– Thomas Klima Joins as Chief Commercial Officer; Nurit Benjamini
Appointed to Board of Directors –
– Patient Enrollment in Phase 3 Study of NiCord® on
Track for Completion in Second Half of 2019; Topline Results Expected in
First Half of 2020 –
– NAM-NK Program Progressing with Additional Data Expected First Half
of 2019 –
SAN FRANCISCO--(BUSINESS WIRE)--Jan. 7, 2019--
Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics
company, reported expected milestones for 2019, which highlight the
company’s progress advancing its clinical development candidates: NiCord®,
an investigational universal bone marrow donor source in late-stage
development for patients with hematologic malignancies (blood cancers),
and NAM-NK, an investigational, cell-based cancer immunotherapy in
development in patients with non-Hodgkin lymphoma and multiple myeloma.
Gamida Cell expects to complete patient enrollment in its Phase 3
clinical study of NiCord in the second half of this year. The
international, randomized, multi-center study is designed to evaluate
the safety and efficacy of NiCord compared to standard umbilical cord
blood for allogeneic hematopoietic stem cell (bone marrow) transplant in
approximately 120 patients with no available matched donor. The company
also expects to report additional data from the ongoing Phase 1 study of
NAM-NK at a medical meeting during the first half of 2019.
Today Gamida Cell also announced the appointment of Thomas Klima to the
newly created role of chief commercial officer. Mr. Klima brings nearly
20 years of global experience in the pharmaceutical industry with
expertise in cellular therapy, hematology, oncology and transplantation.
During his career, he has played key roles in building commercial
organizations and leading multiple successful product launches.
Additionally, the company announced that Nurit Benjamini, an experienced
financial executive, has been appointed to Gamida Cell’s board of
directors and will chair the board’s audit committee.
“We are intently focused on advancing NiCord, which has potential to
expand and improve bone marrow transplants, giving patients a chance for
a cure. We are on track to complete enrollment by the end of this year,
with topline data from the Phase 3 study anticipated in first half of
2020,” stated Julian Adams, Ph.D., chief executive officer at Gamida
Cell. “We are also continuing to build a pipeline based on our
proprietary nicotinamide, or NAM, technology and plan to report
additional data from the ongoing Phase 1 study of NAM-NK in the coming
“We have also augmented our team with two new experienced individuals.
I’m pleased to welcome Tom Klima, who will join as chief commercial
officer, and Nurit Benjamini, who will serve as an independent director
on the company’s board. Their experience and contributions will be
invaluable as we advance toward anticipated commercialization,” Dr.
Mr. Klima most recently served as head of global commercial planning and
operations at Atara Biotherapeutics, prior to which he played a key role
as senior vice president and chief commercial officer at Navidea
Biopharmaceuticals Ltd. Mr. Klima also served as head of sales and
commercial operations at Algeta U.S. and led the successful commercial
build-out and launch of Xofigo®. Before Algeta, he held
various commercial leadership positions at Dendreon. Mr. Klima began his
pharmaceutical career at Eli Lilly where he held several positions of
increasing responsibility and participated in the global launch of
Cymbalta®. Mr. Klima earned a B.A. in Business Administration
and Marketing from Western State College.
Ms. Benjamini has served as chief financial officer of TabTale Ltd.
since 2013. Previously, she held a number of chief financial officer
positions, including at Wix.com Ltd., Sigma Designs Israel Ltd. and
Compugen Ltd. She has served as a director at RedHill Biopharma Ltd.,
BioLine Rx and Allot Communications. Ms. Benjamini holds a BA in
Economics and Business and an MBA in Finance from Bar Ilan University,
Expected 2019 Milestones
Gamida Cell expects to achieve the following milestones this year:
Present additional data from the Phase 1 study of NAM-NK in first half
Report early data from the Phase 1/2 study of NiCord in patients with
severe aplastic anemia data in the first half of 2019
Complete patient enrollment in the Phase 3 study of NiCord in patients
with high-risk hematologic malignancies in the second half of 2019
2019 Financial Outlook
Gamida Cell ended 2018 with cash, cash equivalents and
available-for-sale securities of approximately $60 million (unaudited).
The company expects that such funds will support the company’s capital
needs through the data readout for the Phase 3 clinical study of NiCord,
which is expected in the first half of 2020. This cash runway guidance
is based on the company’s current operational plans and excludes any
additional funding that may be received or business development
activities that may be undertaken.
Gamida Cell intends to provide additional financial guidance for 2019
when it reports its fourth quarter and full-year 2018 financial results
in March 2019.
NiCord, the company’s lead clinical program, is under development as a
universal bone marrow transplant solution for patients with high-risk
hematologic malignancies. NiCord has been granted Breakthrough Therapy
designation by the U.S. Food and Drug Administration, making it the
first bone marrow transplant alternative to receive this designation. It
has also received U.S. and EU orphan drug designation. A Phase 3
clinical study evaluating NiCord in patients with leukemia and lymphoma
is ongoing in the United States, Europe and Asia.1 For more
information on clinical trials of NiCord, please visit www.clinicaltrials.gov.
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.2
NiCord and NAM-NK 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 leveraging its
proprietary technology to develop cell therapies that are designed to
cure cancer and rare, serious hematologic diseases. The company is
leveraging its nicotinamide-, or NAM-, based cell expansion technology
to develop a pipeline of products designed to address the limitations of
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 timing of patient enrollment in Gamida
Cell’s ongoing Phase 3 clinical study of NiCord, the timing of topline
data therefrom and from Gamida Cell’s NAM-NK Phase 1 clinical study, and
the anticipated duration of Gamida Cell’s cash runway, which statements
are subject to a number of risks, uncertainties and assumptions,
including, but not limited to the scope, progress and expansion of
Gamida Cell’s ongoing studies, and changes to Gamida Cell’s current
operational plans including with respect to additional funding to be
received or business development activities undertaken. 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-1 filed with the SEC on September 28, 2018, 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.
Xofigo® is a registered trademark of Bayer. Cymbalta®
is a registered trademark of Eli Lilly and Company.
1 ClinicalTrials.gov identifier NCT02730299.
2 ClinicalTrials.gov identifier NCT03019666.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190107005290/en/
Source: Gamida Cell Ltd.
Jaren Irene Madden