Gameto’s CEO and co-founder
Any woman who has frozen her eggs or undergone in vitro fertilization (IVF) to try and get pregnant knows how challenging and time consuming the process can be. This is something Gameto’s CEO and co-founder Dina Radenkovic Turner, MD, is trying to change.
The company’s lead candidate treatment Fertilo is currently in Phase III trials in the U.S. and already has approval in several other countries. It aims to cut the time needed for ovarian stimulation and egg collection from two weeks to a few days by using engineered ovarian support cells to mature the eggs outside the body. In addition, the company plans to develop treatments for menopause and ovarian disease.
Gameto has raised a total of $127 million in a difficult funding climate, with Fertilo being the first induced pluripotent stem cell (iPSC)-derived therapy to reach late-stage clinical development in the U.S.
Radenkovic Turner became interested in ovarian health and extending female fertility while working as a researcher at the Buck Institute for Research on Aging in California. Originally from Serbia, she studied medicine and physiology at University College London. She worked as a research clinician in the U.K. for a few years at Kings College London before moving to the U.S. She joined SALT Bio Fund as a partner in New York in 2020 while also working part-time at the Buck Institute, before going on to found Gameto in 2021.
Inside Precision Medicine senior editor Helen Albert spoke to Radenkovic Turner about her inspirations, goals for Gameto, and her hopes for the future of women’s reproductive health.
Q: What inspired you to get into science and medicine?
Radenkovic Turner: I think growing up, I was always very passionate about science. I was much better at science than other subjects. I went to STEM competitions in mathematics, physics, biology, and chemistry. I also come from a medical family. My father was a professor of embryology, and my aunt was a doctor too. So there was a lot of interest there. In my teens, I was trying to decide which area to go into. For me, medicine was a mix of science, but also human impact. I felt that having that short loop of seeing how your work can change people’s lives and still have human interaction was the perfect combination of my passion for science and my love for interacting and working with people, and seeing that positive impact. So that’s when I decided that I’d like to study medicine, I think I was about 14 years old at the time.
Q: How did you make that jump between doing medicine and founding your own biotech?
Radenkovic Turner: I was born in South Serbia and then I moved to the U.K. Where I come from, a lot of these fields like bioengineering or biotech as an industry don’t really exist. If you do anything healthcare-related, you are either a doctor or there’s not much left. I got into medical school and around the second year I took part in a competition called the F-Factor, organized by the Founders Forum by Brent Hoberman. It was like the X-Factor for STEM. I had this idea for a gestational diabetes app and how it could fix everything I’ve seen in my placements in the NHS. I didn’t know that world existed before. Since then, I felt that that’s where I really belong. Even during my medical training, I was providing scientific diligence to certain venture funds and getting into this ecosystem. I just realized that I work better in this multitasking environment where I’m still doing science and affecting patients, but also doing a breadth of things involving business and operations and corporate and legal. It was still a big decision. Sometimes I do miss patient contact, but working in biotech, we actually do interact quite a lot with patients, and we see the positive impact we make.
Q: Can you tell me a bit more about the story behind Gameto?
Radenkovic Turner: I stopped practicing clinical medicine as I moved to the U.S., but I kept my research post at the Buck Institute for Research on Aging, which gave me an angle into ovarian aging that I became really obsessed with. Working at the cutting edge and seeing a lot of companies focused on extending healthspan, I felt that if we do nothing to address female reproductive span and the health of our ovaries, we spend two-thirds of our lives in infertility and one-half of our life in worse health post menopause. It’s not just what menopause means for fertility, it’s what it means for systemic health. Post-menopause women have a lot more health conditions than men. We live longer, but we have longer time in morbidity.
To launch Gameto, I joined forces with Martin Varsavsky, who is also a co-founder. He’s a serial entrepreneur and has built five unicorns. He is founder and chairman of one of the largest fertility clinic networks in the U.S. We decided to form a women’s health biotech that would address infertility, but also have a broader women’s health journey, primarily focusing on menopause and the conditions that happen afterwards. We found very interesting science being developed in George Church’s lab at the Wyss Institute at Harvard Medical School and were able to influence the science through the sponsor research agreement we did with the lab. They were already working on doing cutting-edge research on induced pluripotent stem cell technology to make different human cells and there was a team that was potentially interested in making human eggs.
We really pivoted that work on not just building ovaries in a dish. I was thinking about my own egg-freezing, and I thought, “Wait, could we make these support cells? We’re already making all of these ovarian cells, and if they do this in vivo, could they do that in vitro?” Then we don’t need to drug the women systemically and cause all the unwanted effects, but can potentially do it outside of the body. We were fortunate and some of the team of founding scientists decided to leave academia and join the company because they felt that they wanted to see some of this science come to life.
Q: What exactly is Fertilo and how have the trials of your therapy progressed so far?
Fertilo is an induced pluripotent stem cell-derived cell line. We call them ovarian support cells. We’ve engineered them so that they essentially mimic what happens in a follicle right before ovulation. A normal IVF cycle hasn’t really changed since 1978; women still inject hormones twice a day for two weeks. That causes a lot of adverse effects because hormones are dirty, they have receptors in all organs. They even cross-react with other receptors. A minority of women end up with severe medical complications.
With Fertilo, we grow these follicles a little bit inside of the body so that they’re still easy to extract in the same retrieval procedure, which uses an ultrasound-guided needle through the vagina to both ovaries. But we can do the final step of maturation outside of the body. We tested this in multiple animal models initially. Then we went on to test it with humans. In our first wave of studies, we looked at what happens when you put human eggs with Fertilo. We’ve shown that they mature and that they are genetically and epigenetically normal, and they resemble the eggs as they come out of the outside of the body with IVF. We’ve also looked at embryos, both genetically and epigenetically, and then we followed the pregnancies. We have now had over 100 couples that have gone through the procedure. We have had five babies born so far with the technology, with about 20-ish pregnancies ongoing.
It’s still early days. We’re in Phase III right now in the U.S. but have certain clinical pilots as post-market studies or ongoing elsewhere. For example, we have pregnancies now in Australia where we are approved. So far, the results are at parity to standard of care IVF.
Q: Are there groups of women who can benefit more from Fertilo than others?
Radenkovic Turner: There may be some populations where it may be more effective, like women with polycystic ovary syndrome (PCOS). We’re going to do a study just in severe PCOS to see if it could be more effective in that population because there’s some signals, but we need a conclusive study to be able to claim that. There are a lot of other patient groups who could benefit from this, like egg donors and egg-freezing patients, patients at risk of certain cancers or with previous history of certain cancers. Finally, there are these groups of patients that have failed. There are only about three regimens of IVF right now that exist. You have couples that go through all of them, and they don’t get anything. It’s not going to solve all of the failures, but if the issue was with your ovarian biology, perhaps it could.
Q: One of the issues with IVF is the high financial costs associated with it. How will Fertilo compare with current therapies?
Radenkovic Turner: I can’t comment yet on definitive pricing as we obviously don’t have it yet, but it certainly won’t be more expensive. I think the hormone injections are a very expensive part. They also lead to a lot of bloodwork and ultrasounds and monitoring. So that’s the other difficulty. A lot of employers are actually now covering fertility treatments in the U.S.. Not small employers, but about a half of Fortune 500 companies. But then the women don’t do it because they have to use 10 days of paid time off to do this procedure and need to do ultrasound and bloodwork and so forth. There is this additional step in the laboratory, but the reduction in physician time that’s needed per patient, the reduction in monitoring and in medications needed allows a safe enough margin that we do expect this treatment to hopefully promote access.
Q: I understand you participated in one of the Gameto experiments. Can you tell me a bit more about that?
Radenkovic Turner: I participated in one of our studies in New York in 2022. We were not allowed to implant, but we were looking at embryo quality. I went through the stimulation, the retrieval process, and I donated my eggs for research. We made embryos, and we looked at the embryo quality genetically and epigenetically. With that data, we were then able to proceed to implantation in the next cohort. I wanted to witness the patient journey myself and really see if this was a better product. I think the summary was, it’s still not a massage. You’re going for an egg retrieval. I wouldn’t recommend it to people as a well-being self-care activity. But it was something that I was able to integrate into my everyday life. I went on Friday for one ultrasound, I took Clomid for the weekend until Tuesday, then on Wednesday morning I was in the clinic for the retrieval. I was able to function. It was much easier. … Normally you have restrictions for about six weeks in terms of intercourse, exercise, and other things, because once you go through full stimulation, your ovaries are enlarged because you have a lot of follicles and then they could twist. It is quite disruptive. We’ve been seeing egg-freezing grow enormously in the U.K. and U.S., but it’s sold to women as some treatment of empowerment. But the treatment itself is the same as what women were doing when they were completely desperate to have a baby as an end-stage infertility treatment. We’ve just rebranded the website and the messaging, but we haven’t changed the product.
Q: What other candidate therapies are you developing?
Radenkovic Turner: Our menopause program, Ameno, is incredibly exciting because we use similar cell-based technology, but the idea is to address the loss of all of the hormones and other factors that are lost by the ovary that lead to some of these acute effects. Many women experience symptoms in the first two years of menopause. Later on, the reduction of these hormones causes things like osteoporosis, heart disease, as well as vaginal dryness, painful urination, and all sorts of things that people don’t want to talk about, but they cause a lot of morbidity.
Last year we won a $10 million ARPA-H grant, which was very competitive. There were 1,700 applicants from universities and companies all across the world, even though it was funded by the U.S. government. With our additional Series C that we’ve also closed recently, we’re hoping that we can bring the first asset from that program to the clinic. It’s a vaginal ring that is similar to some of these estrogen-based rings that we already have on the market. But the difference here is that it can last longer. … It contains a full cocktail of what is lost during menopause—estrogen, progesterone, androgens as well.
Beyond that, we also have a bit more of a moonshot that is an implant that is currently being tested in animals, so it’s a little bit earlier. Essentially it uses the cells themselves in microbeads that would be implanted, for example in the arm. Because it’s the cells themselves, they’re responsive to signals from the brain and would provide real-time hormone replacement. In animals, it’s so far looking good, but we don’t know if it will be fully translatable from animals to humans.
In the Deovo program, that’s actually stem cell-derived ovaries in a dish. We know that a big reason why there wasn’t too many great companies in the space was also because we didn’t have good models to understand the female reproductive system. Mice and rats that we use in the lab today don’t even menstruate and primates and sheep don’t go through menopause and infertility the way we do. We induce them into menopause or infertility, but for the vast majority of women, it’s not an acute event. It’s a gradual decline and loss of these follicles. With our ovaries in a dish, we have published that it beats previous mouse chimeric models, and that it replicates the female reproductive system better. It allows us to test any drug before you put it into clinical trials in women of childbearing age.
Q: How has the field of women’s health changed over the last few years?
Radenkovic Turner: Well, I think it’s trending in the right direction overall. What I really want to see in women’s health is just honestly this becoming a biopharma category. We’re talking about half the population and the largest pharma companies don’t even have women’s health divisions. There is increased awareness and more startups. There’s also more women in positions of founders or investors. The science has advanced, and we discuss it more. Every administration in the U.S. has been trying to do something. With Jill Biden, she organized the ARPA-H program, and this administration has done enormous amounts for hormone replacement therapy and menopause.
I think it’s getting better, but as you go from the seed to Series A, to a couple of million funding stage, things just dry down before you become a large company with a few hundred million market cap that has several programs in either clinical trials or approved. You need to have more pharma companies in this space. We already have so much on the consumer side in women’s health. We don’t need more of that. But I think what I’d like to see is more validated claims that have gone into trials.
Q: What’s the best way to get more investors and more money in this field in your opinion?
Radenkovic Turner: Just by good exits. Ultimately, I think everybody cares about impact and so forth, but once they have to put in their own money … they need to think that they will make money. Nobody does it because they like you. Our Series C makes it easier for somebody at an earlier stage now to raise a round, for example. Investors want to see that there’s collectively enough funding to bring something to market because they will only make money if the thing makes it in the long term. If you only have money for the seed stage, but you know that nobody will fund the Phase II or Phase III, it doesn’t make sense to invest.
There are obviously other reasons too. Some funds say, “We don’t have a woman on the company, suggesting that should be a prerequisite or suchlike.” So there’s an element of that sometimes, but we’re seeing more diversification. Most people just want to do a good job, and they want to have a return for investors. If you convince them that it’s good science and that it’s likely going to work the total addressable market, [that] makes it really easy to sell.
Q: This is your first time running a company as CEO. How have you found the experience?
Radenkovic Turner: Ultimately, you can read a lot of books, you can have great mentors, but it can’t totally prepare you. The summary is always, try to do the best you can, spending the least money, as fast as you can. Over time, you get better. For example, I’m definitely much better at recruiting and I’m much, much better at saying no. Previously, I was worried about not being sure. Now I’m confident it’s a no, because I know it’s a no.
In terms of the company, our big challenges were, honestly, the regulatory pathway. You always start with a little bit of a risk that even if you do your best job, things may not work out. But then the risk that we’ve had to navigate, was “Okay, how does this get approved?” Particularly with Fertilo, because it’s a cell therapy in a dish. It’s unusual. Legally, it meets the definition of a device. It’s not a drug product like the hormone injections, but it’s living cells, so that was very hard.
We were the first induced pluripotent stem cell Phase III trial cleared by the FDA. Big pharma companies were reaching out to us and saying things like “What does the FDA think is the Phase III GMP (good manufacturing practice)?” They set the precedent with us. It took a bit longer to initiate this trial because we had to go through all of these screens on the manufacturing side. Now, obviously, that’s a huge asset for us because it’s massive defensibility in addition to all of the patents and biologic exclusivity. We also navigated it with different regulators across the world. That’s why we have clearances in Japan, in Singapore, in India, in Australia for Fertilo and now we have a designation in Europe as well, which is a step towards approval.
Q: Is there anything you’d do differently if you could start the process again?
Radenkovic Turner: Oh, I’m sure. I mean, there’s lots of things in terms of hiring paths, definitely improving efficiency in different areas. In startups, it’s hard because you often cannot hire, especially in the early stages, the best expert for the field. So you have to find somebody who can become that expert with a little bit of advice from experts, so you can still afford them. You have to spot it early.
But I think that’s all part of the growth. As a CEO, I always have to think about the future. I mostly worry about future problems. I mean, people always say, “Oh, are you celebrating this milestone?” and I say, “No, I’m already stressed about the next problems that have not yet started!”
I think timing is key. You have to be as fast as you possibly can. Essentially, death is always chasing us, so I always ask. “What are we doing today to escape it? What value are we creating?”
Helen Albert is senior editor at Inside Precision Medicine and a freelance science journalist. Prior to going freelance, she was editor-in-chief at Labiotech, an English-language, digital publication based in Berlin focusing on the European biotech industry. Before moving to Germany, she worked at a range of different science and health-focused publications in London. She was editor of The Biochemist magazine and blog, but also worked as a senior reporter at Springer Nature’s medwireNews for a number of years, as well as freelancing for various international publications. She has written for New Scientist, Chemistry World, Biodesigned, The BMJ, Forbes, Science Business, Cosmos magazine, and GEN. Helen has academic degrees in genetics and anthropology, and also spent some time early in her career working at the Sanger Institute in Cambridge before deciding to move into journalism.
