Product candidate FPI-1434, administered at three different dose levels, demonstrated a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity
Imaging shows drug uptake across multiple tumor types
Enrollment in multi-dosing cohorts continues
Fusion also reported preclinical data showing the combination of FPI-1434 with olaparib resulting in synergistic efficacy against colorectal and lung cancer xenografts, and combination with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models
Data featured in oral sessions and posters at the SNMMI 2021 Virtual Annual Meeting
HAMILTON, Canada and BOSTON, MA, USA I June 14, 2021 I Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells.
“The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types,” said Chief Executive Officer John Valliant, Ph.D. “Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity.”
In both the oral session and the poster titled, “Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors,” results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.
Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors
In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.
The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434’s efficacy dominated at higher dose levels.
Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong “vaccine” effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.
Dr. Valliant continued, “We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies.”
Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at https://fusionpharma.com/fusion-scientific-presentations/.
About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.
Fusion’s lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (Pembrolizumab) in patients with solid tumors expressing IGF-1R.
SOURCE: Fusion Pharmaceuticals
Post Views: 163
Product candidate FPI-1434, administered at three different dose levels, demonstrated a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity
Imaging shows drug uptake across multiple tumor types
Enrollment in multi-dosing cohorts continues
Fusion also reported preclinical data showing the combination of FPI-1434 with olaparib resulting in synergistic efficacy against colorectal and lung cancer xenografts, and combination with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models
Data featured in oral sessions and posters at the SNMMI 2021 Virtual Annual Meeting
HAMILTON, Canada and BOSTON, MA, USA I June 14, 2021 I Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells.
“The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types,” said Chief Executive Officer John Valliant, Ph.D. “Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity.”
In both the oral session and the poster titled, “Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors,” results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.
Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors
In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.
The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434’s efficacy dominated at higher dose levels.
Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong “vaccine” effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.
Dr. Valliant continued, “We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies.”
Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at https://fusionpharma.com/fusion-scientific-presentations/.
About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.
Fusion’s lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (Pembrolizumab) in patients with solid tumors expressing IGF-1R.
SOURCE: Fusion Pharmaceuticals
Post Views: 163
