Geron Announces Imetelstat Presentations at Upcoming American Society of Hematology Annual Meeting
November 04 2021 - 9:12AM
Business Wire
Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical
company focused on the development and commercialization of
treatments for hematologic malignancies, today announced that three
abstracts related to imetelstat, the Company’s first-in-class
telomerase inhibitor, have been accepted as poster presentations at
the 63rd American Society of Hematology (ASH) Annual Meeting to be
held from December 11-14, 2021. The abstracts are available on the
ASH website at www.hematology.org.
“The abstracts for this year’s ASH Meeting reflect the breadth
of ongoing activity with imetelstat from pre-clinical studies in a
new indication, as well as use of imetelstat as a single agent and
in combination with other therapies, to analyses of clinical data
supporting our Phase 3 development,” said Aleksandra Rizo, M.D.,
Ph.D., Geron’s Chief Medical Officer. “We look forward to continued
work in these areas as we expand the potential applications for
imetelstat in hematologic malignancies.”
Clinical Data – 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)
The abstract describes new analyses of data from the IMerge
Phase 2 clinical trial. In the analyses, a significant correlation
was observed between achieving an optimal pharmacodynamic (PD)
effect in imetelstat-treated patients with durable red blood cell
transfusion independence (RBC-TI). In addition, a trend of improved
overall survival rate was seen in patients who achieved optimal PD
effect. The authors believe these results demonstrate a potential
link between imetelstat activity and clinical efficacy.
Additionally, patients in IMerge Phase 2 who achieved an optimal PD
effect with imetelstat treatment did not have higher rates of
cytopenias or liver enzyme elevations compared to patients without
an optimal PD effect.
Poster Presentation Details
Abstract: #2598 Date: Sunday, December 12, 2021 Time: 6:00 p.m. –
8:00 p.m. ET
Pre-Clinical Data – Pediatric Acute Myeloid Leukemia
Abstract Title: Imetelstat Significantly Reduces Leukemia
Stem Cells in Patient-Derived Xenograft Models of Pediatric
AML
The abstract reports results from pre-clinical studies of
imetelstat in pediatric acute myeloid leukemia (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 evaluated. In cell
line experiments, imetelstat treatment resulted in cell
apoptosis/death of leukemia stem cells (LSCs) in a dose-dependent
manner. In the in vivo studies, imetelstat treatment reduced LSC
numbers and increased median survival in mice. In addition,
combining imetelstat with chemotherapy or azacitidine further
enhanced activity against LSCs. The authors conclude that the
results of these pre-clinical studies suggest imetelstat could
represent an effective therapeutic strategy for pediatric AML.
Poster Presentation Details
Abstract: #3352 Date: Monday, December 13, 2021 Time: 6:00 p.m. –
8:00 p.m. ET
Trials in Progress Poster Presentation – IMpactMF Phase 3
trial in Refractory MF
Abstracts for this category describe innovative clinical trials
that have not reached their primary endpoint to provide
opportunities for early engagement and collaboration amongst
investigators, translational research, clinical and industry
investigators, statisticians and regulators.
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)
Poster Presentation Details
Abstract: #1503 Date: Saturday, December 11, 2021 Time: 6:00 p.m. –
8:00 p.m. ET
In accordance with ASH policies, abstracts submitted to the ASH
Annual Meeting are embargoed from the time of submission. To be
eligible for presentation at the ASH Annual Meeting, any additional
data or information to be presented at the Annual Meeting may not
be made public before the presentation. The posters will be
available at www.geron.com/r-d/publications following the ASH
Annual Meeting presentations.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in myeloid
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) the potential
link between imetelstat activity and clinical efficacy in lower
risk MDS; (ii) that imetelstat may have potential disease-modifying
activity; (iii) that there may be additional potential applications
for imetelstat in hematologic malignancies; and (iv) 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 is safe and efficacious in clinical trials; and (iv) 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 June 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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Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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