Geron Corporation (Nasdaq: GERN), a late-stage clinical
development biopharmaceutical company, today announced 2019
accomplishments and key development priorities for 2020. The
Company is currently enrolling patients in the Phase 3 IMerge
clinical trial of imetelstat in lower risk myelodysplastic
syndromes (MDS), and plans to complete enrollment by the end of
2020 with top-line results expected by mid-year 2022.
“From regaining control of the imetelstat program and building
an impressive in-house development team to initiating the Company’s
first Phase 3 clinical trial, 2019 was a pivotal year for Geron,”
said John A. Scarlett, M.D., Chairman and Chief Executive Officer.
“We plan to build on the progress achieved in 2019 as we set our
2020 priorities and finalize our development plans.”
2019 – A Year of Accomplishments
Advancing the Imetelstat Development
Program
In May 2019, Geron assumed the imetelstat investigational new
drug (IND) sponsorship from Janssen Biotech, Inc. (Janssen), and
executed on its 2019 imetelstat development plans, including
advancing into late-stage clinical development with the initiation
of the Phase 3 IMerge clinical trial in lower risk MDS.
Geron completed the transition of the imetelstat program,
including the transfer of the remaining non-clinical, manufacturing
and ex-U.S. clinical and regulatory responsibilities from Janssen
at the end of September 2019.
Throughout the year, Geron continued to build a solid foundation
of extensive hematology-oncology and drug development expertise in
key functional areas by attracting senior leadership with extensive
experience, including many new development team members and
executives with prior experience with imetelstat. This highly
capable in-house team will support current and future imetelstat
development plans, including plans to explore additional
indications, as well as provide the ability to evaluate other
hematology-oncology assets to expand the Company’s pipeline in the
future.
Commencing the Phase 3 in Lower Risk
MDS
In June 2019, Geron presented updated efficacy and safety data
for the Phase 2 IMerge clinical trial. The presentation highlighted
meaningful and durable transfusion independence, activity across
different MDS subtypes and potential disease-modifying activity in
lower risk MDS with imetelstat treatment.
Geron achieved a significant milestone in August 2019 with the
opening of the Phase 3 IMerge clinical trial for patient screening
and enrollment, and the first patient was dosed in October. Many
key aspects from the Phase 2 portion of IMerge remained the same
for the Phase 3 portion, including the primary and secondary
endpoints, the dose and schedule of imetelstat administration, and
the target patient population. This trial is an important step in
developing imetelstat as a potential alternative for lower risk MDS
patients who have limited treatment options.
Regulatory Interactions Related to
Myelofibrosis (MF)
The United States Food and Drug Administration (FDA) granted
Fast Track designation to imetelstat for the treatment of adult
patients with Intermediate-2 or High-risk MF whose disease has
relapsed after or is refractory to janus kinase (JAK) inhibitor
treatment, or relapsed/refractory MF, in September 2019. The FDA's
Fast Track Program is designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious
conditions and supported by data that demonstrate the potential to
address an unmet medical need.
Geron announced that it conducted an End of Phase 2 meeting with
the FDA to discuss the results of the IMbark Phase 2 clinical trial
of imetelstat in patients with relapsed/refractory MF in December
2019.
Development Priorities for 2020
Geron is setting development priorities that are expected to
shape the Company’s 2020 milestones, which will be discussed at a
conference call to be held in March 2020 in connection with the
announcement of the Company’s year-end 2019 financial results.
Building Momentum in Phase 3 IMerge
Clinical Trial in Lower Risk MDS
The Company expects to complete enrollment for the Phase 3
IMerge clinical trial in 2020, which is a key step toward achieving
top-line results from the trial by mid-year 2022. As of the
beginning of 2020, approximately 40% of the planned clinical sites
are open for enrollment.
Determining Potential Late-Stage
Development in MF
Based on feedback from the End of Phase 2 meeting, Geron plans
to submit several Phase 3 trial design proposals in MF, and to have
further discussions with the FDA regarding a potential regulatory
approval path. Subsequent to these additional discussions, and
after considering the timing and resources required, as well as
other clinical development opportunities for imetelstat, Geron
plans to make a decision regarding potential late-stage development
of imetelstat in MF.
Broadening Imetelstat Program with
Additional Hematologic Myeloid Malignancy Indication
Geron expects to expand development of imetelstat within
hematologic myeloid malignancies by initiating a proof-of-concept
study in an additional indication in 2020.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Early clinical data suggest imetelstat may
have disease-modifying activity through the suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower
risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial
in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has
been granted Fast Track designation by the United States Food and
Drug Administration for both the treatment of patients with
non-del(5q) lower risk MDS who are refractory or resistant to an
erythropoiesis-stimulating agent and for patients with
Intermediate-2 or High-risk MF whose disease has relapsed after or
is refractory to janus kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused
on the development and potential commercialization of a
first-in-class telomerase inhibitor, imetelstat, in hematologic
myeloid malignancies. For more information about Geron, visit
www.geron.com.
Use of Forward-Looking Statements
Except for statements of historical fact, the statements
contained in this press release are forward-looking statements made
pursuant to the Safe Harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include statements regarding the expectations, plans, timelines,
potential and prospects for imetelstat and Geron, including,
without limitation, statements related to: (i) that imetelstat may
have disease-modifying activity; (ii) that Geron expects top-line
results from the IMerge clinical trial by mid-year 2022; (iii) that
Geron plans to discuss a potential regulatory path with the FDA and
to make a decision regarding late-stage development of imetelstat
in MF in 2020; (iv) Geron’s plan to complete enrollment of IMerge
in 2020; (v) that Geron expects to initiate a proof-of-concept
study for imetelstat in 2020; (vi) Geron’s plans to explore
additional indications for imetelstat and to potentially evaluate
other hematology-oncology assets; (vii) that imetelstat is a
potential alternative for lower risk MDS patients; and (viii) other
statements that are not historical facts. These statements involve
risks and uncertainties that can cause actual results to differ
materially from those in such forward-looking statements. These
risks and uncertainties, include, without limitation, the
following: (a) regulatory authorities may not permit the further
development of imetelstat for MF and/or MDS and/or potential
additional indications on a timely basis, or at all, and may impose
clinical holds; (b) after interactions with the FDA, Geron may
decide not to pursue further development of imetelstat in MF; (c)
imetelstat may not demonstrate successful efficacy and safety in
clinical trials; (d) Geron may be unable to complete enrollment of
IMerge in 2020 due to lack of patients, regulatory holds,
insufficient number of sites, unavailability of drug, and other
factors and therefore, will be unable to have top-line results by
mid-year 2022, if at all; (e) there may be failures or delays in
manufacturing sufficient quantities of imetelstat, or other
clinical trial materials, in a manner that meets the quality
standards of the FDA and other regulatory authorities; (f) Geron
may not be able to obtain sufficient funding to support further
development of imetelstat; (g) imetelstat may fail to demonstrate
in clinical trials that it has disease-modifying activity; and (h)
Geron may not acquire an additional product candidate assets and
may decide not to pursue any additional indications or start a
proof-of-concept study for imetelstat in 2020. Additional
information and factors that could cause actual results to differ
materially from those in the forward-looking statements are
contained in Geron's periodic reports filed with the Securities and
Exchange Commission under the heading “Risk Factors,” including in
Geron's quarterly report on Form 10-Q for the quarter ended
September 30, 2019 and in subsequent filings on Form 8-K. Undue
reliance should not be placed on forward-looking statements, which
speak only as of the date they are made, and the facts and
assumptions underlying the forward-looking statements may change.
Except as required by law, Geron disclaims any obligation to update
these forward-looking statements to reflect future information,
events or circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20200113005272/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com CG Capital 877-889-1972
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