Biotech’s Recently Under the Microscope

Advaxis, Inc. (NASDAQ: ADXS), a clinical stage biotechnology company, focused on Lm-LLO cancer immunotherapies has announced that Anthony Lombardo, interim chief executive officer, will present a company overview at the Cantor Fitzgerald Global Healthcare Conference being held Sept. 25-27, 2017 in New York.

Lombardo has nearly 30 years of leadership experience in the life sciences industry with a proven track record of helping global companies achieve significant growth. Honored by the American College of Radiology and the Society of Abdominal Radiology for his years of service to the clinical community, he currently serves as chairman of the advisory board of Morristown Medical Center, a part of Atlantic Health System Hospitals.

The company’s shares have declined almost 30% after recent quarterly financials indicated a wider loss per share in the YOY period.

Advaxis intends to begin a combination study with Opdivo from Bristol-Myers Squibb that could lead to another application for treatment of cervical cancer, but the study isn’t slated to begin until next year. The company also has another candidate, ADXS-PSA, in early-stage combination therapy trials with Keytruda from Merck & Co. that could lead to a prostate cancer application.

The ADXS immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. Advaxis has four franchises in various stages of clinical and pre-clinical development: HPV-associated cancers, prostate cancer, neoantigen therapy and hotspot mutation therapy.


Anavex Life Sciences Corp (NASDAQ: AVXL) was issued U.S. Patent Number 9,750,746 entitled “ANAVEX 2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection. The patent provides the Company with intellectual property protection covering composition of matter for ANAVEX™ 2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil.  The issued patent offers protection through 2033.

“This newly issued patent expands the proprietary position of ANAVEX™ 2-73,” said Christopher U. Missling, PhD, President, and Chief Executive Officer of Anavex. “This new patent is a continuation of Anavex’s vigorous pursuit of intellectual property protection for our neuroprotective therapeutics and we look forward to continued progress, including advancing ANAVEX™ 2-73 in clinical studies this year. “

ANAVEX™ 2-73 is an orally available, small-molecule activator of the sigma-1 receptor which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.1 Donepezil is currently the leading compound for the treatment of Alzheimer’s disease in more than 50 countries and is postulated to exert a therapeutic effect by enhancing cholinergic function.  ANAVEX™ 2-73 is to advance this year into a Phase 2/3 clinical trial for the treatment of Alzheimer’s disease, as well as other neurodegenerative and neurodevelopmental CNS indications, including the orphan designation Rett syndrome.


Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, today announced that the company will exhibit at the upcoming 2017 BioProcess International Conference & Exhibition, being held September 25-28, 2017 in Boston, MA.  Avid will showcase the company’s comprehensive range of process development, analytical development, testing and characterization services and high-quality cGMP clinical and commercial biologics manufacturing of monoclonal antibodies and recombinant proteins.

At BioProcess International, the Avid team will be able to discuss the company’s innovative processes for generating a broad range of biopharmaceutical product types including monoclonal antibodies, highly-glycosylated recombinant proteins, and enzymes, among others.  As previously announced, the company will soon be ready to offer new larger scale capacity from the two recently installed 2,000-liter, single-use bioreactors at the Myford facility.

The Myford facility is designed with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process.  A wide range of innovative features are incorporated into this new facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions.  Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics API manufacturing.

Avid Bioservices was established as Peregrine’s internal biologics manufacturing and development group, and began formal operations in January 2002.  The company has grown from an internal support operation to a full service CDMO that manufactures bulk drug substance for products that are approved and marketed in over 18 countries by leading biopharma companies, including the US and EU. Avid was recently recognized as a leading CDMO by Life Science Leader as a recipient of multiple 2017 Contract Manufacturing Leadership Awards for Quality, Reliability, Capabilities, Expertise, and Compatibility.


22nd Century Group, Inc. (NYSE: XXII) Mitch Zeller, Director, US Food and Drug Administration’s Center for Tobacco Products. Together with FDA Commissioner, Dr. Scott Gottlieb, in August 2017, released an article entitled, “A Nicotine-Focused Framework of Public Health.” The article spells out the FDA’s regulatory authority for mandating non-addictive levels of nicotine in combustible cigarettes.

Dr. Dorothy Hatsukami, Forster Family Chair in Cancer Prevention; Associate Director, Masonic Cancer Center; and Professor of Psychiatry, University of Minnesota. In 2016, together with two other prominent scientists, Dr. Dorothy Hatsukami wrote in Tobacco Control that failure to act on the World Health Organization (WHO) recommendation of mandating nicotine reductions in cigarettes to non-addictive levels could lead to the loss of millions of lives.

“Since the FDA announced its intention to mandate that all cigarettes have very low, non-addictive levels of nicotine, the public health community has focused much of its attention on 22nd Century,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We look forward to working together with scientists and policymakers to make Very Low Nicotine cigarettes a public health reality in the United States and around the world.”

22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants.



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