Atara Biotherapeutics' clinical trial design and results are reviewed in a ROTH Capital Partners report.
In a May 26 research note, ROTH Capital Partners analyst Tony Butler purported that Atara Biotherapeutics Inc.'s (ATRA:NASDAQ) "updated data from the Phase 1 trial of ATA188 in progressive multiple sclerosis look promising" as they showed "distinct improvements in patient outcomes based on sustained disability improvement (SDI)" scores.
Butler described the results, which California-based immunotherapy company Atara presented in a poster session titled "Phase 1 Study of the Safety and Efficacy of ATA188, an Off-the-Shelf, Allogeneic Epstein-Barr Virus-targeted T-cell Immunotherapy to Treat Progressive Forms of Multiple Sclerosis."
The data are from cohorts 1–4 (n=24) at six months and cohorts 1–3 (n=17) at 12 months. The cutoff was April 2020. About half of the patients had primary progressive multiple sclerosis, and the other half had secondary progressive multiple sclerosis.
Patients in the trial received a single administration of ATA188 at doses of 5 million (cohort 1, n=6), 10 million (cohort 2, n=6), 20 million (cohort 3, n=6), and 40 million cells (cohort 4, n=6). Patients who finished year 1 may enroll in an open-label extension study, in which they will receive annual administrations of ATA188 for up to four years and then will have a final visit.
Several ATA188-treated patients in all cohorts experienced improvement of their baseline SDI score, which included expanded disability status scale, and improvement in a timed 25-foot walk test. SDI improvements were associated with increased dose. Improvements were greatest in cohorts 3 and 4. It is unknown whether ATA188 reversed disease, as determination of that would require MRI scans be taken to assess lesion size. Treatment-related adverse events included muscle spasticity and relapse of multiple sclerosis.
"Albeit early with a small number of patients, it will be a unique feature for ATA188 if this shows halted disease progression or sustained reversal of disability over time whereas existing approved therapies only delay the progression of the disease," commented Butler.
For comparison's sake, Butler included in his report results from Study 3 of ocrelizumab (Ocrevis), which is an antibody drug on the market used to treatment relapsing forms and primary progressive multiple sclerosis in adults.
In that trial, patients were randomized 2:1, with 488 receiving 600 milligrams of ocrelizumab and 244 receiving a placebo. They were administered as two 300 milligram intravenous infusions two weeks apart every 24 weeks for at least 120 weeks.
Twenty-one percent of Ocrevis-treated patients and 34% of placebo-receiving patients did not complete the study. Of the patients who did finish, 20% percent showed worsening of the timed 25-foot walk at 12 weeks. Of those, 49% had been treated with ocrelizumab, and 59% had been treated with a placebo.
ROTH has a Buy rating and a $30 per share price target on Atara, the stock of which is currently trading at about $11.30 per share.
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Disclosures from ROTH Capital Partners, Atara Biotherapeutics, Inc., Company Note, May 26, 2020
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of Atara Biotherapeutics, Inc. and as such, buys and sells from customers on a principal basis.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.