Dive Brief:
- Bayer is expanding in cell therapy, announcing Tuesday the opening of a new manufacturing plant in Berkeley, California, that’s meant to advance its development of regenerative medicines.
- The $250 million facility will support late-stage clinical trials, and potentially a commercial launch, of BlueRock Therapeutics’ bemdaneprocel, a cell therapy being investigated by the Bayer subsidiary as a treatment for Parkinson’s disease.
- The facility, which spans 100,000 square feet, also has space for another production “module” that could be used to support additional cell therapies Bayer develops.
Dive Insight:
The new facility is the latest investment from Bayer into cell and gene therapy. Bayer has been investing hundreds of millions of dollars into its Berkeley location, recently launching a Cell Culture Technology Center and cell therapy labs.
Notably, the plant will backstop development of bemdaneprocel, which originated from Cambridge-based BlueRock.
Bayer first took a bet on the cell therapy when it took a stake in BlueRock, later agreeing to buy the rest of the company for $240 million in 2019. As it has with other acquisitions, the large pharma agreed to operate the biotech as an independent subsidiary to preserve its culture.
Since then, BlueRock has made progress with bemdaneprocel, reading out promising results from an early-stage clinical trial. According to BlueRock, the experimental cell therapy met the study's main goal by showing treatment to be safe and well-tolerated in the 12 study participants treated.
Parkinson’s damages the nerve cells responsible for movement to become impaired or die off, causing difficulty in controlling actions such as walking, as well as shaking and stiffness.
Treatments for the disease include drugs that deliver the chemical messenger dopamine, which is responsible for several functions including motor function. BlueRock’s cell therapy also targets dopamine by replacing dopamine-producing neurons that become lost as a result of the disease. The neuron precursors are derived from pluripotent stem cells.
BlueRock said it is planning a mid-stage study that will start enroll participants next year.
“Our team is excited to be working shoulder to shoulder with Bayer’s biotech scientists and manufacturing experts as we look to scale up manufacturing for our first investigational therapy, bemdaneprocel for Parkinson’s disease, as it advances through clinical trials,” said Seth Ettenberg, president and CEO of BlueRock.
