Pharma Focus Europe

Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator

Wednesday, May 24, 2023

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.

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