Cell therapy weekly: Antibody combination prepares mice for mismatched donor transplantations

This week: FDA Orphan Drug designation awarded for diabetes therapy, a new partnership aims to standardize cell and gene therapy delivery and cord blood processing system approved by Health Canada

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Jun 20, 2019
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The news highlights:

Antibody combination prepares mice for mismatched donor transplantations
Orgenesis receives FDA Orphan Drug designation for their severe hypoglycemia-prone diabetes treatment
New collaboration aims to integrate cell and gene therapy supply
Health Canada approves ThermoGenesis’ cord blood processing AXP® II system

Antibody combination prepares mice for mismatched donor transplantations

Researchers at the Stanford University School of Medicine (CA, USA) have found that a cocktail of six antibodies can prepare mice to accept immune and blood stem cells from immunologically incompatible donors. The recipient mice could then receive donor cell-matching tissue and organ transplantations, without requiring ongoing immunosuppressive treatment. If reproduced in humans, the research has great implications for the treatment of certain immune and blood disorders with allogeneic therapies, and for increasing the number of organs available for patients requiring transplantations.

Irving Weissman, professor of pathology and developmental biology at Stanford, commented that previously: “…stem cell transplants have required a complete match to avoid rejection and reduce the chance of graft-versus-host disease...Now we’ve shown in mice that a ‘half match’…works without the need for radiation, chemotherapy or ongoing immunosuppression. This may open up the possibility of transplant for nearly everyone who needs it.”

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Orgenesis receives FDA Orphan Drug designation for their severe hypoglycemia-prone diabetes treatment

The FDA has granted Orgenesis (MD, USA) Orphan Drug designation for their novel autologous insulin-producing (AIP) cell therapy for the treatment of severe hypoglycemia-prone diabetes, which results from pancreatectomy. The glucose-sensitive, AIP cells are derived from patients liver cells, reprogrammed and returned to patients via liver transfusions. FDA Orphan Drug designation qualifies Orgenesis for 7 years of drug market exclusivity, following regulatory approval, and provides benefits to Orgenesis that may aid the process of drug development.

Vered Caplan, CEO of Orgenesis, stated: “We are honored to receive Orphan Drug designation from the FDA, as this represents a major milestone for both Orgenesis and patients who have to suffer the tremendous hardships associated with total pancreatectomy. Orphan Drug designation has the potential to reduce the time and costs required to bring our AIP cell therapy to market and should help streamline the approval process.”

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New collaboration aims to integrate cell and gene therapy supply

Be The Match BioTherapies® (MN, USA) and TrackCel (Cardiff, UK) have announced their partnership aiming to provide integrated solutions for companies looking to develop cell and gene therapies. The collaboration will make use of Be The Match BioTherapies’ solutions for cell sourcing, clinical study design and IT systems, and TrakCel’s chain of custody/chain of identity, scheduling and logistics management software platform.

Ravi Nalliah, TrakCel CEO, commented that the collaboration: “…will enable us to provide a more standardized and streamlined cell and gene therapy development process. That, in turn, will accelerate the delivery of vital new therapies to patients.”

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Health Canada approves ThermoGenesis’ cord blood processing AXP® II system

Automated cellular processing market leaders ThermoGenesis (CA, USA) have been granted Health Canada approval for their novel cord blood processing system, AXP®II. The FDA-approved system provides users enhanced functionality, compatibility with newer systems and a ‘functionally closed’ system, and enables users to comply with current good manufacturing process (cGMP) and good tissue practice (cGTP) guidelines.

Haihong Zhu, ThermoGenesis president, commented that: "Health Canada's approval of the AXP® II…marks the achievement of yet another key milestone and should allow us to meaningfully expand our footprint with a best-in-class system that, today, continues to hold a market-leading position.”

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.

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