- Prioritizing the development of EO-3021, a potential
best-in-class ADC targeting Claudin18.2, and additional pipeline
programs including those through its existing partnership with
Caris Life Sciences
- Planning to present EO-3021 preclinical proof-of-concept
data at a major medical conference in the first half of 2023, and
initiate Phase 1 trial in the US in the second half of 2023; CSPC
is actively recruiting patients in an ongoing Phase 1 clinical
trial in China
- Pausing further investment in the clinical development of
seribantumab; intends to pursue further development only in
collaboration with a partner
- Joseph Ferra, CFO, appointed
as Interim CEO; Shawn Leland has
resigned as CEO and member of the Board of Directors
- Realigning resources to focus on advancing EO-3021 and
additional pipeline programs expected to extend cash runway into
the fourth quarter of 2024, announces approximately 30% reduction
YORK, Jan. 6, 2023 /PRNewswire/ -- 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, today announced 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.
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
"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
"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 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.
- 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.
- 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
- 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.
About Elevation Oncology, Inc.
Elevation Oncology is
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. We
are rethinking drug development by seeking out innovative,
selective cancer therapies that can be matched to a patient's
unique tumor characteristics. Our lead candidate, EO-3021, is a
potential best-in-class, antibody drug conjugate (ADC) designed to
target Claudin18.2, a clinically validated molecular target that
can selectively deliver a cytotoxic payload directly to kill cancer
cells. We are working to rapidly advance EO-3021 into the clinic in
the US across a range of solid tumor indications to demonstrate its
potential, as well as exploring other opportunities through new or
existing partnerships and business development opportunities to
expand our novel oncology pipeline. For more information, visit
Forward Looking Statements:
This press release
contains forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, anticipated preclinical and
clinical development activities, expected timing of announcements
of clinical results, potential benefits of Elevation Oncology's
product candidates, potential opportunities to expand Elevation
Oncology's product candidate pipeline, potential market
opportunities for Elevation Oncology's product candidates, the
ability of Elevation Oncology's product candidates to treat their
targeted indications, the ability for Elevation Oncology to achieve
cost savings and Elevation Oncology's expectations about its cash
runway. All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. These
forward-looking statements may be accompanied by such words as
"aim," "anticipate," "believe," "could," "estimate," "expect,"
"forecast," "goal," "intend," "may," "might," "plan," "potential,"
"possible," "will," "would," and other words and terms of similar
meaning. Although Elevation Oncology believes that the
expectations reflected in such forward-looking statements are
reasonable, Elevation Oncology cannot guarantee future events,
results, actions, levels of activity, performance or achievements,
and the timing and results of biotechnology development and
potential regulatory approval is inherently uncertain.
Forward-looking statements are subject to risks and uncertainties
that may cause Elevation Oncology's actual activities or results to
differ significantly from those expressed in any forward-looking
statement, including risks and uncertainties related to Elevation
Oncology's ability to advance its product candidates, the timing
and results of preclinical studies and clinical trials, approvals
and commercialization of product candidates, the receipt and timing
of potential regulatory designations, the impact of the COVID-19
pandemic on Elevation Oncology's business, Elevation Oncology's
ability to fund development activities and achieve development
goals, Elevation Oncology's ability to protect intellectual
property, Elevation Oncology's ability to establish and maintain
collaborations with third parties and other risks and uncertainties
described under the heading "Risk Factors" in documents Elevation
Oncology files from time to time with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date of this press release, and Elevation Oncology undertakes no
obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media
Senior Director, Corporate Communications & Investor
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SOURCE Elevation Oncology