June 27, 2017
By Mark Terry, BioSpace.com Breaking News Staff
As part of a strategic review, Cambridge, Mass.-based Dimension Therapeutics (DMTX), plans to cut 25 percent of its staff by the end of the year.
Dimension focuses on gene therapy utilizing adeno-associated virus (AAV) technology targeting the liver. As of March 31, 2017, the company had $59.1 million in cash, cash equivalent and marketable securities. It is also receiving reimbursements and $15 million in potential milestones from Bayer . As such, it expects to be able to fund operations to the end of 2018. If the milestones aren’t achieved, operations can continue to mid-2018.
“As we enter the second half of 2017 and look to 2018, we expect each of our core programs to achieve important clinical milestones that will bring us closer to our goal of delivering innovative AAV-based therapies for people living with devastating rare and metabolic diseases associated with the liver,” said Annalisa Jenkins, Dimension’s chief executive officer, in a statement. “Our key focus is to deliver the initial data from our ongoing Phase I/II clinical trial for DTX301 in OTC deficiency, advance two proof-of-concept studies for glycogen storage disease type Ia (GSDI1) and hemophilia A, the latter in collaboration with Bayer, and advance our unique HeLa 2.0 manufacturing platform. We believe we can deliver these important objectives in 2017-2018 with our current financial position.”
DTX301 is in an ongoing multi-center Phase I/II study. Four sites are in the U.S. and Spain and initial data is expected by late 2017. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have given the drug Fast Track and Orphan Drug designation for OTC deficiency.
The company expects to file an IND with the FDA for DTX401 in early 2018, with initial data in mid-2018.
Dimension also has ongoing nonclinical operations for a compound selection for Wilson disease in the first half of next year.
The company also expects to file an Investigational New Drug (IND) application in early 2018 for DTX201 in collaboration with Bayer to treat moderate/severe to severe hemophilia A, with initial data sometime in 2018.
Dimension also indicates it has ongoing cGMP programs with a contract manufacturing organization (CMO) this year. It also stated that its “Woburn facility producing material at 250L capacity with HEK293 suspension and HeLa 2.0 to support all needs for GLP toxicology studies and tech transfer to CMO partners.”
The company reported its first-quarter financials on May 10. At that time, it announced that it was discontinuing development of DTX101, an AAVrh10-based gene therapy product for hemophilia B. It would focus more on its inherited metabolic disease (IMD) programs, which include DTX301, DTX401, DTX501, DTX701 and DTX601.
The company reported $3.6 million in revenue for the quarter tied to its collaboration deal with Bayer, up from $2.2 million in the same period the year before. Research-and-development expenses for the quarter were about $13.7 million compared to $8.8 million in 2016’s first quarter. The increase was related to increased manufacturing and clinical activities.
In the quarter, the company reported a net loss of $13.5 million, or $(0.54) per share, compared to a net loss of $(9.5) million, or $(0.38) per share in the first quarter of 2016.
Dimension Therapeutics is currently trading for $1.58.
