TIBA Biotech, one of the target recipients, signed a $750,000 contract with Barda, which is scheduled to end on October 30. The company is developing RNAi-based treatments for H1N1 influenza, also known as swine flu. RNAi is the abbreviation for RNA interference, which refers to small pieces of RNA that can close down specific proteins. This method has been thoroughly studied and is on the market. The first was approved in 2018 to treat nerve damage caused by a rare disease called hereditary thyroxine-mediated amyloidosis.
The cancellation of the contract surprised TIBA, which received a stop-work order on August 5 that did not cite Barda’s mRNA vaccine development activity. “Our project does not involve the development of mRNA products, not therapeutic, not a vaccine,” said Jasdave Chahal, chief scientific officer of TIBA.
Government contracts often include specific milestones that the contractor must achieve in order to obtain funds and continue the project. Tiba said its project has achieved its goals so far and has been completed.
In the cancelled contract, a $750,000 award was awarded at Emory University, which converts mRNA-based antiviral therapy and a vid award into an inhaled dry powder formula. This project does not involve vaccine development. “Unfortunately, we don’t have much insight into the grant cancellation,” Emory spokesman Brian Katzowitz told Wired in an email.
The cuts are consistent with Kennedy’s desire to lose research on infectious diseases, although experts warn that the cuts could make the United States more vulnerable to future pandemics.
Although it has narrowed down the research on infectious diseases related to RNA, the government has expressed enthusiasm for some non-ovarian studies involving mRNA.
Shortly after taking office, President Trump announced a joint venture between OpenAI, Oracle and Softbank, saying STARGATE invested up to $500 billion in ATALGATE for AI infrastructure. At the time, Oracle CEO Larry Ellison talked about the potential of AI to personalize mRNA-based cancers.
In an August 12 column in the Washington Post, NIH director Jay Bhattacharya acknowledged the mRNA commitment. “I have no objection to its potential. In the future, it may lead to breakthroughs in the treatment of diseases such as cancer, and HHS is continuing to invest in ongoing research on oncology and other complex diseases applications,” he wrote.
Unlike his boss, Bhattacharya said he doesn’t think the mRNA vaccine will cause mass damage. But he said the reason for stopping mRNA vaccine research was because the platform lost public trust, which was a reason for Kennedy to deviate.
However, mRNA may be more receptive when treating very sick patients with genetic diseases.
Earlier this year, FDA GreenLit’s modulators were tailored gene editing treatments for a baby named KJ Muldoon, suffering from rare and life-threatening liver disease. Created in just six months, it uses mRNA to pass gene editing ingredients to his liver. This is the first time that a customized gene editing therapy has been used to successfully treat patients.
In June, FDA Commissioner Marty Makary praised his podcast achievements, calling it a “great victory in the medical science” and said at the FDA roundtable that the agency will continue to provide a promotion of regulatory processes for these types of products.
The researchers behind a customized gene editing treatment plan use the same approach for more patients and have recently encountered recommendations for clinical trials with the FDA. “The FDA is very positive about the proposal and effectively gives us a green light to continue our work,” said Kiran Musunuru, professor of translational studies at the University of Pennsylvania and professor of translational studies at Children’s Hospital in Philadelphia.
The team held another meeting with the FDA within one or two months to discuss extending the platform concept to a wider range of diseases beyond a single disease or a single gene. “We’ll see how things are going,” he said.
