Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator
May 23 2023 - 6:00AM
Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL), a contract
development and manufacturing organization (CDMO) dedicated to
solving complex formulation and manufacturing challenges primarily
in small molecule therapeutic development, today announced that it
has been selected by Atossa Therapeutics (Nasdaq: ATOS) to provide
a range of its Clinical Trial Services (CTS) offerings focused on
Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM),
(Z)-endoxifen. The agreement spans a range of activities including
analytical method transfer/development and validation, cleaning
verification method validation, manufacturing of multiple R&D
engineering batches, and stability testing of the R&D
engineering batches.
“Societal’s demonstrated expertise in the
technology transfer of established drug products, along with our
long track record of successfully formulating and manufacturing
innovative small molecules, positions us well to align with Atossa
and support the ongoing clinical development of the company’s
proprietary oral formulation of (Z)-endoxifen. We are eager to
initiate this important work and deliver exceptional results for
Atossa,” said David Enloe, chief executive officer of Societal
CDMO. “It is important to highlight that we are continuing to see
growing demand for the CTS portion of our business, which is
helping to both grow our overall revenue and diversify our
expanding customer base.”
About
(Z)-Endoxifen(Z)-endoxifen is the most active metabolite
of the FDA approved Selective Estrogen Receptor Modulator (SERM),
tamoxifen. Studies by others have demonstrated that the
anti-estrogenic effects of tamoxifen are driven in a
concentration-dependent manner by (Z)-endoxifen. In addition to its
potent anti-estrogen effects, (Z)-endoxifen at higher
concentrations has been shown to target PKCβ1, a known oncogenic
protein.
Atossa has developed a proprietary oral
formulation of (Z)-endoxifen that does not require liver metabolism
to achieve therapeutic concentrations and is encapsulated to bypass
the stomach as acidic conditions converts a greater proportion of
(Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen
has been shown to be well tolerated in Phase 1 studies and in a
small Phase 2 study of women with breast cancer. The company is
currently studying (Z)-endoxifen in healthy women with measurable
breast density and premenopausal women with ER+/HER2- breast
cancer. Atossa’s (Z)-endoxifen is protected by two
issued U.S. patents and numerous pending patent
applications.
About Atossa
TherapeuticsAtossa Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing innovative
medicines in areas of significant unmet medical need in oncology
with a current focus on breast cancer. For more information, please
visit www.atossatherapeutics.com
About Societal CDMOSocietal
CDMO (NASDAQ: SCTL) is a bi-coastal contract development and
manufacturing organization (CDMO) with capabilities spanning
pre-Investigational New Drug (IND) development to commercial
manufacturing and packaging for a wide range of therapeutic dosage
forms with a primary focus in the area of small molecules. With an
expertise in solving complex manufacturing problems, Societal CDMO
is a leading CDMO providing therapeutic development, end-to-end
regulatory support, clinical and commercial manufacturing, aseptic
fill/finish, lyophilization, packaging and logistics services to
the global pharmaceutical market.
In addition to our experience in handling DEA
controlled substances and developing and manufacturing
modified-release dosage forms, Societal CDMO has the expertise to
deliver on our clients’ pharmaceutical development and
manufacturing projects, regardless of complexity level. We do all
of this in our best-in-class facilities, which total 145,000 square
feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For
more information about Societal CDMO’s customer solutions, visit
societalcdmo.com.
Forward-Looking StatementsThis
press release includes 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. These statements, among
other things, the Company’s expectations regarding the completion
of the proposed public offering, the Company’s use of proceeds from
the proposed offering, and other statements. The words
“anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”,
“intend”, “may”, “plan”, “predict”, “project”, “will” and similar
terms and phrases may be used to identify forward-looking
statements in this press release. Our operations involve risks and
uncertainties, many of which are outside our control, and any one
of which, or a combination of which, could materially affect our
results of operations and whether the forward-looking statements
ultimately prove to be correct. Factors that could cause the
company’s actual outcomes to differ materially from those expressed
in or underlying these forward-looking statements include risks and
uncertainties associated with demand for the company’s services,
which depends in part on customers’ research and development and
the clinical plans and market success of their products; customers’
changing inventory requirements and manufacturing plans; customers
and prospective customers decisions to move forward with the
company’s manufacturing services; the average profitability, or
mix, of the products the company manufactures; the company’s
ability to enhance existing or introduce new services in a timely
manner; fluctuations in the costs, availability, and suitability of
the components of the products the company manufactures, including
active pharmaceutical ingredients, excipients, purchased components
and raw materials, or the company’s customers facing increasing or
new competition. These forward-looking statements should be
considered together with the risks and uncertainties that may
affect our business and future results presented herein along with
those risks and uncertainties discussed in our filings with the
Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to us, and we assume no obligation to update any
forward-looking statements except as required by applicable
law.
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
Ryan D. Lake (CFO)
Societal CDMO
770-531-8365
ryan.lake@societalcdmo.com
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