In addition, the Phase II CRESTONE study has begun, examining the efficacy and safety of seribantumab in patients with solid tumors that feature a neuregulin-1 (NRG1) fusion.
Clinical stage biopharmaceutical company Elevation Oncology emerged from stealth today with the conclusion of a $32.5 million Series A financing round. In addition, the Phase II CRESTONE study has begun, examining the efficacy and safety of seribantumab in patients with solid tumors that feature a neuregulin-1 (NRG1) fusion.
“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,” said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. “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. With our lead development program, seribantumab, and the partnerships announced today, we are taking our first steps toward this future.”
Aisling Capital led the Series A financing round, with additional contributions from Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners. Elevation Oncology has also established new partnerships with Next Generation Sequencing diagnostic providers including Ashion Analytics, Strata Oncology and Tempus. The goal is to look into new models for the real-time identification, patient referral and enrollment of patients with tumors driven by rare genomic alterations.
Seribantumab, which is being examined in the CRESTONE trial, is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is typically activated through the binding of its primary ligand, NRG1. The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner gene to develop chimeric NRG1 “fusion proteins.”
Elevation Oncology acquired seribantumab back in 2019. Its development program is building upon prior clinical experience from more than 800 patients demonstrating consistent safety and tolerability. However, previous clinical trials with seribantumab did not select for tumors with an NRG1 fusion. The CRESTONE study will leverage seribantumab’s design with recent discoveries on the significance of the NRG1 gene fusion.
“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,” said Lori Kunkel, MD, Chair of the Elevation Oncology Scientific Advisory Board and former Chief Medical Officer LOXO Oncology.
This is not the first time a company has explored potential uses for seribantumab. Merrimack Pharmaceuticals announced back in 2018 that it had initiated a Phase II trial involving patients with non-small cell lung cancer, utilizing seribantumab as a form of treatment. However, the product missed the mark in the study, failing to improve progression-free survival after being added to docetaxel.
“We are very disappointed by the outcome of this study, in particular for patients and families facing this difficult diagnosis,” said Sergio Santillana, M.D., M.Sc., Chief Medical Officer of Merrimack, following the announcement of the trial results. “We deeply appreciate the support from all investigators, patients and their families who participated in this trial. We also want to recognize our team’s efforts and commitment to the development of MM-121 [seribantumab] in non-small cell lung cancer over the past several years.”
After the conclusion of the failed Phase II trial, Merrimack announced that it would be conducting a comprehensive review of its drug candidate pipeline. In addition, it stated that assess the impact of these results on the continued development of seribantumab, which is one of its lead drug candidates.
