Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced that ten abstracts
containing clinical data and analyses related to imetelstat, the
Company’s first-in-class telomerase inhibitor, have been accepted
for presentation at the 62nd American Society of Hematology (ASH)
Annual Meeting to be held online from December 5-8, 2020. The
abstracts are available on the ASH website at
www.hematology.org.
“We are pleased that all ten of the abstracts we submitted were
accepted for presentation at this year’s ASH Meeting,” said
Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “The
analyses and data from our Phase 2 IMbark and IMerge trials
reported in these abstracts continue to support our ongoing Phase 3
trial in lower risk MDS and our upcoming Phase 3 trial in
refractory MF and highlight the clinical benefits and the potential
disease-modifying activity achievable with imetelstat
treatment.”
Lower Risk Myelodysplastic Syndromes (MDS) – Oral
Presentation
Abstract Title: Treatment with Imetelstat Provides Durable
Transfusion Independence (TI) in Heavily Transfused Non-del(5q)
Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis
Stimulating Agents (ESAs)
Long-term efficacy, safety and biomarker data from 38 patients
in the IMerge Phase 2 clinical trial, based on a February 4, 2020
cut-off date and a median follow-up of 24 months, are reported.
Consistent with prior presentations, 42% of patients achieved
>8-week red blood cell transfusion
independence (RBC-TI) with a median duration of 20 months, which is
the longest so far reported with any agent in relapsed/refractory
non-del(5q) lower risk MDS. In addition, 29% of patients were
transfusion free more than a year. These data were previously
presented at the European Hematology Association (EHA) Annual
Congress in June.
Oral Presentation Details Abstract:
#658 Date: Monday, December 7, 2020 Time: 12:45 p.m. PT
Relapsed/Refractory Myelofibrosis (MF) – Three Oral
Presentations
Abstract Title: Potential Disease-Modifying Activity of
Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal
Clones and Mutation Burden Leads to Clinical Benefits in
Relapsed/Refractory Myelofibrosis Patients
Results from new analyses on samples from patients in the IMbark
Phase 2 clinical trial highlight significant dose-dependent
reductions of mutation burden by imetelstat. These results were
correlated with improved overall clinical benefits, including
higher rates of spleen and symptom responses, bone marrow fibrosis
improvement and prolonged overall survival (OS). As concluded in
the abstract, the clinical data that suggest improvement in median
OS in these patients, together with the data in the abstract,
further demonstrate that imetelstat has disease-modifying activity
by targeting malignant cells, as evidenced by depletion of
cytogenetically abnormal clones and reduction in mutation
burden.
Oral Presentation Details Abstract:
#346 Date: Sunday, December 6, 2020 Time: 10:30 a.m. PT
Abstract Title: Telomerase Activity, Telomere Length and
hTERT Expression Correlate with Clinical Outcomes in Higher-Risk
Myelofibrosis (MF) Relapsed/Refractory (R/R) to Janus Kinase
Inhibitor Treated with Imetelstat
Dose-dependent inhibition of the telomerase target, as evaluated
by reductions in telomerase activity, human reverse transcriptase
(hTERT) levels and telomere length, reported in patients treated
with imetelstat in the IMbark Phase 2 clinical trial. Analyses of
these biomarker data correlated with clinical responses and longer
OS. In addition, dose-dependent reduction in variant allele
frequency of driver mutations was noted, indicating that imetelstat
targets the underlying clone. These data are consistent with
telomere biology in cancer cells and provide evidence for on-target
mechanism of action of imetelstat through telomerase inhibition.
These results were previously reported as a poster presentation at
the EHA Annual Congress in June.
Oral Presentation Details Abstract:
#347 Date: Sunday, December 6, 2020 Time: 10:45 a.m. PT
Abstract Title: Favorable Overall Survival with Imetelstat
Treatment Correlates with Other Clinical Benefits in Intermediate-2
or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase
Inhibitor
Overall survival results from IMbark Phase 2 were correlated
with clinical benefits observed with imetelstat treatment. The
correlation analyses showed a trend of longer OS in patients who
achieved symptom response, spleen volume reductions ranging from
> 10% to > 35%, and improvement in bone marrow fibrosis,
in a dose-dependent manner. These results were previously reported
as a poster presentation at the EHA Annual Congress in June.
Oral Presentation Details Abstract:
#53 Date: Saturday, December 5, 2020 Time: 8:00 a.m. PT
Relapsed/Refractory Myelofibrosis (MF) – Three Poster
Presentations
Collectively, these poster presentations describe on-target and
potential disease-modifying activity of the higher dose of
imetelstat from the IMbark Phase 2, and how that relates to better
clinical outcomes, including OS, fibrosis improvement; and symptom
response, especially in a subset of patients defined as triple
negative MF, known to have poor outcome.
Abstract Title: Correlation Analyses of Imetelstat Exposure
with Pharmacodynamic Effect, Efficacy and Safety in A Phase 2 Study
in Patients with Higher-risk Myelofibrosis Refractory to Janus
Kinase Inhibitor Identified an Optimal Dosing Regimen for Phase 3
Study
Poster Presentation Details
Abstract: #1283 Date: Saturday, December 5, 2020 Time: 7:00 a.m. –
3:30 p.m. PT
Abstract Title: Imetelstat Treatment Results in Clinical
Benefits, Including Improved Overall Survival, in Patients with
Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to
Janus Kinase Inhibitors (JAKi)
Poster Presentation Details
Abstract: #3084 Date: Monday, December 7, 2020 Time: 7:00 a.m. –
3:30 p.m. PT
Abstract Title: Treatment with Imetelstat Improves
Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes
in Patients with Relapsed or Refractory Higher-Risk
Myelofibrosis
Poster Presentation Details
Abstract: #3088 Date: Monday, December 7, 2020 Time: 7:00 a.m. –
3:30 p.m. PT
Myeloproliferative Neoplasms (MPN) –Poster
Presentation
Collaborators at UC San Diego report non-clinical data on hTERT
and ADAR1 activity in pre-leukemia stem cells and leukemia stem
cells (LSC). In various lab experiments and animal models,
treatment with imetelstat can prevent pre-leukemia stem cells from
evolving into LSCs, suggesting telomerase inhibition may be an
effective strategy for preventing MPN progression.
Abstract Title: Imetelstat Inhibits Telomerase and Prevents
Propagation of ADAR1-Activated Myeloproliferative Neoplasm and
Leukemia Stem Cells
Poster Presentation Details
Abstract: #1264 Date: Saturday, December 5, 2020 Time: 7:00 a.m. –
3:30 p.m. PT
Two Trials in Progress Poster Presentations – Planned Phase 3
in Refractory MF and Ongoing IMerge Phase 3
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 in Patients with
Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus
Kinase (JAK) Inhibitor
Poster Presentation Details
Abstract: #2194 Date: Sunday, December 6, 2020 Time: 7:00 a.m. –
3:00 p.m. PT
Abstract Title: IMerge: A Phase 3 Study to Evaluate
Imetelstat in Transfusion-Dependent Subjects with IPSS Low or
Intermediate-1 Risk Myelodysplastic Syndromes (MDS) that is
Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA)
Treatment
Poster Presentation Details
Abstract: #3113 Date: Monday, December 7, 2020 Time: 7:00 a.m. –
3:30 p.m. PT
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 Congress may not
be made public before the presentation. The slide presentation and
posters will be available at www.geron.com/r-d/publications
following the ASH Annual Meeting presentations.
Ongoing IMerge Phase 2/3 Clinical Trial
The IMerge Phase 2/3 trial is a two-part clinical trial of
imetelstat in transfusion dependent patients with Low or
Intermediate-1 risk, also referred to as lower risk myelodysplastic
syndromes (MDS), who have relapsed after or are refractory to prior
treatment with an erythropoiesis stimulating agent (ESA). The
primary endpoint is the rate of red blood cell (RBC) transfusion
independence (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.
The IMerge Phase 2 was an open label, single arm trial to assess
the safety and efficacy of imetelstat of a 7.5 mg/kg dose of
imetelstat administered as an intravenous infusion every four
weeks. The IMerge Phase 2 is no longer enrolling patients, and
patients remaining in the treatment phase continue to receive
imetelstat treatment, per investigator discretion.
The IMerge Phase 3 is a double-blind, randomized,
placebo-controlled clinical trial with registration intent. The
trial is designed to enroll approximately 170 patients with lower
risk transfusion dependent MDS who meet the defined target patient
population identified in the Phase 2 portion of the trial. The
IMerge Phase 3 is currently enrolling patients.
IMbark Phase 2 Clinical Trial
IMbark was designed as a Phase 2 clinical trial to evaluate two
dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg
administered by intravenous infusion every three weeks) in patients
with Intermediate-2 or High-risk myelofibrosis (MF) who have
relapsed after or are refractory to prior treatment with a janus
kinase inhibitor (JAKi). The co-primary efficacy endpoints for
IMbark were spleen response rate, defined as the proportion of
patients who achieve a reduction of at least 35% in spleen volume
as assessed by imaging, and symptom response rate, defined as the
proportion of patients who achieve a reduction of at least 50% in
Total Symptom Score (TSS), at 24 weeks. Key secondary endpoints
were overall survival (OS) and safety.
Phase 3 Clinical Trial in Refractory Myelofibrosis
The Phase 3 clinical trial in refractory MF, with OS as the
primary endpoint, is an open label 2:1 randomized, controlled
clinical trial to evaluate imetelstat in approximately 320 patients
with Intermediate-2 or High-risk disease who are refractory to
prior treatment with a JAK inhibitor. Patients refractory to a JAK
inhibitor are defined as having an inadequate spleen response or
symptom response after treatment with a JAK inhibitor for at least
six months, including an optimal dose of a JAK inhibitor for at
least two months. The control arm of best available therapy
excludes JAK inhibitors. 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.
Geron expects the trial to be open for screening and enrollment
in the first quarter of 2021.
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 apoptosis of malignant
stem and progenitor cells, which allows potential recovery of
normal hematopoiesis. Current clinical studies of imetelstat
include IMerge, an ongoing Phase 2/3 trial in lower risk
myelodysplastic syndromes (MDS), and a planned Phase 3 clinical
trial in refractory 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 clinical stage 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 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) imetelstat’s
potential survival benefit for MF patients who have relapsed after,
or are refractory to, prior treatment with a JAKi
(relapsed/refractory MF); (ii) that imetelstat may have
disease-modifying activity; and (iii) 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 in clinical trials is able to demonstrate an overall
survival benefit in patients who have relapsed after, or are
refractory to, prior treatment with a JAKi (relapsed/refractory
MF); (ii) imetelstat demonstrates disease-modifying activity in
clinical trials; (iii) regulatory authorities permit the further
development of imetelstat; (iv) imetelstat is safe and efficacious;
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 June 30, 2020. 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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Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com
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