A world first in male fertility
May 14, 2015
A world first in male fertility: Kallistem obtains complete
human spermatozoa in vitro
This research paves the way for innovative therapies to preserve and restore male fertility, a major issue with global impact; numbers of spermatozoa have declined by 50% over the last fifty years
Lyon, France, May 5, 2015 – Kallistem, which develops innovative cell culture technologies in reproductive biology, today announces 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 ICSI. 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.”
Treating male infertility: a global issue
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 worldwide3. Nor is there any solution for adult males living with infertility not addressed by current treatments. Over 120,000 men live with nonobstructive 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.
About Kallistem SAS
Kallistem is a biotechnology company developing innovative cell culture technologies in reproductive biology to address the global challenges of male infertility and meet the demands of modern toxicology. Founded in 2012 and based at the École Nationale Supérieure (ENS) in Lyon, France, the company leverages the research of specialists Philippe Durand and Marie-Hélène Perrard, who have achieved worldwide recognition for their work on male reproductive biology and more specifically, spermatogenesis in vitro. Kallistem makes use of two specific, patented cell culture technologies to preserve fertility and treat male infertility: Artistem® and Bio-AlteR®. Artistem® is the first technological platform in the world that can produce human spermatozoa in vitro. Bio-AlteR® supports the mechanistic studies required for the therapeutic project, which are useful in conducting predictive studies in testicular toxicology.
Kallistem’s solution for the treatment of male infertility fits into the pre-existing logistical structure involving biopsies and the storage of spermatozoa, ovarian and testicular germ cell tissue in specialist centers such as France’s center for the study and storage of eggs and sperm (CECOS) and biobanks worldwide. Incubated at the Pulsalys innovation accelerator in Lyon, France, Kallistem received the Novacité and Jeune Entreprise Innovante (Innovative Young Business) labels in 2012. The company was selected for the Artis project by the CLARA cancer cluster in 2012 and is supported by France’s National Center for Scientific Research (CNRS), the National Institute of Health and Medical Research (INSERM) and the National Institute for Agricultural Research (INRA). It won the Investor Conference panel’s special award at BIOVISION in 2015.
This research paves the way for innovative therapies to preserve and restore male fertility, a major issue with global impact; numbers of spermatozoa have declined by 50% over the last fifty years
Lyon, France, May 5, 2015 – Kallistem, which develops innovative cell culture technologies in reproductive biology, today announces 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 ICSI. 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.”
Treating male infertility: a global issue
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 worldwide3. Nor is there any solution for adult males living with infertility not addressed by current treatments. Over 120,000 men live with nonobstructive 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.
About Kallistem SAS
Kallistem is a biotechnology company developing innovative cell culture technologies in reproductive biology to address the global challenges of male infertility and meet the demands of modern toxicology. Founded in 2012 and based at the École Nationale Supérieure (ENS) in Lyon, France, the company leverages the research of specialists Philippe Durand and Marie-Hélène Perrard, who have achieved worldwide recognition for their work on male reproductive biology and more specifically, spermatogenesis in vitro. Kallistem makes use of two specific, patented cell culture technologies to preserve fertility and treat male infertility: Artistem® and Bio-AlteR®. Artistem® is the first technological platform in the world that can produce human spermatozoa in vitro. Bio-AlteR® supports the mechanistic studies required for the therapeutic project, which are useful in conducting predictive studies in testicular toxicology.
Kallistem’s solution for the treatment of male infertility fits into the pre-existing logistical structure involving biopsies and the storage of spermatozoa, ovarian and testicular germ cell tissue in specialist centers such as France’s center for the study and storage of eggs and sperm (CECOS) and biobanks worldwide. Incubated at the Pulsalys innovation accelerator in Lyon, France, Kallistem received the Novacité and Jeune Entreprise Innovante (Innovative Young Business) labels in 2012. The company was selected for the Artis project by the CLARA cancer cluster in 2012 and is supported by France’s National Center for Scientific Research (CNRS), the National Institute of Health and Medical Research (INSERM) and the National Institute for Agricultural Research (INRA). It won the Investor Conference panel’s special award at BIOVISION in 2015.