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Chinese biotechs aim PD-L1 antibody at hepatitis B

Cancer therapies could help boost patient's immune system


Checkpoint inhibitors are already making a big impact in cancer, but two Chinese biotechs want to explore their activity in viral diseases, and specifically hepatitis B.

Suzhou Alphamab is already testing its PD-L1 inhibitor antibody KN035 in a number of clinical trials across tumour types in the US, China and Japan, but has licensed rights for viral diseases to Ascletis in China, potentially opening up a new revenue stream for the drug.

The deal stems from speculation that the immune-boosting activity of checkpoint inhibitors could have a role to play in infectious disease, and particularly chronic, hard-to-treat infections like hepatitis B virus (HBV), HIV and tuberculosis.

Under the terms of the deal, Ascletis has agreed to pay an undisclosed upfront cash fee, plus milestones and royalties on any future sales in return for rights in Greater China, where HBV is a major public health problem. Around a third of all the 350 to 400 million people infected with HBV worldwide are in China, with many unaware they are carrying the virus.

HBV can be treated effectively with antiviral drugs but so far no cure has been developed, meaning that there is always a risk of the infection re-emerging to cause liver disease including cancer later in life.

Professor Guiqiang Wang, an infectious disease specialist at Peking University First Hospital, explains that chronic HBV infection leads to the “exhaustion” of T cells that are trying to fight the infection. “Blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to a clinical cure,” he suggests.

For Alphamab, handing over rights to KN035 to Ascletis allows it to maintain its focus on the drug in cancer – where it has reached late-stage development in China – and may also allow it to steal a march on more established PD-1/L1 developers.

Front-runners in the immuno-oncology category such as Bristol-Myers Squibb (BMS) with Opdivo (nivolumab) and Merck & Co/MSD with Keytruda (pembrolizumab) have not started trialling their blockbuster drugs in infectious diseases, according to their latest pipeline updates.

KN035 has one additional advantage over its rivals in that it can be delivered by subcutaneous injection rather than intravenously, which should “increase patient compliance in clinical practice,” according to Prof Wang.

BMS and Merck are both trying to develop subcutaneous formulations of their drugs but at the moment they are available as infusions only.

Article by
Phil Taylor

14th January 2019

From: Research



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