NEW YORK — Octave Biosciences is working to generate data supporting its Multiple Sclerosis Disease Activity (MSDA) test as it aims to launch the assay for clinical use this year.
The company is currently in the process of "building the body of evidence" around the test, said Ferhan Qureshi, vice president of biomarker product development at Octave, adding that bringing it to the clinic is "a big focus for Octave this year."
Last week, Octave presented eight posters at the ACTRIMS (Americas Committee for Treatment and Research in Multiple Sclerosis) Forum 2022 meeting detailing analytical and clinical validation data for the MSDA test, which the company is developing as a tool to help physicians manage treatment of patients with MS.
Octave was launched in 2016 by a team led by William Hagstrom, formerly the CEO of rheumatoid arthritis firm Crescendo Bioscience, acquired in 2014 by Myriad Genetics for $270 million. In May 2021, Myriad sold its Crescendo assets to Laboratory Corporation of America for $150 million.
With Octave, Hagstrom is taking aim at another autoimmune condition, one that affects roughly 400,000 people in the US. According to the company, the cost of managing the disease can run into the millions of dollars over the course of a patient's lifetime and requires ongoing monitoring that typically consists of the regular observation of symptoms combined with occasional imaging studies.
Octave is developing a product for managing MS that combines protein biomarker measurements along with tools for extracting more actionable data from imaging studies and for collecting and communicating patient symptoms between those patients and their care team.
"We are focused on an entire, comprehensive care solution to manage patients with MS," Qureshi said. "We have an enhanced MRI imaging program. We have a patient care insights program. And then we have blood-based biomarkers."
At the core of this portfolio is the company's MSDA test, a blood-based panel of 18 proteins Octave is exploring for uses including measuring disease activity and assessing the effect of therapy.
The company did its original protein biomarker-based research on Rules Based Medicine's immunoassay platform but has since moved to Olink's Explore system, which uses that company's proximity extension assay immunoassay technology to measure up to 3,000 proteins per sample. Using the Olink system, it winnowed an initial set of around 1,400 protein markers to a set of 21 proteins that it then developed with Olink into a custom panel. That panel has since been further refined to produce the 18-protein panel detailed in the posters presented at last week's ACTRIMS meeting.
The 18 markers "are associated with four primary pathways in multiple sclerosis, that are then stacked into an overall disease activity algorithm," Qureshi said, adding that the panel "significantly associates with several disease activity endpoints."
"MS is a very complex, very heterogenous disease, so there are these different pathways that are involved with disease progression, immune modulations, neuro-inflammation, myelin biology, [and] neuro-axonal integrity," he said
Octave researchers presented analytical validation of the 21 protein panel at the 2021 ACTRIMS annual meeting, producing data that indicated that 20 of the 21 proteins met acceptable performance levels.
At the ECTRIMS (European Committee for Treatment. and Research in Multiple Sclerosis) 2021 annual meeting in October, the company presented clinical validation data on the 18-protein panel, evaluating whether test measurements could be correlated with three endpoints: the presence on MRI of lesions characteristic of MS; the development of new or enlarging lesions; and whether a patient has active or stable disease.
The study looked at 617 serum samples, 70 percent of which were used as a training set and 30 percent to evaluate test performance. It found that the panel could distinguish between patients with and without lesions, with and without new or enlarging lesions, and with stable or active disease with areas under the curve, respectively, or .765, .734, and .773. The widely used MS biomarker neurofilament light chain, or NfL, alone performed with AUCs of .694, .663, and .618, indicating that the panel provided information beyond that offered by NfL.
The posters presented at the ACTRIM meeting last week are intended to flesh out the performance of the test beyond those top-level results, Qureshi said.
In one, Octave researchers looked at patients from a separate cohort from the ECTRIMS poster, collecting paired samples from 69 patients both while they were in remission and while they were experiencing disease relapse to assess whether the MSDA test could distinguish between the two states. They identified six proteins from the panel that were significantly correlated with relapse. Additionally, they evaluated the test against the endpoints used in the ECTRIMS study and found that it performed similarly in this separate cohort.
The company's researchers also explored whether the test might be correlated with treatment and analyzed 502 serum samples collected at four sites and representing patients on six different classes of MS therapies. They found that 17 markers showed significant differences across the six different therapy classes, indicating that the panel could potentially reflect treatment-related changes in patient biology. Octave said it is planning to expand its evaluation of the test for this purpose with additional studies and endpoints.
Qureshi said Octave plans to bring the MSDA test to the clinic on the Olink platform.
The company also plans to adapt the approach it has taken to developing MS management tools to other neurodegenerative diseases, he said. Octave closed a $14 million Series A funding round in 2018 and a $32 million Series B round in 2020. In October, the company received a strategic investment of an undisclosed amount from the Merck Global Health Innovation Fund.