As CAR-T and T-cell therapies continue to make headlines, GlaxoSmithKline has taken up the option to work on Adaptimmune’s T-cell therapy.
GSK has been shaking up its R&D following the arrival of new CEO Emma Walmsley, including potentially dropping some work on rare diseases. It also comes a few years after it sold much of its cancer drugs over to Novartis in exchange for its vaccines unit.
But Walmsley clearly still wants to be in the oncology R&D game, and will pay the U.K. biotech up to £48 million ($61 million) to exclusively license the right to research, develop, and sell Adaptimmune’s so-called NY-ESO SPEAR T-cell therapy program. This option was contained within a contract the pair signed back in 2014.
The payment includes development milestones of up to £18 million ($23 million) and the option payment of £30 million ($38 million), which also allows GSK to nominate two additional targets following completion of the transition. If the drug reaches the markets, further biobucks and royalties are also lined up, although exact details have not been given.
“This is a very exciting day for Adaptimmune as GSK has exercised its option over our NY-ESO program, earlier than originally planned,” said James Noble, CEO at Adaptimmune.
“The commitment by one of the world’s leading pharmaceutical companies to the NY-ESO SPEAR T-cell program as a new treatment modality is a testament to the strength of our data in synovial sarcoma recently presented at ASCO. From a financial perspective, this option exercise extends our cash runway into 2020. We anticipate the transition of NY-ESO to GSK to be completed over the coming months, after which we will focus our clinical resources on delivery and execution from our wholly-owned assets MAGE-A4, MAGE-A10 and AFP.”
Adaptimmune pointed out it that it holds on to a series of its own internal candidates, including other SPEAR T-cells targeting MAGE‑A10, MAGE‑A4, and AFP that are being tested in four active clinical trials across eight solid tumor indications. Early data across each of these studies is expected over the next 12 months or so.
Axel Hoos, SVP of Oncology R&D at GSK, added: “The aim of GSK’s R&D is to develop medicines with transformational potential for patients. We have seen compelling data for the NY-ESO investigational cell therapy in synovial sarcoma and, following this option exercise, we will capitalize on our in-house Cell and Gene Therapy capabilities to support the development program for GSK3377794. We will continue to explore the potential for this novel cell therapy in multiple tumor types, and in combination with other cancer therapies.”
The two said they would work together over the coming months to “ensure a smooth transition of the NY-ESO SPEAR T-cell development program to GSK.”
After this, GSK takes on all work for NY-ESO, which is currently focusing on a range of cancers, including: sarcoma, non-small cell lung cancer, ovarian cancer, where Adaptimmune says it will cease enrollment in the ongoing ovarian study, and “GSK will assume responsibility for any additional work in this indication,” as well as multiple myeloma.
In this regard, there may be a snag. The drug is being studied alongside Merck’s Keytruda (pembrolizumab), an anti-PD-1 inhibitor, but a safety scare and deaths from a recent trial of the marketed medication has halted its studies, along with a series of PD-1 and PD-L1 combo trials, in the multiple myeloma setting.
Adaptimmune CEO James Noble told FierceBiotech he had no concerns about the combo test with Keytruda, had not received any communication from the FDA about any trial holds and didn’t expect any. He said it looks as if the problem was specific to the combinations being used, and that this didn’t impact the T-cell-Keytruda program.
“GSK will be talking directly to Merck, but I don’t see any issues. We are enrolling [in that study], and we’ve already been in touch with Merck this morning, of course, because of our deal with GSK being exercised. They confirmed that the test is carrying on. It seems a specific issue, and we’re something completely different.”