On January 6, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported it plans to prioritize key research and development efforts to advance EO-3021, its potential best-in-class antibody-drug conjugate (ADC) designed to target Claudin18.2, and other pipeline programs including those through its existing partnership with Caris Life Sciences (Press release, Elevation Oncology, JAN 6, 2023, View Source [SID1234625987]).
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Elevation Oncology is pausing further investment in the clinical development of seribantumab and realigning its resources to focus on advancing EO-3021 and other pipeline programs. Elevation Oncology intends to pursue further development of seribantumab only in collaboration with a partner.
In addition, the Company announced that Shawn M. Leland, PharmD, RPh, has resigned from his role as Chief Executive Officer and a member of the Board of Directors, effective immediately. The Board of Directors has appointed Joseph J. Ferra as Interim Chief Executive Officer. Mr. Ferra will remain as the Company’s Chief Financial Officer, and lead Elevation Oncology along with Valerie Malyvanh Jansen, MD, PhD, Chief Medical Officer and David Dornan, PhD, Chief Scientific Officer.
"We remain focused on developing innovative cancer therapies to treat patients with significant unmet medical needs, and in EO-3021 we believe we have a potential best-in-class asset that can target solid tumors expressing Claudin18.2 and plan to enter the clinic in the US in the second half of 2023," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "In light of our ongoing evaluation of our pipeline, we are pausing further investment in the development of seribantumab and the CRESTONE study. Additionally, we have made the difficult decision to reduce our workforce which will enable us to realign our resources towards advancing EO-3021 and additional pipeline programs. We would like to extend our deepest gratitude to the patients and their families, the investigators and study teams as well as our employees for their invaluable contributions to the CRESTONE study."
"Shawn’s dedication and leadership were instrumental in the founding and building of Elevation Oncology. On behalf of the Board of Directors, I would like to sincerely thank Shawn for his many contributions and his stewardship of the company," said Steve Elms, Chairman of the Board of Directors of Elevation Oncology. "We have the utmost confidence in Joe’s ability to lead Elevation Oncology as Interim CEO during this time of significant transition for the Company in order to realize the full potential of EO-3021, and additional pipeline programs, to benefit patients with significant unmet medical needs."
Strategic Actions Summary
EO-3021:
EO-3021 is a potential best-in-class, clinical-stage ADC designed to target Claudin18.2 and selectively deliver a cytotoxic payload directly to kill cancer cells. Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types including many gastrointestinal cancers such as gastric, gastroesophageal junction and pancreatic cancer.
Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (HKEX: 01093), is actively recruiting patients in the Phase I clinical trial of EO-3021 (SYSA1801) in China (NCT05009966).
The Investigational New Drug (IND) filing has been cleared in the US and transferred to Elevation Oncology.
Elevation Oncology plans to present preclinical proof-of-concept data of EO-3021 at a major medical conference in the first half of 2023.
Preparations are ongoing to initiate a Phase 1 clinical trial of EO-3021 in the US in the second half of 2023.
Seribantumab:
Elevation Oncology is pausing further investment in the clinical development of seribantumab and realigning resources to focus on advancing EO-3021 and other pipeline programs.
Elevation Oncology intends to pursue further clinical development of seribantumab only in collaboration with a partner. Further enrollment into the CRESTONE study will be paused, pending entering into a partnership.
Elevation Oncology plans to present additional interim data from the CRESTONE study in the first half of 2023
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Other Pipeline Programs:
Elevation Oncology continues its research and development efforts to advance novel therapeutic drug candidates and targets, including those through its existing partnership with Caris Life Sciences.
Leadership Transition:
Shawn M. Leland, PharmD, RPh, has resigned from his role as Chief Executive Officer and member of the Board of Directors, effective immediately. Dr. Leland will serve as an advisor to the Company.
Joseph J. Ferra has been appointed Interim Chief Executive Officer and will continue in his current role as Chief Financial Officer.
Workforce Reduction:
As part of the realignment of its pipeline, Elevation Oncology’s workforce will be reduced by approximately 30% to prioritize key research and development efforts to advance EO-3021 and additional pipeline programs.
Updated Cash Runway:
As of December 31, 2022, Elevation Oncology had preliminary unaudited cash, cash equivalents and marketable securities totaling $90.3 million. The Company currently expects the pipeline prioritization and realignment of resources to extend cash runway into the fourth quarter of 2024, without giving effect to financial covenant compliance under the Company’s debt facility.