- Allogene Therapeutics, maker of allogeneic T cell therapies, has leased a 118,000-square-foot space in Newark, California, to develop a manufacturing facility.
- The facility's production processes will meet good manufacturing practice standards, according to a Feb. 20 statement, and provide the clinical supply and commercial product for Allogene's cell therapies pending regulatory approval. Currently, the biotech gets its clinical trial supply through a contracting organization — though that should continue to be "a component of the company’s long-term manufacturing strategy."
- Regarding its new lease, Allogene paid close to $193,000 for the pre-payment for the first month of rent and estimated operating expenses The lease has a term of almost 16 years and is expected to commence in March 2020. Allogene reported $83 million in cash and cash equivalents in its most recent quarterly filing with the Securities and Exchange Commission.
Autologous therapies like the marketed CAR-T products Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) present unique production challenges. Case in point: Kymriah sales have thus far underwhelmed Wall Street, due in no small part to the manufacturing challenges it poses for developer Novartis.
Allogeneic treatments, which allow patients to receive cells from a source other than themselves, also pose their own production problems. For instance, manufacturers must build considerable scale to deliver on the "off-the-shelf" appeal promised by allogeneic treatments.
"Now that people understand that cell therapy can do what it can do ... everybody wants to sort of take the field to the next [level]," Allogene CEO David Chang told BioPharma Dive in early December at the American Society of Hematology's annual conference.
"The next revolution in cell therapy is now moving away from one patient at a time to a more pharmaceutical [model]," Chang added, "not only to make the therapy more readily available, but ultimately eliminating the manufacturing cost from the pricing consideration."
So far, Allogene has had to rely on a contract manufacturing organization as well as facilities provided by Pfizer to supply the therapy it needs for testing. In April, the biotech inked a deal giving a 25% ownership stake to Pfizer in exchange for rights to 16 preclinical CAR-T assets and one clinical allogeneic CAR-T therapy.
Wednesday's announcement, however, indicates Allogene is taking steps forward in its pursuit to manufacture cell therapies on its own.
"Building state-of-the-art manufacturing capabilities is at the core of our strategy to deliver readily available cell therapy faster, more reliably and at greater scale," Alison Moore, chief technical officer at Allogene, said in the Feb. 20 statement.
According to an SEC filing, Allogene must pay a monthly rent of $159,150 per month for the first twelve months of the lease term, though that's subject to rent abatement for months two through nine of the lease. The lease term will then increase at a rate of 3% per year.
Allogene shares were down 3.7% to $30.69 apiece by market's close Wednesday.