Although antibodies have gained plenty of ground in recent years as vehicles for cancer therapies, Aridis Pharmaceuticals wants to use them as nature intended – to fight infection.
“These are human monoclonal antibodies being investigated as anti-infectives to treat bacterial infections associated with pneumonia,” founder & CEO Vu Truong told Drug Delivery Business News, referring to the company’s projects that are in pivotal trials.
“The fundamental reason is that this is exactly what the antibody is designed to do – that is, to fight infection,” he explained.
Nearly all infectious diseases produce a sub-population of patients that manage the infection better than the average person, Truong said. When he started the company 12 years ago, he wanted to find a way to use the cells that produce the antibodies in these specialized groups of patients.
“You have a patient population from virtually every infectious disease that is a reservoir for discovery of rare B-cells,” the chief executive said.
It can take two years from the time a scientist identifies the B-cell to a final product with current monoclonal antibody discovery tech, according to Truong. But Aridis has figured out a way to speed that process up dramatically.
“Now, we can get from a patient’s blood to a fully-released antibody product in six to eight months time,” he said.
The company has three human monoclonal antibodies being studied in pivotal trials, all tackling bacterial infections linked to pneumonia.
Antibodies provide a number of strategic advantages in the fight against infections compared to antibiotics, Truong said. A typical human monoclonal antibody sports a half-life of three to four weeks, much longer than any antibiotic on the market.
The larger problem with antibiotics is a looming battle against drug resistance.
“The more prolific that we prescribe these antibiotics, the higher the selective pressure for mutation, therefore resistance,” Truong said. “This is happening across the world. We all know this is a time bomb.”
Just as oncologists are transitioning from chemotherapy, cancer-killing drugs that affect all kinds of cells, to targeted immunotherapies, so to will clinicians looking to combat infectious disease, according to Truong.
“In the future, the industry is going to transition from these broad-spectrum antibiotics to more narrow-spectrum, targeted therapies,” he said.
“When we started Aridis, we were betting on the immune system as the next great frontier in terms of infection fighting and we’re betting that you’re going to find all kinds of interesting components that have been evolving in humans since we’ve walked the earth to fight infection.”
One obstacle that Aridis has stumbled into is reimbursement, Truong said. He believes that the key to landing reimbursement is to demonstrate value-based outcomes using superiority trials.
“We can be operating on non-inferiority designs, which is the kind of design that essentially all antibiotics that have come to the market in the last three or four decades have used. We need move away from that. We need to show superiority compared to standard of care,” he explained.
Over the eight years following Aridis’ launch, they amassed more than $40 million in grant funding. In recent years, the company has started taking private investments and Truong said he could see an IPO in the company’s future.
“What we’re proposing to do is very new. It’s fundamentally new. We’re proposing the use of biologics to treat infection. We’re proposing also to use [them] adjunctively so that we can show superiority compared to just conventional antibiotics alone. And we’re proposing a very different reimbursement approach. So we’re asking a lot,” he said. “But the reward is big.”