Krystal Biotech is confident enough about its pipeline of candidates of gene therapies for treating skin diseases that has started work on a new commercial manufacturing facility. It has even given it a name.
The Pittsburgh, Pennsylvania-based Kystal broke ground Friday on a 100,000-square-foot manufacturing facility that it is calling Astra. A spokesman for the company said in an email today the biotech expects to invest $75 million to $90 million on the facility, which is a modular enlargement of its existing facility in Pittsburgh.
The plant is slated to be complete in 12 to 15 months and will initially employ 75 workers, with the potential for 200 when it is fully operational, the company said.
“Biologics manufacturing is a complex science and is a competitive advantage for Krystal Biotech,” Krystal CEO Krish S. Krishnan said in a statement…”The success with our first GMP facility, Ancoris, gives us the experience and confidence to have Astra be functionally ready in time for the anticipated launch of our lead therapeutic, B-VEC (previously KB103).”
In its earnings report in November, the company said that it was reassured during a meeting with the FDA about manufacturing controls that it has a scalable GMP commercial process in place. It intends to make the clinical material for an upcoming phase 3 trial of B-VEC at its Ancoris facility and anticipates starting the trial in Q1 2020.
B-VEC is being developed to treat the most severe form of epidermolysis bullosa, a disease that is usually diagnosed in infancy and that results from mutations in the COL7A1 gene. Babies born with the more severe form will have widespread blistering and areas where there is no skin. The disease can lead to vision loss, difficulty eating due to blistering and scarring in the mouth and esophagus and other issues.
It reported last fall that in its phase 2 trial, five out of six wounds treated with B-VEC closed 100% in an average of 23 days.
The FDA also has fast-tracked Krystal’s second product candidate, KB105, an HSV-1 based gene therapy engineered to deliver a human transglutaminase-1 (TGM1) gene to patients with TGM1-deficient autosomal recessive congenital ichthyosis (ARCI).
The company, which raised about $45 million in a 2017 IPO, reported cash equivalents and short-term investments of $203.2 million at the end of its third quarter on September 30, 2019. It had a net loss of $0.25 a share compared with a $0.26 per share loss in the same quarter of 2018.
