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The clinical trial is ready to roll and news of the first...

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    The clinical trial is ready to roll and news of the first patient is eagerly awaited. From the Review of Operations and Activities, we learn that 'it should be possible to get early signs of efficacy from a small number of patients by monitoring their immune systems' even before the tumour responds. We are reminded that HER-Vaxx targets the immune system.

    Undoubtedly, clinicians are looking for key data on immune response rates as well as the monitoring of any immune related adverse effects. Immune response rates will include induction of T cell responses, reduction of Treg as well as the production of antibodies. From Clinical Trials, the estimated enrolment in the open label Phase 1b will be 18.

    Patients will be closely monitored. A lot of data is expected from 'as few patients as possible'. Its a case of Every breathe you take, Every move you make, We'll be watching you.

    HER-Vaxx works at two levels - a primary level and secondary level. Each level is critically important but the secondary level may end up being the biggest breakthrough. The primary level is the production of antibodies designed to attack the tumor. The secondary level could be described as firing up the immune system to facilitate its primary mission: the induction of T cell responses and the reduction of immunosuppresive T regulatory cells (Treg). We are about to find out whether friendly fire will create the microenvironment in which the power of checkpoint inhibitors can be unleashed for the benefit of a wider subset of cancer patients.

    From the article Attacking cancer: are therapeutic vaccines on the verge of fulfilling their potential? by Malini Guha, published 23 July 2015, we learn that many cancer immunologists are starting to wonder whether vaccine priming could increase the number of patients who would respond to checkpoint inhibitors.

    It could go either way. Either therapeutic vaccines could open the door for checkpoint inhibitors to become more effective; for more people, or the other way round. Arguably cancer vaccines have previously been ineffective because of immune checkpoints. PD-1 or PD-L1 drugs could release the immune brakes so that the vaccine antibodies can properly go to work. The chicken or the egg!

    Therapeutic vaccines is about to become the talking point in the next wave of immuno-oncology. The HER-Vaxx trial is ideally positioned.
 
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