Nurturing the next great healthcare breakthroughs

Acclinate—a digital health company that is devoted to increasing diversity in clinical trials—was inspired by the personal stories of both of its founders. When Tiffany Whitlow, the company’s Chief Development Officer, became a first-time mom at age 19, her infant son was hospitalized for asthma and treated with a medication that is less effective in Blacks and Puerto Ricans. And the mother of Acclinate CEO Del Smith, Ph.D., passed away from tuberculosis after trying drug after drug that failed to work.

More than 40% of the U.S. population is non-white, yet Blacks represent only 5% of participants in clinical trials and Hispanic Americans just 1%. To determine if medicines are equally safe and effective for everyone, “we want to achieve more inclusive research that reflects all populations,” Whitlow says.

“There’s a dynamic playing out where certain minority groups are at a higher propensity for specific diseases, but when you look at the drugs being developed for them, the clinical trials that study those medications don’t adequately represent these groups,” says Whitlow.

To help address these concerns, the U.S. Food and Drug Administration (FDA) issued new draft guidance to improve clinical trial diversity. And Johnson & Johnson has already been doing key work in that area, such as sponsoring and supporting thousands of clinical trials in more than 40 countries, increasing the number of doctors of color that lead the clinical trials and working to proactively identify and address barriers to enrollment for patients in underrepresented communities.

One big challenge to diversifying trials is that many people of color have a deep mistrust of the healthcare community, especially medical research. So step one for Acclinate—which is a BLUE KNIGHT™ company—is to build rapport with local communities and educate them about healthy living through informational materials, personal stories and expert insights.

“We want to collaborate with communities of color on health-related issues that are important to them, while also presenting these communities with opportunities to take part in clinical trials that offer potential treatment options,” says Whitlow. “I believe everyone should be offered an opportunity to consider clinical trials as a treatment option. Too often communities of color are not included in research and we are working to change that.”

“The FDA has said the lack of diversity is a significant health concern and that if drug companies don’t diversify their trials, they run the risk of their drugs not being approved,” adds Whitlow. That’s one reason Acclinate developed e-DICT (short for “electronic diversity in clinical trials”), a HIPAA-compliant platform that helps to identify diverse members who may be willing to participate in clinical trials so that researchers can contact them to assess their interest.

Although Acclinate has its headquarters in Birmingham, Alabama, the JLABS @ Washington, DC location is ideal as the company continues to scale its business in underserved communities, as well as engage in community outreach while meeting with government officials, including those from the FDA. “This is a spot where so much regulation takes place—we want to be at those meeting tables to lend our insights and possible solutions,” says Whitlow.

Acclinate is also working closely with another JLABS company to expand diversity in clinical trials; specifically, in the role of the microbiome—the bacteria that live in the GI tract—on the treatment, diagnosis and prevention of colorectal cancer. African Americans are about 20% more likely to develop this cancer and 40% more likely to die from it than other groups, according to the American Cancer Society.

“We began collaborating even before the research sites were planned, to ensure the clinical trials would happen in locations that are inclusive,” says Whitlow. “Our goal is to engage and support studies with other JLABS companies to help promote diversity.”

Measuring a patient’s level of pain can be a difficult task, as the diagnosis of pain typically consists of both subjective and objective measures. Doctors rely on a subjective 10-point scale, with 0 meaning no pain and 10 indicating extreme pain. Due to the different ways each individual experiences pain, one patient’s level 4 could be another patient’s 8.

Julia Finkel, M.D., knew there had to be a more reliable approach.

A pediatric anesthesiologist and pain researcher at Children’s National Hospital in Washington, DC, she wanted a straightforward system to figure out how much pain her patients were experiencing: “It’s especially difficult in infants and young children,” she says.

The result of her research was the AlgometRx Nociometer, a small handheld eye-tracking device that aims to objectively measure pain intensity and type and drug effects in real time by capturing a digital image of a patient’s pupils and how they respond to light.

“We use a nonpainful, barely perceptible stimulus to dilate pupils in order to capture information from each of the three different sensory nerve fiber types that make up our pain sensations,” says Dr. Finkel. The result is a composite picture of specific nervous system activity that helps doctors figure out if there is pain, but also what kind of pain it is and whether it’s responsive to a given intervention or treatment.

But the AlgometRx Nociometer goes beyond just diagnosing pain. It can also help doctors measure other symptoms such as numbness, burning and tingling. “This can help us figure out if there’s inflammation, like what you’d see in conditions such as rheumatoid arthritis, or even neuroinflammation from long COVID,” says Dr. Finkel.

This is particularly important, as the current 0-10 measurement system doesn’t address the complexity of pain and its diverse types—such as the difference between acute pain from a bone break versus a neuropathic-type pain such as sciatica. “Our AlgometRx technology provides a more objective assessment of pain type and intensity, which can provide a better understanding of a patient’s pain state and inform the best course of treatment,” she says.

One research goal Dr. Finkel hopes to achieve as a JLABS @ Washington, DC company is to use the AlgometRx Nociometer on patients with a type of nerve damage often seen in pediatric leukemia patients undergoing a particular chemotherapy treatment that can linger even after they finish therapy.

“It’s a cornerstone chemotherapy agent in children, but we find that they often don’t tell us about symptoms such as numbness,” explains Dr. Finkel. “We sometimes do not pick it up until the very late stages, when they have trouble with fine motor skills like holding a pencil. But with this technology, we can see changes before they’re apparent even to the patient, which gives us time to intervene.”

Dr. Finkel says that the ecosystem JLABS provides is invaluable. “We’ve been given introductions that are absolutely instrumental,” she says. For example, one of the markers the AlgometRx Nociometer looks for is inflammation, but many clinical trials fail because of a lack of precise measuring. “Having a better understanding of Johnson & Johnson’s standards for submitting products to the FDA has helped us shape our direction and commercialization path,” says Dr. Finkel. She’s hoping to submit an application for a first FDA clearance later this year.

Bona fide a-ha moments don’t usually happen during happy hour, but a life-changing one did for Joshua Wang, Ph.D., a vaccine scientist and biotechnology entrepreneur. In 2017, he and several other startup founders were enjoying a few rounds of beer one night when conversation turned to problems in the field of cancer immunology.

“Someone was asking why childhood vaccines work so well against infectious diseases, and I explained that it’s because they’re lifelong,” he recalls. After all, with vaccines, your body remembers how to fight a particular virus in the future. “Then it hit me: What if we could trick the body to see cancer as a past disease? That way, we could potentially control it for life.”

In that moment, the idea for VerImmune took root. Its mission? Redirect the same immune memory that protects against various diseases like measles or polio to target cancer with a first-in-class therapeutic approach known as Anti-tumor Immune Redirection (AIR).

“We are pioneering a revolutionary cancer treatment that basically tricks your body into seeing cancer like it would a viral infection such as chicken pox or the flu,” says Wang, the company’s founding CEO and president.

When you get any of these diseases, he points out, the hope is that in response to the preexisting immune memory in your system, your body will mount an immune response that clears the disease permanently “We’re essentially repurposing what’s good in you: using your preexisting immunity to target cancer and hopefully kill it.”

Along with VerImmune colleague and Chief Operating Officer John Troyer, Ph.D., Wang developed a proprietary Virus-inspired Particle (ViP) platform technology to be initially used as a delivery system to target and treat cancer—and, ultimately, the goal is to use the ViP for numerous other diseases.

“With ViP, we can attach a viral protein onto a cell’s surface so it serves as the delivery system,” he says. “The resulting ViP will then target tumor cells to make them look as if they are virally infected, which signals your body to say, ‘Hey! I see an infected cell, and it’s not supposed to be here!’ Your preexisting immunity is activated and works to try and clear the infection.”

In 2021, Wang connected with JLABS @ Washington, DC, which provided not only much-needed company space but also an opportunity to discuss ideas and collaborate with Janssen R&D. “They really wanted a collaboration on this concept of repurposing the immune response to a past viral infection,” he says. The goal, he hopes, is to create a treatment that’s truly a game-changer when it comes to cancer therapy.

“The fundamental vision is that in the future, a physician can look at a cancer patient’s health records—including their past vaccine records—and give them one of our AIR-ViPs to target their cancer, rather than having to throw the kitchen sink at them,” he says. “Sure, we’ve made leaps and bounds in cancer treatment, but a lot of people still don’t respond and are unfortunately, sent home with palliative care. This is a whole other chance for them to get the treatment they need.”