Geron Corporation (Nasdaq: GERN) today announced that Janssen
Biotech, Inc. (Janssen) has terminated the 2014 Collaboration and
License Agreement (CLA) with the Company. Janssen stated in their
press release issued today that they made this decision as the
result of a strategic portfolio evaluation and prioritization of
assets within their portfolio. As such, Geron has regained the
global rights to develop and commercialize imetelstat, a
first-in-class telomerase inhibitor.
“We are grateful for the collaboration with Janssen, who
successfully managed two Phase 2 trials of imetelstat,” said John
A. Scarlett, M.D., Geron’s President and Chief Executive Officer.
“We believe the clinical results from IMbark provide valuable
insights into the potential future development of imetelstat for an
underserved relapsed and refractory myelofibrosis patient
population. We also believe the combined data of 38 patients from
the initial and expansion cohorts for the target patient population
from the Phase 2 portion of IMerge support further development of
imetelstat, and we are therefore prioritizing the initiation of the
Phase 3 portion of IMerge.”
Under the terms of the CLA, the effective date of the
termination is September 28, 2018, after which the licensed rights
to the imetelstat program, including intellectual property rights
generated under the collaboration, return to Geron without any
continuing economic obligations to Janssen, and Janssen has no
further obligations to fund any of the current ongoing imetelstat
clinical trials.
Transition of the imetelstat program to Geron is expected to
occur over approximately 12 months with operational support from
Janssen, including the orderly transfer of all ongoing clinical,
regulatory, medical affairs, manufacturing and preclinical
activities to Geron. In addition, Janssen is expected to supply
imetelstat to Geron for up to 24 months during a transition period
for clinical manufacturing.
Patients currently enrolled in the ongoing imetelstat clinical
trials in myelofibrosis (IMbark) and myelodysplastic syndromes
(IMerge) will continue to be supported through the respective trial
protocols, including treatment and follow-up.
Expanded Phase 2 Portion of IMerge Data Snapshot
Highlights
IMerge is a two-part clinical trial evaluating imetelstat in
transfusion dependent patients with Low or Intermediate-1 risk
myelodysplastic syndromes (MDS) who have relapsed after or are
refractory to prior treatment with an erythropoiesis stimulating
agent (ESA).
The first part of the trial was originally designed as a Phase
2, open-label, single-arm trial to assess the efficacy and safety
of imetelstat. The second part of the trial is planned as a Phase 3
double-blind, randomized, placebo-controlled trial in approximately
170 patients. The primary efficacy endpoint is the rate of red
blood cell transfusion independence, or RBC-TI rate, lasting at
least 8 weeks. Key secondary endpoints include the RBC-TI rate
lasting at least 24 weeks, amount and relative change in red blood
cell transfusions and hematologic improvement.
In the original Phase 2 portion 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 reported at the European Hematology Association Annual
Congress in June 2018, the initial cohort of 13 patients showed an
increased durability and rate of transfusion independence compared
to the overall trial population (≥8-week RBC-TI rate: 54% vs. 34%).
Based on these data from the initial cohort, enrollment into the
Phase 2 portion of IMerge was expanded to include an additional 25
patients (expansion cohort) who are non-del(5q) and naïve to HMA
and lenalidomide treatment in order to increase the clinical
experience and confirm the benefit-risk profile of imetelstat dosed
at 7.5 mg/kg every four weeks in this target patient
population.
To align with the completion of the IMbark primary analysis and
their decision about the collaboration, Janssen conducted an
initial data review of the expansion cohort, which they called a
data snapshot. This data snapshot represented an early look at the
expansion cohort since the median follow-up was less than half the
time the 13-patient initial cohort had been followed when their
data were first reported. The median baseline RBC transfusion
burden for the expansion cohort (n=25) was 8.0 units/8 weeks,
compared to 6.0 units for the initial 13-patient cohort.
In the data snapshot for the expansion cohort (n=25), the
≥8-week RBC-TI rate was 28%. Combining the expansion cohort with
the 13-patient initial cohort for the target patient population
(n=38), the ≥8-week RBC-TI rate was 37%. As of the data snapshot,
sufficient time had not elapsed in the expansion cohort to assess
the ≥24-week RBC-TI rate.
The safety profile from the additional enrolled patients was
consistent with the safety profile from the original 32 patients,
as well as with other clinical trials of imetelstat in hematologic
myeloid malignancies. No new safety signals were identified. The
most common adverse events were cytopenias.
Geron believes the combined data from the initial and expansion
cohorts for the target patient population (n=38) support initiating
the Phase 3 portion of IMerge to address an unmet medical need for
patients who have failed ESAs and for whom currently available
therapies show only modest efficacy.
Janssen submitted detailed results from the combined initial and
expansion cohorts for the target patient population (n=38) in the
Phase 2 portion of IMerge as an abstract for potential presentation
at the 60th Annual Meeting of the American Society of Hematology
(ASH). If the abstract is accepted for presentation at ASH, Geron
expects more mature data from the target patient population in the
Phase 2 portion of IMerge to be included in the ASH presentation.
The Company also expects final data from the Phase 2 portion of
IMerge to be available in 2019 and anticipates submitting such
final data for presentation at a future medical conference in
2019.
Phase 3 Development Plan for Lower Risk MDS
Based on the combined data from the initial and expansion
cohorts for the target patient population in the Phase 2 portion of
IMerge, Geron plans to initiate the Phase 3 portion of IMerge after
the sponsorship of the ongoing imetelstat clinical trials has been
transferred from Janssen to Geron. Geron anticipates patient
screening and enrollment for the Phase 3 portion of IMerge to begin
by mid-year of 2019. In addition, Geron has engaged a global
contract research organization (CRO) to support imetelstat clinical
development.
IMbark Protocol-Specified Primary Analysis
Highlights
IMbark was designed as a Phase 2 clinical trial to evaluate two
starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg
administered by intravenous infusion every three weeks) in
approximately 200 patients with Intermediate-2 or High-risk
myelofibrosis (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, defined as the proportion of patients who achieve a
≥35% reduction in spleen volume assessed by imaging; and symptom
response rate, defined as the proportion of patients who achieve a
≥50% reduction in Total Symptom Score, at 24 weeks. Key secondary
endpoints are safety and overall survival.
For the 9.4 mg/kg dosing arm (n=59), highlights from the primary
analysis included a spleen response rate of 10% and a symptom
response rate of 32%. No patients achieved complete remission, and
one patient achieved partial remission. The safety profile 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. At the time of the primary
analysis, median overall survival had not been reached after 23
months of median follow-up.
The extension phase of IMbark is ongoing to allow the long-term
treatment and follow-up of patients. Data collection during this
phase will consist of serious adverse events and survival.
Janssen submitted detailed results from the IMbark primary
analysis as an abstract for potential presentation at the 60th
Annual Meeting of the American Society of Hematology. If the
abstract is accepted for presentation at ASH, Geron expects more
mature data from the extension phase of IMbark to be included in
the ASH presentation.
Geron intends to discuss the results of the IMbark primary
analysis, including the assessment of overall survival as it
compares to historical data, with experts in myelofibrosis, as well
as regulatory authorities. The Company believes feedback from these
discussions will provide important information on the scope and
design of any potential future clinical trials for imetelstat in
Intermediate-2 or High-risk MF patients who have relapsed after or
are refractory to prior treatment with a JAK inhibitor.
Revised Financial Guidance
As a result of the termination of the CLA and Geron’s decision
to continue the development of imetelstat independently, the
Company has revised its financial projections and now anticipates
2018 operating expenses to be approximately $37 million (previously
$30 million). The Company expects its operating expenses to
increase as it hires additional personnel and external service
providers to support the development of imetelstat. As of August
31, 2018, the Company had approximately $183 million in cash and
marketable securities which is expected to be sufficient to support
its plans to initiate the Phase 3 portion of IMerge in 2019.
Conference Call
Geron will host a conference call to discuss its future
development plans for imetelstat at 8:00 a.m. ET on Thursday,
September 27, 2018.
Participants may access the conference call live via telephone
by dialing domestically +1 (877) 303-9139 or internationally +1
(760) 536-5195. The passcode is 7987354. A live, listen-only
webcast will also be available on the Company’s website at
www.geron.com/investors/events. If you are unable to listen to the
live call, an archived webcast will be available on the Company’s
website for 30 days.
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 suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat include a Phase 2/3 trial called IMerge in
lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial
called IMbark in Intermediate-2 to High risk myelofibrosis.
Imetelstat received Fast Track designation from the United States
Food and Drug Administration for the treatment of patients with
transfusion-dependent anemia due to lower risk MDS who are
non-del(5q) and refractory or resistant to an erythroid stimulating
agent.
About Geron
Geron is a clinical stage biopharmaceutical company focused on
the 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 such statements
regarding that Geron: (i) expects patient screening and enrollment
of the Phase 3 portion of IMerge for lower risk MDS to begin by
mid-2019; (ii) expects the transition of the imetelstat program
from Janssen to Geron to take approximately 12 months; (iii)
expects that Janssen will supply imetelstat to Geron for 24 months;
(iv) believes that the combined data from the initial and expansion
cohorts in the Phase 2 portion of IMerge support initiating the
Phase 3 portion of IMerge; (v) expects more mature data from IMerge
and IMbark to be presented at ASH in 2018; (vi) expects final data
from IMerge to be available in 2019 and plans to submit such data
for presentation at a medical conference in 2019; and (vii) expects
that 2018 operating expenses will be approximately $37 million, and
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 the transition from Janssen to Geron
proceeds expeditiously and without delay; (ii) whether the United
States Food and Drug Administration or other regulatory authorities
permit the ongoing or future clinical trials of imetelstat,
including without limitation, the Phase 3 portion of IMerge to
proceed; (iii) whether Janssen provides the required supply of
imetelstat on a timely basis, or at all; (iv) whether more mature
data is collected and made available for presentation at ASH in
2018; (v) whether Geron is able to administer, operate and commence
the Phase 3 portion of IMerge expeditiously; (vi) whether the final
data from IMerge is available in 2019, or at all; and (vii) whether
the operating expenses for the remainder of 2018 are greater than
expected due to unforeseen events. 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,
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.com media@geron.com
CG Capital877-889-1972
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