Advaxis, Inc., a clinical stage biotechnology company developing cancer immunotherapies, welcomed New Jersey Governor Christopher J. Christie and BioNJ President and Chief Executive Officer Debbie Hart on Sept. 9 to celebrate the completion of its new state-of-the-art manufacturing facility and laboratory with a ribbon-cutting event before close to 200 people.
Advaxis built out the 30,000-square-foot expansion at its College Road East headquarters to include a clean-room manufacturing and laboratory facility to develop and manufacture clinical-grade products to support Advaxis’ clinical trials and future commercialization of its immuno-oncology therapeutics.
“I’m proud Advaxis is increasing its footprint and investment in the Garden State and specifically the Princeton Corridor, which in the past several years has grown as a beacon for world-renowned biotech and life sciences accomplishments,” Governor Christie said. “For the benefit of New Jerseyans, Advaxis is emerging as a leading innovator in the biotech industry, rapidly developing state-of-the-art cancer treatment for patients in need, creating great private-sector jobs and attracting private investments from global companies who want to be a part of its budding successes.”
Advaxis is conducting several clinical trials evaluating its proprietary Lm Technology™ using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria to activate the immune system to attack cancer cells. In addition, the company announced a global collaboration agreement with Amgen for its My Immunotherapy Neo-Epitopes or MINE™ program for the development of ADXS-NEO, which will enter phase 1 trials in 2017.
“The Advaxis team believed in this technology and believed that it could help patients in need even when the company was struggling a few years ago, but just this year, the company has reported two complete responses in patients who have received AXAL in clinical trials, meaning the cancer in these two patients has disappeared,” said Ms. Hart during the event. “Advaxis is a true New Jersey success story.”
AXAL, or axalimogene filolisbac, is being tested in a Phase 3 clinical study called AIM2CERV to evaluate safety and efficacy in patients with high-risk, locally advanced cervical cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation as well as Fast Track designation for adjuvant therapy and a Special Protocol Assessment for the Phase 3 AIM2CERV trial. The trial is set to dose its first patient this year.
“Governor Christie’s administration has worked to help life science companies like Advaxis and many others succeed here in New Jersey, and his leadership in this field has benefited our state with jobs and economic development, and, more importantly, has facilitated Advaxis’ opportunity to develop its immunotherapies with the goal of helping cancer patients around the world for years to come,” said Daniel J. O’Connor, president and CEO of Advaxis.