Atossa Therapeutics Inc (NASDAQ:ATOS) is targeting three different stages of the breast cancer continuum with its proprietary oral form of Endoxifen, a drug that combines estrogen receptor degradation, suppression, and protein kinase C (PKC) beta inhibition.
Atossa CEO Dr Steven Quay told Proactive that the company is conducting three trials targeting different stages of the disease from prevention through to reducing the chances of recurrence in breast cancer patients in the five years following surgery and possibly radiation therapy.
Starting with prevention, the company is targeting high mammographic breast density as this makes it harder to find cancers via a mammogram and contributes to the future risk of breast cancer six to eightfold, Quay explained.
“We're very interested in seeing if we can change the density to make mammograms easier to read and to also help prevent [breast cancer] in the future,” he said.
At a trial at the Karolinska Institute in Stockholm, Sweden, the company is evaluating if Endoxifen can reduce a person’s breast density.
“There are two aspects to this trial: can we lower density and then is it durable once the patient is off the drug,” Quay said.
“The patient will have a mammogram on day one and then take the drug for six months. Then they will do a mammogram at 24 months, or 18 months [after last taking the drug] to see if it’s durable.
“The last woman will go on that trial at the end of this year, which means in six months from that in June 2024 we'll get the readout on reduction and then 18 months later, we'll get the readout on durability.”
The second phase of the breast cancer continuum being targeted by Atossa is the neoadjuvant window, the period of time between a patient’s breast cancer diagnosis and their initial treatment with the goal of rapidly reducing tumour activity post-diagnosis.
“Typically, estrogen-driven cancers, which are two-thirds or three-fourths of all cancers, don't have any treatment in this timeframe because it's only a matter of a few months, even sometimes three or four weeks, and most drugs don't have a big enough effect,” Quay said.
He noted that a trial Atossa completed in Australia showed that within 14 days its drug Endoxifen could reduce tumor activity for neoadjuvant patients.
It is now carrying out another two trials investigating Endoxifen in the neoadjuvant setting, one at the Mayo Clinic involving only pre-menopausal women and another at the University of California San Fransico including pre-and post-menopausal women.
“The concept is that a patient gets their diagnosis and then they begin taking our drug right away,” Quay said. “Then we measure endpoints like imaging looking at whether the cancer can shrink or not, and certain markers of cancer growth in those two trials.”
Finally, Atossa is also targeting breast cancer in the adjuvant setting, being the five-year window after a breast cancer patient has undergone surgery and potentially radiation therapy in order to prevent the recurrence of the cancer in the local breast or local tissue.
‘We want to prevent cancer in the other breast because we know once a woman has breast cancer in one breast, she's at an increased risk for the other breast,” Quay explained.
He summarized: “Prevention, neoadjuvant, and adjuvant are sort of the three legs of the entire breast cancer treatment paradigm, and we want to be involved with all of them.”
Atossa is focused on breast cancer because it is the most common cancer in women.
“Being able to do something in this most important cancer for women is the thing that gets us all up in the morning,” Quay said. “I believe Endoxifen in this setting will be the most important drug [Atossa has] invented.”
Atossa is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
Contact the author at emily.jarvie@proactiveinvestors.com
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