The U.S. Department of Defense has awarded Edina-based Humanetics a $20 million contract to develop a pill that prevents radiation damage in military members and first responders affected by events such as nuclear accidents, warfare and dirty bombs.
The DOD's contract, however, will not only accelerate development of the drug for the U.S. military, but also test the pill's efficacy in treating patients with non-small-cell lung cancer or severe lung issues related to long-haul COVID-19, said Humanetics CEO Ron Zenk.
"It is exciting," said Army Col. Matthew Clark, joint project manager for the military's Chemical Biological Radiological and Nuclear Medical division. "We look forward to collaborating with Humanetics on this effort."
Department of Defense researchers last month presented the latest findings on Humanetics' Bio 300 drug to the Military Health System Research Symposium in Florida and another conference in Montreal.
The hope through the latest contract is securing emergency use preapproval from the Food and Drug Administration. If that happens, it could be issued to U.S. military personnel on missions around the world, Zenk said.
The ability to deliver fast-acting and portable relief for different types of medical emergencies on and off the battlefield is significant, Zenk said.
"We are the little engine that could," he said. "And we are tremendously honored to partner with DOD to provide this important capability."
It has taken nine years to get to this stage of approval — and the journey took a village.
People suffering from nuclear war or accidents, cancer radiation therapies and long-haul COVID-19 experience similar tissue damage from high doses of radiation, said Dr. Rany Condos, a pulmonologist at New York University's Grossman School of Medicine.
Since 2021, she's tested a Bio 300 cough syrup on 30 long-haul COVID-19 patients with badly inflamed lungs. Several gave up their oxygen tanks after being in the clinical trial for 12 weeks. They reported feeling better, being more active and wheezing less.
While several patients received placebos and formal results have not been fully analyzed, early indications are promising.
"I believe in this drug," Condos said, adding that it's been easy to use.
If the drug proves successful, it could be a game-changer for the small Minnesota-based Humanetics, which does not do its own manufacturing.
If equally successful in testing for the military, BIO 300 pills will be given to soldiers, giving them an easy-to-use anti-radiation therapy while in battle or on duty anywhere in the world, Zenk said.
The BIO 300 drug is very different from other anti-radiation therapies because it is shelf-stable, portable, does not require refrigeration and protects more than just one organ from damage.
Humanetics' new defense contract was received with the help of U.S. Rep. Betty McCollum, D-Minn., and Navy officials. It is the latest in a long line of grants and research work designed to make the drug viable.
In an email to the Star Tribune, McCollum, chair of Congress' House Appropriations Subcommittee on Defense, said she recognized U.S. troops faced "a long-standing threat from radiation exposure," and so secured funding to develop a radiation countermeasure.
Humanetics acquired the licensing rights to the early-stage drug from DOD in 2014. It has since won 19 federal grants and contracts worth roughly $40 million to further test and develop.
The installation of another $20 million in research funds should help yank the drug across the FDA's critical Emergency Use threshold. After that, it must go through another set of clinical trials to get full FDA approval.
The drug works at the molecular level, promoting DNA protection and repair and activating anti-inflammatory pathways at the cellular level, company officials and researchers said.
The University of Minnesota and other yet-to-be-named researchers and production facilities are expected to be involved in the final leg of the project for the military, Zenk said.
At the same time, Humanetics is involved in several Phase 2 clinical trials that are testing the drug's efficacy in treating lung cancer or long-haul COVID-19 at NYU, Memorial Sloan Kettering Cancer Center/New York Proton Center, and the University of Maryland in Baltimore.
Humanetics found that severe COVID mimics the "acute radiation" injury seen in the lungs of people who have endured nuclear accidents. Both conditions cause dangerous and sometime fatal lung and esophagus inflammation and scarring.
But those problems were alleviated by the new drug during small, initial clinical trials, said Sloan Kettering and New York Proton Center radiation oncologist Dr. Charles B. Simone II.
Between 2017 and November 2020, Simone put 21 lung cancer patients on oral doses of Bio 300 "with the hope it would help mitigate the toxicity of radiation therapy. And it does look like it did that," he said. "In this patient population, treatment was actually very well tolerated."
That's important since there are "240,000 people diagnosed with lung cancer each year," who could stand to benefit from the drug, Simone said.
Patients who took the drug while going through weeks of radiation and chemotherapy had "much better" quality of life, weight stability, esophagus health and white blood cell counts. "They were stable throughout treatment, where as we often saw [these] decline in other clinical studies," Simone said.
The new radiation protectant didn't interfere with radiation's tumor shrinkage, said Simone, who will begin phase 3 clinical trials of Bio 300 on 160 patients next year.
His team learned this week about the Department of Defense's hopes for the Bio 300 in soldiers.
"If there are great signals that it can help [therapeutic] radiation toxicity, the thought is that it should be able to mitigate a more significant type of radiation as well," he said. "It's exciting as both fields develop that they can have shared benefits in both patient populations."