The First Annual Spinal Cord Injury Investors Symposium Convenes Thought Leaders from Around the Globe

Maggie Goldberg and Marco BaptistaOn June 29, 2023, the Christopher & Dana Reeve Foundation, in collaboration with Lineage Cell Therapeutics, brought together the foremost experts in spinal cord injury (SCI), and their funders, along with research participants and caregivers to advance promising research and accelerate new treatments for SCI.

“The meeting was designed for people who are ‘invested’ in SCI research—people who are willing to think outside the box, generate new ideas, and forge partnerships to pave a pathway toward promising discoveries,” says Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation. “It was astonishing and awe-inspiring to see competitors in the same room together working toward a common goal.”

During the meeting, insight from SCI research participants, panel discussions, and industry presentations brought to light a few key themes:

  1. The need for improved outcome measures.
  2. Evidence for reimagining clinical trial design.
  3. A call for greater collaboration between scientists, industry, and regulatory agencies.

Improved Outcomes Measures

SCI Investor SymposiumThe meeting opened with an important panel discussion featuring SCI research participants, Jake Javier and Jerod Nieder, both of whom are clinical trial participants. Just weeks after his injury, Javier became a participant in a CIRM-funded clinical trial of OPC1. And eight years after his 2011 injury, Nieder joined, by lottery, a randomized clinical trial investigating whether epidural stimulation can produce functional improvements for SCI patients.

Moderated by Jack Allen, senior research analyst at Baird Equity Research, the discussion shined a light on one of the most important issues in current SCI research: Developing meaningful outcome measures for people with SCI.

Javier mentioned that current functional tests aren’t assessing abilities that relate to participant's everyday lives. “They’re asking us to do things like put a coin in a coin slot,” he said. “I can’t remember the last time I had to do that.” And Nieder highlighted the fact that studies aren’t capturing important variables that impact performance, such as sleep, hydration, and nutrition.

Throughout the day, SCI researchers discussed how to develop outcome measures that make a difference in the lives of participants and caregivers. “Within the SCI space, we have 156 outcome measures, none of which are approved by the FDA,” said Mary Jane Mulcahey, Ph.D., OTR/L, professor in the Department of Occupational Therapy at Thomas Jefferson University. “There’s tremendous variability within spinal cord injury so outcome measures need to be tailored to the individual.”

Reimagined Clinical Trial Design

 Michael Fehlings, M.D., Ph.D.Historically, SCI primarily affected young men in their 20s. Today, doctors are seeing more SCIs among people in their 50s, 60s, and beyond—and age plays a critical role in recovery. Unfortunately, traditional classification models don’t account for the tremendous variability within the world of SCI whether from age or severity of injury.

“Someone who is 25 at the time of injury will have a dramatically different recovery trajectory than someone who is 65, even with the same injury,” said Michael Fehlings, M.D., Ph.D., professor of neurosurgery at the University of Toronto. And until the field has SCI biomarkers to better classify injuries, scientists may need to get creative.

Fehlings is one of many researchers suggesting that SCI research would benefit from group-based trajectory modeling, meaning scientists would cluster clinical features that track together to achieve significance. “With that approach, we’re comparing apples to apples instead of apples to watermelons,” he said.

Work is also underway to develop computerized adaptive testing, a step-wise testing approach that tailors questions based on the individual’s responses. For example, if a person is able to do a certain function, the test adapts and presents more challenging tests. If the person responds negatively, the next tests will be easier in difficulty. And future tests should be able to distinguish between and document compensatory strategies research participants use to function and true adaptive movement.

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Greater Collaboration

From cell therapies to brain-computer interfaces to complex biologics, companies at the forefront of SCI discoveries can learn from one another to advance treatments for complex SCI.

Here’s just a sampling of what various companies have in the pipeline:

  • AbbVie: The company has a monoclonal antibody called Elezanumab in phase 2a trials.
  • Lineage Cell Therapeutics: 30 patients have been dosed with Lineage’s (oligodendrocyte progenitor) cell transplant, and the company plans to begin another clinical trial in 2024 in both chronic and sub-acute SCI patients.
  • Mitsubishi Tanabe Pharma Development America (MTDA), Inc.: In July 2021, the FDA fast-tracked the monoclonal antibody MT-3921 for the treatment of spinal cord injury. MTDA is currently running a multi-center phase 2 clinical trial in the U.S., Canada and Japan.
  • NerveGen Pharma Co.: NervGen completed phase 1 study with their lead drug candidate, NVG-291, a first-in-its-class therapeutic targeting the pathogenic mechanisms that interfere with nervous system repair.
  • ONWARD: In May 2023, ONWARD published a study in Nature showing that a wireless brain-computer interface (BCI) enabled a paralyzed man to regain voluntary control over when and how he moved his legs.
  • EG 427: EG 427 aims to unlock the full potential of DNA medicine for the treatment of severe localized chronic diseases using non-replicative HSV-based vectors.

“The SCI Investor Symposium drove home the idea that no one group is going to solve spinal cord injury. It’s only by working together and sharing information that we will arrive at meaningful change for members of the SCI community,” says Baptista. “This meeting was brought together major industry players and key stakeholders, including the investment community, in a new format that we look forward to continuing each year as we work to accelerate cures.”

All presentations and panels from the 2023 SCI Investor Symposium can be viewed here.

About the Author - Reeve Staff

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Reeve Staff

The opinions expressed in these blogs are the author's own and do not necessarily reflect the views of the Christopher & Dana Reeve Foundation.