Geron Corporation (Nasdaq: GERN) today announced an expansion of
its development team’s senior leadership with the addition of three
highly experienced professionals for key functional areas. Their
oncology and drug development expertise will support Geron’s
late-stage clinical development, including the planned opening of
the Phase 3 clinical trial of imetelstat in lower risk
myelodysplastic syndromes for screening and enrollment by mid-year
2019.
Vice President, Clinical Development – Faye Feller, M.D.
Prior to Geron, Faye Feller, M.D., was Senior Director, Clinical
Leader on the myeloid program at Janssen Research and Development,
LLC (Janssen). Prior to that role, Dr. Feller was a physician for
multiple clinical trials of late-stage development assets at
Janssen, including the IMbark Phase 2 clinical trial of imetelstat,
and was responsible for protocol writing, regulatory interactions,
medical monitoring, study results interpretation and preparation of
abstracts and final study reports. Prior to Janssen, Dr. Feller was
an attending physician and instructor in the leukemia department of
Memorial Sloan Kettering Cancer Center in New York. Dr. Feller
holds a B.A. from New York University and an M.D. from Mount Sinai
School of Medicine. She completed her residency in internal
medicine at Mount Sinai Hospital and her fellowship in medical
oncology at Memorial Sloan Kettering Cancer Center.
As Vice President, Clinical Development, Dr. Feller will provide
hematology-oncology medical expertise to the clinical science and
operations teams in the execution and monitoring of clinical
trials. In addition, she will also act as the primary medical point
of contact between Geron and other medically qualified healthcare
professionals, including clinical investigators, prescribers,
medical professionals at payer organizations and regulatory
authorities.
Vice President, Clinical Science and Operations – Laurie
Sherman
Laurie Sherman has more than 20 years of experience in oncology
drug development. Prior to joining Geron, Ms. Sherman was Senior
Director, Compound Development Team Leader for non-small cell lung
cancer (NSCLC) assets at Janssen, where she was responsible for
multiple aspects of drug development, including: clinical strategy
and execution; chemistry, manufacturing and controls (CMC);
toxicology; and clinical pharmacokinetics. Preceding that role, Ms.
Sherman held several senior positions in the late-stage team at
Janssen, including Senior Director, Myeloid Portfolio Clinical
Scientist Leader, where she led development strategy and overall
clinical execution of myeloid clinical trials, including the
imetelstat clinical trials, IMerge and IMbark. Prior to that role
she was Senior Director, Lead Project Scientist on the ibrutinib
mantle cell lymphoma program. Ms. Sherman has held various
positions with increasing responsibilities across various drugs’
product life cycles, from initial Phase 1 clinical trials through
late-stage development, including operational leadership for
pivotal Phase 3 clinical trials and supporting regulatory filings
of New Drug Applications and Marketing Authorization Applications
at multiple pharmaceutical companies and organizations, including:
GlaxoSmithKline plc; Pfizer Inc.; World Wide Clinical Trials, Inc.;
and Affiliated Research Institute. Ms. Sherman has a B.S. in
nursing from the University of Washington.
As Vice President, Clinical Science and Operations, Ms. Sherman
will provide oversight and management of current and future
clinical trials, as well as strategic and technical guidance to and
management of the Company’s contract research organization and
other vendors supporting clinical operation activities. She will
also directly oversee and manage internal operations and personnel
involved with clinical operations, clinical science, data
management and medical writing functions.
Vice President, Quality – Denise Grippo
Denise Grippo has more than 18 years of experience in drug
development. Prior to joining Geron, Ms. Grippo was Vice President,
Quality at Iovance Biotherapeutics, Inc. where she was responsible
for developing and executing quality policies and plans to ensure
lifecycle management of their early- and late-stage clinical
oncology portfolio. In addition to Iovance, Ms. Grippo has held
various quality and compliance positions with increasing
responsibility and scope at XenoPort, Inc.; Mylan Pharmaceuticals,
Inc.; Watson Laboratories, Inc.; Alvogen, Inc.; and Marietta
Corporation. Ms. Grippo has an M.S. in clinical chemistry from
University of Scranton and a B.A. in biology from Temple
University.
As Vice President, Quality, Ms. Grippo will manage and direct
the quality function at Geron, including establishing systems for
quality assurance, quality control, quality systems, and overall
clinical and manufacturing compliance. She will implement the
Company’s quality vision and commitment internally and through
interactions with partners, clinical research organizations,
manufacturers and vendors.
Inducement Grants Under Nasdaq Listing Rule
5635(c)(4)
In addition to the new senior leadership announced today, two
clinical development professionals with prior experience with
imetelstat have also joined the development organization. In
connection with the commencement of employment for the five new
hires announced today, the Company has granted non-statutory stock
options to purchase an aggregate of 1,580,000 shares of Geron
common stock. The stock options were granted on April 17, 2019 at
an exercise price of $1.74 per share, which is equal to the closing
price of Geron common stock on the date of grant. The stock options
underlying 1,500,000 shares have a 10-year term and vest over four
years, with 12.5% of the shares underlying the options vesting on
the six-month anniversary of commencement of employment and the
remaining shares vesting over the following 42 months in equal
installments of whole shares, subject to continued employment with
Geron through the applicable vesting dates. The stock options
underlying 80,000 shares have a 10-year term and vest entirely on
the third anniversary of the Vice President, Clinical Development’s
hire date, subject to continued employment with Geron on the vest
date. Each stock option was granted as a material inducement to
employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is
subject to the terms and conditions of a stock option agreement
covering the grant and Geron’s 2018 Inducement Award Plan, which
was adopted December 14, 2018 and provides for the granting of
stock options to new employees.
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
begin by mid-year 2019; (ii) that imetelstat may have
disease-modifying activity; and (iii) 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 clinical, safety and efficacy, technical,
scientific, manufacturing and regulatory challenges to enable the
screening and enrollment of the Phase 3 portion of IMerge to begin
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; and (iv) 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 annual report
on Form 10-K for the year ended December 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 Capital877-889-1972
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