Geron Corporation (Nasdaq:GERN) today announced updates to the
clinical development plans for IMerge and IMbark, the ongoing
trials of the telomerase inhibitor imetelstat in lower risk
myelodysplastic syndromes (MDS) and relapsed or refractory
myelofibrosis (MF), respectively, being conducted by Janssen
Research & Development, LLC. For IMerge, Part 1 will be
expanded to enroll additional patients in a refined MDS population
to confirm the clinical benefit and safety observed from current
results. For IMbark, the trial remains unchanged. Geron expects
that the IMbark protocol-specified primary analysis, the completion
of which triggers a future Continuation Decision by Janssen, will
begin no later than the third quarter of 2018.
IMerge
Original Trial Design
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 (RBC) transfusion independence (TI) lasting
at least 8 weeks.
Trial Status Update
In Part 1 of IMerge, 32 patients were enrolled, of which a
subset of 13 patients had not received prior treatment with either
a hypomethylating agent (HMA) or lenalidomide and did not have a
del(5q) chromosomal abnormality. As of May 2017, the 13-patient
subset showed an increased durability and rate of transfusion
independence compared to the overall trial population (≥8-week
RBC-TI: 53.8% vs 34.4%). The safety profile in Part 1 was
consistent with prior clinical trials of imetelstat in hematologic
malignancies, and no new safety signals were identified. The most
common adverse events were cytopenias, which were manageable, and
included grade 3/4 neutropenia and thrombocytopenia.
Based on these data from the 13-patient subset, the Joint
Steering Committee has decided to amend Part 1 of the protocol to
enroll approximately 20 additional patients who are non-del5q and
naïve to HMA and lenalidomide treatment in order to increase the
experience and confirm the benefit-risk profile of imetelstat dosed
at 7.5 mg/kg every four weeks in this refined target patient
population. Enrollment into the expanded Part 1 is expected to
begin in the fourth quarter of 2017.
Separately, a data package and proposed refinements to the trial
design for Part 2 of IMerge were previously provided to the FDA
following an internal data review completed by Janssen in April,
and related interactions are ongoing. Feedback from ongoing FDA
interactions, data from the expanded Part 1, and other imetelstat
program information, including the protocol-specified primary
analysis for IMbark, are expected to inform Janssen’s decision of
whether to move forward to Part 2 of IMerge.
Detailed results for the original 32 patients in Part 1 of
IMerge, including key secondary endpoints of hematologic
improvement and rate of RBC-TI lasting at least 24 weeks, as well
as duration of response and detailed safety information, will be
submitted for presentation at a major medical conference.
IMbark
Trial Status Update
IMbark (NCT02426086) is a Phase 2 trial in patients with
Intermediate-2 or High Risk MF who have relapsed after or are
refractory to prior treatment with a JAK inhibitor. The trial
continues without modification, and patients remaining in the
treatment phase may continue to receive imetelstat. All safety and
efficacy assessments will be conducted as planned in the protocol,
which includes an assessment of a potential survival benefit
associated with imetelstat treatment. To date, median overall
survival has not yet been reached in either the 4.7 mg/kg or 9.4
mg/kg dosing arm. Enrollment of new patients to the trial remains
suspended because the total number of patients enrolled to date is
adequate to perform the protocol-specified primary analysis. Geron
expects Janssen to perform an internal data review in the first
quarter of 2018 to enable a potential protocol amendment to allow
the long-term treatment and follow-up of patients, including for
survival, beyond the current April 2018 per-protocol end-of-study
date.
Continuation Decision
The Joint Steering Committee has agreed that the timing of the
protocol-specified primary analysis for IMbark will begin upon the
earlier of either a pre-specified number of deaths occurring in the
trial or the end of the third quarter of 2018. Following completion
of this primary analysis, which includes an assessment of potential
survival benefit associated with imetelstat treatment, Janssen will
notify Geron whether it elects to maintain the license rights and
continue the development of imetelstat in any indication, i.e., the
Continuation Decision.
Conference Call
At 8:00 a.m. EDT on August 1, 2017, Geron’s management will host
a conference call to discuss these updates to imetelstat clinical
development. Participants can access the conference call live via
telephone by dialing 877-303-9139 (U.S.); +1-760-536-5195
(international). The conference ID number is 42220500. 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/oqg6hyn5. The audio webcast of the
conference call will be available for replay approximately one hour
following the live broadcast through September 1, 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 conduct by Janssen of IMbark
and/or IMerge and any future clinical trials of imetelstat; (ii)
amending the protocol for Part 1 of IMerge to expand enrollment in
a refined target patient population; (iii) the timing for
enrollment to begin for the expanded Part 1 of IMerge; (iv)
potential feedback from ongoing FDA interactions; (v) any future
presentation of data from current clinical trials of imetelstat by
Janssen at a major medical conference; (vi) that Janssen will
conduct an internal data review for IMbark in the first quarter of
2018 to enable a potential protocol amendment to allow long-term
treatment and follow-up of patients; (vii) potential outcomes of
any data reviews conducted by Janssen for IMbark or IMerge; (viii)
the safety and efficacy of imetelstat; (ix) that median overall
survival may be reached in IMbark; (x) the timing of the
protocol-specified primary analysis for IMbark; (xi) that the
number of patients enrolled to date in IMbark is adequate to
perform the protocol-specified primary analysis and that
approximately 20 additional patients in IMerge will be sufficient
for decision-making; (xii) 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 (xiii) 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/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 the FDA or other 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) whether 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) 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, 2017. 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
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