Metalmark has invested $50m in Morgenesis, Orgenesis’ newly created US-based point of care (POCare) services subsidiary. The deal consists of an upfront investment of US$30m and two future payments of US$10m each, subject to the achievement of certain milestones.
Orgenesis leverages its POCare Platform to identify promising new cell and gene therapies and guide them through development in order to treat patients at a lowered cost. The platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network, which brings together patients, doctors, industry partners, research institutes and hospitals worldwide.
Due to substantial demand for its POCare services, the group has now created the subsidiary to manage their delivery through its POCare network, explained Vered Caplan, CEO of the Maryland biotech.
It is streamlining all existing POCare services into one entity, Morgenesis, which will cover initial process development, regulatory strategy, and implementation, full cGMP process development, including closing/automating the process for point of care treatments, full cGMP processing and supply of therapeutic product to patients at the point of care, to clinical trial design and management.
Howard Hoffen, CEO of Metalmark, commented on the investment: “The company has built an impressive and differentiated point of care model which accelerates access for patients to innovative therapies, and we look forward to supporting Morgenesis as it continues to expand globally and in the US.”
Decentralized processing
Caplan told BioPharma-Reporter about the advantages of its decentralized POCare model.
“From around 2015 to 2016, there were ad nauseum debates in terms of ‘centralized’ versus ‘decentralized’ processing of cell and gene therapies at industry events and conferences.
“We, at Orgenesis, had had a pioneering experience with a centralized structure through one of our subsidiaries. We knew this type of model was safe and effective but not efficient enough to truly scale autologous therapies. Therefore, in 2020, we transitioned to a decentralized model through the creation of our proprietary POCare platform. We enabled decentralized processing to go from the theoretical realm to reality.
“Initially, we started working within hospitals themselves, but due to some structural inefficiencies, we realized it would not be possible to achieve meaningful scale. We identified the lack of uniform processing environments in different hospitals as a major barrier to success. This realization led us to innovate our Orgenesis Mobile Processing Units and Labs (OMPULs).
“Bringing this solution to the market allows CGT companies as well as hospitals the first real new option in quite some time. Now, when they are deciding whether to build or expand their facility/infrastructure, or to outsource to a solutions provider, they have the further option to choose, or combine their traditional centralized production with, our decentralized POCare model.”
The OMPULs can be ordered, installed, and validated in four to six months as opposed to the 24-36 months required for traditional cleanroom set up, and they also ensure lower COGs, claims the CEO.
“We believe that through this combination of faster capacity expansion and lower COGs CGTs will be able to reach many more people and allow companies of any size the ability to scale globally.”
