RoslinCT and Ayrmid Pharma Ltd. Announce Their Intent to Enter Into a Strategic Partnership to Manufacture FDA Approved Cell Therapy Omisirge® (omidubicel-onlv)

Intent that RoslinCT is to perform technology transfer and commercial manufacture of Omisirge® at RoslinCT’s cell therapy manufacturing facility in Hopkinton, MA.Omisirge® is a commercialized mismatched unrelated cell therapy derived from the youngest donor source and banked for ease of infusion for patients with hematological malignancies.

Ayrmid Pharma Ltd., a cell therapy pioneer working to turn cells into powerful therapeutics and RoslinCT, a world leading cell and gene therapy contract development and manufacturing organization (CDMO), today announced their intent to enter into a strategic partnership for the production of Omisirge, a commercial product for the treatment of hematologic malignancies commercialized in the US by Gamida Cell Inc, a subsidiary of Ayrmid Pharma Ltd.

It is the intent of the two companies to enter into an agreement whereby RoslinCT will perform technology transfer and commercial manufacture of Gamida Cell’s Omisirge. The cell-based product is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy that was FDA approved and launched in 2023. It is the intent of the two companies that the technology transfer and commercial manufacturing will take place in RoslinCT's state-of-the-art, purpose-built cell therapy CGMP manufacturing facility in Hopkinton, MA.

“As part of our global dual sourcing strategy we are delighted to announce that we intend to work with RoslinCT on the technology transfer of Omisirge to their state-of-the-art facility in Hopkinton, MA,” said Dr Joe Wiley, Chief Executive Officer of Ayrmid. He added, “This key strategic move will allow Gamida Cell to source Omisirge for our patients from both our internal manufacturing capability and RoslinCT.”

“The dynamic interactions between the two teams are very productive and we look forward to working with the Aymrid Pharma Ltd. and Gamida Cell Inc. teams to support the production of this innovative product for their patients in the United States,” said Peter Coleman, Chief Executive Officer of RoslinCT. He added, “We’re delighted about the intent to partner with Gamida Cell and add this product to the portfolio of commercial products manufactured at RoslinCT.”

About Gamida Cell

Gamida Cell Inc, a subsidiary of Ayrmid Pharma Ltd.

Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to transform cells to create allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies including Omisirge, approved and launched in 2023. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram.

About RoslinCT

RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies. Established in 2006 and built upon the ground-breaking technology cloning of Dolly the Sheep at the Roslin Institute in 1997, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones. These include being among one of the first in the world to produce clinical-grade human pluripotent stem cells. In collaboration with the partners, RoslinCT also developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Equipped with 22 purpose-built CGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, CGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and CGMP iPSC cell line development, gene editing, and differentiation.

With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialisation and deliver life-saving Cell and Gene Therapies worldwide. RoslinCT is a GHO Capital portfolio company. Discover more about our services at www.roslinct.com or follow RoslinCT on Linkedin, Twitter, Facebook.

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