– Shawn Cline Tomasello and Stephen T. Wills bring extensive
experience in building successful commercial-stage life sciences
companies –
BOSTON--(BUSINESS WIRE)--Mar. 21, 2019--
Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune
therapeutics company, today announced the nominations of Shawn Cline
Tomasello and Stephen T. Wills to its board of directors. These
nominations require approval at the Annual Shareholders Meeting, which
will take place in May 2019. If elected, Ms. Tomasello will join the
compensation committee, and Mr. Wills will join the company’s audit
committee, bringing commercial, operational and financial experience to
Gamida Cell’s board of directors as the company advances its clinical
development candidates: NiCord®, an investigational advanced
cell therapy in Phase 3 clinical development designed to enhance and
expand the life-saving benefits of hematopoietic stem cell (bone marrow)
transplant, and NAM-NK, an investigational, cell-based cancer
immunotherapy in Phase 1 development in patients with non-Hodgkin
lymphoma and multiple myeloma.
“We are delighted to nominate Shawn and Stephen to our Board of
Directors. Stephen brings a depth of financial and operational
experience in public accounting and healthcare, and Shawn’s experience
in leading the commercialization of multiple first-in-class medicines
for the treatment of cancer is a potentially tremendous asset as we
begin executing commercial readiness activities for NiCord,” said Julian
Adams, Ph.D., chief executive officer at Gamida Cell. “We look forward
to their contributions to as we continue to advance our pipeline.”
“Shawn and Stephen will replace two current board members, Roger
Kornberg and Boaz Lifschitz, who will complete their tenure on Gamida
Cell’s board of directors in May. We are grateful for Roger and Boaz’s
service and commitment to the company. They brought a wealth of
expertise as we advanced Gamida Cell toward late-stage development and
potential commercialization, and we are pleased that Roger will continue
to work with the company as a member of our scientific advisory board,”
Dr. Adams continued.
Ms. Tomasello has over 30 years of strategic experience in building
world-class organizations encompassing all aspects of commercial and
medical affairs functions. From 2015 to 2018, Ms. Tomasello served as
chief commercial officer of Kite Pharma, now part of Gilead Sciences,
where she oversaw the global commercialization of Yescarta®,
the first approved CAR-T therapy for non-Hodgkin lymphoma. From 2014 to
2015, Ms. Tomasello served as the chief commercial officer of commercial
and medical affairs at Pharmacyclics, now part of AbbVie, where she led
commercial and medical affairs activities for Imbruvica®, a
first-in-class treatment for hematologic malignancies. From 2005 to
2014, Ms. Tomasello served in leading commercial roles with multiple
major pharmaceutical companies, including Celgene as president of the
Americas hematology and oncology, where she led the company through five
successful product launches encompassing 11 indications and played a
critical role in acquisitions. Ms. Tomasello received her B.S. in
marketing from the University of Cincinnati and her M.B.A. from Murray
State University in Kentucky.
Mr. Wills brings extensive operational, financial and transactional
experience over nearly three decades in the life sciences and accounting
industries. He has served as chief financial officer of Palatin
Technologies, a publicly-traded biotechnology company developing peptide
therapeutics, since 1997 and also serves as Palatin’s chief operating
officer and executive vice president. Mr. Wills serves as active
chairman of MediWound Ltd., a publicly-traded biotechnology company
developing treatments for burns and wound management. Previously, Mr.
Wills was executive chairman and interim principal executive officer of
Derma Sciences, a provider of advanced wound care products now part of
Integra LifeSciences. Mr. Wills, a certified public accountant, earned
his B.S. in accounting from West Chester University, and an M.S. in
taxation from Temple University.
“I am pleased to be nominated to the Gamida Cell Board at such a pivotal
time in the company’s growth,” stated Ms. Tomasello. “With patient
enrollment in the Phase 3 study of NiCord expected to be completed in
the second half of 2019 and activities underway to enable potential
regulatory submissions and launch, I look forward to supporting Gamida
Cell in its efforts to deliver a new standard of care to patients in
need of bone marrow transplant.”
Commented Mr. Wills, “This is an exciting time to be joining Gamida
Cell’s board of directors. The company has demonstrated substantial
progress since completing its initial public offering late last year and
continues to leverage the transformative potential of its proprietary
nicotinamide-, or NAM-based, cell expansion technology, to deliver a
multi-product pipeline. I look forward to contributing to Gamida Cell’s
progress as a leader in advanced cell therapy.”
About NiCord
NiCord, the company’s lead clinical program, is
an advanced cell therapy under development as a potential life-saving
allogeneic hematopoietic stem cell (bone marrow) transplant solution for
patients with hematologic malignancies (blood cancers). NiCord is the
first bone marrow transplant product to receive Breakthrough Therapy
Designation from the U.S. Food and Drug Administration and has also
received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2
clinical study, NiCord demonstrated rapid and durable time to
engraftment and was generally well-tolerated.1 A Phase 3
study evaluating NiCord in patients with leukemia and lymphoma is
ongoing in the U.S., Europe and Asia.2 NiCord is also being
evaluated in a Phase 1/2 clinical study in patients with severe aplastic
anemia.3 The aplastic anemia investigational new drug
application is currently filed with the FDA under the brand name CordIn®,
which is the same investigational development candidate as NiCord. For
more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.
About NAM-NK
Gamida Cell applied the capabilities of its
NAM-based cell expansion technology to highly functional NK cells to
develop NAM-NK, an innate immunotherapy for the treatment of hematologic
and solid tumors in combination with standard of care antibody
therapies. NAM-NK addresses key limitations of NK cells by increasing
the cytotoxicity and in vivo retention and proliferation in the bone
marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in
Phase 1 development through an investigator-sponsored study in patients
with refractory non-Hodgkin lymphoma and multiple myeloma.4
NAM-NK and NiCord are investigational therapies, and their safety and
efficacy have not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Gamida Cell
Gamida Cell is a clinical-stage
biopharmaceutical company committed to developing advanced cell
therapies with the potential to cure blood cancers and rare, serious
hematologic diseases. We are leveraging our proprietary
nicotinamide-based, or NAM-based, cell expansion technology to develop
product candidates designed to address the limitations of cell
therapies. For additional information, please visit www.gamida-cell.com.
Cautionary Note Regarding Forward Looking Statements
This
press release contains forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995,
including with respect to the scheduling of the company’s 2019 Annual
Meeting, the contributions to our board of directors by Ms. Tomasello
and Mr. Wills and completion of patient enrollment in the ongoing Phase
3 study of NiCord in patients with leukemia and lymphoma, which
statements are subject to a number of risks, uncertainties and
assumptions, including, but not limited to the progress of Gamida Cell’s
studies and other clinical, scientific and technical developments. In
light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of our
Registration Statement on Form F-20 filed with the SEC on February 25,
2019, and other filings that Gamida Cell makes with the SEC from time to
time (which are available at http://www.sec.gov),
the events and circumstances discussed in such forward-looking
statements may not occur, and Gamida Cell’s actual results could differ
materially and adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Gamida Cell as of the
date of this release.
1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al.
Phase I/II study of stem-cell transplantation using a single cord blood
unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb
10;37(5):367-374.
2 ClinicalTrials.gov identifier
NCT02730299.
3 ClinicalTrials.gov identifier NCT03173937.
4
ClinicalTrials.gov identifier NCT03019666.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190321005019/en/
Source: Gamida Cell Ltd.
Jaren Irene Madden
jaren@gamida-cell.com
617-286-6264
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