Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical
company focused on the development and commercialization of
treatments for hematologic malignancies, today announced three
poster presentations related to imetelstat, the Company’s first in
class telomerase inhibitor, at the 63rd American Society of
Hematology (ASH) Annual Meeting. The posters are available at
www.geron.com/r-d/publications.
“The posters for this year’s ASH Meeting highlight our ongoing
Phase 3 development of imetelstat in lower risk MDS and refractory
MF, as well as exploratory work in new indications to maximize the
potential value of imetelstat,” said Aleksandra Rizo, M.D., Ph.D.,
Geron’s Chief Medical Officer. “We believe the unique telomerase
inhibition MOA of imetelstat has the potential to transform the
standard of care in hematologic malignancies.”
Clinical Posters
Lower Risk Myelodysplastic Syndromes
(MDS)
Abstract Title: On-Target Activity of Imetelstat Correlates
with Clinical Benefits, Including Overall Survival (OS), in Heavily
Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory
(R/R) to Erythropoiesis Stimulating Agents (ESAs) Abstract
#2598
The poster reports new analyses to assess the correlation
between imetelstat’s inhibition of telomerase with the efficacy and
safety data from the IMerge Phase 2 clinical trial. These
correlative analyses indicating that patients who achieved optimal
pharmacodynamic (PD) effect achieved higher rates of red blood cell
transfusion independence (RBC-TI), longer RBC-TI and a trend toward
improved overall survival. Importantly, these patients did not have
higher rates of Grade 3+ neutropenia, thrombocytopenia or liver
function elevations compared to patients who did not achieve
optimal PD effect.
These data provide further evidence for the on-target mechanism
of action (MOA) of imetelstat through telomerase inhibition and
links imetelstat’s on-target activity with clinical benefits.
To confirm these and other results from IMerge Phase 2, the
Company is conducting a double-blind, randomized,
placebo-controlled Phase 3 clinical trial with registrational
intent. The trial is designed to enroll approximately 170
transfusion dependent patients with Low or Intermediate-1 risk
myelodysplastic syndromes (MDS), also referred to as lower risk
MDS, who have relapsed after or are refractory to prior treatment
with an erythropoiesis stimulating agent (ESA). The primary
endpoint is the rate of RBC-TI for any consecutive period of eight
weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints
include the rate of RBC-TI lasting at least 24 weeks, or 24-week
RBC-TI rate, and the rate of hematologic improvement-erythroid
(HI-E), defined as a reduction of at least four units of RBC
transfusions over eight weeks compared with the prior RBC
transfusion burden.
IMerge Phase 3 is fully enrolled and patient enrollment has been
closed. Based on current planning assumptions, the Company expects
top-line results from IMerge Phase 3 in early January 2023.
Refractory Myelofibrosis (MF)
Abstract Title: A Randomized Open-Label, Phase 3 Study to
Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients
with Intermediate-2 (Int-2) or High-risk Myelofibrosis (MF)
Refractory to Janus Kinase Inhibitor (JAKi) Abstract #1503
Trials in Progress
IMpactMF is an open label, randomized, controlled Phase 3
clinical trial with registrational intent. The trial is planned to
enroll approximately 320 patients with Intermediate-2 or High-risk
myelofibrosis who are refractory to prior treatment with a JAK
inhibitor, also referred to as refractory MF. Patients will be
randomized to receive either imetelstat or best available therapy.
The primary endpoint is overall survival (OS). Key secondary
endpoints include symptom response, spleen response, progression
free survival, complete response, partial response, clinical
improvement, duration of response, safety, pharmacokinetics, and
patient reported outcomes.
IMpactMF is currently enrolling patients. For further
information about IMpactMF, including enrollment criteria,
locations and current status, visit
ClinicalTrials.gov/NCT04576156.
Pre-Clinical Poster – Pediatric Acute Myeloid
Leukemia
Abstract Title: Imetelstat Significantly Reduces Leukemia
Stem Cells in Patient-Derived Xenograft Models of Pediatric AML
Abstract #3352
Acute myeloid leukemia (AML) is the deadliest malignancy in
children. To improve survival in pediatric AML, novel targeted
therapies and other alternative treatment methods are needed. Due
to the significant unmet medical need in this disease, the use of
imetelstat was evaluated to determine whether the drug 1) has
anti-leukemia activity and 2) could be used as a therapeutic for
pediatric AML.
The poster describes results from pre-clinical studies of
imetelstat in pediatric AML cell lines (in vitro studies) and
patient derived (PDX) mouse models (in vivo studies). The efficacy
of imetelstat either as a single agent or in combination with
chemotherapy or azacitidine was also evaluated. In cell line
experiments, imetelstat treatment resulted in cell apoptosis/death
of leukemia stem cells (LSCs) in a time- and dose-dependent manner
and with minimal effect on normal bone marrow samples. In the in
vivo studies, imetelstat treatment reduced LSC numbers and
prolonged survival in mice. Observations of prolonged survival in
mice were also seen when combining imetelstat with chemotherapy or
azacitidine.
These data suggest imetelstat may represent an effective
therapeutic strategy to target the LSC population in pediatric AML
patients.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
malignancies. Data from Phase 2 clinical trials provide strong
evidence that imetelstat targets telomerase to inhibit the
uncontrolled proliferation of malignant stem and progenitor cells
in myeloid hematologic malignancies resulting in malignant cell
apoptosis and potential disease-modifying activity. 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 associated 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 myeloid
hematologic malignancies. The Company currently is conducting two
Phase 3 clinical trials: IMerge in lower risk myelodysplastic
syndromes and IMpactMF in refractory myelofibrosis. For more
information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this
press release contains forward-looking statements made pursuant to
the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that such statements,
include, without limitation, those regarding: (i) that the Company
believes the unique telomerase inhibition MOA of imetelstat has the
potential to transform the standard of care in hematologic
malignancies; (ii) that there may be a potential link between
imetelstat activity and clinical efficacy in lower risk MDS; (iii)
that there is strong evidence that imetelstat targets telomerase to
inhibit the uncontrolled proliferation of malignant stem and
progenitor cells in myeloid hematologic malignancies resulting in
malignant cell apoptosis and potential disease-modifying activity;
(iv) that the IMerge Phase 3 and IMpactMF clinical trials have
registrational intent; (v) that the Company expects top-line
results from IMerge Phase 3 in early January 2023; (vi) that there
may be additional potential applications for imetelstat in
hematologic malignancies; and (vii) other statements that are not
historical facts, constitute forward-looking statements. These
forward-looking 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, risks and uncertainties related to whether: (i)
imetelstat demonstrates disease-modifying activity in clinical
trials; (ii) regulatory authorities permit the further development
of imetelstat; (iii) imetelstat demonstrates to regular authorities
that it is safe and efficacious in Phase 3 clinical trials; (iv)
Geron is able to expeditiously manage the delivery of the results
of IMerge Phase 3 by early January 2023; and (v) any future
efficacy or safety results cause the benefit-risk profile of
imetelstat to become unacceptable. Additional information on the
above risks and uncertainties and additional risks, uncertainties
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 Geron’s
quarterly report on Form 10-Q for the quarter ended September 30,
2021. 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/20211214006133/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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