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SynCo Bio Partners Expands Live Microbial Product Experience

February 11, 2014

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. [http://www.syncobiopartners.com ], 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. [http://www.advaxis.com ] (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.


Source: PR Newswire



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