On January 10, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that highlighted its 2021 corporate achievements and outlined its expected milestones for 2022 (Press release, Elevation Oncology, JAN 10, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-highlights-2021-achievements-and-outlines-expected-2022-milestones [SID1234605454]). Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer, will present these corporate priorities on Wednesday, January 12, 2022, at 9:45 a.m. ET at the virtual 40th Annual J.P. Morgan Healthcare Conference.
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"In 2021, Elevation Oncology made outstanding operational progress, marked by the advancement of seribantumab in the Phase 2 CRESTONE study, a successful initial public offering, strong growth in building an industry-leading team, and the launch of a novel partnership with Caris Life Sciences to accelerate the identification of new, actionable genomic targets for potential future drug development," said Dr. Leland. "Looking ahead, 2022 is set to be a transformative year with the planned reporting of our initial clinical data for seribantumab on approximately 10 patients from Cohort 1 in the Phase 2 CRESTONE study in mid-2022. A priority throughout 2022 is to execute on our strategy aimed at expanding our product candidate pipeline, including maximizing the potential of seribantumab, advancing new discoveries through our Caris Life Sciences collaboration, and progressing our ongoing business development activities. We believe we are well-positioned to deliver on our mission to advance precision medicines for patients with genomically defined cancers."
2021 Key Corporate Achievements
Seribantumab
Launched new global clinical trial sites with the Phase 2 CRESTONE study now enrolling patients across the US, Australia, and Canada
Announced an investigator-presented case study under a compassionate use program that highlighted a patient with pancreatic cancer harboring an NRG1 fusion and treated with seribantumab which showed a confirmed partial response and durable clinical benefit
Established 3 grams weekly as the optimized dose for the Phase 2 CRESTONE study
Presented new preclinical data on additional tumor models harboring an NRG1 fusion at AACR (Free AACR Whitepaper) 2021
Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models in Clinical Cancer Research
Business Objectives
Entered into a joint discovery and development collaboration with Caris Life Sciences whereby the partners will utilize the diagnostic data to accelerate the identification of new, actionable genomic alterations for potential future drug development
Formed new strategic diagnostic collaborations bringing the total diagnostic consortium to a total of 10 patient identification collaborators for the Phase 2 CRESTONE study
Completed a successful initial public offering, raising $106.5 million in gross proceeds, before deducting underwriting discounts, commissions, and estimated offering expenses
Strengthened corporate leadership team with the addition of Joseph Ferra as Chief Financial Officer, the promotion of Valerie Malyvanh Jansen, MD, PhD to Chief Medical Officer and the appointment of R. Michael Carruthers to the Board of Directors
Expected 2022 Milestones and Operational Objectives
Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Ongoing target evaluation and continued execution of our strategy for future pipeline expansion
Financial Outlook
Elevation Oncology anticipates that cash and cash equivalents totaling $155.2 million as of September 30, 2021 are expected to fund current operations into the second quarter of 2023.
Webcast
A live audio webcast of Dr. Leland’s presentation will be available on January 12, 2022 at 9:45 a.m. ET within the Investors & Media section of the Elevation Oncology website. An archived replay will be accessible following the event for a period of 30 days.
About Seribantumab and NRG1 Gene Fusions
Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.
NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.
About the Phase 2 CRESTONE Study
Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.