NextCure’s Clinical Development Strategy Centers People and Patients at the Core

Look up any health-focused biotech’s mission and vision, and we’d wager that somewhere in the copy there is a reference to helping patients. This isn’t a surprise – in fact, people would probably give your company a side eye if you didn’t mention that you hope to treat or cure someone’s disease.

But what does it actually mean to say that patients are at the core of everything your company does?

NextCure (Nasdaq: NXTC), a growing clinical-stage biotechnology company nestled in Beltsville, Maryland, is setting the example. The company works to create novel immunomedicines to treat cancer and other immune-related diseases, and if you’ve read some of BioBuzz’s previous stories you should know by now that when NextCure says they are committed to something, they truly are committed.

So far we’ve given you an inside look into everything from the company’s vibrant office environment and decor to its meticulous care in maintaining the highest Quality standards to tremendous opportunities for career growth. Throughout these stories there’s a common theme – people truly matter, and by empowering our team we can better deliver on our mission to help patients.

Now, let’s take a deeper dive into NextCure’s scientific approach and clinical operations – you’ll see that this theme still very much holds true.

Interrogating New Targets to Treat Cancer and Beyond

Checkpoint inhibitor cancer therapy has gained notable traction in recent years since the initial US FDA approval of Yervoy (ipilimumab) in 2011. Current approved therapies target either CTLA4, PD-1, or PD-L1. While these therapies have extended the lives of thousands of patients and provided new alternatives to chemotherapy and radiation, they also have limitations. Responsiveness varies amongst patients, and many eventually relapse. Furthermore, many cancers are not currently targetable. It’s imperative that we continue exploring potential new targets to broaden our cancer-fighting toolbox.

Using its FIND-IO™ technology platform, NextCure can screen thousands of genes to understand how certain receptors and signaling molecules affect immune cell activation. Proteins that dampen down immune cell activation serve as potential immunomedicine targets that can be explored further. You can learn more about the intricacies of the platform here.

So far the platform has yielded several potential drug candidates that are working their way through validation and preclinical development, each targeting different signaling pathways beyond CTLA4 and PD-1/PD-L1. NextCure’s drug candidates are unique in that they promote immune-modulatory effects which create a more conducive tumor microenvironment for the immune system to attack the tumor cells. This gives way to countless therapy potentials not only as monotherapies but also as combination therapies with approved anti-cancer agents. 

Other discovery programs are also currently underway. The beauty of the platform is that it is also adaptable to other areas beyond cancer, broadening the realm of possibilities for treating other challenging diseases such as Alzheimer’s.

For scientist jobseekers who want to move out of academia but still have an itch for exploring the unknown, NextCure is the perfect place to take your career. “The targets that we have uncovered so far have not been explored as heavily as others out there, meaning we are not a “Me Too” company. We’re not only developing new therapies to treat disease, but we’re discovering and building on our understanding of the biology at the same time,” said NextCure Chief Medical Officer Dr. Han Myint.

Clinical Development – Keeping the Patient Center-Stage

Protocols are the backbone of any clinical trial – they’re the roadmap for investigators and clinical staff to know everything from when and how to dose, what procedures to perform, how to process and ship lab samples, how long to follow up with patients, and who to contact with questions.

While many things in a protocol might seem straightforward on paper, NextCure’s Clinical Development team knows that actually running a trial is trickier than it seems, especially when a major global pandemic enters the fray.

“With COVID, cancer patients are often hesitant to visit the hospital any more than usual, especially when cases are spiking” said Stephanie Kordahi, Director of Clinical Operations at NextCure. “Our team understood and empathized with this, so we critically evaluated our protocols to identify ways to minimize or consolidate the frequency of samples and procedures to help reduce the burden on the patients.”

Beyond helping the patients themselves, the NextCure team also knew that hospital staffing and turnovers needed to be considered to ensure that protocols could be executed properly. “You had staff being pulled in different directions to help care for COVID patients, and you also had staff who were quitting because of burnout. Departments were and still are stretched thin,” said Megan Nelson, Director of Clinical Research at NextCure. “As the trial sponsor, we needed to take extra care to walk new staff through the protocol and make sure they understood what needed to happen when, especially because some of the nurses had been trained in other fields. As a trained RN myself, I knew how confusing it could be if a nurse was specialized in hematological oncology and got pulled into managing a solid tumor cancer trial in an entirely different indication.”

“We also knew we needed to not only be available to investigators and staff when they had questions, but also be patient with them as they navigated all of these uncertainties,” Stephanie added. 

And as the months passed and COVID ebbed and flowed, those uncertainties remained.

When Han joined as CMO in early 2021, one of his first major tasks was to write the protocol for the NC762 Phase 1 trial. Coincidentally, this was also when the first COVID vaccines were being rolled out to the public, putting Han and his team in another peculiar predicament that so many trial sponsors faced. 

How long should patients wait post-vaccine to receive the investigational therapy, or vice-versa? When should follow-up doses of vaccine and therapy be delivered? Could the vaccine affect how the investigational therapy performs in the body? mRNA vaccines were also completely new, throwing another wrench in knowing what to expect.

“We couldn’t just tell cancer patients to not get the COVID vaccine to make things easier for our own trial planning. That wouldn’t be ethical,” said Han. “I took a deep dive into whatever scarce literature I could find at the time to help inform how we should proceed, knowing that we were charting new territory and would need to be adaptable as more data becomes available.”

Beyond COVID, the NextCure team continues to maintain a standard of excellence when it comes to managing their trials, knowing that the health of patients depends on it.

“It’s not just about us as the sponsor – we ensure that everyone who touches our trials is set up for success. Investigators know they can pick up the phone and call Han directly at any time, and the coordinators know that we will respond to their questions ASAP, usually within the same day,” said Stephanie. 

“I recall a time where we had to change the type of sample collection tubes we used, and one site didn’t have the right centrifuge for the tubes to fit in. We worked with our facilities team to help get a new centrifuge to that trial site in a matter of days,” Megan added. “That’s a testament to our commitment to these sites and our patients – we’re all in this together.”

Breaking Down the Silos

We’ve mentioned before how NextCure offers tremendous opportunities for its employers to learn and grow – the discovery and clinical operations teams are no exception.

“NextCure is a truly special place – while we’re still small, we have many of the in-house capabilities that you’ll see in big pharma companies, including discovery, bench-to-bedside research, GMP manufacturing, and GLP facilities. This not only means that we’re able to expedite getting therapies to patients because we don’t have to outsource, but we can also utilize available translational data to continuously improve our developing therapies in real-time.” said Han.

“I left my prior CRO clinical project management role in search of an opportunity that would allow me to be involved in and make a more direct impact on the development of new therapies for patients in need,” said Stephanie. “Here you have the unique opportunity to collaborate with many different peers who have various expertise within the spectrum of drug development. Each member of our team comes from a different background which contributes to the collegiate environment that allows our organization to constantly lean on and learn from each other to achieve our goals and grow.” Since joining the team in late 2020, Stephanie now leads the Clinical Operations team at NextCure.

Interested in taking your career to a place where you can truly learn and grow all while helping patients? Check out NextCure’s latest open positions.