Here is the story:
Advaxis Inc. ADXS, -12.42% shares dropped in the extended session Monday after the biotech developer said the Food and Drug Administration issued a clinical hold against one of its drugs affecting four studies. Advaxis shares dropped 28% to $7.40 on heavy volume. The company said the FDA placed the clinical hold on its axalimogene filolisbac treatment studies after one patient died of her end-stage cervical cancer following treament. Advaxis said the FDA has requested information supporting the company’s claim that the medication did not cause the patient’s death.
This is old news, very old news. It is a very different market for biotechs now, I prefer to look through the carnage and find the gem.
What they bring to the table:
Advaxis ADXS, -12.42% is a clinical-stage biotechnology company that has taken a different immunotherapeutic approach to try and destroy cancer cells. With its Listeria monocytogenes (Lm)-LLO immuno-oncology technology licensed from the University of Pennsylvania. Advaxis uses live attenuated bioengineered gram-positive bacteria to stimulate the immune system to selectively target tumor cells for elimination.
The company calls this a Trojan Horse approach because its genetically engineered bacteria trick the immune system into thinking cancer cells (which, as aforementioned, can evade the immune system) are bacterial infections. To wit, the antigen-presenting cells are recognized as foreign, generating an immune response. Advaxis heralds that its cancer immunotherapy is the only shown to actively suppress the key components in the tumor microenvironment – regulatory T cells (tregs) and myeloid-derived suppressor cells (MDSCs) – that protect the tumor from immunologic attack, although researchers, such as those at MD Anderson, are working on peptides that specifically target and destroy MDSCs as well.
They partner with the likes of Merck and Asteroid Silica (AZN). Aduro BioTech, Inc. (ADRO) is using similar approaches and is seeing successes in clinical trials.
I own it.
Enjoy the holidays, looks like fall is coming to the east coast finally
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