The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in patients with advanced cancers expressing PIWIL1
First immunotherapy program to target PIWIL1, a cancer-testis antigen overexpressed in a range of cancers, including colorectal cancer
OXFORDSHIRE, UK & CONSHOHOCKEN, PA & ROCKVILLE, MD, USA I December 17, 2024 I Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announces that the first patient has been treated in the Phase 1/2 trial of its novel ImmTAC candidate, IMC-R117C, targeting PIWIL1 in colorectal and other gastrointestinal cancers.
IMC-R117C is Immunocore’s fifth ImmTAC candidate to enter the clinic. PIWIL1 is overexpressed in multiple malignancies, including colorectal cancer (CRC), and is associated with aggressive tumor growth and poor patient survival.i Despite the development and approval of novel therapeutics, there remains a significant unmet medical need in patients with these cancers, especially in advanced colorectal cancer that is refractory to or has relapsed following standard chemotherapies and targeted therapies.
The Company believes IMC-R117C is the first PIWIL1-targeted immunotherapy and estimates that there are up to 20,000 colorectal cancer patients globally that are positive for both PIWIL1 and HLA-A*02:01.
“We are proud to bring forward the first immunotherapy program to target PIWIL1, through our novel ImmTAC candidate, IMC-R117C,” said Mohammed Dar, Senior Vice President, Clinical Development and Chief Medical Officer of Immunocore. “PIWIL1 is expressed across all major subsets of colorectal cancer – including microsatellite-stable CRC, which has historically been insensitive to immunotherapy.”
The trial will evaluate the safety and clinical activity of IMC-R117C in HLA-A*02:01-positive patients with select advanced solid tumors. In addition to evaluating IMC-R117C as a single agent, the trial will also test combinations with standards of care.
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About ImmTAC® molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.
About the Phase 1/2 trial of IMC-R117C
IMC-R117C-1004 is a Phase 1/2, multicenter, open-label, first-in-human trial of IMC-R117C in HLA-A*02:01-positive patients with advanced cancers that express PIWIL1. This trial is designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and clinical activity of IMC-R117C as monotherapy and in combination with other therapies.
About colorectal cancer
Colorectal cancer (CRC) is one of the most prevalent forms of cancer affecting the colon and rectum. Most patients with CRC are diagnosed at an early stage, but survival rates remain low for those with advanced or metastatic disease. Despite advancements in CRC treatment, there is a significant need for new therapies that enhance first-line response rates and extend the duration of response, particularly for patients who do not respond to initial treatments. Early detection through regular screening is crucial for improving outcomes associated with CRC.
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases, and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
i Sun, Rui, Chun-li Gao, Dong-hai Li, Bo-jun Li, and Yan-hong Ding. 2017. “Expression Status of PIWIL1 as a Prognostic Marker of Colorectal Cancer.” Disease Markers 2017:1204937. https://doi.org/10.1155/2017/1204937
SOURCE: Immunocore
Post Views: 192
The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in patients with advanced cancers expressing PIWIL1
First immunotherapy program to target PIWIL1, a cancer-testis antigen overexpressed in a range of cancers, including colorectal cancer
OXFORDSHIRE, UK & CONSHOHOCKEN, PA & ROCKVILLE, MD, USA I December 17, 2024 I Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announces that the first patient has been treated in the Phase 1/2 trial of its novel ImmTAC candidate, IMC-R117C, targeting PIWIL1 in colorectal and other gastrointestinal cancers.
IMC-R117C is Immunocore’s fifth ImmTAC candidate to enter the clinic. PIWIL1 is overexpressed in multiple malignancies, including colorectal cancer (CRC), and is associated with aggressive tumor growth and poor patient survival.i Despite the development and approval of novel therapeutics, there remains a significant unmet medical need in patients with these cancers, especially in advanced colorectal cancer that is refractory to or has relapsed following standard chemotherapies and targeted therapies.
The Company believes IMC-R117C is the first PIWIL1-targeted immunotherapy and estimates that there are up to 20,000 colorectal cancer patients globally that are positive for both PIWIL1 and HLA-A*02:01.
“We are proud to bring forward the first immunotherapy program to target PIWIL1, through our novel ImmTAC candidate, IMC-R117C,” said Mohammed Dar, Senior Vice President, Clinical Development and Chief Medical Officer of Immunocore. “PIWIL1 is expressed across all major subsets of colorectal cancer – including microsatellite-stable CRC, which has historically been insensitive to immunotherapy.”
The trial will evaluate the safety and clinical activity of IMC-R117C in HLA-A*02:01-positive patients with select advanced solid tumors. In addition to evaluating IMC-R117C as a single agent, the trial will also test combinations with standards of care.
###
About ImmTAC® molecules for cancer
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.
About the Phase 1/2 trial of IMC-R117C
IMC-R117C-1004 is a Phase 1/2, multicenter, open-label, first-in-human trial of IMC-R117C in HLA-A*02:01-positive patients with advanced cancers that express PIWIL1. This trial is designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and clinical activity of IMC-R117C as monotherapy and in combination with other therapies.
About colorectal cancer
Colorectal cancer (CRC) is one of the most prevalent forms of cancer affecting the colon and rectum. Most patients with CRC are diagnosed at an early stage, but survival rates remain low for those with advanced or metastatic disease. Despite advancements in CRC treatment, there is a significant need for new therapies that enhance first-line response rates and extend the duration of response, particularly for patients who do not respond to initial treatments. Early detection through regular screening is crucial for improving outcomes associated with CRC.
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases, and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
i Sun, Rui, Chun-li Gao, Dong-hai Li, Bo-jun Li, and Yan-hong Ding. 2017. “Expression Status of PIWIL1 as a Prognostic Marker of Colorectal Cancer.” Disease Markers 2017:1204937. https://doi.org/10.1155/2017/1204937
SOURCE: Immunocore
Post Views: 192
