AMSTERDAM, February 11, 2014 /PRNewswire/ --
- SynCo's live microbial track record, GMP scale-up and commercial manufacturing capabilities will facilitate the advancement of Advaxis' ADXS-HPV program -
SynCo Bio Partners B.V., a leading services provider for GMP manufacturing of live microbial vaccines and biotherapeutics today announces that they have entered into a long term manufacturing collaboration with Advaxis, Inc. (NASDAQ: ADXS), a biotechnology company developing the next generation of cancer immunotherapies. Under the agreement, SynCo will support Advaxis with scale-up for supply of ADXS-HPV bulk drug substance and drug product for pivotal clinical studies and licensure. ADXS-HPV is a therapeutic vaccine administered intravenously that is being evaluated for the treatment of HPV-associated cancers and is the leading candidate from Advaxis' novel immunotherapeutic platform.
"SynCo's ability to manufacture both drug substance and drug product for ADXS-HPV will offer us increased flexibility as we expand our manufacturing process in preparation for commercial scale production," commented Daniel J. O'Connor, Chief Executive Officer of Advaxis. "To have the support of a world class manufacturer such as SynCo, is pivotal to our ability to make ADXS-HPV available to patients on a global scale upon approval."
SynCo's unique position through its technical and quality track record for live microbial products combined with the clinical and commercial biopharmaceutical manufacturing experience, gives the company an edge as a low risk partner to bring these product safely to the patient. The manufacturing collaboration with Advaxis means that SynCo now has experience with 16 different strains of microorganisms for multiple clients to produce biopharmaceuticals. Ten of these microorganisms are live or whole cell microbial products, with three of these products being parenterally administered hence requiring monoseptic bulk drug substance operations prior to completing the drug product.
Pierre Warffemius, Chief Executive Officer of SynCo Bio Partners, commented, "Adding Advaxis to our client portfolio, with their next generation cancer immunotherapy technology, is key to SynCo's strategic goal of becoming the number 1 CMO of choice for live microbial products. We're all looking forward to a long and successful collaboration, and improving patient healthcare."
About SynCo Bio Partners B.V.
SynCo Bio Partners B.V. is a biopharmaceutical GMP Contract Manufacturing Organization located in Amsterdam, the Netherlands, licensed for clinical and commercial GMP manufacturing of bulk drug substances and drug products. As a global player, SynCo offers a fully integrated range of biopharmaceutical development and manufacturing services supporting small biotech to large pharmaceutical organizations worldwide from the earliest stages in process development, through pre-clinical and clinical trials, biologic license approval and market supply. For more information, please visit http://www.syncobiopartners.com.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis' immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.
ADXS-HPV, Advaxis' lead immunotherapy for the treatment of HPV-associated cancers, has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has orphan drug status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted exclusive licenses for the development and commercialization of ADXS-HPV in Asia and India. For more information please visit http://www.advaxis.com
SOURCE SynCo Bio Partners B.V.