Startup Seeks Funding for Controversial Human Embryo Gene Editing

A California-based startup, Bootstrap Bio, is seeking funding for its controversial plan to edit human embryo genes. The company, established around 18 months ago, aims to develop technology that alters the DNA of embryos. This process, known as "germline editing," involves modifying cells to cultivate genetically edited babies, with the goal of eliminating hereditary diseases or enhancing desirable traits that could be passed on to future generations.

Scientists and ethicists have raised concerns about the potential risks and uncertainties of this technology. The process, if flawed, could introduce genetic defects in embryos, affecting every cell and developmental stage. Even if the technology proves feasible, there are fears it could usher in a new era of eugenics and exacerbate social inequalities.

“When you are tampering with the safety of babies, you have to be absolutely sure,” said a Stanford University law professor and bioethics expert. “We have no idea what might happen to edited babies.”

Another expert, a professor of religion and ethics at the University of Chicago, expressed particular concern if such research is conducted in private labs, lacking public oversight, regulation, review, or safeguards.

“There are safer ways to avoid having children with genetic diseases than treating babies as custom-built products with ‘cool features,’” the professor stated.

The founders of Bootstrap Bio, the CEO and the chief technology officer, initially discussed the idea of using gene editing to make adults smarter on a popular Silicon Valley forum. They later shifted their focus to germline editing, hiring a chief scientific officer, setting up a lab, and adjusting their research direction. The company plans to raise seed funding this year.

Early investors in Bootstrap Bio include a couple known for advocating higher birth rates to prevent "population collapse." The couple, who are associated with billionaire Elon Musk and have been criticized for promoting eugenics, deny the label. They mentioned considering germline editing for some of their own embryos to reduce health risks for future children.

“We will act as soon as possible,” the couple said, declining to disclose their specific investment in Bootstrap Bio. “I know people are afraid of unforeseen chain reactions, but the ability to completely eliminate a risk for all descendants is significant.”

The couple, who identify as entrepreneurs, stated that their primary goal is not financial gain from their investment in Bootstrap Bio but rather to help others.

Despite strict regulations on germline editing research in the United States, progress has been made. However, experts agree that the technology is not yet mature. The U.S. clinical trial database does not list any studies involving embryo germline editing or genetic engineering.

Scientists working with the technology in highly regulated labs at Columbia University emphasize the need for more research before discussing its clinical application. A Harvard University law professor and bioethics expert noted that companies must obtain FDA approval before testing new drugs or technologies on humans. Federal law prohibits the FDA from accepting applications involving germline editing, including embryos.

However, germline editing in private labs using private funds is not entirely prohibited. Bootstrap Bio has shared some of its future commercial plans with investors, including potential human trials in Honduras by 2026 or 2027, possibly to circumvent U.S. regulations. It is unclear whether these plans are still in progress or if they were part of the company's initial focus on adult gene editing.

In May, an international scientific organization called for a 10-year moratorium on the technology, citing its complex challenges and the lack of urgent medical need. The chief executive of the Regenerative Medicine Alliance, one of the moratorium's signatories, stated, “Germline editing faces enormous and complex challenges, and it is not clear if there is an urgent medical need.”