Merck and Advaxis team up on immuno-oncology
pharmafile | August 26, 2014 | News story | Manufacturing and Production, Medical Communications, Research and Development | ASCO, Merck, immunology, pd-1, pembrolizumab
Advaxis and Merck have signed a research deal to investigational Merck’s PD-1 inhibitor pembrolizumab in combination with Advaxis’ listeria-based cancer immunotherapy ADXS-PSA for the treatment of prostate cancer.
The deal will see ADXS-PSA assessed as both as a monotherapy and in combination with pembrolizumab in early and mid-stage trials in patients with previously treated metastatic, castration-resistant prostate cancer.
Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body’s own defences in fighting cancer.
This collaboration will be Merck’s first adventure into prostate cancer with their PD-1 therapy, which is already being evaluated in melanoma, non-small cell lung cancer and kidney cancer.
In fact pembrolizumab has taken a big step towards becoming Europe’s first PD-1 cancer treatment after the EMA accepted the medicine for review last month. The EU’s drugs regulator will look at the drug for the treatment of melanoma.
The drug was also filed for approval in the US in January and could be approved by the FDA by October.
Reuters is today reporting that this approval could be brought forward to early September however, citing people familiar with the situation.
The therapy, known as programmed cell death 1 (PD-1) protein and its PD-L1 ligand, is a form of immunotherapy that helps the body recognise and destroy cancer cells, and was the hottest topic of research at June’s ASCO cancer conference in Chicago.
Major players such as Roche, AstraZeneca and Bristol-Myers Squibb also have candidates in development, with all vying for pole position in the race to a market potentially worth up to $25-35 billion per year.
But of all these medicines, Merck’s pembrolizumab won particular plaudits from the ASCO board, both for its efficacy and side effects profile.
‘Exciting’ combination
This is also Advaxis’ second major pharma deal with a checkpoint inhibitor. Last month, Advaxis announced a deal with AstraZeneca’s subsidiary MedImmune, to evaluate their PD-L1, MEDI4736 with Advaxis’ ADXS-HPV, for the treatment of HPV-related head and neck cancer and cervical cancer.
Daniel O’Connor, president and chief executive of Advaxis, says: “We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck’s anti-PD-1 immune checkpoint inhibitor.
“We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers.”
Under the terms of the agreement, Advaxis will sponsor and fund the study whilst Merck will provide pembrolizumab; the companies will collaboratively oversee the conduct of the study, which is planned to begin in early 2015, according to a joint statement.
“Collaborations such as this are an integral part of Merck’s strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers,” explains Dr Eric Rubin, vice president of oncology at Merck Research Laboratories.
“We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.”
Ben Adams
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