Caladrius Biosciences and Cognate BioServices Establish Manufacturing Agreement for Phase 3 Confirmatory Pivotal Clinical Tri...
August 07 2019 - 8:30AM
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a late-stage therapeutics development biopharmaceutical
company pioneering advancements of cell therapies in select
cardiovascular and autoimmune diseases, and Cognate
BioServices, Inc. (“Cognate”), a leading contract development and
manufacturing organization in the global cellular therapies
industry, announced today that they have entered into a
manufacturing agreement for the production of CLBS14, Caladrius’
CD34+ cell therapy. Under the terms of the agreement, Cognate will
manufacture CLBS14 for Caladrius’ Phase 3 confirmatory pivotal
clinical trial in subjects with no-option refractory disabling
angina (“NORDA”).
“Selecting the right company for the manufacturing and supply of
CLBS14 is critical to the success of this study. Cognate has a
track record of producing personalized cellular therapy products
reliably and cost-efficiently and we are excited to be working with
them as we take this next step toward getting this important
product to patients suffering from this terrible disease,” said
David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “In
addition to Cognate’s capabilities to support our Phase 3 program,
Cognate has experience as a commercial manufacturer of cell
therapies and Cognate’s facility has passed multiple FDA
inspections.”
In Spring 2018, Caladrius applied for, and was subsequently
granted by the U.S. Food and Drug Administration (“FDA”),
Regenerative Medicine Advanced Therapy (“RMAT”) designation for
CLBS14. Since then, the Company has worked closely with the FDA to
finalize details of a Phase 3 trial that would satisfy the
requirements, in combination with previously submitted Phase 1, 2
and 3 clinical data, for filing a biologics license application
(“BLA”) for CLBS14 in NORDA.
“We are incredibly excited to be selected as the manufacturer of
CLBS14 at this important phase of clinical development,” commented
J. Kelly Ganjei, Chief Executive Officer of Cognate. “With
patients at the heart of Cognate’s mission and culture, we
believe our teams will deliver high quality products for Caladrius.
Our U.S. and EU cell therapy experience, and the recent investments
in capacity and quality are nicely aligned with Caladrius’
commercial goals.”
About CLBS14CLBS14 is a proprietary formulation
of autologous G-CSF mobilized peripheral blood derived CD34+ cells
– endothelial progenitor cells that reside naturally in the bone
marrow. Among the functions of these cells is the preprogrammed
ability to induce capillary growth to regenerate microcirculation
in damaged tissue experiencing microvascular insufficiency. CLBS14,
administered via intramyocardial injection, is formulated
specifically to enhance the potency of the natural process whereby
CD34+ cells repair and regenerate microvasculature.
About No-Option Refractory Disabling
Angina (NORDA)Nearly 100,000 refractory angina patients in
the United States are categorized as “no-option and disabled”
resulting in disease that is recalcitrant to medical therapy and
not amenable to conventional revascularization procedures. Patients
have recurring lifestyle-limiting symptoms such as chest pain and
shortness of breath and are easily fatigued. These symptoms are
often due to totally occluded coronary arteries or to diffuse
coronary atherosclerosis that makes revascularization problematic.
As the population ages and the incidence of diabetes mellitus
increases, this clinical condition is expected to become more
prevalent. Patients with this condition have significant morbidity
and experience a lower quality of life.¹
About Caladrius BiosciencesCaladrius is a
late-stage therapeutics development biopharmaceutical company
pioneering advancements of cell therapies for select cardiovascular
and autoimmune diseases. Our leadership team collectively has
decades of biopharmaceutical development experience and
world-recognized scientific achievement in the fields of
cardiovascular and autoimmune disease, among other areas. Our
current product candidates include three developmental treatments
for cardiovascular diseases based on our CD34+ cell therapy
platform: CLBS12, recipient of a SAKIGAKE designation in Japan and
advanced therapy medicinal product classification (“ATMP”) in
Europe, eligible for early conditional approval for the treatment
of critical limb ischemia in Japan based on an ongoing clinical
trial; CLBS16, subject of the proof-of-concept ESCaPE-CMD clinical
trial in the U.S. for the treatment of coronary microvascular
dysfunction; and CLBS14, recipient of a RMAT designation in the
U.S. and for which we are in preparation to commence a Phase 3
clinical trial in no option refractory disabling angina. For more
information on the company, please
visit www.caladrius.com.
About Cognate BioServicesCognate is a
results-driven contract development and manufacturing organization
(CDMO) specializing in cell and cell-mediated gene therapy
products. Since 2002, Cognate has serviced autologous and
allogeneic products in various stages of development from
preclinical to Phase 3, and most recently in pivotal Phase 3 with
FDA pre-approval inspection preparation. With development and
manufacturing at our core, Cognate made significant investments in
infrastructure and quality systems; and we have developed a broad
range of commercialization services that facilitate logistics,
supply chain planning, and capacity planning to bridge clinical to
commercial manufacturing. Cognate provides and develops
commercially scalable solutions so that our clients are able to
offer safe and high-quality products to as many patients as
possible. Please visit www.cognatebioservices.com to find out
more about us.
Safe Harbor for Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements reflect management’s current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. All statements other than
statements of historical fact contained in this press release are
forward-looking statements including, without limitation, all
statements related to any expectations of revenues, expenses,
cash flows, earnings or losses from operations, cash required to
maintain current and planned operations, capital or other financial
items; any statements of the plans, strategies and objectives of
management for future operations; any plans or expectations with
respect to product research, development and commercialization,
including regulatory approvals; any other statements of
expectations, plans, intentions or beliefs; and any statements of
assumptions underlying any of the foregoing. Without limiting the
foregoing, the words “plan,” “project,” “forecast,” “outlook,”
“intend,” “may,” “will,” “expect,” “likely,” “believe,” “could,”
“anticipate,” “estimate,” “continue” or similar expressions or
other variations or comparable terminology are intended to identify
such forward-looking statements, although some forward-looking
statements are expressed differently. Factors that could cause
future results to differ materially from the recent results or
those projected in forward-looking statements include the “Risk
Factors” described in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission (“SEC”) on March
14, 2019 and in the Company’s other periodic filings with the SEC.
The Company’s further development is highly dependent on, among
other things, future medical and research developments and market
acceptance, which are outside of its control. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date of this Press Release. Caladrius does not
intend, and disclaims any obligation, to update or revise any
forward-looking information contained in this Press Release or with
respect to the matters described herein.
¹Grise MA and Verma A. Ochsner J. 2009 Winter; 9(4):
220–226.
Contacts:Investors: Caladrius Biosciences, Inc.
John Menditto Executive Director, Investor Relations and Corporate
Communications Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
Cognate BioServices
+1.901.541.9800Email: press@cognatebioservices.com
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