Cell therapy weekly: RoslinCT and Lykan Bioscience combine forces to expand their capabilities
This week: RoslinCT and Lykan Bioscience combine forces to expand their capabilities, Core Biogenesis to build bioproduction facility with US$10.5 million series A funding and FDA accepts biologics license application for Gamida Cell’s omidubicel.
The news highlights:
RoslinCT and Lykan Bioscience combine forces to expand their capabilities
RoslinCT (Edinburgh, UK), a cell and gene therapy contract development and manufacturing organization (CDMO) and Lykan Bioscience (MA, USA), a cell therapy focused CDMO have announced their business combination agreement to form a global leading innovative advanced therapies CDMO. The combined group will offer current Good Manufacturing Practice (cGMP) manufacturing and process development expertise for an array of autologous and allogenic cell therapies. By combining their current facilities and expanding RoslinCT’s cGMP suites, the aim of this merger is to shorten development and manufacturing timelines for advanced therapy sponsors. Both Patrick Lucy, president & CEO of Lykan, and Peter Coleman, CEO of RoslinCT, will continue in their current positions.
Peter Coleman, stated: “This combination puts us in a strong position as a leading global CDMO in the process development and manufacturing of advanced cell therapies and we look forward to working with our new colleagues at Lykan to fuel future growth and meet the increasing demand for innovative therapies.”
Core Biogenesis to build bioproduction facility with US$10.5 million series A funding
Core Biogenesis (Paris, France), a biotechnology startup specializing in plant-based cell therapy manufacturing has secured US$10.5 million in series A funding to build a new production facility. The facility will be dedicated to the manufacture of GMP-grade growth factors and cytokines for the cell therapy market and cellular agriculture sector. The funding round was led by XAnge (Paris, France) and supported by Blue Horizon Ventures (Zurich, Switzerland) and Thia Ventures (Geneva, Switzerland).
“Growth factors are critical cell culture media components and are widely employed in cell therapy manufacturing. We have generated stable lines expressing growth factors and cytokines at a high yield and have demonstrated that our products de-risk the cell-expansion operation. Further, our technology drives down cell therapy manufacturing costs which will help to improve patient access to these life-saving therapies,” explained Alexandre Reeber, CEO and Co-Founder, Core Biogenesis.
FDA accepts biologics license application for Gamida Cell’s omidubicel
Gamida Cell (MA, USA) has reported that their biologics license application with the FDA for omidubicel, an advanced nicotinamide-enabled stem cell therapy candidate, has been accepted. The FDA has granted priority review for omidubicel as a potential treatment for patients with blood cancers who need an allogeneic hematopoietic stem cell transplant.
CEO of Gamida Cell, Julian Adams stated: “The FDA’s acceptance of our [Biologics License Application] with priority review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant. We are encouraged by the positive and sustained follow-up results from patients participating in the Phase 3 trial of omidubicel, including a positive overall survival trend one-year out from treatment. These results provide promising rationale that, if approved, omidubicel could become a treatment of choice for patients in need of an allo-[Hematopoietic Stem Cell Transplant]. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible.”
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