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Cynata Therapeutics aims for commercial production of cutting-edge STEM cell products

Cynata Therapeutics Ltd (ASX:CYP) is ready to move up to scalable production of its graft-versus-host disease (GvHD) drug after a clinical trial proved the safety and efficacy of the drug.

Cynata managing director and chief executive officer Dr Ross Macdonald told Proactive that showing the product had a desirable clinical effect in people was an excellent result for the company.

He said: “We achieved all of the study endpoints, demonstrating primarily the safety of the product but also efficacy, and therein lies one of the secrets to success in biotech land, which is demonstrating that the product or technology works in humans.”

The trial results included a 54% complete response rate, an 87% overall response rate and a greater than 87% survival rate of patients using the GvHD drug.

Not only is the technology safe and effective, it also bypasses complex and invasive surgeries for patients and hospitals, and lowers costs incurred by healthcare systems.

Cutting edge-technology[hhmc]..

Cynata Therapeutics Ltd (ASX:CYP) is ready to move up to scalable production of its graft-versus-host disease (GvHD) drug after a clinical trial proved the safety and efficacy of the drug.

Cynata managing director and chief executive officer Dr Ross Macdonald told Proactive that showing the product had a desirable clinical effect in people was an excellent result for the company.

He said: “We achieved all of the study endpoints, demonstrating primarily the safety of the product but also efficacy, and therein lies one of the secrets to success in biotech land, which is demonstrating that the product or technology works in humans.”

The trial results included a 54% complete response rate, an 87% overall response rate and a greater than 87% survival rate of patients using the GvHD drug.

Not only is the technology safe and effective, it also bypasses complex and invasive surgeries for patients and hospitals, and lowers costs incurred by healthcare systems.

Cutting edge-technology


Cynatas Cymerus technology overcomes the challenges of other production methods to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Macdonald said this put Cynata ahead of the pack in terms of commercial product development.

He said: “For a small Aussie company with a hundred million or so market cap to be the leader in the world in this area – and theres no dispute about that as for this particular type of cell therapy we are well and truly the leader as first company to complete a clinical study – its really a very exciting place to be.

“The technology provides a consistent manufacturing process – and that consistency and reproducibility is a vital element of successful drug product development.”

Fuji Film partnership


The company now has the full support and resources to achieve commercial production after signing on the dotted line with new partner, pharmaceutical giant, Fuji Film.

Macdonald said: “Australia is a great place for medical research and development, but it has some limitations when it comes to access to the amount of capital thats required to fully develop a drug product.

“Instead of trying to squeeze blood out of a stone, our strategy was to access the necessary resources through partnership.

“Fuji Film is very active in pharmaceuticals and in the manufacture of drug products and thats what drew us together.

“Its also consistent with our strategy of partnering our technology with global players who have the capacity and the access to resources that are necessary to ultimately bring our drug product to market.”

Cynata's Cymerus platform has potential applications across a wide range of diseases

Advancing the product to market


Fuji Film now has global rights to Cynatas first product, GvHD, and has already paid a US$3 million licence fee, bought US$3 million worth of stock at a 35% premium, and will pay further US$40 million in milestones plus a double-digit royalty on product sales.

Macdonald said: “This year they expect to start a phase two clinical trial.

“In Fuji Films hands, GvHD is expected to get to market sometime late in 2022 or early 2023.”

Further trials in 2020


Cynata has three fully-funded clinical trials upcoming, one is the phase two GvHD trial with Fuji Film, one is in Osteoarthritis (OA) which is funded by the Australian Government and one is in critical limb ischemia (CLI).

MacdonaRead More – Source

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Compumedics secures US Food and Drug Administration approval for Orion Lifespan™ technology

Compumedics Limited (ASX:CMP) has confirmed US Food and Drug Administration (FDA) approval of its Neuroscan Orion LifeSpan Magnetoencephalography (MEG) system.

The approval follows the successful installation and first phase commissioning of the system at the Barrow Neurological Institute in Arizona, USA.

MEG is a neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.

Compumedics chairman and chief executive officer Dr David Burton said the company was pleased to achieve this milestone.

He said: “Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R &D over many years.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory.”

The FDA clearance now allows for routine clinical use of the single MEG device, primarily for epilepsy and pre-sur..

Compumedics Limited (ASX:CMP) has confirmed US Food and Drug Administration (FDA) approval of its Neuroscan Orion LifeSpan™ Magnetoencephalography (MEG) system.

The approval follows the successful installation and first phase commissioning of the system at the Barrow Neurological Institute in Arizona, USA.

MEG is a neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.

Compumedics chairman and chief executive officer Dr David Burton said the company was pleased to achieve this milestone.

He said: “Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R &D over many years.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory.”

The FDA clearance now allows for routine clinical use of the single MEG device, primarily for epilepsy and pre-surgical brain function mapping.

“The foundation for commercialisation”


With the FDA approval in place, Compumedics may now enter the lucrative US clinical market with its technology.

Burton added: “It represents a foundation for the commercialisation of our MEG technology.

"This market clearance will allow us to transition from product development to full commercialisation.

“Compumedics continues to actively pursue 40 identified MEG opportunities around the world, with four opportunities substantively advanced.”

Each system will typically sell for around US$3 million to US$4 million, depending on specification.

Additionally, sites using the system may now routinely bill both private and public insurance plans for MEG examinations.

Ground-breaking features


The MEG hardware approval comes in addition to tRead More – Source

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Cobalt Blue outlines strategy for cobalt processing and BHCP project

Cobalt Blue Holdings Ltd (ASX:COB) has outlined its near to mid-term strategy to develop the Broken Hill Cobalt Project (BHCP) alongside commercialising its proprietary cobalt processing technology.

This two-part strategy has been developed by the pure-play cobalt company which has recently secured 100% ownership of the BHCP, which is just outside the traditional mining centre of Broken Hill.

Chief executive officer Joe Kaderavek explains the key aspects of the strategy to Proactive.

PROACTIVE: Can you articulate the Cobalt Blue Holdings (COB) strategy?[hhmc]
CEO: COB has a two-part strategy:

Bringing the BHCP into production; and
Commercialisation of COBs proprietary technology through COB Partnerships

With regards to our second aim, COB is examining opportunities to apply the technology to third-party cobalt/copper resources. There are two third-party test work programs underway:

Millennium Project (100% Global Energy Metals Corporation – CVE:GEMX) – Cloncurry district, North Q..

Cobalt Blue Holdings Ltd (ASX:COB) has outlined its near to mid-term strategy to develop the Broken Hill Cobalt Project (BHCP) alongside commercialising its proprietary cobalt processing technology.

This two-part strategy has been developed by the pure-play cobalt company which has recently secured 100% ownership of the BHCP, which is just outside the traditional mining centre of Broken Hill.

Chief executive officer Joe Kaderavek explains the key aspects of the strategy to Proactive.

PROACTIVE: Can you articulate the Cobalt Blue Holdings (COB) strategy?


CEO: COB has a two-part strategy:

  1. Bringing the BHCP into production; and
  2. Commercialisation of COBs proprietary technology through COB Partnerships

With regards to our second aim, COB is examining opportunities to apply the technology to third-party cobalt/copper resources. There are two third-party test work programs underway:

  • Millennium Project (100% Global Energy Metals Corporation – CVE:GEMX) – Cloncurry district, North Queensland. COB is focused on the extraction of cobalt, copper and gold. This is an exciting opportunity as we are dealing with Mt Isa style mineralisation over a very large district. Positive test results will unlock a new territory for our technology, with final results expected shortly.
  • Carrapateena Mine (100% OZ Minerals Ltd – ASX:OZL). OZL has recently brought Carrapateena into operation to produce copper concentrates. OZL has engaged COB to evaluate the treatment of a secondary pyrite concentrate using the COB technology for recovery of cobalt sulphate (along with copper and gold). The test work program is expected to conclude by the end of May.

Why is the investment in a pilot and then demonstration plant so important?


CEO: A key stepping-stone on our development path is to build a metallurgical testing centre in Broken Hill. This centre will scale from an initial Pilot Plant operation producing ~100-300 kilograms of cobalt sulphate from 90 tonnes of ore and we expect commissioning in late Q2 with first operations mid-year.

This facility will then be upgraded to a larger-scale fully integrated Demonstration Plant, producing 1-2 tonnes of cobalt sulphate, by year-end.

The Demonstration Plant is aiming to deliver multiple production samples to leading battery facilities across Asia, Europe and North America.

Global industry uptake of our product requires extensive acceptance testing so that our commercial product can qualify as a precursor feedstock from the outset of BHCP operations.

Potential commercial partners will be able to visit the project mine site as well as the Demonstration Plant in 2020, providing inspection of the entire production chain.

What do you mean by flexible production at BHCP?


CEO: In order to take advantage of prevailing cobalt market conditions, the BHCP has a flexible production strategy. By developing a process that produces a range of commercially saleable products, the project will be able to optimise its suite of products at any one time. In simple terms – Capture the maximum cobalt margin across the price cycle for our shareholders.

The BHCP refinery will therefore produce:

  • An intermediate Mixed Hydroxide Product (MHP) containing ~25% cobalt and ~2% nickel. The high cobalt to nickel ratio is unique and is likely to command a premium payable content sale price, for blending with typical nickel rich MHPs.
  • A final Cobalt Sulphate will be produced from further refining the MHP. The target product specification is a >20.5% cobalt content sulphate crystal, suitable for use in cathode precursor manufacture.

COB is involved in various Federal Government initiatives, from the FBI CRC and the CRC-P, can you summarise this involvement?


CEO: COB has recently joined the Future Battery Industries Cooperative Research Centre (FBI CRC) (http://www.fbicrc.com.au/). The FBI CRC was granted A$25 million from the Australian Government and has received pledges from industry participants totalling A$100 million. COB will be taking an active role in the FBI CRC cathode precursor pilot plant, which is aiming to produce cathodes using Australian sourced raw materials (eg CoSO4.7H2O and NiSO4.6H2O)

COB has also been awarded A$2.4 million from the Cooperative Research Centre (CRC) – Project Round 8 Funding from the Australian Government, for applied research and development of the processing of cobalt-pyrite orRead More – Source

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Hexagon Energy Metals partner signs rare earth separation deal with Ucore

Hexagon Energy Metals Ltds (ASX:HXG) partner in the commercialisation of the RapidSX rare earth element (REE) separation technology, Innovation Metals Corp, has entered into an agreement with Ucore Rare Metals Inc (CVE:UCU).

Ucore will assess RapidSXs potential utilisation for the separation of REEs into high-purity REE oxides (REOs) using concentrate material from Ucores flagship Bokan-Dotsan Ridge REE Project in Alaska, US.

Hexagons management team in North America and Australia was instrumental in bringing the parties together and advancing the first binding Technical Services Agreement (TSA) signed for test processing the material.

Hexagon managing director Mike Rosenstreich said: “Ucores interest in and commitment to evaluating RapidSX is significant; they are a REE industry stalwart in the USA with an advanced project with US$145 million in designated financing from the Alaska Industrial Development and Export Authority (AIDEA).

“Ucore plans to develop heavy and light REE dow..

Hexagon Energy Metals Ltds (ASX:HXG) partner in the commercialisation of the RapidSX rare earth element (REE) separation technology, Innovation Metals Corp, has entered into an agreement with Ucore Rare Metals Inc (CVE:UCU).

Ucore will assess RapidSXs potential utilisation for the separation of REEs into high-purity REE oxides (REOs) using concentrate material from Ucores flagship Bokan-Dotsan Ridge REE Project in Alaska, US.

Hexagons management team in North America and Australia was instrumental in bringing the parties together and advancing the first binding Technical Services Agreement (TSA) signed for test processing the material.

Hexagon managing director Mike Rosenstreich said: “Ucores interest in and commitment to evaluating RapidSX is significant; they are a REE industry stalwart in the USA with an advanced project with US$145 million in designated financing from the Alaska Industrial Development and Export Authority (AIDEA).

“Ucore plans to develop heavy and light REE downstream processing capabilities through its planned Alaska Strategic Metals Complex to produce separated high-purity REOs.”

Third-party validation of a unique technology


“Ucore brings a tremendous amount of third-party validation to RapidSX, underscoring Hexagons focus on the commercialisation of this important technology.

“Over the past several years, Ucore has evaluated a range of alternative REE-separation processes, resulting in the selection of solvent-extraction chemistry, which led to their interest in the proprietary RapidSX REE separation technology, offering significant CapEx and OpEx savings compared to current conventional SX-based commercial REE separation.

Read More – Source

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