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FDA Lifts Clinical Hold for Cancer Drugs

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The stock price of Advaxis surged after the U.S. Food and Drug Administration (FDA) lifted a clinical hold on all of its Investigational Drug Applications (IND) for its three cancer drugs.

Advaxis is a clinical-stage biotechnology company focused on developing different cancer immunotherapies that use the natural immune system of the body to redirect the immune response to kill cancer.

FDA’s review

In a statement, Daniel J. O’Connor, president and chief executive officer of the company said, “We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials.”

In October, the FDA issued a clinical hold on Advaxis IND applications for its cancer drugs in response to the safety report submitted to the agency. The biotechnology company engaged in discussions with the FDA and agreed to comply with the recommendations of the agency including the implementation of risk mitigation measures such as revised study protocol inclusion/exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.

The biotechnology company’s three experimental cancer treatments include axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2.

Axalimogene filolisbac (ADXS-HPV) is Advaxis lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers. The drug is under clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer.

According to Advaxis, The results of its Phase 2 Study of axalimogene filolisbac in recurrent/refractory cervical cancer showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy.

Yesterday, the company announced that it received an orphan drug designation for axalimogene filolisbac for the treatment of anal cancer from the European Medicines Agency (EMA).

The European Union grants orphan drug designation to drugs or biologics that treat a life-threatening chronically debilitating rare disease affecting fewer than five in 10,000 individuals in the region.

ADXS-PSA is a Lm technology immunotherapy. The drug is intended for patients with prostate cancer. The biotechnology company is experimenting the drug to target prostate-specific antigen (PSA) associated with prostate cancer. The drug is in a clinical development stage as a monotherapy and in combination with checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

ADXS-HER2 is also a Lm technology immunotherapy that received an orphan drug designation for the treatment of osteosarcoma from the FDA and EMA. Advaxis is developing the drug for both human and animal health.

Advaxis said it would resume its clinical trial on the cancer treatments.

Advaxis stock performance

The shares of Advaxis were trading around $12.45 per share, up by more than 14% at the time of this writing around 1:17 in the afternoon in New York.

Over the past 52-weeks, the company’s stock traded between $4.36 and $30.13 per share over the past 52 weeks. Advaxis gained 150 % in stock value over the past year.

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