Back to Newsroom
Back to Newsroom

Advaxis, Inc. – “From Two Checkpoint Inhibitor Development Agreements to Two IND Filings in Four Months – A Special Thanks…”

Monday, 24 November 2014 08:15 AM

Topic:
New York, NY / ACCESSWIRE / November 24, 2014 / Advaxis, Inc. (NASDAQ: ADXS) today published a new blog post on The Chairman’s Blog, written by the Company’s CEO, Daniel J. O’Connor. TheChairmansBlog.com is an exclusive online media publication that enables key executive officers a unique platform to share insights about their company and industry trends.

In his latest post, Mr. O’Connor reflected on the Company’s latest progress in filing two separate Investigational New Drug applications involving its ADXS-HPV and ADXS-PSA technologies. "2014 has been a tremendous year at our company, and much of our success is due to your tireless work," he reflected. Read the full blog post from Mr. O’Connor on TheChairmansBlog.com (http://www.thechairmansblog.com/advaxis/daniel-oconnor/two-checkpoint-inhibitor-development-agreements-two-ind-filings-four-months-special-thanks/).

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor Keytruda® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

For more information please visit www.advaxis.com.

About TheChairmansBlog.com

TheChairmansBlog.com is an exclusive, online media publication where publicly and privately held firms alike share insights about their companies and industries. TheChairmansBlog.com enables upper tier management to discuss issues that are of importance to their stakeholders, shareholders, and interested parties in an informal environment. www.thechairmansblog.com


Source: Advaxis, Inc.
Topic:
Back to newsroom
Back to Newsroom
Share by: