In major news released today, Cynata announced that it has entered into a License Option agreement with apceth GmbH & Co. KG. The agreement provides apceth with an option to certain uses of Cynata’s unique Cymerus™ mesenchymal stem cell (MSC) technology, exercisable by apceth into a definitive license agreement.
The relationship combines Cynata’s Cymerus MSC technology with apceth’s technologies for genetically modifying MSCs to open up prospective new therapeutic fields, particularly the treatment of cancer. This substantially broadens the commercial horizons for Cymerus, as it provides both an immediate cash payment as well as the potential to provide substantial license revenue in the form of milestones and royalties on eventual product sales. Cynata will work with apceth in the coming months to plan out the development path for the scope of the agreement and also explore other areas into which the relationship could be extended.
Outside of the arrangement with apceth, Cynata remains free to develop all other opportunities for Cymerus and intends to continue the vigorous pursuit of our commercial strategy. The announcement comes at a great time as Cynata prepares for its Phase 1 clinical trial in graft-versus-host disease (GvHD) and also on the back of favourable advice from the UK regulatory body and compelling data from the proof-of-concept model in GvHD.
Additionally, Cynata also has a strategic alliance with Regience K.K., who has an exclusive 2-year option to license Cynata’s unique Cymerus™ technology in Japan and certain other Asian countries. According to recent analysis by Shaw and Partners, the Regience deal is also important for validation and potential earnings. To learn more, read the press release below issued by Cynata Therapeutics, printed with permission from Cynata CEO Ross Macdonald.
Cynata Enters License Option Agreement with apceth GmbH & Co. KG
• apceth to develop Cynata’s CymerusTM mesenchymal stem cells (MSCs) engineered with apceth’s proprietary genetic modification technology
• Therapeutic targets include cancer and several other devastating diseases
• Upfront and milestone payments potentially exceed A$40m in addition to royalty payments
• Commercial development of CymerusTM to be investigated by a global leader and innovator in modified MSC technology
Melbourne, Australia and Munich, Germany; 9 May 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has entered into a worldwide license option agreement with apceth GmbH & Co. KG for the use of Cynata’s unique Cymerus technology in combination with genetic modification technologies designed to open up prospective new therapeutic fields to MSCs, particularly the treatment of cancer.
The agreement provides for an immediate upfront cash payment to Cynata, followed by a series of success-based milestones, which could potentially total more than A$40m. Royalties on product sales will be also payable to Cynata. Given the substantial unmet medical needsthat this relationship seeks to address, the agreement has the potential for substantial revenues to Cynata.
apceth is presently evaluating Cynata’s technology in its in-house cell culture and genetic modification systems as part of an initial collaboration, expected to conclude toward the end of 2016. Further development by apceth will be pursuant to a development plan to be discussed by both parties and incorporated into the definitive license agreement.
“We are delighted to have concluded this license option agreement with Cynata for the further development and eventual commercialisation of Cymerus, a very innovative therapeutic MSC technology, in combination with genetic modification techniques. With access now to Cymerus, a truly scalable manufacturing technology for therapeutic MSCs, we are very excited about future off-the-shelf therapeutic products,” said Dr Christine Günther, Chief Executive Officer at apceth.
“The combined technologies of Cynata and apceth provide a powerful solution that significantly expands the range of therapeutic applications for MSCs. Through the apceth-engineered enhancements of our Cymerus MSCs we expect to see the development of new treatments that were previously not appropriate for MSCs, one of the most promising and fastest growing areas of medicine today. Outside of the arrangement with apceth Cynata remains free to develop all other applications of its technologies,” said Dr Ross Macdonald, Chief Executive Officer and Managing Director at Cynata.
CONTACTS:
Dr Ross Macdonald, CEO: Tel: 0412 119343; email ross.macdonald@cynata.com
Dr Stewart Washer, Executive Chairman: Tel: 0418 288212; email stewart.washer@cynata.com
Kirin Smith, Chief Operations Officer, Investor Contact, + 1 646-863-6519, ksmith@pcgadvisory.com
Sean Leous, Chief Communications Officer, Media Contact, +1 646-863-8998, sleous@pcgadvisory.com
Rudi Michelson, Monsoon, Australia Media Contact, 0411 402 737, rudim@monsoon.com.au
About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, CymerusTM, originating from the University of Wisconsin-Madison, a world leader in stem cell research. The proprietary CymerusTM technology addresses a critical shortcoming in existing methods of production of mesenchymal stem cells (MSCs) for therapeutic use, which is the ability to achieve economic manufacture at commercial scale. CymerusTM does so through the production of a particular type of MSC precursor, called a mesenchymoangioblast (MCA). The CymerusTM MCA platform provides a source of MSCs that is independent of donor limitations and provides a potential “off-the-shelf” stem cell platform for therapeutic product use, with a pharmaceutical business model and economies of scale. This has the potential to create a new standard in the emergent arena of stem cell therapeutics and provides both a unique differentiator and an important competitive position.
About apceth GmbH & Co. KG.
apceth is a pioneering clinical stage biopharmaceutical company which is expanding its pipeline of next-generation cell-based therapeutics. apceth’s modular platform technology is based on genetically modified MSCs, and the lead program Agenmestencel is a first-in-man, genetically modified MSC product for the treatment of cancer. In addition, apceth develops new cell therapy candidates for the treatment of lung diseases and forimmunomodulation. Based in Munich, apceth provides its know-how, expertise and GMP-certified facilities to industrial and academic partners around the world. apceth was founded in 2007 as a start-up company and is privately owned by its founders and private investors Santo Holding GmbH and FCP Biotech Holding GmbH.