The drug discovery pipeline can take, on average, a decade to get from the lab to the patient. Ori Biotech aims to speed up the innovation of cell and gene therapies via the manufacturing platform it is bringing to market.

The London and Woodcliff Lake, New Jersey-based company is developing a platform that closes, automates and standardizes manufacturing for cell and gene therapy developers so they can move their treatments from the pre-clinical process through to scale commercially.

“These products are super expensive to manufacture, and even with the biggest good manufacturing practices in place, you couldn’t do beyond a few thousand doses,” Farlan Veraitch, Ph.D., co-founder and chief scientific officer at Ori Biotech, told Crunchbase News. “We are using our novel automation to reduce the cost of goods and the footprint. Producing hundreds of thousands of doses per year is impossible right now, but with Ori you will be able to do it.”

Helping the company get its platform on the market is a new $30 million Series A round of funding led by Northpond Ventures, with participation from Octopus Ventures and Ori’s existing institutional investors: Amadeus Capital Partners, Delin Ventures and Kindred Capital.. The new funding gives Ori Biotech a total of $40 million in funding since its inception in 2015, including a $10 million seed round in 2018, Veraitch said.

In addition to taking the platform to the market, estimated to be in late 2021 or early 2022, the company expects to double its employee count in the next four months and double that again by next year. Currently, the company has eight employees, including its first two in the U.S.

The company has been working with external partners over the past four months doing testing. One partner is already getting good results from testing the platform on its treatment for solid tumors, Ori Biotech’s CEO Jason Foster said in an interview.

“We are hoping to grow our external partnerships from three to six in the next year,” Foster added.

Meanwhile, the company is addressing a $9 billion market that has 1,500 gene therapy clinical trials going on in cancer, diabetes and rare diseases. There are approximately eight approved products, and most are in pre-clinical or Phase 1 testing, he said.

Sharon Kedar, co-founder and partner at Northpond Ventures, said in an interview that Veraitch is “obsessed” with how cell and gene therapies need to be brought to market.

Northpond looked at a lot of companies in this space, and thought the Ori Biotech team and modular approach was differentiated and had the opportunity to change how these therapies are made.

“Farlan and Jason are phenomenal humans doing critical work,” she said. “Globally speaking, the health care system is broken, and the cost of developing drugs is outpacing the ability to pay for them. Now you can treat someone on a personalized basis without the cost burden, and Ori has a chance to be that solution.”

Illustration: Li-Anne Dias

Original article: https://news.crunchbase.com

Cell and gene therapies (CGT) represent a significant breakthrough in the treatment of patients suffering from cancer and rare diseases. Ori Biotech, a London and Philadelphia-based innovator in cell and gene therapy manufacturing, is on a mission to enable patient access to this new generation of life saving treatments. Ori’s platform technology has the potential to enable the production of cell and gene therapies at market scale, for market relevant cost, making it possible for patients to get access to high quality, affordable cell therapies earlier in the treatment pathway. As Ori’s design and development partner, PA Consulting is accelerating product development towards launch, utilising our broad range of scientific, engineering, manufacturing and design expertise, and by locating development work at our Global Innovation and Technology Centre in Cambridge, UK.

Key Successes

Realising the potential of cell therapy

Currently, there are over 1000 ongoing clinical trials exploring different aspects of the efficacy and safety of cell and gene therapies, but only a few have so far been approved – like Kymriah® (Novartis), Yescarta® (Gilead), and Zynteglo® (Bluebird). Due to their expensive and labour-intensive manufacturing process, these drugs are currently amongst the most expensive therapies on the market, carrying price tags between $500,000 – $2 million per patient. The high prices are putting considerable strain on payers and healthcare systems.

Ori is developing a proprietary, flexible manufacturing platform that closes, automates and standardises manufacturing, allowing therapeutics developers to further develop and bring their products from pre-clinical process development directly through to commercial scale manufacturing. The initial focus of the platform is on supporting cell therapies (like CAR-T), though the flexible platform has the capability to support a wide range of processes. Chimeric Antigen Receptor (CAR) T cell therapy is a cellular therapy based on the genetic modification and re-direction of a patient’s T cells in order to specifically target cancerous tumour cells.

Turning the vision into reality

We’ve been working together with Ori to design, develop and build the technology for research laboratories and therapeutics partners to test. We’re also supporting Ori in shaping their future vision to ensure that we are designing a fully automatable system from the outset, scaling directly from a unit of one to a high throughput system capable of producing thousands of therapies a year.

It’s meant bringing together a diverse team of experts at our Global Innovation and Technology Centre in Cambridge, including:

With our support, Ori is moving towards product launch at pace. Ori aim to launch their first commercial product in early 2022 and scale towards a high throughput, fully automated commercial manufacturing system within three years post-launch.

We partnered with PA Consulting because they had the broad range of expertise we needed, from science to engineering to design to robotics and automation. We need to develop our technology at pace, because time is of the essence for patients with cancer and rare diseases. PA has delivered what we’d hoped for through the early stages of our partnership.

Dr. Farlan VeraitchOri Biotech Co-Founder and CSO

We’re delighted to work with the Ori Biotech team on a project that is set to bring real benefits to patients. Realising a truly innovative idea in the market is not easy and requires vision, commercial expertise and technical capabilities. The passion and commitment Ori Biotech has demonstrated is a precious thing. Our multidisciplinary team recognises this and feels very privileged to be part of their mission to enable patient access to life saving treatments.

Dr. Simon BurnellPA Consulting, Life Sciences Expert

Original Article: paconsulting.com

April 7, 2020

Cell and gene therapy firms are not ready to fully embrace artificial intelligence (AI) says an official at the US subsidiary of Hitachi Chemical, who thinks developers and manufacturers must learn to automate production first. The Japanese conglomerate cemented its presence in the cell therapy contract manufacturing space in January with the opening of a facility in Allendale, NJ. The facility, which is operated by Hitachi Chemical Advanced Therapeutics Solutions (HCATS), is the first designed “to meet the unique needs of commercial cell and gene therapy products,” according to Thomas Heathman, PhD, HCATS’ business leader in North America.

These needs include being able to vary output, he continues, adding that it is harder to predict approval timelines and commercial demand for cell therapies than for other biopharmaceuticals. “We have built out our infrastructure in a modular manner so that we can build specific capacity to meet commercial customer needs as we get a clearer picture of the forecasts and needs.”

Data exchange is also built into the plant’s design. “Manufacturing Execution Systems and LIMS systems are being implemented to move from paper systems to electronic and enable seamless data flow throughout the facility,” he points out.

A focus on data and greater interconnectivity in manufacturing is something other cell and gene therapy firms should consider.

“The cell and gene therapy industry is not quite ready for advanced manufacturing systems such as AI. We are really at the point of product understanding and transferring processes from manual to semi-automated systems,” he says. “The next phase after that would be full automation, and then on to AI and other advanced technologies to make critical process decisions based on manufacturing data.”

This view is shared by David Smith, PhD, HCATS’ R&D director.

“There is a growing need as the volumes increase to rely less on manual operations and move towards automation,” he explains “This is not only for process, where most people concentrate efforts, but also on testing and all other manufacturing associated functions to include quality assurance, supply chain and storage. Therefore, not only is there a need for process automation with companies like Ori Biotech, but also in-line sensing for analytics such as those Sartorius is working on, as well as electronic systems like LIMS, MES, and Enterprise Resource Planning to help bring everything together without the need for unreliable physical human input.”

Automation has applications across the whole lifecycle of a product, but the high cost of labour and need for reproducibility within manufacturing functions really drive the need, Smith says.

Future

HCATS’ facility also houses a development laboratory. The idea is to help customers improve processes and integrate novel manufacturing techniques as the sector develops, notes Heathman.

Embracing innovation is also critical for cell and gene therapy developers, according to Smith, who says techniques and technologies are advancing quickly. “There is a vast increase in the development of non-viral genetic engineering solutions, such as Avectas, Kytopen, SQZ Biotech, that are generating novel methods to add or remove genetic material to cells, therefore enhancing their function.”

Demand for more advanced hardware is also a factor Smith says, explaining “There is a drive for suppliers of software solutions to start spreading their reach. We see software companies now increasing capabilities to not focus on one facet but incorporate adjoining needs, like an MES company offering LIMS or Track and Trace, with companies like Werum, L7 and Vineti.”

Source genengnews.com

Wednesday, January 29, 2020

Ori Biotech estimates its automated and closed manufacturing platform can reduce COGS for autologous cell therapies by 60-80% and has teamed with HCATS to help take it to the clinic.

One of the key takeaways from this year’s Phacilitate conference last week was the need for partnerships and collaboration to overcome the many issues currently plaguing the cell and gene therapy space, and specifically manufacturing.

One such collaboration is between Hitachi Chemical Advanced Therapeutics Solutions (HCATS), the contract development and manufacturing organization (CDMO) subsidiary of Hitachi Chemical Company, and London, UK-based tech developer Ori Biotech over the latter’s cell and gene therapy manufacturing platform.

Speaking with Bioprocess Insider at the event in Miami, Ori’s CEO Jason C. Foster said the development agreement with HCATS aims to validate his firm’s processing system. If successful, he said the flexible and scalable bioreactor and fluid handling system could potentially reduce the cost of goods sold (COGS) for autologous therapies by as much as 60-80%, dramatically increasing patient access to these life-saving therapies.

The commercial success of chimeric antigen receptor (CAR) T-cell therapies such as Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) has been blighted by their high price. Both are autologous therapies, meaning the starting material is a patient’s own cells that are then engineered and grown before being inserted back into the patient. The process is essentially the product, and thus the high cost of production leads to high prices for patients and healthcare systems.

With many autologous cell therapies moving through the clinic, an effort is clearly needed to reduce the risk, time, and human involvement – and therefore the cost – in their production, and this is what Foster said Ori’s technology aims to do.

The standardized tech is fully automated and closed, he said, and easily scalable to the extent where a small cleanroom could house tens of units.

Ori raised £7 million (about $9.4 million at the time) last year, though this was not announced until earlier this month when the company came out of stealth mode. Therefore, specific details surrounding the tech remain undisclosed for now.

However, the decision for a technology firm to work with a CDMO is “a unique concept, not normally done,” he explained, adding that HCATS’ experience with “just about every piece of cell therapy equipment” means the firm can critique the system, and help move it on to the next stage of development.

Along with two external customers, feedback will be gathered over the next six months. A next-generation version of the tech will hopefully be qualified by the end of 2020, before the system is validated by the US FDA as part of an IND application.

We asked Foster what next for Ori.

“Our ambition is to solve this very large problem – that’s the reason I got involved – and whatever the future holds for the company we want to make sure that is achieved. That could be partnering with another organization who has that interest, there certainly is a lot of interest in this area, and what we want to do is partner with the best-in-breed partners in the ecosystem and really take a partnership approach.

“We’re talking to software providers, we’re talking to raw material providers, MES [manufacturing execution system] providers; everyone who has a stake in making this system work.”

Source: bioprocessintl.com

Monday, March 2, 2020 

Ori Biotech has partnered with software firm TrakCel to add supply chain monitoring technology to its cell and gene therapy manufacturing system.

The non-exclusive deal – financial terms of which were not disclosed – will allow cell and gene therapy developers and contract development and manufacturing organizations (CDMOs) that use the Ori platform to monitor manufacturing processes in real-time using Trakcel’s technologies.

The firms plan to develop “suitable points of integration in order for a shared data platform to be available to partners.”

Ori co-founder and CSO Farlan Veraitch said, “The integration of TrakCel’s advanced therapy supply chain tracking software with the Ori full-stack platform is another step forward enabling our customers to have full visibility throughout the supply chain.”

This was echoed by Fiona Withey, co-founder and CEO, TrakCel.

She said, “Closed system manufacturing is becoming progressively more important for the ongoing future of the cell and gene therapy sector, and we look forward to working with Ori to offer more integrated solutions to the wider industry.”

Cell therapy

Ori’s technology is an automated, closed cell process system composed of a scalable bioreactor and fluid handling platform.

The platform is designed to help developers reduce the time and cost involved in making autologous cell therapies according to CEO Jason C. Foster who spoke with Bioprocess Insider in January.

The deal with Trakcel comes after a busy period for Ori.

In early January firm completed a $9.4M (£7M) Seed Round with backers including Amadeus Capital Partners, Delin Ventures and Kindred Capital. At the time Ori said it would use the proceeds to bring its manufacturing platform to market.

A few weeks later Ori announced it had partnered with Hitachi Chemical Advanced Therapeutics Solutions (HCATS), the contract development and manufacturing organization (CDMO) subsidiary of Hitachi Chemical Company.

The deal covered the development and commercialization of technology solutions specific to the cell and gene therapy industry.

Ori told us “The first external tests of the Ori platform begin in March 2020 with our CDMO partner, HCATS, and our two therapeutics developer partners.”

Source: BioProcess International

27th February 2020

TrakCel and Ori Biotech have announced a new non-exclusive strategic partnership to “achieve supply chain orchestration” within closed system manufacturing for the cell and gene therapy sector.

The Ori platform enables therapy developers and contract manufacturers to achieve automated CGT manufacturing in a closed platform, and so the collaboration aims to enable users of the Ori Biotech manufacturing platform to benefit from “live supply chain visibility” through TrakCel software.

The companies plan to work together to give TrakCel customers greater visibility into the manufacturing process via data services within the Ori platform, and to develop suitable points of integration in order for a shared data platform to be available to partners.

“TrakCel has developed an extensive partnership network with contract manufacturers and companies across the cell and gene therapy sector. This enables therapeutic developers to be supported by more standardised and integrated solutions,” said Fiona Withey, co-founder and chief executive officer, TrakCel.

Fiona continued, “Closed system manufacturing is becoming progressively more important for the ongoing future of the cell and gene therapy sector, and we look forward to working with Ori to offer more integrated solutions to the wider industry.”

TrakCel was created in 2012 in order to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. Its platform accelerates global scale-up and scale-out of cell and gene therapy products, aiming to increase efficiency and decrease complexity.

Source: Pharma Times

In London, the firm Ori Biotech is developing an automated way to manufacture gene and cell therapies, a bottleneck for many biotech companies.

Mission: To develop a robotic system to automate the labor-intensive tasks involved in manufacturing cell and gene therapies, such as gene transduction and cell expansion.

Gene and cell therapies are maturing as a field, as advances in genomics and data analysis open up the way for ever more advanced therapies. One limitation of this trend is that much of the manufacturing process is currently manual, making it expensive and hard to produce consistent results.

The first generation of cell and gene therapies have demonstrated the revolutionary potential of these products but also the challenge of making them available to patients at scale,” Ori Biotech’s co-founder and CSO, Farlan Veraitch, told me.

Ori Biotech aims to address this manufacturing bottleneck by making robots take care of simple, but time-consuming tasks. For example, adding or taking away cells from cell culture containers in current practice is laborious, and also can also introduce contamination into the batch. Part of Ori’s approach is to make adjustable containers that reduce the need for moving cells between containers and exposing them to contamination.

There are many companies similarly developing methods for improving the manufacture of gene and cell therapies. For example, the Belgian company Univercells recently raised €50M to fund manufacturing technology to make viral vector production cheaper in gene therapies. Synthace is another company automating lab protocols involved in the quality control process of manufacturing. According to Veraitch, Ori stands out from other companies because it was set up by experts in the gene therapy field.

Many of them are startups innovating in one unit operation, others are part of established service providers that aren’t really technology companies and still others are repurposing technologies from other uses to try to find a way to fit a square peg to into a round hole,” he told me.

Ori Biotech has a number of partners involved, such as Hitachi Chemical, and the UK innovation center Cell and Gene Therapy Catapult. The company aims to test its system in early 2020 in its partners’ labs. Ori is funding the development with an €8.6M seed round that it raised last month.

What we think:

With the current difficulties in manufacturing cell and gene therapies, they are expensive to make and aren’t meeting their full mainstream potential. With companies like Ori Biotech working on it, this may not be the case for long.

With the amazing clinical data coming through and more than 900 companies running more than 1,000 clinical trials in cell and gene therapy, the industry is poised at a tipping point,” Veraitch said. “We are seeing cures for previously untreatable types of cancer and terminal rare disease being studied and approved so there is plenty of reason to be hopeful.

In addition, Veraitch believes that overcoming manufacturing obstacles will also lead to the treatments becoming more accessible to healthcare systems and patients. At present, gene therapies are among the most expensive drugs in the world, such as Novartis’ spinal muscular atrophy treatment Zolgensma, which is priced at over €1.8M per person.

The industry is currently at a similar stage to Henry Ford building one Model-T at a time in his workshop and needs a move to the equivalent of assembly-line manufacturing, which would increase throughput, decrease costs, and increase quality,” concluded Veraitch.

Source Labiotech.eu