Kallistem, a biotechnology company developing innovative cell culture technologies in reproductive biology, announced that the company has obtained a world first: human spermatogenesis in vitro. At the end of 2014 the company was able to produce fully formed human spermatozoa in the laboratory setting, using patient testicular biopsies containing only immature germ cells, or spermatogonia.
A number of teams throughout the world have been trying for over 15 years to achieve human spermatogenesis in vitro. Spermatogenesis is an extremely complex physiological process that takes 72 days in vivo. To achieve this world first, Kallistem is leveraging two innovative, patented technologies capable of meeting current regulatory standards.
This scientific and technological breakthrough will help confirm Kallistem’s position as the world leader in spermatogenesis in vitro. To date, Kallistem has funded its development on its own. In 2015 it aims to raise funds to accelerate its plans for growth and is also looking for partners for its expansion into the US.
The company is setting up a therapeutic development project for patients whose fertility is at risk. Preclinical trials are expected to last until 2016, with clinical trials starting in 2017. Kallistem’s five-year objective is to market its technologies under license to suppliers in the assisted reproductive technology market, as well as selling them directly to public and private fertility clinics.
“Kallistem is addressing a major issue whose impacts are felt worldwide: the treatment of male infertility. Our team is the first in the world to have developed the technology required to obtain fully formed spermatozoa in vitro with sufficient yield for IVF using ICS. This is a major scientific outcome that enhances both our credibility and our development potential,” said Isabelle Cuoc, CEO of Kallistem. “We are targeting a global market worth several billion euros in which there are currently no players. This should convince future financial partners to participate in Series A funding, which we expect to take place before the end of 2015.”
“Achieving full spermatogenesis in vitro, from spermatogonia through to the final stage of mature spermatozoa, not just in animal species, but also in humans, is a real biotechnology achievement,” said Professor Hervé Lejeune of the Department of Reproductive Medicine at Lyon University Hospital’s Women’s, Mother and Baby center. “This opens up long-awaited therapeutic possibilities.”
According to the company’s estimates, the treatment of male infertility could provide a market worth over €2.3 billion ($2.58 billion), with more than 50,000 new patients each year. In developed countries, the number of spermatozoa per ejaculate has halved over the last fifty years. Therapeutic approaches for patients in this area are limited. For example, there is currently no treatment to preserve the fertility of pre-pubescent boys undergoing gonadotoxic treatment such as chemotherapy. This affects over 15,000 young cancer patients worldwide. Nor is there any solution for adult males living with infertility not addressed by current treatments. Over 120,000 men live with non-obstructive azoospermia. Kallistem aims to meet the needs of these patients. From a testicular biopsy, it will be possible to obtain spermatozoa that will be cryopreserved until the man wishes to father a child, and then used in ICSI in vitro fertilization.