CAMBRIDGE, MA, USA I July 22, 2024 I Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
“HER2 alterations are an important category of oncogenic drivers within NSCLC that includes both HER2 amplification and HER2 mutations, the majority of which are exon 20 mutations. While HER2- targeted therapies have been developed, there are currently no approved TKIs for the HER2-mutant NSCLC patient population,” said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. “At the outset of our program, physician-scientists outlined the need for a HER2 therapy that maintained activity against HER2 exon 20 mutations, was selective for HER2 versus wild-type EGFR to limit gastrointestinal and skin toxicities associated with EGFR inhibition, and was brain penetrant to address and limit brain metastases. NVL-330’s preclinical profile has demonstrated the potential to be differentiated through combining these desired characteristics, and supports its initial clinical investigation in our HEROEX-1 trial for patients with HER2-altered NSCLC.”
HEROEX-1 is a Phase 1a/1b, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-330 in pre-treated patients with advanced HER2-altered NSCLC, including those with HER2 exon 20 mutations. The trial will evaluate the overall safety and tolerability of NVL-330. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.
“The initiation of this trial represents a significant milestone for Nuvalent, marking the third program from our novel pipeline to enter clinical development in under three years,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “This rapid execution serves as a testament to our team’s dedication to rapid progress and growth across our pipeline, and our unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer.”
About NVL-330
NVL-330 is a novel brain-penetrant HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-altered tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases. NVL-330 is currently being investigated in the HEROEX-1 Phase 1a/1b clinical trial for pre-treated patients with advanced HER2-altered NSCLC.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.
SOURCE: Nuvalent
Post Views: 5,948
CAMBRIDGE, MA, USA I July 22, 2024 I Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
“HER2 alterations are an important category of oncogenic drivers within NSCLC that includes both HER2 amplification and HER2 mutations, the majority of which are exon 20 mutations. While HER2- targeted therapies have been developed, there are currently no approved TKIs for the HER2-mutant NSCLC patient population,” said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. “At the outset of our program, physician-scientists outlined the need for a HER2 therapy that maintained activity against HER2 exon 20 mutations, was selective for HER2 versus wild-type EGFR to limit gastrointestinal and skin toxicities associated with EGFR inhibition, and was brain penetrant to address and limit brain metastases. NVL-330’s preclinical profile has demonstrated the potential to be differentiated through combining these desired characteristics, and supports its initial clinical investigation in our HEROEX-1 trial for patients with HER2-altered NSCLC.”
HEROEX-1 is a Phase 1a/1b, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-330 in pre-treated patients with advanced HER2-altered NSCLC, including those with HER2 exon 20 mutations. The trial will evaluate the overall safety and tolerability of NVL-330. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.
“The initiation of this trial represents a significant milestone for Nuvalent, marking the third program from our novel pipeline to enter clinical development in under three years,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “This rapid execution serves as a testament to our team’s dedication to rapid progress and growth across our pipeline, and our unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer.”
About NVL-330
NVL-330 is a novel brain-penetrant HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-altered tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases. NVL-330 is currently being investigated in the HEROEX-1 Phase 1a/1b clinical trial for pre-treated patients with advanced HER2-altered NSCLC.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.
SOURCE: Nuvalent
Post Views: 5,948
