Compared to the three months ended May 31, 2018 (due to a changed fiscal year), Orgensis reported a revenue increase of 95% to $7.8m for the second quarter ended June 30, 2019.
Addressing the company’s ‘record’ results, Peter Molloy, executive vice president, corporate development, Orgenesis, noted that industry and investors have increased attention to cell and gene therapy products (CGTs), as the space transitioned from ‘experimental’ to commercial after the first US approvals in 2017.
“Pharma companies have been investing large amounts of capital into the space, and/or acquiring existing businesses that bring in-house additional therapies and manufacturing capability. At the same time, the investment community has increased substantially the availability of funds to support new CGT development,” Molloy told us.
Additionally, there also has been a push to propose and accept new ways to pay for these often-curative therapies. Said Molloy, “All this is reflected in the rapid growth in the number of CGT clinical trials in progress, which now stands at close to 1,000 trials.” From 2020 onward, the US Food and Drug Administration (FDA) predicts an additional 200 trials to start each year, and from 2025, new drug approvals (NDAs) to range from 10-20 annually, he added.
“Despite all the drivers to the demand side of the sector,” Molloy said, “there remain substantial supply-side constraints, most evidently in the areas of process development, manufacturing, and analytical technologies. The shortage in manufacturing capacity itself reflects a shortfall of physical capacity, trained personnel, and raw materials.”
As Molloy explained, this is increasing demand for companies such as Orgenesis, which, though its contract development and manufacturing organization (CDMO) subsidiary, Masthercell, supports customers from process development to clinical trials and commercial manufacturing.
In addition, Orgenesis’ Point of Care Cell Therapy Platform (POCare Platform) is a ‘longer-term’ solution for processing these therapies at scale.
A ‘distributed’ processing solution
Molloy said the company’s vision is to create a global network of centers of excellence at hospitals and academic institutions leveraging Orgenesis’s technologies “to provide highly scalable and cost-effective processing solutions for the most advanced cell and gene therapies.”
Orgenesis’ platform is comprised of three elements, he explained, including its development and supply network and technology for building cell-type specific closed systems to enable the automated processing of these therapies.
“These systems are composed of a combination of Orgenesis’ own and in-licensed technologies and are customized for the specific requirements of different cell types, for example, scaffolds for adherent cells, transfection technologies for gene engineering,” Molloy added.
The third element is ‘system integration,’ he said, adding that the company will be integrating these systems with a variety of different cell therapies – both Orgenesis’ and partner therapies – in multi-center clinical trials across its hospital network over the next two years.
“Once these systems are fully integrated, Orgenesis will have a ‘distributed’ processing solution that can be rapidly scaled across a global network of hospitals to provide approved cell therapies to patients, and at a price point that is at a fraction of today’s costs,” said Molloy.
From the hospital’s perspective, the solution addresses the challenge of building and staffing in-house cell therapy development capabilities. It also will accelerate in-house research programs and increase access to clinical trials, Molloy said. For patients, Orgnesis hopes the solution will provide more affordable treatments in a shorter timeframe, as well as a ‘continuity of clinician’ from diagnosis through treatment.
Joint venture partners
Because its platform is built around a partnering model, the company has structured a franchise-like model with joint venture (JV) partners across markets in which it operates, including the US, Europe, Japan, Korea, India, China.
As Molloy explained, these partners – with support from Orgenesis – are responsible for forming partnerships with local hospitals and academic institutions. The company also sub-licenses its technologies and therapies to its partners and provides any needed training and regulatory support.
“Key to the long-term success of Orgeneis’s POCare platform is ensuring we and our partners are always at the forefront of innovation,” said Molloy, “which means continually being open to forging new partnerships with the owners and creators of novel therapies and technologies.”