NEWS BRIEF
GE HealthCare’s Pharmaceutical Diagnostics segment develops and manufactures pharmaceutical imaging agents.
GE HealthCare’s Pharmaceutical Diagnostics segment develops and manufactures pharmaceutical imaging agents used to support over 100 million patient imaging procedures per year - equivalent to three patient procedures every second - across all major care pathways. With over 4000 employees globally and seven current Good Manufacturing Practice (cGMP) manufacturing sites, Pharmaceutical Diagnostics products are used in 130+ countries.
Recent news announcements focus on shaping the future of Molecular Imaging to enable Precision Care.
New Data Validating Artificial Intelligence Models for Predicting Patient Response to Immunotherapies
GE HealthCare announced new data validating Artificial Intelligence (AI) models for predicting patient response to immunotherapies with 70 to 80 percent accuracy, based on a pan-cancer cohort, according to findings presented on Saturday, November 4th at the Society for Immunotherapy of Cancer (SITC) in San Diego, U.S.
Originally developed based on a cohort of over 3,000 immunotherapy patients from Vanderbilt University Medical Center (VUMC) and subsequently validated on a cohort of 4,000 patients from the University Medicine Essen, Germany (UME), the AI models predict efficacy outcomes and the likelihood of an individual patient developing an adverse reaction. This could enable precision care by unlocking the potential for clinicians to select the appropriate personalized treatment pathway sooner while potentially sparing unnecessary side effects and cost.
Investment co-led by GE HealthCare in Nucleus RadioPharma to Expand Production of Radiopharmaceutical Treatments for Cancer Patients
Nucleus RadioPharma, a Contract Development and Manufacturing Organization (CDMO), announced $56 Million Series A Funding secured to expand production of radiopharmaceutical treatments for cancer patients. Co-led by Eclipse and GE HealthCare, the investment will accelerate research, streamline supply chains, and make targeted radiopharmaceutical therapies accessible.
Nucleus aims to advance radiopharmaceutical treatments through clinical trials to commercialization utilizing new manufacturing facilities around the U.S. Nucleus can establish itself as a leading CDMO to make targeted radiotherapies and Theranostics more accessible to patients and to accelerate clinical trials.
GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment brings experience and expertise of developing, producing and commercializing radiopharmaceuticals reliably, globally and at scale. Through this investment, PDx will be participating in the high growth segment of radiotherapeutics, addressing one of the key pain points that exists today within the supply chain.
SOFIE and GE HealthCare Enter Licensing Agreement to Develop FAP PET Radiotracers
GE HealthCare announced an exclusive global licensing agreement with SOFIE Biosciences to develop, manufacture and commercialize SOFIE’s Gallium-68 and Fluorine-18 labelled diagnostics targeting fibroblast activation protein (FAP).
FAP is an enzyme highly expressed in cancer associated fibroblasts (CAF), a key component of the tumor microenvironment which supports the growth and spread of cancerous cells. The development of FAP-targeted diagnostics holds great potential in oncology as well as other conditions including inflammation, fibrosis and arthritis.
Based on this agreement, GE HealthCare will take on global rights for [68Ga]FAPI-46 and outside-U.S. rights for [18F]FAPI-74, both currently in Phase II clinical trials in the U.S.; [68Ga]FAPI-46 and [18F]-FAPI-74. SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S.
Unlocking the Potential of Immunotherapy in Cancer Treatment
Immunotherapies use the immune system to recognize and attack cancer cells and can be more effective than traditional treatments, but response rates are often low and side effects can be severe. GE HealthCare is addressing these challenges by developing diagnostics that aim to help identify a patient’s likelihood to respond to immunotherapies before starting cancer treatment, as well as enabling faster and earlier monitoring of a patient’s response once they start treatment. This could help avoid unnecessary treatment for those less likely to respond, or those not responding, who could be offered alternative treatment options earlier.
First ever 18F-CD8 PET imaging radiopharmaceutical in human clinical trials
With immunotherapy emerging as one of the most important treatment options in oncology, GE HealthCare has announced the first patient scanned in a Phase I clinical trial of a first-of-its kind fluorine-18 PET radiopharmaceutical ([18F]GEH200521) specific for CD8, which is expressed on CD8+ T cells – a subpopulation of white blood cells which fight cancer. The clinical trial will use this investigational radiopharmaceutical to help understand if patients have CD8+ T cells in their tumors and will, therefore, be more likely to respond to immune checkpoint inhibitors, the main class of immunotherapies currently approved for use. The study will also then help identify early response to immunotherapies, using sequential whole-body imaging to monitor CD8 changes over time, enabling physicians to switch patients who are not responding to alternative treatment options sooner.
FES for imaging recurrent or metastatic breast cancer included in the NCCN clinical practice guidelines in oncology
GE HealthCare has announced that NCCN Guidelines® for clinicians and patients now recommend the use of FES PET for ER+ positive disease under certain circumstances during the systemic staging workup of patients with recurrent or metastatic breast cancer. GE HealthCare’s Cerianna, available in the U.S., is the only FDA approved FES PET imaging agent. This inclusion in the NCCN Guidelines comes after the Society of Nuclear Medicine and Molecular Imaging (SNMMI) recently published Appropriate Use Criteria to guide referring and imaging physicians in appropriate use of estrogen receptor (ER)-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol.
MEDIA CONTACT
Mathilde Bouscaillou
M: +33 6 47 00 82 71
Mathilde.bouscaillou@ge.com
Recent news announcements focus on shaping the future of Molecular Imaging to enable Precision Care.
New Data Validating Artificial Intelligence Models for Predicting Patient Response to Immunotherapies
GE HealthCare announced new data validating Artificial Intelligence (AI) models for predicting patient response to immunotherapies with 70 to 80 percent accuracy, based on a pan-cancer cohort, according to findings presented on Saturday, November 4th at the Society for Immunotherapy of Cancer (SITC) in San Diego, U.S.
Originally developed based on a cohort of over 3,000 immunotherapy patients from Vanderbilt University Medical Center (VUMC) and subsequently validated on a cohort of 4,000 patients from the University Medicine Essen, Germany (UME), the AI models predict efficacy outcomes and the likelihood of an individual patient developing an adverse reaction. This could enable precision care by unlocking the potential for clinicians to select the appropriate personalized treatment pathway sooner while potentially sparing unnecessary side effects and cost.
Investment co-led by GE HealthCare in Nucleus RadioPharma to Expand Production of Radiopharmaceutical Treatments for Cancer Patients
Nucleus RadioPharma, a Contract Development and Manufacturing Organization (CDMO), announced $56 Million Series A Funding secured to expand production of radiopharmaceutical treatments for cancer patients. Co-led by Eclipse and GE HealthCare, the investment will accelerate research, streamline supply chains, and make targeted radiopharmaceutical therapies accessible.
Nucleus aims to advance radiopharmaceutical treatments through clinical trials to commercialization utilizing new manufacturing facilities around the U.S. Nucleus can establish itself as a leading CDMO to make targeted radiotherapies and Theranostics more accessible to patients and to accelerate clinical trials.
GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment brings experience and expertise of developing, producing and commercializing radiopharmaceuticals reliably, globally and at scale. Through this investment, PDx will be participating in the high growth segment of radiotherapeutics, addressing one of the key pain points that exists today within the supply chain.
SOFIE and GE HealthCare Enter Licensing Agreement to Develop FAP PET Radiotracers
GE HealthCare announced an exclusive global licensing agreement with SOFIE Biosciences to develop, manufacture and commercialize SOFIE’s Gallium-68 and Fluorine-18 labelled diagnostics targeting fibroblast activation protein (FAP).
FAP is an enzyme highly expressed in cancer associated fibroblasts (CAF), a key component of the tumor microenvironment which supports the growth and spread of cancerous cells. The development of FAP-targeted diagnostics holds great potential in oncology as well as other conditions including inflammation, fibrosis and arthritis.
Based on this agreement, GE HealthCare will take on global rights for [68Ga]FAPI-46 and outside-U.S. rights for [18F]FAPI-74, both currently in Phase II clinical trials in the U.S.; [68Ga]FAPI-46 and [18F]-FAPI-74. SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S.
Unlocking the Potential of Immunotherapy in Cancer Treatment
Immunotherapies use the immune system to recognize and attack cancer cells and can be more effective than traditional treatments, but response rates are often low and side effects can be severe. GE HealthCare is addressing these challenges by developing diagnostics that aim to help identify a patient’s likelihood to respond to immunotherapies before starting cancer treatment, as well as enabling faster and earlier monitoring of a patient’s response once they start treatment. This could help avoid unnecessary treatment for those less likely to respond, or those not responding, who could be offered alternative treatment options earlier.
First ever 18F-CD8 PET imaging radiopharmaceutical in human clinical trials
With immunotherapy emerging as one of the most important treatment options in oncology, GE HealthCare has announced the first patient scanned in a Phase I clinical trial of a first-of-its kind fluorine-18 PET radiopharmaceutical ([18F]GEH200521) specific for CD8, which is expressed on CD8+ T cells – a subpopulation of white blood cells which fight cancer. The clinical trial will use this investigational radiopharmaceutical to help understand if patients have CD8+ T cells in their tumors and will, therefore, be more likely to respond to immune checkpoint inhibitors, the main class of immunotherapies currently approved for use. The study will also then help identify early response to immunotherapies, using sequential whole-body imaging to monitor CD8 changes over time, enabling physicians to switch patients who are not responding to alternative treatment options sooner.
FES for imaging recurrent or metastatic breast cancer included in the NCCN clinical practice guidelines in oncology
GE HealthCare has announced that NCCN Guidelines® for clinicians and patients now recommend the use of FES PET for ER+ positive disease under certain circumstances during the systemic staging workup of patients with recurrent or metastatic breast cancer. GE HealthCare’s Cerianna, available in the U.S., is the only FDA approved FES PET imaging agent. This inclusion in the NCCN Guidelines comes after the Society of Nuclear Medicine and Molecular Imaging (SNMMI) recently published Appropriate Use Criteria to guide referring and imaging physicians in appropriate use of estrogen receptor (ER)-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol.
MEDIA CONTACT
Mathilde Bouscaillou
M: +33 6 47 00 82 71
Mathilde.bouscaillou@ge.com