Fortress Biotech Forms New Subsidiary, Caelum Biosciences, Inc., to Develop Novel Treatment for AL Amyloidosis
January 04 2017 - 8:00AM
Caelum Program Evaluating CAEL-101 (11-1F4) for
AL Amyloidosis In-licensed from Columbia University
Fortress Biotech, Inc. (Nasdaq:FBIO) today announced the formation
of a new subsidiary company, Caelum Biosciences, Inc., to advance
the development of CAEL-101 (11-1F4) for the treatment of amyloid
light chain (“AL”) amyloidosis. Caelum has entered into an
agreement with Columbia University (“Columbia”) to secure exclusive
worldwide license rights to CAEL-101, a chimeric fibril-reactive
monoclonal antibody (mAb) currently being evaluated in a Phase
1a/1b study. In addition, Fortress announced the appointment of
Michael Spector as Caelum’s Chief Executive Officer.
AL amyloidosis is a rare systemic disorder
caused by an abnormality of plasma cells in the bone marrow.
Misfolded amyloid proteins produced by plasma cells cause buildup
in and around tissues, nerves and organs, gradually affecting their
function. This can cause progressive and widespread organ damage,
and high mortality rates.
Alan Solomon, M.D., Professor of Medicine
Emeritus and a former American Cancer Society Clinical Research
Professor at the University of Tennessee Graduate School of
Medicine, who pioneered early development of antibodies that work
to break up pre-existing amyloid in tissues and oversaw preclinical
research on CAEL-101, said: “Existing AL amyloidosis treatment
using chemotherapy eliminates the plasma cells that produce the
abnormal proteins, but most often the pathologic amyloid deposits
in the body’s vital tissues remain or progress, resulting in organ
failure and even death. For this reason, our research efforts were
focused on helping the body’s immune system remove this deleterious
material. Our “anti-amyloid” monoclonal antibody 11-1F4, now
designated CAEL-101, has demonstrated its ability to bind to
amyloid and promote dissolution in mice bearing human AL amyloid
tumors. Most importantly, CAEL-101 injection has been shown to
specifically bind to the amyloid and not to normal tissue in
patients with AL amyloidosis. We hope that this anti-amyloid
immunotherapy, in combination with anti-plasma cell chemotherapy,
will benefit patients with this fatal disease.”
Dr. Lindsay A. Rosenwald, Fortress Biotech’s
Chairman, President and Chief Executive Officer, said, “We are
thrilled to enter this collaboration with Columbia to advance the
development of CAEL-101. The launch of Caelum, Fortress Biotech’s
eighth subsidiary, underscores our mission of developing a broad
pipeline of novel products across areas of unmet need.”
CAEL-101 Phase 1a/1b Study
UpdateData from an ongoing Phase 1a/1b study
(ClinicalTrials.gov Identifier: NCT02245867) have demonstrated that
CAEL-101 is well tolerated and safe with no drug-related grade four
or five adverse events or dose-limiting toxicity up to 500mg/m2. A
single infusion of CAEL-101 or one weekly infusion for four weeks
have demonstrated early and sustained organ response in cardiac,
renal, gastrointestinal, skin and soft tissue. Interim clinical
efficacy data show CAEL-101 promotes amyloid resolution in 67
percent of patients (63 percent in Phase 1a; 70 percent in Phase
1b). These data were presented by Columbia University on December
5, 2016 at the American Society of Hematology’s (ASH) 58th Annual
Meeting.
Suzanne Lentzsch, M.D., Ph.D., Professor of
Medicine at Columbia University Medical Center, College of
Physicians and Surgeons of Columbia University and at New York
Presbyterian Hospital, and the principle investigator on the Phase
1a/1b study, said, “These interim results demonstrate strong
biomarker activity that may speak to CAEL-101’s ability to safely
promote amyloid elimination and the subsequent improvement of organ
function. We look forward to working with Caelum on this promising
program and expect to report full Phase 1a/1b data in the first
half of 2017 and initiate a Phase 2 study in 2018.”
Michael Spector Named Chief Executive
Officer Michael Spector joins Caelum from Fortress,
Caelum’s parent company. At Fortress, Michael has leveraged
his more than 25 years of experience in biotechnology to identify
emerging and innovative technologies to launch as new biotech and
specialty pharmaceutical companies. Before joining Fortress, Mr.
Spector served as Senior Vice President, Global Commercial
Operations at Iroko Pharmaceuticals. Earlier in his career, he
spent 15 years at GlaxoSmithKline in multiple senior management
positions, including Vice President and General Manager of
GlaxoSmithKline South Africa, where he led the overall business
strategy and was elected to run the South African Pharmaceutical
Manufacturers Association. Mr. Spector is also a founding member of
Windhoek Healthcare, where he launched two specialty pharmaceutical
companies: Laurel Pharmaceuticals and North Creek
Pharmaceuticals.
Mr. Spector holds an M.B.A. from Rider
University in Lawrenceville, N.J., where he serves on the school’s
Business and Scientific Advisory Boards, and a B.S. in biology from
the University of Pittsburgh. He also serves on the board of
Jacaranda Health, a nonprofit organization that seeks to transform
maternal and neonatal healthcare in East Africa.
About Fortress BiotechFortress
Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated
to acquiring, developing and commercializing novel pharmaceutical
and biotechnology products. Fortress develops and commercializes
products both within Fortress and through certain of its subsidiary
companies, also known as Fortress Companies. Additionally,
Fortress recently acquired a controlling interest in National
Holdings Corporation (NASDAQ:NHLD), a diversified independent
brokerage company (together with its subsidiaries, “NHLD”). In
addition to its internal development programs, Fortress leverages
its biopharmaceutical business expertise and drug development
capabilities and provides funding and management services to help
the Fortress Companies achieve their goals. Fortress and the
Fortress Companies may seek licensings, acquisitions, partnerships,
joint ventures and/or public and private financings to accelerate
and provide additional funding to support their research and
development programs. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
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Contacts:
Caelum Biosciences, Inc.
Michael Spector
212-574-2811
mspector@fortressbiotech.com
Fortress Biotech, Inc.
Lucy Lu, MD, Executive Vice President & Chief Financial Officer
(781) 652-4500
ir@fortressbiotech.com
Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com
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