Atossa Genetics Inc (NASDAQ:ATOS) unleashed final results from its Phase 1 trial evaluating breast cancer prevention asset oral endoxifen. The verdict? The results indicate the design of the oral formulation achieves steady-state serum levels that surpass the therapeutic threshold- and better yet, within just 7 days’ time. This is a colossal success against standard of care tamoxifen that needs a much slower 50 to 200-day period to achieve the same impact.
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Maxim analyst Jason Kolbert takes the news in confident stride, noting this is not only a quicker-paced delivery, but likewise the results demonstrate “higher” therapeutic drug levels. In other words, this bodes well for eradicating tumors- fast.
In reaction, the analyst reiterates a Buy rating on ATOS stock with a $2 price target, which implies a massive nearly 208% upside potential from current levels. (To watch Kolbert’s track record, click here)
Consider that to kill breast cancer cells and prevent these cells from recurring, the therapeutic threshold circles 30nm. Kolbert notes that in standard of care tamoxifen, high metabolizers produce 50 to 75nm, noting this is the case in up to half of breast cancer patients. Yet, in comparison, the drug maker’s oral endoxifen candidate generated levels that soared up to 125nm, which is markedly 50% more than the standard of care drug.
Kolbert writes, “Women taking tamoxifen have to ‘watch and wait’ for months to see if they produce therapeutic levels of endoxifen, if at all, during which time breast cancer tumors can grow significantly. Oral Endoxifen hits peak levels in 4-8 hours and steady state at high therapeutic levels in only 7 days, meaning tumor killing should initiate much more rapidly, potentially improving clinical outcomes.”
The next step for Atossa will be a Phase 2 trial in women who are resistant in responding to tamoxifen, anticipated to kickstart by the first quarter of this year. Additionally, Kolbert looks to another Phase 2 trial also set to initiate investigating the treatment of topical endoxifen for patients with mammographic breast density.
Bigger picture, “Endoxifen is a known drug metabolite of tamoxifen with published safety and efficacy profiles which we view as de-risking. More rapid delivery and higher therapeutic levels of endoxifen, as demonstrated in the P1 study, could give women a therapeutic option that kills breast cancer cells earlier to improve long-term outcomes and removes the watch and wait with tamoxifen, in our view,” Kolbert concludes, upbeat on the clinical opportunity ahead.