Atossa Therapeutics Presents Data from Study Investigating Anti-Cancer Activity of (Z)-Endoxifen-Related Compounds at AACR Special Conference in Cancer Research
Atossa Therapeutics (NASDAQ: ATOS) presented research on the anti-cancer activity of (Z)-endoxifen and its byproducts at the AACR Special Conference. The study investigated four (Z)-endoxifen byproducts for treating estrogen receptor-positive (ERα+) breast cancer, including endocrine-resistant tumors.
Two compounds, AT416E and AT402E, showed strong anti-proliferative activity, with AT416E demonstrating enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen proved most effective at inducing cell cycle arrest and apoptosis.
The company plans future in vivo studies to validate these compounds' potential in overcoming current endocrine therapy limitations.
Atossa Therapeutics (NASDAQ: ATOS) ha presentato una ricerca sull'attività anti-cancerogena del (Z)-endoxifene e dei suoi sottoprodotti durante la Conferenza Speciale AACR. Lo studio ha esaminato quattro sottoprodotti del (Z)-endoxifene per il trattamento del carcinoma mammario positivo ai recettori estrogeni (ERα+), compresi i tumori resistenti agli ormoni.
Due composti, AT416E e AT402E, hanno mostrato una forte attività anti-proliferativa, con AT416E che ha dimostrato un'inibizione potenziata della migrazione e invasione cellulare. Tutti e quattro i sottoprodotti hanno presentato effetti anti-proliferativi superiori rispetto al (Z)-endoxifene in condizioni di carenza estrogenica, mentre il (Z)-endoxifene si è dimostrato il più efficace nell'indurre l'arresto del ciclo cellulare e l'apoptosi.
L'azienda prevede studi futuri in vivo per convalidare il potenziale di questi composti nel superare le attuali limitazioni della terapia endocrina.
Atossa Therapeutics (NASDAQ: ATOS) presentó una investigación sobre la actividad anticancerígena del (Z)-endoxifeno y sus subproductos en la Conferencia Especial de AACR. El estudio investigó cuatro subproductos del (Z)-endoxifeno para el tratamiento del cáncer de mama positivo a receptores de estrógeno (ERα+), incluidos los tumores resistentes a hormonas.
Dos compuestos, AT416E y AT402E, mostraron una fuerte actividad antiproliferativa, siendo AT416E el que demostró una inhibición mejorada de la migración y la invasión celular. Los cuatro subproductos presentaron efectos antiproliferativos mayores que el (Z)-endoxifeno en condiciones de deficiencia de estrógenos, mientras que el (Z)-endoxifeno resultó ser el más efectivo en inducir arresto del ciclo celular y apoptosis.
La empresa planea estudios futuros in vivo para validar el potencial de estos compuestos para superar las limitaciones actuales de la terapia endocrina.
Atossa Therapeutics (NASDAQ: ATOS)는 AACR 특별 컨퍼런스에서 (Z)-엔독시펜 및 그 부산물의 항암 활성을 연구한 결과를 발표했습니다. 이 연구는 호르몬 수용체 양성 (ERα+) 유방암 치료를 위한 4개의 (Z)-엔독시펜 부산물을 조사했으며, 여기에는 내분비 저항성 종양도 포함되었습니다.
두 가지 화합물인 AT416E와 AT402E는 강력한 항증식 활성을 보였으며, AT416E는 세포 이동 및 침투 억제가 향상되었습니다. 네 개의 부산물 모두 에스트로젠 결핍 조건에서 (Z)-엔독시펜보다 더 큰 항증식 효과를 나타냈으며, (Z)-엔독시펜은 세포 주기 정지 및 세포 사멸을 유도하는 데 가장 효과적이었습니다.
회사는 기존 내분비 요법의 한계를 극복할 수 있는 이들 화합물의 잠재력을 검증하기 위한 향후 생체 내 연구를 계획하고 있습니다.
Atossa Therapeutics (NASDAQ: ATOS) a présenté des recherches sur l'activité anticancéreuse du (Z)-endoxifène et de ses sous-produits lors de la Conférence spéciale de l'AACR. L'étude a examiné quatre sous-produits du (Z)-endoxifène pour traiter le cancer du sein positif aux récepteurs des œstrogènes (ERα+), y compris les tumeurs résistantes aux traitements endocriniens.
Deux composés, AT416E et AT402E, ont montré une forte activité antiproliférative, AT416E démontrant une inhibition accrue de la migration et de l'invasion cellulaires. Tous les quatre sous-produits ont montré de meilleurs effets antiprolifératifs que le (Z)-endoxifène dans des conditions de déficit en œstrogènes, tandis que le (Z)-endoxifène s'est révélé le plus efficace pour induire un arrêt du cycle cellulaire et l'apoptose.
L'entreprise prévoit des études futures in vivo pour valider le potentiel de ces composés à surmonter les limitations actuelles des thérapies endocriniennes.
Atossa Therapeutics (NASDAQ: ATOS) präsentierte auf der AACR-Sonderkonferenz Forschung zur anti-krebswirksamen Aktivität von (Z)-Endoxifen und seinen Nebenprodukten. Die Studie untersuchte vier Nebenprodukte von (Z)-Endoxifen zur Behandlung von östrogenrezeptor-positivem (ERα+) Brustkrebs, einschließlich hormonresistenter Tumore.
Zwei Verbindungen, AT416E und AT402E, zeigten eine starke anti-proliferative Aktivität, wobei AT416E eine verbesserte Hemmung der Zellmigration und -invasion demonstrierte. Alle vier Nebenprodukte wiesen eine höhere anti-proliferative Wirkung als (Z)-Endoxifen unter östrogendem Mangel auf, während (Z)-Endoxifen am effektivsten darin war, den Zellzyklus zu stoppen und Apoptose auszulösen.
Das Unternehmen plant zukünftige in vivo Studien, um das Potenzial dieser Verbindungen zur Überwindung der aktuellen Einschränkungen der endokrinen Therapie zu validieren.
- Two compounds (AT416E and AT402E) demonstrated strong anti-proliferative activity against breast cancer cells
- All tested byproducts showed superior anti-proliferative effects compared to (Z)-endoxifen in estrogen-deficient conditions
- (Z)-endoxifen proved most effective at inducing cell cycle arrest and apoptosis
- Results are preliminary and require future in vivo studies for validation
- Clinical application and effectiveness in humans remains uncertain
Insights
This research on (Z)-endoxifen byproducts presents significant potential for treating endocrine-resistant breast cancer. The standout compounds AT416E and AT402E showed robust anti-proliferative properties, with AT416E demonstrating enhanced abilities to prevent cancer cell movement and invasion. This could be particularly valuable for patients with ESR1 mutations who have developed resistance to current treatments.
The study's findings that these byproducts outperform (Z)-endoxifen in estrogen-deficient conditions is particularly noteworthy, as this represents a common therapeutic scenario in breast cancer treatment. However, (Z)-endoxifen's superior performance in inducing cell cycle arrest and apoptosis suggests a potential complementary approach using both the parent compound and its derivatives.
While these preclinical results are promising, the planned in vivo studies will be important to validate these findings and determine their clinical relevance. The development of new compounds that can overcome endocrine resistance could significantly impact treatment options for ER+ breast cancer patients who have exhausted current therapeutic options.
The development of novel compounds with demonstrated efficacy against endocrine-resistant breast cancer could represent a significant market opportunity for Atossa. The ER+ breast cancer market is substantial and resistance to current therapies remains a major challenge. These new compounds could potentially address an unmet medical need in a market valued at several billion dollars annually.
The company's strategic focus on developing multiple compounds rather than relying solely on (Z)-endoxifen demonstrates smart risk management and potential for expanded IP protection. The different efficacy profiles of these compounds in various conditions also suggest possibilities for combination therapies or targeted applications based on specific patient characteristics.
However, investors should note that this is still early-stage research and significant clinical development work lies ahead. The planned in vivo studies will be important milestones to watch, as they will provide more concrete evidence of these compounds' therapeutic potential and help define their path to commercialization.
Novel Compounds Demonstrate Promising Anti-Tumor Activity in Estrogen Receptor-Positive (ERα+) Breast Cancer, Including Endocrine-Resistant Tumors
SEATTLE, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced the presentation of research investigating the anti-cancer activity of (Z)-endoxifen and its byproducts at the American Association for Cancer Research (AACR) Special Conference in Cancer Research, taking place in Toronto from December 9-11.
The poster, titled, "Anti-cancer activity of (Z)-endoxifen-related compounds in ERα+ breast cancer," outlines results from a study investigating four (Z)-endoxifen byproducts for their anti-estrogenic and anti-tumor effects in estrogen receptor-positive (ERα+) breast cancer cell lines, including those with ESR1 mutations (Y537S and D538G) associated with endocrine resistance. Notably, compounds AT416E and AT402E demonstrated strong anti-proliferative activity, with AT416E also showing enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen remained the most potent at inducing cell cycle arrest and apoptosis, reinforcing its potential as a therapeutic agent.
“These findings highlight the therapeutic potential of (Z)-endoxifen and its byproducts in addressing ER+ breast cancers, including those resistant to current endocrine therapies, which represent a significant challenge for patients,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “The ability of these compounds to inhibit key cancer mechanisms positions them as promising, targeted candidates for future therapeutic development aimed at expanding treatment options for this difficult-to-treat population.”
Building on these findings, future in vivo studies are planned to validate the potential of (Z)-endoxifen byproducts to overcome the limitations of existing endocrine therapies and to explore their clinical application in developing new treatment strategies for estrogen receptor-positive breast cancer.
| Poster Details | |
| Title: Anti-cancer activity of (Z)-endoxifen-related compounds in ERα+ breast cancer | |
| • Description | Explores the optimization of therapeutic efficacy and tolerability through modifications to (Z)-endoxifen chemistry. |
| • Time/Place | Tuesday, December 10, 2024 |
| 6:30-8:00 pm ET. | |
For additional information, please visit the conference website here.
About (Z)-Endoxifen
(Z)-endoxifen is one of the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and may cause estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant 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. (Z)-endoxifen is currently being studied in five Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and three other studies including the EVANGELINE study and two I-SPY studies in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by four issued U.S. patents and numerous pending patent applications.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on using (Z)-endoxifen to prevent and treat breast cancer. For more information, please visit www.atossatherapeutics.com.
FORWARD LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “design,” “predict,” “future,” or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the expected timing of data and related publications, and the potential milestones and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to remain compliant with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Contact:
Michael Parks
VP, Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
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