A world first in male fertility: Kallistem obtains complete human

 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 1 . 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
1
ICSI: IntraCytoplasmic Sperm Injection
the last fifty years2. 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 azoospermia4. 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.
Find out more: http://www.kallistem.com/fr/
Media contacts and analysts
Andrew Lloyd & Associates
Juliette dos Santos / Lise Beltzung
[email protected] - [email protected]
Tel: +33 1 56 54 07 00 2
Geoffroy-Siraudin C, Loundou AD, Romain F, Achard V, Courbière B, Perrard MH, Durand P, Guichaoua MR.
Decline of semen quality among 10 932 males consulting for couple infertility over a 20-year period in
Marseille, France. Asian J Androl. 2012 Jul;14(4):584-90. doi: 10.1038/aja.2011.173. Epub 2012 Apr 23.
Carlsen E, Giwercman A, Keiding N, Skakkebaek NE. Evidence for decreasing quality
of semen during past 50 years. BMJ 1992; 305: 609–13
3
4
Global cancer control, February 2011
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