Small cap British biotech Adaptimmune will combine its experimental NY-ESO SPEAR T-cell therapy with Merck’s ($MRK) blockbuster checkpoint inhibitor Keytruda (pembrolizumab) for tests in myeloma.
But this comes as its med is under scrutiny from the FDA, as back in August the U.S. regulator put a partial clinical hold on its pivotal study on NY-ESO, a specific peptide enhanced affinity receptor T-cell therapy targeting the NY-ESO cancer antigen, to treat myxoid-round cell liposarcoma.
The FDA said it wanted more information on chemistry, manufacturing and controls, as well as other “undisclosed questions” about the trial. Safety was not a concern, the biotech stressed.
Six weeks later, the biotech signed a new, 5-year deal with contract manufacturing organization PCT for it to help with the manufacturing and supply of Adaptimmune’s SPEAR T-cell therapies.
Merck clearly still has confidence in the therapy, with the multiple myeloma targeting combo slated to start in the first half of next year.
This is not new ground for Adaptimmune as its T-cell therapy has previously been tested in multiple myeloma in a single agent Phase I/II trial, in which 20 out of 22 patients experienced a response at day 100 post autologous stem cell transplant, according to the biotech.
The hope is that a combination deal, which is all the rage with PD-1 and PD-L1 meds right now, will boost efficacy in fighting off cancer, and also help the body’s immune system attack the disease.
“In initial single-agent studies of our NY-ESO SPEAR T-cell therapy in patients with advanced myeloma in the context of stem cell transplantation, we have seen encouraging evidence of antitumor effect, safe administration and prolonged persistence of transduced cells,” said Rafael Amado, Adaptimmune’s chief medical officer.
“Keytruda has shown preliminary evidence of activity in multiple myeloma, and there is preclinical evidence to support the view that the combination of NY-ESO SPEAR T-cell therapy and anti-PD-1 therapy may lead to meaningful anti-tumor activity.
“We look forward to evaluating our therapy alone and in combination with Keytruda in a randomized trial of patients with multiple myeloma who are refractory or have relapsed with standard therapy.”
Money terms weren’t given, but: “The agreement also includes provision for potential expansion to include Phase III registration studies in the same indication,” the companies said in statement.
Adaptimmune has seen its value drop significantly since its IPO last May that saw it raise $191 million at $17 a share--which valued the company at $1.3 billion. In August, when the partial hold was announced, it was just $9 each, giving it a market cap of about $620 million.
It ended down 11% yesterday but bounced up 7.3% after hours on the Merck news, but its shares are now just $4.69, with a market cap of just over $300 million.
A few weeks back, the company also announced it was tweaking an ovarian cancer trial protocol, also using NY-ESO SPEAR, after: “No objective clinical responses [were to date] reported in the ovarian cancer patients who received NY-ESO SPEAR T-cell therapy in the initial iteration of this trial.”