Atossa Therapeutics and Quantum Leap Healthcare Collaborative Dose First Patient in I-SPY 2 Trial Combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- Breast Cancer
Atossa Therapeutics (Nasdaq: ATOS) and Quantum Leap Healthcare Collaborative have dosed the first patient in their clinical trial evaluating Atossa's (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. The study, part of the I-SPY 2 Endocrine Optimization Pilot Protocol, aims to enroll 80 participants across two cohorts, focusing on patients with newly diagnosed ER+ invasive breast cancer. Participants will receive 80 mg (Z)-endoxifen daily and 150 mg abemaciclib twice daily for 24 weeks before surgery. The second cohort will also include ovarian function suppression for premenopausal women. Results are expected in 2026, potentially validating (Z)-endoxifen's safety and efficacy in both pre- and postmenopausal breast cancer patients.
Atossa Therapeutics (Nasdaq: ATOS) e Quantum Leap Healthcare Collaborative hanno somministrato il primo paziente nel loro studio clinico che valuta l'(Z)-endoxifene combinato con abemaciclib (VERZENIO®) per il cancro al seno ER+/HER2-. Lo studio, parte del I-SPY 2 Endocrine Optimization Pilot Protocol, mira a reclutare 80 partecipanti suddivisi in due coorti, concentrandosi su pazienti con carcinoma mammario invasivo ER+ appena diagnosticato. I partecipanti riceveranno 80 mg di (Z)-endoxifene al giorno e 150 mg di abemaciclib due volte al giorno per 24 settimane prima dell'intervento chirurgico. La seconda coorte comprenderà anche la soppressione della funzione ovarica per le donne in premenopausa. I risultati sono attesi nel 2026, con la possibilità di convalidare la sicurezza e l'efficacia dell'(Z)-endoxifene sia per le pazienti in premenopausa che in postmenopausa.
Atossa Therapeutics (Nasdaq: ATOS) y Quantum Leap Healthcare Collaborative han dado el primer tratamiento a un paciente en su ensayo clínico que evalúa el (Z)-endoxifeno combinado con abemaciclib (VERZENIO®) para el cáncer de mama ER+/HER2-. El estudio, parte del I-SPY 2 Endocrine Optimization Pilot Protocol, tiene como objetivo reclutar 80 participantes en dos cohortes, enfocado en pacientes con cáncer de mama invasivo ER+ recién diagnosticado. Los participantes recibirán 80 mg de (Z)-endoxifeno diariamente y 150 mg de abemaciclib dos veces al día durante 24 semanas antes de la cirugía. La segunda cohorte también incluirá la supresión de la función ovárica para mujeres en edad fértil. Se esperan resultados en 2026, con la posibilidad de validar la seguridad y eficacia del (Z)-endoxifeno en pacientes con cáncer de mama tanto premenopáusicas como posmenopáusicas.
Atossa Therapeutics (Nasdaq: ATOS)와 Quantum Leap Healthcare Collaborative는 첫 번째 환자에게 치료를 시작했습니다. 이 임상 시험은 Atossa의 (Z)-엔독시펜과 아베마시클립 (VERZENIO®)의 조합을 ER+/HER2- 유방암 환자에게 평가하고 있습니다. 이 연구는 I-SPY 2 Endocrine Optimization Pilot Protocol의 일환으로, 새로 진단된 ER+ 침윤성 유방암 환자를 대상으로 80명의 참가자를 모집할 예정입니다. 참가자들은 수술 전 24주 동안 매일 80mg의 (Z)-엔독시펜과 하루 두 번 150mg의 아베마시클립을 투여받게 됩니다. 두 번째 코호트에는 생리 전 여성의 난소 기능 억제도 포함됩니다. 결과는 2026년에 예상되며, (Z)-엔독시펜의 안전성과 효능이 생리 전후 유방암 환자 모두에게 유효함을 입증할 수 있습니다.
Atossa Therapeutics (Nasdaq: ATOS) et Quantum Leap Healthcare Collaborative ont traité le premier patient dans leur essai clinique évaluant le (Z)-endoxifène associé à abemaciclib (VERZENIO®) pour le cancer du sein ER+/HER2-. L'étude, qui fait partie du I-SPY 2 Endocrine Optimization Pilot Protocol, vise à recruter 80 participants répartis en deux cohortes, axée sur les patients récemment diagnostiqués avec un cancer du sein invasif ER+. Les participants recevront 80 mg de (Z)-endoxifène par jour et 150 mg d'abemaciclib deux fois par jour pendant 24 semaines avant la chirurgie. La seconde cohorte inclura également une suppression de la fonction ovarienne pour les femmes pré ménopausées. Les résultats sont attendus en 2026, ce qui pourrait valider la sécurité et l'efficacité de (Z)-endoxifène chez les patientes atteintes de cancer du sein pré et post ménopausées.
Atossa Therapeutics (Nasdaq: ATOS) und Quantum Leap Healthcare Collaborative haben den ersten Patienten behandelt in ihrer klinischen Studie zur Evaluierung von Atossas (Z)-Endoxifen in Kombination mit Abemaciclib (VERZENIO®) für ER+/HER2- Brustkrebs. Die Studie, Teil des I-SPY 2 Endocrine Optimization Pilot Protocol, zielt darauf ab, 80 Teilnehmer in zwei Kohorten zu rekrutieren, die sich auf Patienten mit neu diagnostiziertem ER+ invasivem Brustkrebs konzentriert. Die Teilnehmer erhalten 24 Wochen vor der Operation täglich 80 mg (Z)-Endoxifen und zweimal täglich 150 mg Abemaciclib. Die zweite Kohorte wird auch eine ovarielle Funktionseinschränkung für prämenopausale Frauen umfassen. Ergebnisse werden für das Jahr 2026 erwartet, was potenziell die Sicherheit und Wirksamkeit von (Z)-Endoxifen sowohl bei prä- als auch bei postmenopausalen Brustkrebspatientinnen validieren könnte.
- First patient dosed in clinical trial combining (Z)-endoxifen with abemaciclib for ER+/HER2- breast cancer
- Study targets high-risk patients with ER+ invasive breast cancer who may not benefit from chemotherapy
- Trial aims to develop more effective and tolerable treatments than current standard of care
- Potential for improved outcomes in safety, efficacy, and patient quality of life
- Results of the study not expected until 2026, indicating a long wait for potential validation
- to 80 participants, which may affect the statistical significance of results
This clinical trial initiation marks a significant step in Atossa's breast cancer research. The combination of (Z)-endoxifen and abemaciclib targets a specific patient group with ER+/HER2- breast cancer, addressing an unmet medical need. The focus on patients who may not benefit from chemotherapy is particularly noteworthy.
The two-cohort design, including pre- and post-menopausal women, with the addition of ovarian function suppression in the second cohort, allows for comprehensive data collection. This could potentially lead to more personalized treatment approaches. The expected data in
This news is positive for Atossa, showcasing its progress in clinical development and strategic partnerships. The collaboration with Quantum Leap Healthcare Collaborative and Eli Lilly demonstrates industry recognition of Atossa's potential. However, investors should note the long timeline until data readout in
The focus on neoadjuvant treatment could open up a significant market opportunity if successful. The trial's design, targeting high-risk patients with current options, could lead to faster regulatory pathways if outcomes are positive. Financially, the shared responsibility for drug supply with Eli Lilly is a prudent approach to resource management for a clinical-stage company.
The combination of (Z)-endoxifen and abemaciclib in the neoadjuvant setting is an intriguing approach. By targeting both estrogen receptor signaling and cell cycle regulation, this combination could potentially achieve superior tumor shrinkage before surgery. The inclusion of ovarian function suppression for premenopausal women in the second cohort is a thoughtful addition, as it may enhance the efficacy of the treatment regimen.
The focus on patients with tumors predicted to be endocrine-sensitive but chemotherapy-resistant addresses a critical clinical challenge. If successful, this approach could significantly improve the risk-benefit ratio of neoadjuvant therapy for this patient population, potentially reducing overtreatment with chemotherapy.
SEATTLE, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ (QLHC), today announced the first patient has been dosed in their clinical trial evaluating Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, as a neoadjuvant treatment in high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in oncology with a focus on breast cancer.
The study evaluating (Z)-endoxifen in combination with abemaciclib is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which focuses on patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel treatments that are more effective and tolerable than the current standard of care.
The combination study, being conducted across the I-SPY network, will enroll approximately 80 participants across two 40-participant cohorts. Both cohorts will include pre-and-post menopausal women who will receive 80 mg (Z)-endoxifen once daily in combination with 150 mg abemaciclib twice daily for 24 weeks prior to surgery. Premenopausal women in the second cohort will also receive ovarian function suppression (OFS). The addition of OFS in premenopausal women enrolled in the second cohort of the study will assess the impact of OFS with this combination. Data from the study, anticipated in 2026, is expected to further validate the growing body of evidence that (Z)-endoxifen is safe and highly efficacious in both premenopausal and postmenopausal breast cancer patients.
“Dosing the first patient in this trial marks a significant milestone for Atossa in support of our important partnership with the QLHC,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The innovative idea of combining (Z)-endoxifen and abemaciclib in the neoadjuvant setting can open the door to the development of gentler more patient-friendly treatment options for women with invasive breast tumors. By combining these therapies, we hope to achieve improved outcomes compared to available therapies, not only in terms of safety and efficacy, but also with respect to patients’ quality of life outcome measures.”
“We are excited to announce that the first patient has been dosed in this clinical trial,” said Dr. Jo Chien, Professor of Medicine at UCSF and PI of the sub study. “Finding better options for patients with HR+ tumors that have high clinical risk and biology that does not respond well to chemotherapy and immunotherapy is an unmet need in the field. This study is addressing this need by exploring the potential of (Z)-endoxifen combined with abemaciclib in the pre-operative setting.”
Under the terms of the study agreement, QLHC will conduct the study with Atossa. Atossa and Eli Lilly and Company are each responsible for supplying their respective study drugs.
About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes 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/tissue 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 does not require liver metabolism to achieve therapeutic concentrations and 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 two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three 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.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/
Contact
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Quantum Leap Healthcare Collaborative Media Contact:
Jacqueline Murray
Director, Marketing and Communications
(415) 839-8082
j.murray@quantumleaphealth.org
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,” “future,” or other comparable words. 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, such as data related to the (Z)-endoxifen program, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, and potential milestones and growth opportunities for the Company, 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 and final clinical results; 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.
FAQ
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