PRINCETON, N.J. and SAN DIEGO -- Advaxis, Inc.(Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a non-exclusive research and clinical trial collaboration agreement with Sorrento Therapeutics, Inc. (Nasdaq:SRNE) to evaluate combinations of Advaxis's Lm-LLO cancer immunotherapy technology platform, including ADXS-HPV, ADXS-PSA and ADXS-HER2, with Sorrento's fully human antibodies targeting immune checkpoints, including GITR, OX40, LAG-3 and TIM-3. Sorrento has one of the largest and most diverse fully human antibody libraries in the industry designed to facilitate rapid identification and selection of highly specific therapeutic monoclonal antibody (mAb) product candidates.
Advaxis's preclinical program for ADXS-HPV previously examined its therapeutic potential in combination with agonistic research antibodies, including anti-OX40 and anti-GITR. Preclinical data demonstrated that the combination of ADXS-HPV with agonistic research antibodies led to significant inhibition of tumor growth and prolonged survival in tumor-bearing mice. Complete regression of established tumors occurred in 40% and 60% of animals treated with ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies, respectively (AACR Abstract #LB-229).
"We welcome the collaboration with Sorrento to evaluate its immunomodulatory antibodies in combination with our Lm-LLO immunotherapy technology platform," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Leveraging Sorrento's fully human antibody library and Advaxis's Lm-LLO immunotherapy technology offers a significant opportunity to target multiple cancer indications and extend the potential of our respective company's technologies."
Under the terms of the agreement, Advaxis will conduct the studies and the companies will equally share the expenses. The companies hope to commence the first of the two planned combination studies in 2016. Results from the studies will be used to determine whether further clinical development of specific combinations is warranted.
"Clinical collaborations are an integral part of Sorrento's strategy to accelerate the development of our diverse portfolio of immuno-oncology antibodies against a broad range of cancers," said Dr. Henry Ji, President and Chief Executive Officer at Sorrento. "We are encouraged by the data presented by Dr. Khleif at the AACR Annual Meeting 2015, and believe there could be an important clinical benefit from the combination of our antibodies with Advaxis's Lm-LLO immunotherapies."
Destum Partners acted as advisor to Advaxis for this collaboration agreement.
About Sorrento Therapeutics, Inc.
Sorrento is an oncology company developing new treatments for cancer and associated pain. Sorrento announced last week that Dr. Patrick Soon-Shiong's NantPharma acquired the rights to Cynviloq™, which recently completed a successful TRIBECA study. Sorrento is also developing resiniferatoxin (RTX), a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the NIH to treat terminal cancer patients suffering from intractable pain.
In December 2014, Sorrento and NantWorks formed a global joint venture, now called Nantibody, to focus on immunotherapies for cancer. Also in December 2014, Sorrento and Conkwest, Inc., a privately-held immuno-oncology company developing proprietary Neukoplast®, a Natural Killer (NK) cell-line based therapy, entered into an agreement to jointly develop CAR.TNK™ (Chimeric Antigen Receptor Tumor-attacking Neukoplast) immunotherapies for the treatment of cancer and infectious diseases. In March 2015, Sorrento entered into a global collaboration with NantCell, a NantWorks company, to discover and develop immunotherapies against tumor neo-epitopes.
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about advances made by Sorrento in human monoclonal antibodies using its proprietary G-MAB™ fully human antibody technology, if any; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento™, CAR.TNK™, the Sorrento logo and G-MAB™ are trademarks owned by Sorrento Therapeutics, Inc. All other trademarks and trade names are the properties of their respective owners.
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 ongoing Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a 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 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.
This news release contains forward-looking statements, including, but not limited to: statements regarding the planned clinical collaboration program between Advaxis and Sorrento, including, but not limited to, any expected achievements; the potential future development and potential clinical benefit of combinations of Advaxis's Lm-LLO cancer immunotherapy technologies with Sorrento's co-stimulatory molecules; Advaxis's ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. 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.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
Company: Advaxis, Inc. Greg Mayes, Executive Vice President and COO 609.452.9813 ext. 102 Sorrento Therapeutics, Inc. George Uy, EVP & Chief Commercial Officer 661.607.4057 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler 646.362.5750