Both IMerge and IMbark Continue in Lower Risk
Myelodysplastic Syndromes and Relapsed or Refractory
Myelofibrosis
Geron Corporation (Nasdaq:GERN) today announced that Janssen
Research & Development, LLC has completed the second internal
data reviews of IMerge and IMbark, the clinical trials of the
telomerase inhibitor imetelstat in lower risk myelodysplastic
syndromes (MDS) and relapsed or refractory myelofibrosis (MF),
respectively. For IMerge, the benefit/risk profile of imetelstat in
the treated patients supports continued development in lower risk
myelodysplastic syndromes. A data package and proposed trial design
refinements are planned to be provided to the FDA. For IMbark, the
current results suggest clinical benefit and a potential overall
survival benefit associated with imetelstat treatment in relapsed
or refractory myelofibrosis; the trial will continue unchanged to
evaluate maturing efficacy and safety data, including an assessment
of overall survival.
IMerge
IMerge (NCT02598661) is a Phase 2/3 clinical trial evaluating
imetelstat in transfusion dependent patients with Low or
Intermediate-1 risk MDS who have relapsed after or are refractory
to prior treatment with an erythropoiesis stimulating agent (ESA).
The clinical trial is in two parts: Part 1 is a Phase 2,
open-label, single-arm design in approximately 30 patients and Part
2 is designed to be a Phase 3, randomized, controlled trial in
approximately 170 patients. The primary efficacy endpoint is the
rate of red blood cell transfusion independence lasting at least 8
weeks. Key secondary endpoints include the rates of red blood cell
transfusion independence lasting at least 24 weeks and hematologic
improvement. Part 1 of the trial is fully enrolled.
The second internal review of IMerge included data from the
approximately 30 patients enrolled in Part 1. Based on this second
internal review, the Collaboration’s Joint Steering Committee has
determined the following:
- The safety profile was consistent with prior clinical trials of
imetelstat in hematologic malignancies, and no new safety signals
were identified.
- The benefit/risk profile of imetelstat, including assessments
of 8-week and 24-week transfusion independence and hematologic
improvement by erythroid (HI-E) response, across multiple MDS
sub-types, supports continued development in lower risk MDS.
- Part 1 of the trial will continue unmodified, and patients
remaining in the treatment phase may continue to receive
imetelstat.
- A data package, as well as proposed refinements to the trial
design for Part 2 of IMerge, is planned to be provided to the
FDA.
- Data from Part 1 are expected to be submitted for consideration
for presentation at a medical conference in the future.
Geron expects that FDA feedback and the totality of imetelstat
program information, including an assessment of the evolving
treatment landscape in MDS and the potential application of
imetelstat in multiple hematologic malignancies, will inform
Janssen’s decision to initiate Part 2 of IMerge. If Part 2 of
IMerge is initiated, Geron expects this Phase 3 stage of IMerge to
be opened for patient enrollment in the fourth quarter of 2017.
IMbark
IMbark (NCT02426086) was originally designed as a Phase 2
clinical trial to evaluate two dose levels of imetelstat (either
4.7 mg/kg or 9.4 mg/kg administered every three weeks) in
approximately 200 patients with Intermediate-2 or High risk MF who
have relapsed after or are refractory to prior treatment with a JAK
inhibitor. The co-primary efficacy endpoints for the trial are
spleen response rate (≥35% reduction of spleen volume assessed by
imaging) and symptom response rate (³50% reduction in Total Symptom
Score) at 24 weeks.
The second internal review of IMbark included data from the
approximately 100 patients who were enrolled in the trial, with
each dosing arm analyzed separately. Based on this second internal
review, the Collaboration’s Joint Steering Committee has determined
the following:
- The safety profile was consistent with prior clinical trials of
imetelstat in hematologic malignancies, and no new safety signals
were identified.
- The data support 9.4 mg/kg as an appropriate starting dose for
the relapsed or refractory MF patient population.
- In these relapsed or refractory MF patients treated in the 9.4
mg/kg dosing arm, the spleen volume response rate observed to date
was less than that reported in front-line MF patients treated in
trials with other drugs. However, activity within multiple outcome
measures was observed with imetelstat treatment, which suggests
clinical benefit in this relapsed or refractory MF patient
population. These outcome measures included a range of spleen
volume reductions, decreases in Total Symptoms Score, and
improvements in hematologic parameters, such as anemia and
peripheral blood counts. In addition, the data suggest a potential
overall survival benefit associated with imetelstat treatment in
these patients.
- The trial will continue without any modifications, including
conduct of all safety and efficacy assessments as planned in the
protocol, including overall survival. Patients remaining in the
treatment phase may continue to receive imetelstat.
- Enrollment of new patients to the trial will remain suspended
because the total number of patients enrolled to date is adequate
to assess longer-term outcome measures when the data are fully
matured.
During the next year, Geron expects Janssen to evaluate maturing
efficacy and safety data from the trial, including an assessment of
overall survival. Geron expects the longer-term data from the
trial, potential health authority feedback, and the totality of
imetelstat program information, including an assessment of the
evolving treatment landscape in MF and the potential application of
imetelstat in multiple hematologic malignancies, including MDS,
will inform Janssen’s decision whether to continue development of
imetelstat in relapsed or refractory MF.
Conference Call
At 8:00 a.m. EDT on April 10, 2017, Geron’s management will host
a conference call to review outcomes from the second internal data
reviews of IMbark and IMerge. Participants can access the
conference call live via telephone by dialing 877-303-9139 (U.S.);
760-536-5195 (international). The conference ID number is 6116409.
A live audio-only webcast is also available through the company’s
website at www.geron.com in the Investors section under Events
and at http://edge.media-server.com/m/p/w5mtfw9k. The audio webcast
of the conference call will be available for replay approximately
one hour following the live broadcast through May 11, 2017.
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 has
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. The joint governance
structure includes a Joint Steering Committee with equal membership
from both companies.
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) continued development of imetelstat by
Janssen for MDS in Part 2 and continued conduct by Janssen of
IMbark and/or IMerge; (ii) data that suggest clinical benefit and
potential overall survival benefit of imetelstat in MF; (iii) a
planned data package will be provided to the FDA for IMerge; (iv)
that Janssen will conduct any additional data reviews for IMbark
during the next year; (v) potential outcomes of any data reviews
conducted by Janssen for IMbark; (vi) any future presentation of
data from current clinical trials of imetelstat by Janssen at a
medical conference; (vii) the safety and efficacy of imetelstat;
(viii) that if Janssen decides to proceed with Part 2 of IMerge,
the clinical trial will be opened for patient enrollment in the
fourth quarter of 2017; (ix) 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; and (x) 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 initiate Part 2 of IMerge and to continue to
conduct IMerge and/or IMbark; (ii) whether imetelstat is safe and
efficacious and will succeed in IMbark and/or IMerge by overcoming
all of the clinical safety and efficacy, technical, scientific,
manufacturing and regulatory challenges; (iii) whether health
authorities permit IMbark and/or IMerge to continue to proceed
under the existing protocols or any amendments thereto; (iv)
Janssen’s ability to collect additional and more mature data from
current clinical trials of imetelstat; (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;
(vi) any future efficacy or safety results from any clinical trial
of imetelstat may cause the benefit/risk profile of imetelstat to
become unacceptable; and (vii) 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 annual report on Form
10-K for the year ended December 31, 2016. 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:
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com
Geron (NASDAQ:GERN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Geron (NASDAQ:GERN)
Historical Stock Chart
From Sep 2023 to Sep 2024