On a Friday evening in late April, Cathy Tie, the Canadian serial entrepreneur and self-styled “Biotech Barbie”, is centre stage at New York City’s famous Carnegie Hall, performing Saint-Saens’ Piano Concerto No 2 on a gleaming Steinway grand piano, accompanied by an orchestra. Her floor-length pink tulle gown shimmers with gold sequins; her dark hair cascades in waves over her caped shoulders. The music is passionate, but Tie’s expression is impassive. Her eyes dart between the piano keys and the sheet music in a flurry of concentration, but the rest of her face is totally still. She isn’t lost in the music; she’s focused on the job. After the last notes ring out, Tie stands up and breaks into a tight smile and a brief bow before walking off stage, only to immediately return to receive the slightly awkward Happy Birthday sung by everyone in the orchestra and auditorium. This is Tie’s 30th birthday party. She has hired Carnegie Hall to mark the occasion. And, as I discover at the cocktail afterparty, most of the people invited to this performance – including me – have either only just met Tie or don’t know her at all. Tie likes to make an impact in whatever she does – but she’s a difficult person to pin down. Since the start of 2025, Tie has launched three separate biotech companies and lived in three different cities (Los Angeles, Toronto and New York). She tried to live in a fourth (Beijing), only to discover that she was banned from China – the country of her birth – while she was en route to begin a new life with her Chinese husband. This time a year ago, Tie had just married one of the most notorious scientists on the planet, the biophysicist He Jiankui, who served three years in prison after he illegally created the world’s first gene-edited babies. Tie and He separated three months after their wedding. Last summer, Tie arrived in New York with little more than a suitcase and her shih-tzu, Charlie, to announce a new venture: a startup that will conduct the same kinds of procedures that had earned her ex the nickname “China’s Dr Frankenstein”. Tie wants to edit the genes of embryos – to alter the building blocks of human life – to prevent diseases including cystic fibrosis, Huntington’s and hereditary cancers. Unlike He, she says she wants her work to be done openly and transparently, with the blessing of regulators – and powered by the rocket fuel of venture capital investment. The hardest thing about genetically engineering a baby is getting permission to do it; the technical part is not particularly complicated. Ever since the Crispr-Cas9 gene editing tool was invented in 2012, so long as you know the sequence of DNA in a genome that you would like to change, you can seek it out, then alter or delete it. It’s a bit like using the find, copy, cut and paste functions on a computer. You don’t even need to be a very experienced molecular biologist to do it. If you edit the sequence of DNA of germline cells – the eggs, sperm and very early embryos that form the first stages of human reproduction – the changes you make will be reproduced in all the other cells of the human being ultimately created from those cells. And not just that particular human: every generation of their descendants will inherit those changes. Of all the possibilities presented in biotechnology, this is arguably the one with the highest stakes for humankind. That’s why the use of germline gene editing for reproductive purposes (rather than research) is banned in the UK, the US and China, and there is widespread international agreement that no research should be conducted on embryos that could grow to term and be born as babies. “This is obviously the most consequential technology of our generation, because it fundamentally impacts and changes our understanding of what we can do with our species,” Tie says when we first meet, three days before Carnegie Hall. Gene editing has the power to alter the trajectory of human evolution for ever; the direction it takes will depend on who wields the editing tools. “There is no public funding available for researchers in the space,” Tie explains. “Everything is privately funded.” It’s up to entrepreneurs to demonstrate the potential benefits for humankind, she says, so regulators may soften their hardline stance and allow them to rewrite human DNA. For anything to change, there needs to be wider public acceptance of gene editing. With that in mind – and in the spirit of the openness she claims as her USP – Tie has invited me to join her in the run-up to her party as she takes on what she calls the “fear dressed up as caution” about her field. Her goal, she says, is to save humanity from the cruel tyranny of heritable diseases. But, as her birthday celebration demonstrates, Tie doesn’t do things by halves. If she succeeds, what next? Money is flowing into human genetic engineering. Since Tie arrived in New York last August, some of the richest men in the world have begun investing in her rivals. Gene editing startup Preventive launched in October with the stated aim of “preventing disease before birth”, and OpenAI’s Sam Altman and his husband, Oliver Mulherin, along with Brian Armstrong, the CEO of the cryptocurrency exchange Coinbase, are among its investors. Seven months before Preventive’s launch, Armstrong coined the term “the Gattaca stack” – after the dystopian 1997 sci-fi film about a near-future society dominated by genetically engineered super-beings – in a post on X describing technologies he says will be routinely used to create the babies of the future. Gene editing “for disease prevention, or enhancement” was included in Armstrong’s list. For him, at least, this is about improving babies, as well as avoiding disease. Another item in Armstrong’s Gattaca stack – preimplantation genetic testing (PGT), so you can “choose the embryo that best matches what you want” – is already routinely used in the US. It’s unremarkable enough that the PGT company Nucelus Genomics advertises on the New York subway with the tagline “Have your best baby”, promising to maximise parents’ chances of having a child that is taller and smarter as well as healthier. PGT is embryo selection – sorting and choosing, rather than editing – but over the past decade it has become a regular part of fertility treatment for many Americans. Eugenics might still be a dirty word in most circles but, in the US at least, it has become quietly acceptable to use whatever tools reproductive technology can provide to optimise future offspring. Tie isn’t fazed by her competition. “I hope there is more funding from billionaires,” she says, simply. She doesn’t regard them as competitors anyway, as there is currently no market in which they can legally compete. “I believe we’re all working on the same goal, which is to show, transparently, what this research can do.” China, of course, has already demonstrated what gene editing can do. It was Chinese researchers who made the very first edits to human embryos in 2015, and a Chinese scientist – Tie’s former husband, He Jiankui – who implanted gene-edited embryos for the first time, creating twin girls known as Lulu and Nana, the first genetically modified human beings ever born. He announced Lulu and Nana’s birth in a presentation at a Hong Kong conference in 2018. He had edited their embryos with the intention of giving them immunity to HIV; the twins’ father was HIV positive, and He was trying to introduce a gene mutation that would protect them from infection. But, according to his own data, he failed to do this; edits were made to the twins’ genetic code, but not the ones he had intended, yet he still allowed the embryos to be implanted and brought to term. The furore after their birth earned He a 3m yuan fine (about £330,000), as well as three years in jail. As for Lulu and Nana, no one knows what happened to them: there is no available information on their health or wellbeing eight years on from He’s experiment. Since he was released from jail in 2022, China’s Dr Frankenstein has emerged as an unlikely social media star, with close to 150,000 followers on X. His posts over the past year have been unrepentant, but also – intriguingly – uncensored by the Chinese government. “Silicon Valley this and that – you are not the only country in the world that has investors,” he wrote in August, followed by, “Designer babies, super smart or super good-looking, are inevitable.” At the same time, China’s biotechnology ambitions have rapidly expanded. On 12 September, premier Li Qiang announced new draft regulations on biomedical technologies that emphasised “the need to promote innovative development” and “accelerate R&D and commercialization”. “Welcome to the dawn of the biological arms race,” Tie posted on X in response to Li’s announcement. “There’s a big geopolitical component to this,” she says. This is one of the reasons why she chose to call her first human gene-editing company the Manhattan Project – the same name as the programme that produced the atomic bomb in 1945. It was also known as Manhattan Genomics, but “I like to call it Manhattan Project”, Tie says. (She earned the nickname Biotech Barbie after she commissioned a promotional video of herself in the style of the Barbie movie. “Both Oppenheimer and the Barbie movie came out at the same time in 2023,” she explains. “It was Barbenheimer summer.”) “Two nuclei are essential for understanding the universe: the nucleus of the atom and the nucleus of the cell,” Tie says. “In the 20th century, we understood the nucleus of the atom very well, and we learned some very difficult lessons via weapons and wars. I don’t want to see the same happen with the second nucleus.” It’s a strange parallel to draw: the atomic bomb was responsible for at least 200,000 deaths, and many wish the research into the possibilities contained in the nucleus of the atom had never been undertaken. “Biology is a double-edged sword – it can be used for good, to heal people, or it can be used for bad,” Tie continues. “Stopping this research will only drive bad actors to do it secretively. There is no way to stop this. This is inevitable. The only way to proceed is to do it openly and transparently.” Despite her declared commitment to openness, much of Tie’s work seems as shrouded in secrecy as the original Manhattan Project. She won’t tell me how many people are working on her team or who they are (“I’m working with pioneers. I’m unable to name them, unfortunately”) or who has invested in her company (“I’m unable to disclose their names, but these are very motivated individuals and funds”). She doesn’t want me to reveal where her work is based, other than that it’s in New York (it’s not in Manhattan). It is also no longer the Manhattan Project. By December, the gene-editing startup Tie launched last August had shut down. “I made a fundamental mistake that a lot of early-stage startup founders do, which is choosing the wrong co-founder,” she tells me. Eriona Hysolli was the former head of biological sciences at Colossal, a company that uses biotechnology to try to de-extinct the woolly mammoth. Hysolli has said she and Tie parted ways because of “a Cayman-based entity” founded by Tie “which confounded the open and transparent mission”. When I ask Tie to tell me more, her reply is terse: “I don’t want to talk too much about that.” But Tie is more than happy to speak at length about the mission of Origin Genomics, her current gene-editing startup. Its aim, she says, is to eliminate severe disorders caused by single gene mutations. “It’s about preventative pre-birth care for the patients that are carriers of these well-known mutations. The goal of Origin Genomics is to help prevent suffering via the newest gene editors applied before birth.” Older gene editors – including the versions of Crispr-Cas9 used by He when he created Lulu and Nana, although Tie doesn’t mention this specifically – were more prone to “off-target” effects, resulting in the wrong edits. “There are new advances in gene editing that make this process a lot safer than it was even five, eight, 10 years ago,” Tie continues. “We sequence the cells before and after the genetic change to ensure that it is safe, and that no unintended genetic changes were made.” In accordance with US federal law, none of the embryos Tie’s company is working with at this stage are implanted, or allowed to grow older than 14 days’ gestation. “This is to prove to the world – the public, the scientific community, the regulators, the bioethicists – that this technology can be safe, if the data shows that it is, and that it should be considered for clinical use,” she says. “I would love to change the global norms of this. I think it’s inevitable, and someone needs to do it right.” (During our conversation in her office, Tie uses the word “inevitable” 12 times.) But there are other ways of treating the same conditions that don’t result in genetic changes that will be passed on to every future generation. Gene therapies work on cells that aren’t involved in reproduction. They are given to carriers of a genetic disease after the patient has been born, and they affect only some, not all, of the body’s cells. Once researchers devise a way of delivering the gene therapy to the right cells, they can correct the relevant genetic mutations. Gene therapy is already being used to target a wide range of conditions, including cystic fibrosis, sickle cell anaemia and spinal muscular atrophy (SMA), once the most common genetic cause of death among children under two years old. Tie is unconvinced. “Many of those therapies have failed in clinical trials,” she says. “It is actually safest to explore this when a human is in its earliest stages of development, because you have fewer cells to deliver the genetic changes to.” Gene therapies can be extremely expensive – Zolgensma, the gene therapy for SMA, had a list price of £1.79m when it was approved on the NHS in 2021; the treatment for sickle cell, Casgevy, has a similar price. “Casgevy is a three-to-six-month process. Patients have to go through chemotherapy and other really invasive procedures,” Tie says. This isn’t the case for all gene therapies, I point out; Zolgesma is given in a single dose, delivered over a few hours. Tie blinks. “I’m not too familiar with that example. The research I’ve done shows gene therapy is quite invasive. And it’s all relative. When you have an embryo that grows up without the mutation, that’s a lot more ideal.” Why not screen embryos and implant those that don’t carry these disorders, instead of editing those that do? Families often don’t have the choice, Tie replies; sometimes all their embryos are affected. And, as we move further into an age when women are having children later in life

Source: The Guardian

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