Geron Corporation (Nasdaq: GERN) today provided an update to its
2019 corporate objectives for the imetelstat program.
“2019 is off to a good start with the imetelstat
IND transfer now complete, enabling us to move forward with the
planned opening of the Phase 3 clinical trial in lower risk
myelodysplastic syndromes for screening and enrollment, which we
continue to expect by mid-year 2019,” said John A. Scarlett, M.D.,
Chairman and Chief Executive Officer. “Our new development team has
refined our regulatory strategies for myelofibrosis, which we plan
to discuss at an End of Phase 2 meeting with the FDA by the end of
the first quarter of 2020. We will be performing analyses to
support these strategies, and we believe the results of these
analyses will enhance the potential of determining a timely and
cost-effective regulatory strategy for imetelstat in
relapsed/refractory myelofibrosis.”
Imetelstat IND Sponsorship Transfer to
Geron
As of May 14, 2019, Geron assumed the imetelstat
investigational new drug (IND) sponsorship from Janssen. With the
IND transfer complete, Geron is proceeding with start-up activities
for the Phase 3 portion of IMerge and continues to expect the Phase
3 portion of IMerge to be open for screening and enrollment by
mid-year. Geron expects to complete the transition of the
imetelstat program by the end of the third quarter of 2019,
including assuming the remaining non-clinical, manufacturing, and
ex-U.S. clinical operational responsibilities from Janssen.
Planned Phase 3 Portion of IMerge Expected
to Open Mid-Year
IMerge is a two-part clinical trial of
imetelstat in transfusion dependent patients with Low or
Intermediate-1 risk myelodysplastic syndromes (lower risk MDS). The
second part of IMerge is designed as a Phase 3 double-blind,
randomized, placebo-controlled trial in approximately 170 patients,
which will evaluate imetelstat in transfusion dependent patients
with non-del(5q) lower risk MDS who have relapsed after or are
refractory to prior treatment with an erythropoiesis stimulating
agent (ESA) and have not received treatment with either a
hypomethylating agent (HMA) or lenalidomide. The Company expects
the trial to be conducted at multiple medical centers globally,
including North America, Europe, Middle East and Asia.
In preparation for the Phase 3 portion of IMerge
and other potential future clinical trials of imetelstat, Geron is
purchasing inventories of drug substance, drug product and raw
materials for imetelstat manufacturing from Janssen. The Company
expects this inventory to be sufficient to supply the Phase 3
portion of IMerge, as well as initial supply for potential future
clinical trials of imetelstat in other indications. In addition,
Geron is re-establishing its drug manufacturing supply chain and
expects to have engaged all necessary contract manufacturing
vendors by the end of the third quarter.
Planning End of Phase 2 Meeting for
Relapsed/Refractory Myelofibrosis (MF)
Geron is revising its objective to communicate a
decision regarding late-stage development in relapsed/refractory
myelofibrosis (MF) by the end of the third quarter of 2019. This
revision is based on recently refined strategies for potential
regulatory approval proposed by the Company’s new development team,
as well as the time required to perform analyses necessary to
support these strategies for discussions with regulatory
authorities. The Company believes the results of these analyses
will enhance the potential for reaching agreement with the U.S.
Food and Drug Administration (FDA) on a timely and cost-effective
regulatory strategy for imetelstat in relapsed/refractory MF.
The Company now plans to conduct an End of Phase 2
(EOP2) meeting with the FDA by the end of the first quarter of
2020. Subsequent to this meeting, the Company expects to provide a
decision regarding late-stage development of imetelstat in
relapsed/refractory MF.
Building a Robust Internal Development
Team
Since the beginning of the year, Geron has
recruited senior leadership with extensive oncology and drug
development experience in key functional areas for its development
team. In addition, several new hires with prior experience with the
imetelstat program have recently joined the Company. The Company’s
successful recruiting efforts are building internal capabilities
and leadership in clinical operations, clinical sciences and
development, translational research, biostatistics,
pharmacovigilance and drug safety, quality, regulatory and
manufacturing.
This growing internal expertise will support the
Company’s current and future development plans, including the
planned opening of the Phase 3 portion of IMerge for screening and
enrollment, and evaluating potential additional indications for
imetelstat, as well as the ability to evaluate other
hematology-oncology assets to expand the Company’s pipeline in the
future.
Revised 2019 Financial
Guidance
For fiscal year 2019, the Company has increased its
total operating expense guidance to a range from $80 to $85
million, of which approximately $20 to $25 million represents
one-time costs. The projected increase from the Company’s prior
total operating expense guidance primarily reflects the purchase of
additional inventories of drug substance, drug product and raw
materials for imetelstat manufacturing from Janssen in 2019 of
approximately $10 million, and expected higher clinical operational
costs of approximately $5 million.
As of May 15, 2019, the Company has 31 employees,
and now plans to grow to a total of approximately 45 to 50
employees by year-end 2019, of whom half will be research and
development personnel.
Current Ongoing Clinical Trials of
Imetelstat
Patients currently enrolled in ongoing imetelstat
clinical trials will continue to be supported through the
respective trial protocols, including treatment and follow-up.
Phase 2 Portion of IMerge
The first part of IMerge was designed as a Phase 2,
open label, single arm study to assess the efficacy and safety of
imetelstat. The primary efficacy endpoint is 8-week RBC-TI rate,
which is defined as the proportion of patients achieving red blood
cell transfusion independence during any consecutive eight weeks
since entry into the trial. 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. To be
eligible for the Phase 2 or Phase 3 portion of IMerge, patients are
required to be transfusion dependent, defined as requiring at least
four units of packed RBCs over an eight-week period during the 16
weeks before entry into the trial. The Phase 2 portion of IMerge is
closed to new patient enrollment.
As reported at the American Society of Hematology
Meeting in December 2018, the 8-week RBC-TI rate in a combined
cohort of 38 patients in the Phase 2 portion of IMerge was 37%
(14/38) using a clinical data cut-off date of October 26, 2018.
Based on the most recent clinical cut-off date, used to prepare the
IMerge clinical data for the transition of the imetelstat program,
the confirmed 8-week RBC-TI rate in the combined cohort is 42%
(16/38).
IMbark
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 patients with Intermediate-2 or High-risk MF who have
relapsed after or are refractory to prior treatment with a janus
kinase (JAK) inhibitor. The co-primary efficacy endpoints for the
trial are spleen response rate and symptom response rate. Key
secondary endpoints are safety and overall survival (OS). IMbark is
closed to new patient enrollment.
As reported at the American Society of Hematology
Meeting in December 2018, the median OS in the 9.4 mg/kg dosing arm
of IMbark was 29.9 months using a data cut-off date of October 22,
2018. Based on the most recent clinical cut-off date, used to
prepare the IMbark clinical data for the transition of the
imetelstat program, the median OS in the 9.4 mg/kg dosing arm is
28.1 months.
Conference Call
Geron will host a conference call to discuss the
imetelstat program update at 9:00 a.m. ET on Thursday, May 16,
2019, which will also include a discussion of future presentations
of imetelstat clinical data.
Participants may access the conference call live
via telephone by dialing domestically +1 (877) 303-9139 or
internationally +1 (760) 536-5195. The conference ID is 1264477. 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 or High-risk myelofibrosis.
Imetelstat has been granted Fast Track designation by 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 late-stage clinical 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) that
patient screening and enrollment for the Phase 3 portion of IMerge
will be open by mid-year 2019; (ii) that the imetelstat program
transition will be complete by the end of the third quarter of
2019; (iii) that the Phase 3 portion of IMerge will be conducted at
multiple medical centers globally; (iv) that the inventory being
purchased from Janssen will be sufficient to supply the Phase 3
portion of IMerge and initial supply for potential future clinical
trials of imetelstat; (v) that Geron expects to have engaged all
necessary contract manufacturing vendors by the end of the third
quarter 2019; (vi) that Geron will conduct an EOP2 meeting with the
FDA regarding relapsed/refractory MF by the end of the first
quarter of 2020 and subsequently will provide its decision
regarding late-stage development of imetelstat for that indication;
(vii) Geron’s belief that the results of the analyses to support
strategies for potential regulatory approval will enhance the
potential for reaching agreement with the FDA on a timely and
cost-effective regulatory strategy for imetelstat in
relapsed/refractory MF; (viii) that the Company’s total operating
expenses will be $80 to $85 million in 2019, and other financial
projections and expectations; (ix) that the Company will grow to a
total of 45 to 50 employees by year-end 2019; (x) that Geron’s
growing internal expertise will support its current and future
development plans; (xi) that Geron has the ability to evaluate
potential additional indications for imetelstat and other
hematology-oncology assets to expand its pipeline in the future;
(xii) that imetelstat may have disease-modifying activity; 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 the Company overcomes all the: (a)
challenges of completing the transition of the imetelstat program
from Janssen, and (b) clinical safety and efficacy, technical,
scientific, manufacturing and regulatory challenges to enable the
screening and enrollment of the Phase 3 portion of IMerge to open
by mid-year 2019; (ii) whether regulatory authorities permit the
further development of imetelstat on a timely basis, or at all,
without any clinical holds; (iii) whether imetelstat is safe and
efficacious, and whether any future efficacy or safety results may
cause the benefit-risk profile of imetelstat to become
unacceptable; (iv) whether the transition of the imetelstat
program to the Company can be completed by the end of the third
quarter of 2019; (v) whether Geron can re-establish the imetelstat
manufacturing supply chain; (vi) whether the inventory being
purchased from Janssen is sufficient to supply the Phase 3 portion
of IMerge and initial supply for potential future clinical trials
of imetelstat; (vii) whether Geron is able to perform the analyses
and complete the required activities in order to conduct an EOP2
meeting by the end of the first quarter of 2020; (viii) whether the
results of the analyses will be sufficient to enable Geron to reach
agreement with the FDA on a timely and cost-effective regulatory
strategy, and to make a decision, regarding late-stage development
in relapsed/refractory MF; (ix) the need for future capital; (x)
whether Geron is successful in engaging all necessary contract
manufacturing vendors by the end of the third quarter 2019; (xi)
whether Geron has underestimated its 2019 operating expenses or has
not anticipated contingencies that may require more expenditures;
(xii) whether Geron is able to hire the additional personnel to
grow to 45 to 50 employees by the end of the year; (xiii) Geron’s
potential inability to successfully retain or recruit key personnel
to support its current and future development plans or to otherwise
successfully manage its growth; and (xiv) whether imetelstat
demonstrates disease-modifying activity. 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 March
31, 2019. 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 Capital877-889-1972
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