Rubius To Build $155-Million Cell Therapy Mfg Facility

Rubius Therapeutics, a Cambridge, Massachusetts-headquartered biopharmaceutical company developing cellular therapies, is investing up to $155 million to establish a manufacturing facility in Rhode Island.

Rubius intends to invest up to $155 million over a more than five-year period to renovate a 135,000-square-foot manufacturing facility through the adaptive reuse of an existing building in Smithfield, Rhode Island.

Rubius is developing a class of therapies that it calls Red Cell Therapeutics (RCTs), which are based on red blood cells. The company has developed a platform to genetically engineer and culture RCTs as cellular therapies. The company says that its cellular therapies can be transfused into approximately 95% of patients since they are produced from O negative donor blood stem cells and that they use scalable and flexible manufacturing to enable production of thousands of doses in bioreactors from a single donor, depending upon the therapeutic application.

The company says its proprietary process can generate a wide variety of allogeneic, ready-to-use RCT product candidates through the following steps: (1) obtaining CD34+ hematopoietic precursor cells from the blood of O negative donors; (2) genetically engineering the cells to express biotherapeutic proteins within the cell or on the cell surface of the RCTs; (3) expanding the number of cells and differentiating them into reticulocytes, which are enucleated red-blood cell precursors; and (4) formulating, characterizing and storing doses of the resulting RCT product candidate for later infusion into patients. The company says that by modifying only one of its initial manufacturing steps in which it adds a gene or genes that encode biotherapeutic proteins within the cell or on the cell surface of RCTs, it is able to develop new RCTs designed to treat different diseases.

Rubius is developing a pipeline of RCT product candidates with an initial focus in rare diseases, cancer, and autoimmune diseases. The company plans to file an investigational new drug application (IND) for its lead drug candidate as a treatment for phenylketonuria in the first quarter of 2019 and INDs for additional RCT product candidates during 2019, 2020, and thereafter, according to information from the company.

In February 2018, Rubius named Spencer Fisk as Senior Vice President, Manufacturing, who joined Rubius from Novartis, where he most recently served as Vice President and Global Head of Cell and Gene Technical Development and Manufacturing. Fisk spent the last six years at Novartis, where he most recently led the chemistry, manufacturing, and controls (CMC) development and manufacturing organization to deliver Novartis’ chimeric antigen receptor (CAR) T cell therapy portfolio for the company and successfully registered and launched, Kymriah (tisagenlecleucel), Novartis’ CAR T therapy for treating B-cell acute lymphoblastic leukemia.

Rubius recently announced an initial public offering of 9.53 million shares with a target prices of $20.00 to $22.00 per share with a target to raise approximately $200 million.

Source: Office of the Governor of Rhode Island of the Governor of Rhode Island, Nasdaq, and US Securities and Exchange Commission

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