The Scoop: The development of IVF technology has proven to be a significant achievement in women’s healthcare, but there has been very little advancement in this field over the decades since. Gameto, a female-led biotech company, is dedicated to redefining women’s healthcare and developing new therapies for female reproductive needs using innovative cell engineering techniques. Gameto’s research aims to make IVF safer, address ovarian diseases, and alleviate health issues caused by menopause.
The use of assisted reproductive technologies like IVF and IUI have reshaped fertility treatment and helped increase the chance of pregnancy for many women. But while most medical technologies have made continuous advancements, the field of female reproduction has remained largely unimproved since its inception decades ago.
This has resulted in inadequate healthcare for women, particularly in the field of fertility care. To help fill this void, some companies are striving to modernize and destigmatize the traditional fertility process.
Gameto, a female-led biotechnology company, is looking to revolutionize women’s healthcare and has been developing new reproductive therapies using cell engineering technology.
“We like to say we’re for women, by women, and we’re developing therapies to improve the reproductive journey,” said Emily Bosworth, Gameto’s Business Development Associate.
In its efforts to create new techniques, Gameto has collaborated with scientists at Harvard Medical School and figured out how to recreate female reproductive system cells that look and behave like the cells in the human body.
Using innovations that have been around for 10 years, scientists can take any cell of the body, typically a skin cell, and reprogram it to be a stem cell so it can develop into a plethora of cell types. This cell engineering works with human-induced pluripotent stem cells, also called hiPSCs.
Gameto uses computational biology to predict which combinations of transcription factors would turn these stem cells into the desired cell lines.
“You can think of the transcription factors as kind of like a recipe,” Emily said. “They basically tell these hiPSCs, which could become almost anything, to become an ovarian cell type or whatever cell type you want.”
Gameto first developed these recipes to determine what will turn a certain stem cell into the cells that the scientists want. They would then test to ensure that the cell is what it was predicted to be.
For the purpose of Gameto’s first product, Fertilo, the biotech company wanted ovarian support cells to improve the fertility process, and it used a few different cell lines to test which ones have the desired effect.
Advances in IVF Therapy with Fertilo
In a regular menstrual cycle, one egg matures per month so it can be fertilized. If it’s not fertilized, the egg is shed.
When going through IVF, the goal is to retrieve many mature eggs at one time.
The process itself can be very challenging. Women typically undergo around two weeks of hormonal injections with the goal of having a group of eggs maturing at one time.
When the physician determines that the eggs are ready, they are retrieved and the patient will then know how many they have. But overall, it is a huge burden on a woman’s body and is also not financially accessible to many people.
“The program we’re testing now is around two to four days of hormonal stimulation versus what is typically two weeks on average,” Emily told us. “Then the fertility doctor can intentionally extract those immature eggs and we mature them in the lab to make the process a lot easier on women’s bodies, and a lot easier to fit into our busy lives.”
The company’s Fertilo cell line basically mimics in the lab the natural ovarian environment that supports the eggs in a woman’s body. In a sense, Fertilo tricks the egg into reacting as if it were back in the ovary so it can mature while being in the lab.
After a regular cycle, up to 30% of eggs can still be immature and are discarded. Since IVF is a numbers game, it can have a huge impact on efficacy. Fertilo technology can be used to rescue eggs and mature them in the lab.
“What we at Gameto want to change is take the IVF process, reduce the burden on women’s bodies, make it easier on them, and then make it more accessible as well,” Emily said.
Egg freezing is something Gameto is very excited about because research has shown that freezing is the most effective way to preserve future fertility. But it can be prohibitively expensive for many people, particularly at the age when egg freezing is most effective.
“We’re told for so long how not to get pregnant, so no one thinks that they’re going to have a problem getting pregnant,” Emily said. “So that kind of pre-emptive fertility care isn’t happening as much, especially given the price tag.”
The team at Gameto believes that, by making it much more affordable and a lot easier, the company can expand the egg freezing market and make it something that women want to do and are able to do so when it’s helpful for them. Fertilo is still in the works, but its innovation could radically change reproductive care in the future.
Research on Reducing The Impact of Menopause
Gameto intends to develop a program called Ameno which may potentially eliminate problems associated with menopause.
Studies often show that women are in better health than men until they reach menopause, and then the trend goes in reverse. But medical researchers are starting to learn more about how different conditions that were assumed to be unrelated to menopause actually have a connection to it.
When going through menopause, women may experience all kinds of hormonal imbalances that create problems in the body. In particular, the loss of estrogen that occurs at that time can lead to side effects, like vasomotor symptoms, as well as other risks like osteoporosis or even Alzheimer’s disease.
The idea behind Ameno is for it to act as a menopause therapeutic that separates the medical impact of menopause from the loss of fertility. “We don’t plan to eradicate menopause, in that women would not still be fertile, but we want that loss of fertility to not come with all of the associated side effects and risks of other conditions,” Emily said.
In theory, it would be similar to hormone replacement therapy, but it would respond to the body’s needs in a more compatible way. Since hormone replacement therapy requires taking a fixed dose at a fixed time, it cannot integrate into what a woman’s body really needs at that moment.
Researchers continue to refine exactly how Ameno would be delivered in the body, but Gameto’s engineered cell lines would behave as a therapeutic.
The final product could potentially be something like an implantable rod or an IUD device. The cells would come into contact with the body and integrate into the chemical conversation such that the cells know what hormones a person needs in real time, and deliver those hormones accordingly.
Testing For Ovarian Disease Detection
Another exciting program Gameto is looking towards is called Deovo, which will look into testing for various diseases that may affect the female reproductive system.
Many products have a general lack of research regarding side effects they may have on women. For example, clinical trials often do not include women of childbearing age, and there are not many suitable animal models for testing human female reproductive systems.
To solve this issue, Deovo will allow researchers to recreate in the lab the female reproductive system, which can then be used for drug discovery to test and develop novel products for ovarian disease.
Since Congress passed the FDA Modernization Act, limitations on animal testing would enable Deovo to perform accurate human cell modeling without relying on animal subjects.
“We can use that model together with potential partners to put their drugs into the model and see how it interacts with the cell lines for things like ovarian toxicity, because a lot of drugs haven’t been tested in women,” Emily said. “So we can see how they affect the cells of the ovary and basically screen for toxicity.”
Gameto hopes to fit into the reproductive healthcare space with the goal of supporting women at every stage of the reproductive journey, from egg freezing to infertility to therapeutics for various conditions.
“We see ourselves as leaders in this new wave of fertility treatments,” Emily said.
“We want to get Fertilo to market first before we accomplish everything else that we want to do.”
Emily envisions that Fertilo could eventually be added to all existing IVF cycles in order to save as many eggs as possible. “We want to start reaching that audience, and we see ourselves as the bridge that can bring IVF and egg freezing to that broader population,” she said.
