Geron Reports Imetelstat Oral Presentation at European Hematology Association Congress
June 18 2018 - 6:45AM
Geron Corporation (Nasdaq:GERN) today announced the oral
presentation of updated data from the ongoing original Part 1 of
IMerge, the Phase 2/3 trial of imetelstat in lower risk
myelodysplastic syndromes (MDS). The data was presented by Dr.
David Steensma from the Dana-Farber Cancer Institute at the 23rd
Congress of the European Hematology Association (EHA) held in
Stockholm, Sweden on June 17. Imetelstat is a telomerase inhibitor
initially developed by Geron and exclusively licensed to Janssen
Biotech, Inc. (Janssen) on a worldwide basis.
“This encore presentation of data from the first 32 patients in
Part 1 of IMerge reiterates the encouraging results that prompted
the expansion of enrollment of Part 1 to a refined population of
lower risk MDS patients who are naïve to lenalidomide and HMAs and
who lacked del(5q). We are pleased that there are multiple patients
that have been on treatment for over two years,” said John A.
Scarlett, M.D., Geron’s President and Chief Executive Officer. “We
look forward to data from the additional patients enrolled earlier
this year in the expanded Part 1 of IMerge, as well as Janssen’s
decision related to the continued development of imetelstat, which
is expected by the end of the third quarter.”
Clinical Data Presentation
Title: Imetelstat in RBC Transfusion-Dependent (TD)
Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating
Agents (ESA) (IMerge): Updated Efficacy and Safety
(Abstract #S1557)
This oral presentation described data as of May 2018 from the
first 32 patients enrolled in Part 1 of IMerge with a median
follow-up of 95 weeks. To be eligible for the trial, all patients
were red blood cell (RBC) transfusion-dependent (TD) at baseline,
requiring ≥4 units over 8 weeks prior to entry into the trial. The
primary efficacy endpoint is the rate of RBC
transfusion-independence (TI) lasting at least 8 weeks, defined as
the proportion of patients without any RBC transfusion during any
consecutive 8 weeks since entry to the trial. Key secondary
endpoints are the rate of 24-week TI and the rate of hematologic
improvement-erythroid (HI-E), defined as a rise in hemoglobin of at
least 1.5 g/dL above the pretreatment level for at least 8 weeks or
a reduction of at least 4 units of RBC transfusions over 8 weeks
compared with the prior RBC transfusion burden. IMerge is designed
in two parts: Part 1 is a Phase 2, open-label, single-arm trial of
imetelstat administered as a single agent by intravenous infusion,
and Part 2 is designed to be a Phase 3, randomized, controlled
trial. Part 2 has not yet begun.
Efficacy in the Overall Trial Population (n=32):
- 34% (11/32) of patients achieved ≥8-week TI
- Median duration of TI was 23.1 weeks
- Mean relative reduction in transfusion burden from baseline was
60%
- 16% (5/32) of patients achieved ≥24-week TI, with the median TI
duration exceeding one year in these patients
- 59% (19/32) of patients achieved an HI-E
- 8-week TI rates were similar among patients with or without
ringed sideroblasts (RS) or with serum erythropoietin (EPO) levels
greater or less than 500mU/mL
Efficacy in the Lenalidomide and HMA Naïve and Non-Del(5q)
Subset (n=13):
- 54% (7/13) of patients achieved ≥8-week TI
- Median duration of TI was 42.9 weeks
- Mean relative reduction in transfusion burden from baseline was
71%
- 31% (4/13) of patients achieved ≥24-week TI
- 69% (9/13) of patients achieved an HI-E
Safety Summary:
- Cytopenias, particularly neutropenia and thrombocytopenia, were
the most frequently reported adverse events which were predictable,
manageable and reversible
The slide presentation is available on Geron’s website at
www.geron.com/r-d/publications.
Based on these data, Part 1 of IMerge was expanded and enrolled
25 additional patients who are naïve to lenalidomide and HMA
treatment and are non-del(5q) to increase the experience and
evaluate the benefit-risk profile of imetelstat in this refined
target patient population. Data from these additional patients are
expected to be available at a future medical conference.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific
inhibitor of telomerase that is administered by intravenous
infusion. This first-in-class compound, discovered by Geron, is a
specially designed and modified short oligonucleotide, which
targets and binds directly with high affinity to the active site of
telomerase. Preliminary clinical data suggest imetelstat might have
disease-modifying activity by inhibiting the progenitor cells of
the malignant clones associated with hematologic malignancies in a
relatively select manner. Most commonly reported adverse events in
imetelstat clinical studies include fatigue, gastrointestinal
symptoms and cytopenias. Imetelstat has not been approved for
marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide
license and collaboration agreement with Janssen Biotech, Inc., to
develop and commercialize imetelstat for oncology, including
hematologic myeloid malignancies, and all other human therapeutics
uses. Under the terms of the agreement, Geron received an upfront
payment of $35 million and is eligible to receive additional
payments up to a potential total of $900 million for the
achievement of development, regulatory and commercial milestones,
as well as royalties on worldwide net sales. All regulatory,
development, manufacturing and promotional activities related to
imetelstat are being managed through a joint governance structure,
with Janssen responsible for these activities.
About Geron
Geron is a clinical stage biopharmaceutical company focused on
the collaborative development 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 statements in this
press release regarding: (i) that imetelstat might have
disease-modifying activity by inhibiting the progenitor cells of
the malignant clones associated with hematologic malignancies in a
relatively select manner; (ii) future data from expanded Part 1 of
IMerge; (iii) the safety and efficacy of imetelstat; (iv) potential
receipt by Geron of additional payments up to a potential total of
$900 million for the achievement of development, regulatory and
commercial milestones, and royalties from sales of imetelstat; (v)
the timing of Janssen’s decision whether to continue development of
imetelstat expected by the end of the third quarter; and (vi) other
statements that are not historical facts, constitute
forward-looking statements. 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, risks and uncertainties
related to: (i) whether Janssen decides to continue to conduct
IMerge and the entire imetelstat program; (ii) whether imetelstat
is safe and efficacious and will gain regulatory approval by
overcoming all of the clinical safety and efficacy, technical,
scientific, manufacturing and regulatory challenges; (iii) whether
the FDA or other health authorities permit IMerge to continue to
proceed under the existing protocols or any amendments thereto;
(iv) whether any future efficacy or safety results may cause the
benefit/risk profile of imetelstat to become unacceptable; (v)
Geron’s dependence on Janssen for the development, regulatory
approval, manufacture and commercialization of imetelstat,
including the risks that if Janssen were to breach or terminate the
collaboration agreement or otherwise fail to successfully develop
and commercialize imetelstat and in a timely manner, or at all,
Geron would not obtain the anticipated financial and other benefits
of the collaboration agreement with Janssen and the clinical
development or commercialization of imetelstat could be delayed or
terminated; and (vi) whether patent coverage of imetelstat enables
Janssen to successfully commercialize imetelstat. Additional
information on the above-stated 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 March 31, 2018. 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital887-889-1972
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