Elevation acquired Seribantumab in 2019. The development program builds on prior clinical experience from over 800 patients demonstrating consistent safety and tolerability.
FREMONT, CA: Clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, Elevation Oncology, announced the launch of the company with a USD 32.5 million Series A funding round led by Aisling Capital and a syndicate of investors including Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners. The company also announced the initiation of Phase 2 CRESTONE study, and new partnerships with Next Generation Sequencing diagnostic providers including Ashion Analytics, Strata Oncology, and Tempus to explore innovative models for real-time identification, patient referral, and enrollment of patients with tumors driven by rare genomic alterations.
"At Elevation Oncology, we envision a future in which each unique genomic testing result can be matched with a purpose-built precision medicine and bring clarity to the patient treatment journey. Focused drug development paired with open collaboration will be instrumental for our industry to fully realize the potential of precision medicine for all patients with cancer," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "With our lead development program, seribantumab, and the partnerships announced today, we are taking our first steps toward this future."
Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (ERBB3 or HER3). HER3 is traditionally activated through the binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner gene to create chimeric NRG1 fusion proteins. Elevation acquired Seribantumab in 2019. The development program builds on prior clinical experience from over 800 patients demonstrating consistent safety and tolerability. Previous clinical trials with Seribantumab did not select for tumors with an NRG1 fusion. The CRESTONE study leverages seribantumab's rational design with recent discoveries on the significance of the NRG1 gene fusion and improvements in diagnostic sensitivity.
"Genomic testing and matched precision therapeutics are creating a revolution in oncology development and regulatory approval paths," said Lori Kunkel, MD, Chair of the Elevation Oncology Scientific Advisory Board and former Chief Medical Officer LOXO Oncology. "The FDA has recently approved several oncology therapeutics for tumor-agnostic indications. I am encouraged to see the evolution in our understanding of how to achieve better clinical outcomes to address the unmet clinical need among patients with a genomically defined cancer, regardless of its tissue of origin. The CRESTONE study potentially expands the actionability of genomic tests to tumors with an NRG1 fusion and is a promising approach for furthering this genomically-driven tumor-agnostic development pathway."