Company to Provide Comprehensive Review of Lm-LLO Immunotherapy Pipeline and Clinical Studies
Six Clinical Investigators to Present and Participate in Question and Answer Session
PRINCETON, N.J., Jan. 20, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it will host and webcast its Analyst & Investor Day on Tuesday, February 3, 2015.
|Event:||Advaxis Analyst & Investor Day|
|Date:||February 3, 2015|
|Time:||1:30 p.m. – 5:30 p.m., EST|
|Location:||Reed Smith Office|
|599 Lexington Ave., 22nd Floor|
|New York, NY 10022|
During the Analyst & Investor Day, Advaxis's senior management team will discuss the Company's Lm-LLO immunotherapy platform and clinical programs, including a comprehensive review of the anticipated AIM2CERV Phase 3 clinical study of ADXS-HPV in cervical cancer. Additionally, the event will feature presentations and a question and answer session involving the principal investigators leading Advaxis's multiple ongoing and planned clinical studies.
The following Key Opinion Leaders will be attending and presenting:
- Yvonne Paterson, Ph.D., Professor of Microbiology at the Perelman School of Medicine, and Associate Dean for Research and Professor at the University of Pennsylvania School of Nursing; Scientific founder of Advaxis's Lm-LLO immunotherapy platform.
- Larry J. Copeland, M.D., Professor of Medicine, Gynecologic Oncology at the Ohio State University Wexner Medical Center, and Vice President at the Gynecologic Oncology Group (GOG) Foundation, Inc. GOG is currently partnered with Advaxis in a Phase 2 study of ADXS-HPV in patients with persistent or recurrent cervical cancer. Additionally, Advaxis and GOG anticipate the initiation of the Phase 3 AIM2CERV trial in 2015 to study ADXS-HPV in patients with high risk, locally advanced cervical cancer.
- Andrew G. Sikora, M.D., Ph.D., Vice Chair for Research and Co-Director Head and Neck Cancer Program at Baylor College of Medicine; principal investigator of clinical trial evaluating ADXS-HPV in HPV-associated head and neck cancer.
- Howard Safran, M.D., Director of the Brown University Oncology Group and Associate Professor of Medicine at The Warren Alpert Medical School of Brown University; principal investigator of clinical trial evaluating ADXS-HPV in HPV-associated anal cancer.
- Samir N. Khleif, M.D., Director of the State of George Cancer Center, George Regents University Cancer Center (GRU) and the Cancer Service Line; Board of Directors, Advaxis, Inc.; formerly Chief of the Cancer Vaccine Section at the National Cancer Institute (NCI) and Special Assistant to the Commissioner of the Food and Drug Administration (FDA) for oncology. GRU has received Institutional Review Board approval to initiate a Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer.
- Nicola J. Mason, B.Vet.Med., Ph.D., Assistant Professor of Medicine and Pathobiology at the University of Pennsylvania School of Veterinary Medicine and principal investigator of two clinical trials evaluating ADXS-HER2 in canine osteosarcoma.
- Naomi B. Haas, M.D., Associated Professor of Medicine and Director of the Prostate and Kidney Cancer Program at the University of Pennsylvania Abramson Cancer Center; principal investigator of a clinical trial evaluating ADXS-PSA as a monotherapy and in combination with Keytruda® (pembrolizumab) in metastatic, castration-resistant prostate cancer (mCRPC).
Attendance and Participation
To register for the event or the live webcast, please visit: www.advaxis.com/advaxis-analyst-investor-day. Alternatively, for a listen-only telephonic broadcast, participants may dial (866) 318-8612 (domestic/U.S.) or (617) 399-5131 (international).
The live webcast, presentation slides and questions submission form will be available in the Investor Relations section of the Company's website at ir.advaxis.com under 'Events & Presentations.' The webcast will be archived on the Company's website.
For questions, please contact us at firstname.lastname@example.org.
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-HER2, to target the Her2 receptor expressing cancers. Her2 is expressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
For more information about our cancer immunotherapies please visit www.advaxis.com.
Some of the statements included in this press release, particularly those regarding the proposed Phase 3 for ADXS-HPV in patients with early stage cervical cancer, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Keytruda is a registered trademark of Merck & Co., Inc.
|Greg Mayes, Executive Vice President and COO|
|609.452.9813 ext. 102|
|Tiberend Strategic Advisors, Inc.|
|Amy S. Wheeler|