Atossa Therapeutics Inc (NASDAQ:ATOS) and its research partner Quantum Leap Healthcare Collaborative announced the initiation of a new study evaluating Atossa’s lead drug candidate (Z)-endoxifen in combination with Eli Lilly and Co (NYSE:LLY)'s abemaciclib (VERZENIO) in women with Estrogen Receptor positive (ER+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
The clinical-stage biopharmaceutical company said the new study arm would enroll approximately 20 women newly diagnosed with ER+/HER2- invasive breast cancer.
Trial participants will receive 40mg of (Z)-endoxifen once daily in combination with 150mg abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, twice daily for 24 weeks before surgery.
“Endocrine therapy in combination with CDK 4/6 inhibition is a widely used treatment for patients with advanced-stage ER+ breast cancer and as an adjuvant therapy for node-positive, hormone-positive early-stage disease, found at the time of surgical resection,” Quantum Leap Healthcare Collaborative founder Dr Laura Esserman said.
“Women with high clinical stage but less proliferative tumors (molecularly low risk or those with late recurrence risk) are challenging to treat. Late recurrence is high regardless of either endocrine or chemotherapy. Thus, we are looking for new combined treatments, which can be used in the pre-surgery (neoadjuvant) setting.”
Atossa CEO Dr Steven Quay highlighted that data recently presented at the American Association for Cancer Research (AACR) annual meeting showed that (Z)-endoxifen can not only stop ER+ breast cancer from growing, but it can also shrink or eliminate the tumor, as measured by MRI imaging.
“Combining this activity with a targeted therapy like CDK 4/6 inhibition, which interrupts the process through which breast cancer cells divide and multiply, has the potential to deliver efficacy beyond the sum of the two monotherapies,” Dr Quay said.
“We look forward to seeing the results of this study as it will help us better understand which patients are best suited for mono vs. combination therapy in the neoadjuvant setting.”
The new study arm is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol, which targets patients who have been newly diagnosed with ER+ invasive breast cancer and predicted to respond well to hormone-based therapy (endocrine therapy), but may not see significant benefit from chemotherapy. These patients face a substantial risk of their cancer reoccurring.
Per the study agreement, Quantum Leap Healthcare Collaborative will carry out the study with Atossa and Eli Lilly each responsible for supplying their respective drugs.