US biotech firm Amgen and early cancer drug discovery company Kite Pharma have signed a major research and development deal focused on therapeutic oncology vaccines.
Under the terms of the agreement, Amgen will contribute cancer targets while Kite will offer up its CAR drug discovery platform, R&D and manufacturing capabilities, as well as its expertise. Kite will also be responsible for conducting all pre-clinical research and cell manufacturing and processing.
Each company will be responsible for clinical development and commercialisation of their respective CAR therapeutic candidates, including all related expenses.
On the financial side, Kite will receive an upfront payment of $60m from Amgen as well as funding for R&D costs. It will also be eligible to receive up to $525m in milestone payments.
This will be based on the successful completion of regulatory and sales milestones, plus royalties for the sales and the licence of Kite’s intellectual property for CAR T cell products.
In return, Amgen is eligible to receive up to $525m in milestone payments per Kite programme, plus tiered single-digit sales royalties, making the deal potentially worth just over $1bn.
The collaboration deal is not, however, for Kite Pharma’s lead drug candidate CD-19, but rather focuses on future immunotherapy targets, meaning the lead time for any marketed medicines will be some years off. Further terms of the agreement have not been disclosed.
“The intersection of immunology and oncology represents one of the most promising approaches to delivering significant impact for patients with cancer,” said Sean Harper, executive vice president of research and development at Amgen.
“With our existing immuno-oncology portfolio of cutting-edge technologies and expertise, we believe joining forces with Kite Pharma will leverage our targets and their leading CAR T cell platform to advance another new promising therapeutic approach to fight cancer.”
Arie Belldegrun, Kite Pharma’s president and chief executive, added: “Amgen is an ideal partner for us, based on their strong presence in oncology and the company’s broad array of cancer targets optimally suited for combining with our CAR technologies. We are proud to announce this unique collaboration and its validation of our R&D expertise, intellectual property position, and therapeutic manufacturing and processing capabilities.
“We believe that the therapeutic candidates resulting from the collaboration will have the potential to dramatically transform CAR approaches and to become some of the most powerful therapies for the treatment of cancer.”
New market
Many big pharma firms have already invested heavily into therapeutic vaccines that can effectively ‘teach’ the body to attack cancerous cells, which is seen as the next stage of oncology drug development.
Bristol-Myers Squibb and Merck & Co have the most advanced products with Opdivo (nivolumab) and Keytruda (pembrolizumab), both of which have recently gained US licences for melanoma and are now seeking extra indications in non-small cell lung cancer.
These drugs, which work by inhibiting PD-1, are expected to reach blockbuster status with the entire cancer immunotherapy market expected to reach $35bn by 2020.
Amgen and Kite will hope to be a part of that, but with both Roche and AstraZeneca having late stage PD-1 drugs in the pipeline and several drugs also already on the market, the firms will need to produce impressive trial results to steal market share in the future.
Amgen already has the drug Blincyto (blinatumomab), its cancer immunotherapy on the market that was approved by the FDA late last year. The drug is for rare types of blood cancer and is not expected to reach the sales heights of the treatments from BMS and Merck.