Forty Seven, Inc. (Nasdaq:FTSV), a clinical-stage,
immuno-oncology company focused on developing therapies to activate
macrophages in the fight against cancer, today outlined its
strategic plan and expected milestones for 2020.
“Our vision is to deliver groundbreaking therapies
to patients by harnessing the potential of the innate immune system
in the fight against disease,” said Mark McCamish, M.D., Ph.D.,
President and Chief Executive Officer of Forty Seven. “As we enter
the new year, we are executing against this strategy with full
force. Our potential-registration enabling programs for magrolimab
in MDS and DLBCL are underway, and we are pleased to have recently
received FDA Orphan Drug designation for magrolimab in MDS. In
parallel, we are preparing to advance FSI-174 and FSI-189 into the
clinic, where we believe we can leverage our deep understanding of
the CD47/SIRPα pathway to engage previously unexploited phagocytic
pathways.”
Dr. McCamish continued, “Following our successful
follow-on offering in December 2019, we are well financed, with
sufficient resources to advance our pipeline through key
milestones, including the potential submission of our first
biologics license application for magrolimab, while scaling our CMC
activities to support future product launches. We expect 2020 to be
a year of notable progress across our portfolio, as we read out
data for each of our magrolimab programs and accelerate ongoing
efforts to offer magrolimab to genomically-defined patient
populations, like TP53-mutant AML, where we believe our approach
can offer targeted benefit. We will simultaneously progress our
earlier-stage assets, FSI-174 and FSI-189, in hopes of delivering
on the full potential of macrophage biology for people living with
cancer and other serious diseases.”
Magrolimab – Registration-Enabling
Programs
Forty Seven is focused on advancing magrolimab in
registration-enabling programs for the treatment of patients with
untreated, higher-risk myelodysplastic syndrome (MDS) and
heavily-pretreated, relapsed or refractory diffuse large B-cell
lymphoma (DLBCL). Magrolimab has previously been granted Fast Track
designation by the FDA for the treatment of MDS and acute myeloid
leukemia (AML), and for the treatment of relapsed or refractory
DLBCL and follicular lymphoma, as well as Orphan Drug designation
by the U.S. Food and Drug Administration (FDA) and European
Medicines Agency for the treatment of AML. In December 2019, the
FDA granted Orphan Drug designation to magrolimab for the treatment
of MDS.
The company expects to achieve the following
milestones in 2020:
Myelodysplastic Syndrome:
- Initiate Phase 3 ENHANCE trial evaluating the combination of
magrolimab and azacitidine compared to azacitidine alone in
patients with untreated, higher risk-MDS in the second
quarter;
- Present updated data from the ongoing Phase 1b clinical trial
evaluating the combination of magrolimab and azacitidine in
untreated patients with higher risk MDS mid-year;
- Complete enrollment in the ongoing Phase 1b clinical trial in
the third quarter.
Diffuse Large B-Cell Lymphoma:
- Initiate single-arm, registration-enabling trial evaluating the
combination of magrolimab and rituximab in heavily pre-treated
relapsed or refractory DLBCL patients who have failed at least two
prior lines of therapy in the first quarter;
- Present initial data from the registration-enabling trial in
the fourth quarter.
Magrolimab – Other Programs
Forty Seven will expand enrollment in its ongoing
Phase 1b clinical trial evaluating the combination of magrolimab
and azacitidine to include additional untreated TP53 mutant AML
patients who are ineligible for induction chemotherapy to inform a
potential registrational path. Updated data from this trial will be
presented mid-year.
Additionally, Forty Seven is evaluating magrolimab
for the treatment of colorectal (CRC) and ovarian cancer. Clinical
data in patients with CRC and ovarian cancer will be presented at
the ASCO Gastrointestinal Cancers Symposium (ASCO-GI), held January
23-25, 2020 in San Francisco, and the ASCO-SITC Clinical
Immuno-Oncology Symposium, held February 6-8, 2020 in Orlando,
respectively. While data from these studies do not support a path
to registration, Forty Seven intends to use these results and
learnings to identify its next steps in solid tumors.
Additional Pipeline Programs
Forty Seven is developing a broad pipeline of
additional programs, which take advantage of the CD47/SIRPα pathway
as a rich target for engaging macrophages. FSI-174, an anti-cKIT
antibody, is being developed in combination with magrolimab as a
novel, all-antibody conditioning regimen to address the limitations
of current stem cell transplantation conditioning regimens.
FSI-189, an anti-SIRPα antibody, is being developed for the
treatment of cancer, as well as certain non-oncology conditions
including transplantation conditioning.
The company expects to achieve the following
milestones in 2020:
- Initiate a Phase 1 clinical trial evaluating the safety and
tolerability of FSI-174 in healthy volunteers in the first
quarter;
- File an investigational new drug application with the FDA for
FSI-189 in the first quarter; and
- Initiate a Phase 1 clinical trial evaluating the safety and
tolerability of FSI-189 for the treatment of cancer in the second
quarter.
Cash Position and Financial
Guidance:
Based on preliminary estimates, Forty Seven had
cash, cash equivalents and short-term investments of $329.1 million
at December 31, 2019. Based on its current operating plans, Forty
Seven expects that its cash, cash equivalents and short-term
investments will fund operating expenses and capital expenditure
requirements into the first quarter of 2022.
About Forty Seven, Inc. Forty
Seven, Inc. is a clinical-stage immuno-oncology company that
is developing therapies targeting cancer immune evasion pathways
and specific cell targeting approaches based on technology licensed
from Stanford University. Forty Seven’s lead program,
magrolimab, is a monoclonal antibody against the CD47 receptor, a
“don’t eat me” signal that cancer cells commandeer to avoid being
ingested by macrophages. This antibody is currently being evaluated
in multiple clinical studies in patients with myelodysplastic
syndrome, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian
cancer and colorectal carcinoma.
Forward Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as
“potential,” “believe,” "expect," "will," "intend," and similar
expressions (as well as other words or expressions referencing
future events, conditions, or circumstances) are intended to
identify forward-looking statements. These statements include those
related to the potential of the innate immune system in the fight
against disease, Forty Seven’s potential-registration enabling
programs for magrolimab in MDS and DLBCL, Forty Seven’s success in
advancing and progressing FSI-174 and FSI-189 into the clinic,
Forty Seven’s potential to leverage the CD47/SIRPα pathway to
engage previously unexploited phagocytic pathways, Forty Seven’s
progress across its portfolio, Forty Seven’s achievement of
milestones this year, initiation of and results from the Phase 3
ENHANCE trial evaluating the combination of magrolimab and
azacitidine in patients with untreated, higher risk-MDS, the
success of the ongoing Phase 1b clinical trial evaluating the
combination of magrolimab and azacitidine in untreated patients
with higher risk MDS, the initiation of a single-arm,
registration-enabling trial evaluating the combination of
magrolimab and rituximab in heavily pre-treated relapsed or
refractory DLBCL patients, the expansion pf enrollment in the
ongoing Phase 1b clinical trial evaluating the combination of
magrolimab and azacitidine to include additional untreated TP53
mutant AML patients, the outcome of the evaluation of magrolimab
for the treatment of colorectal (CRC) and ovarian cancer, the
development of FSI-174 in combination with magrolimab as a novel,
all-antibody conditioning regimen to address the limitations of
current stem cell transplantation conditioning regimens, the
development of FSI-189 for the treatment of cancer, as well as
certain non-oncology conditions including transplantation
conditioning, the timing of reports of data from ongoing clinical
trials and preclinical studies, the clinical potential of Forty
Seven’s product candidates, the expected 2020 milestones for Forty
Seven’s research programs generally, and Forty Seven’s expected
cash, cash equivalents and short-term investments as of
December 31, 2019 and expected utilization of cash and
investments into the first quarter of 2022.
Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. The
product candidates that Forty Seven develops may not progress
through clinical development or receive required regulatory
approvals within expected timelines or at all. In addition,
clinical trials may not confirm any safety, potency or other
product characteristics described or assumed in this press release.
Such product candidates may not be beneficial to patients or
successfully commercialized. The failure to meet expectations with
respect to any of the foregoing matters may have a negative effect
on Forty Seven's stock price. Additional information concerning
these and other risk factors affecting Forty Seven's business can
be found in Forty Seven's periodic filings with the Securities
and Exchange Commission at www.sec.gov. These
forward-looking statements are not guarantees of future performance
and speak only as of the date hereof, and, except as required by
law, Forty Seven disclaims any obligation to update these
forward-looking statements to reflect future events or
circumstances.
For more information please visit
www.fortyseveninc.com or contact info@fortyseveninc.com.
For journalist enquiries please contact Sarah
Plumridge at fortyseven@hdmz.com or phone (312) 506-5218.
For investor enquiries please contact Hannah
Deresiewicz at Stern Investor Relations Inc. at
hannah.deresiewicz@sternir.com or phone (212) 362-1200.
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