell carcinoma, squamous non-small cell lung cancer,
and other locally advanced or metastatic malignant tumors.
About SunHo
SunHo is a clinical-stage biopharmaceutical company dedicated to
the discovery, development, manufacturing, and commercialization of
innovative immunocytokines and bifunctional antibody fusion
proteins in the fields of cancer immunotherapy and autoimmune
diseases.
Sunho has developed proprietary and patented Armed
ImmunoCytokine Platform (AIC™), Armed Innate Effector Multispecific
Platform (AIM™), and ADCC Enhanced Antibody Platform (AEA™). With
profound understanding of immunology and tumor microenvironment,
SunHo strives to identify and meet the most critical clinical
needs, as evidenced by their pipeline of over 20 truly innovative
and differentiated products, of which 4 are undergoing clinical
trials, 4 in IND application and 6 are at the pre-clinical
stage.
SunHo's GMP facilities offer manufacture solutions from drug
substance (DS) to drug product (DP) production. 1× 1000 L and 3×
200 L GMP bioreactor lines are available for DS production, and
another 2x5000 L lines are coming soon. 1× liquid filling line and
1× lyophilization line also cater to the need of aseptic processing
of biologics (liquid and lyophilized preparations) for clinical
trials and commercialization. The quality management system of
SunHo lives up to the expectations of U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA), and
China's National Medicinal
Products Administration (NMPA).
For more information, please visit: www.sunho-bio.com and follow
SunHo on LinkedIn:
www.linkedin.com/company/sunho-china-biopharmaceutical-co-ltd/.
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SOURCE SUNHO (China)
BioPharmaceutical Co., Ltd.