This year has seen the FDA grant a flurry of Breakthrough Device Designations, and the latest is from Immunicom and its proprietary novel blood filtering technology called ‘Immunopheresis’.
The San Diego-based firm’s lead therapy focuses on removing soluble tumour necrosis factor receptors (sTNF-Rs), from cancer patients’ blood, cytokines which have an immunosuppressive action. By filtering these out of a patient’s blood using a novel apheresis or blood filtering process, the company believes the therapy can restore TNF-α anti-tumour activity and ‘reactivate’ a patient’s immune system to fight the cancer.
The process is based on a proprietary recombinant protein initially developed at University of Stuttgart from which Immunicom has licensed the worldwide exclusive rights.
Immunicom’s therapeutic approach is still very much in its early stages, the company having only conducted preclinical studies on dogs thus far.
Nevertheless, the company claims significant efficacy in these studies – its says its LW02 device reduced or halted the growth of metastatic tumours in around half of the 16 evaluable animals studied to date, with treatment shown to be generally safe and well tolerated.
Immunicom’s illustration of its novel Immunopheresis technology
The company says it sees Immunopheresis as an adjunct to a wide range of cancer treatments, including immunotherapies, and is aiming to eventually gain approval in late/end stage IV cancer patients with metastatic solid tumours in the first instance.
Amir Jafri, CEO of Immunicom, says the great potential of the technology is that it adds no new active ingredient into the patient’s body – but is instead ‘subtractive’, and thus completely free of side-effects.
The US regulator first launched the Breakthrough Therapy Designation for innovative medicines six years ago, but it was only in late 2017 when existing fast-track systems for medical devices were upgraded to have the same Breakthrough status.
Since the start of this year, the FDA has granted the status to a new AI diagnostic for diabetic retinopathy, a biodegradable patch for surgical wounds and a new diagnostic which can detect and identifying bacteria from blood in less than an hour.
The first of these IDx-DR, developed by IDx, gained marketing permission from the FDA in April. It is the first market-approved device to provide a screening decision without the need for a clinician to also interpret the image or results, allowing broad use across more patients and making it usable by non-expert healthcare workers.