Adaxis-AZ immunotherapy combo hit by clinical hold after death

pharmafile | March 13, 2018 | News story | Manufacturing and Production, Research and Development Adaxis, AstraZeneca, Imfinzi, biotech, drugs, immunotherapy, pharma, pharmaceutical 

Adaxis and AstraZeneca announced that they had agreed a combination program for axalimogene filolisbac and Imfinzi, respectively, back in 2014 to explore the possibility of treating HPV-associated cervical cancer and HPV-associated head and neck cancer.

The news on that front had gone quiet until now, with Adaxis announcing that a patient death in trials had led to a clinical hold being imposed by the FDA.

The death was announced as being due to respiratory failure following a sixth dosing with the combination treatment in a Phase 1/2 trial.

As a result, enrolment and further treatment are suspended until all stakeholders review the event and determine what led to the death.

Adaxis’ cancer vaccine, axalimogene filolisbac, enhances the ability of immune cells to combat tumours, by introducing Lm bacteria into the human body, which stokes a strong immune response to be redirected against cancer cells.

It was hoped that using this in combination with an immunotherapy, such as Imfinzi, would bring about a stronger immune response and boost the ability for cancer cells to be destroyed.

However, the clinical hold now raises questions about whether the treatment could be potentially unsafe. It’s not the first time immunotherapies have been hit by such a concerns, with numerous companies facing a lockdown on trials into blood cancers last year.

“We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers. We believe in the potential of our Lm Technology to provide new advancements in the area of cancer care,” stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. “We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers.”

The cancer vaccine is also being tested in combination with BMS, in addition to Opdivo, and the biotech had agreed a separate deal with Amgen, sealed in 2016, to develop ADXS-NEO, another cancer immunotherapy treatment.

Ben Hargreaves

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