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Synthetic Biologics Developing Monoclonal Antibodies To Treat Acinetobacter Infections

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Synthetics Biologics
(credit: istock) Technology Report
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ANN ARBOR — Synthetic Biologics Inc. (NYSE: SYN), a developer of synthetic biologics and innovative medicines for serious diseases and unmet medical needs, today announced that it has initiated efforts to develop a monoclonal antibody (mAb) therapy for the treatment of acinetobacter infections.

Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected by natural disasters.

The company also announced that it has engaged Lewis Barrett, former assistant vice president, established products at Pfizer and vice president global business manager, infectious diseases at Wyeth Pharmaceuticals, to bring his expertise in the development, commercialization and launch of infectious disease product candidates to the Synthetic Biologics team.

Acinetobacter is a difficult to treat pathogen due to its rapid and well-established resistance to most antibiotics, making it a multidrug-resistant pathogen. In addition, as a biofilm-forming pathogen, Acinetobacter has the ability to survive up to twice as long as non-biofilm-forming pathogens. In the United States, Acinetobacter has been reported to be the cause of up to 2.6 percent of hospital acquired infections, 1.3 percent of bloodstream infections and 7 percent of ICU respiratory tract infections and more than half of the Acinetobacter isolates are multidrug-resistant.  Patients with infections caused by Acinetobacter have been reported having mortality rates ranging from 7.8 to 43 percent in the hospital and in the ICU. While Acinetobacter is a well-documented pathogen in the hospital setting, this pathogen also poses an increasing danger to wounded servicemen and women in military treatment centers and to those treated in trauma centers following natural disasters.

The initiation of mAb development for the treatment of acinetobacter infection is the first of the three initial targeted infectious diseases the Company intends to pursue as part of its most recent collaboration with Intrexon Corp. In August 2012, Synthetic Biologics entered into a worldwide exclusive channel collaboration with Intrexon Corp. for the development and commercialization of mAb therapies to treat certain infectious diseases not adequately addressed by existing therapies. Under this collaboration, the company intends to use Intrexon’s comprehensive suite of proprietary technologies, including the mAbLogix and LEAP platforms, to develop fully human mAbs to specifically and rapidly neutralize/clear acinetobacter pathogens. The collaboration may optionally be expanded to include up to an additional five infectious disease indications.

“We are pleased to begin work on a mAb therapy to treat acinetobacter infections. Acinetobacter has developed an increased resistance to antibiotics and other drugs over time, and a new therapeutic option is needed to treat infectious diseases caused by this bacteria,” said Jeffrey Riley, CEO of Synthetic Biologics Inc. “Our collaboration with Intrexon provides access to state-of-the-art platforms that have tremendous potential to produce a broad spectrum of fully human antibodies to fight against Acinetobacter where other options have failed.”

And, Riley added, “We welcome Lew Barrett to our team and look forward to benefiting from his many years of experience around the development and commercialization of anti-infectives, as we develop mAbs for the treatment of acinetobacter infections. We also look forward to disclosing additional infectious disease indications we intend to pursue in the near future.”

During his 25-year career at Wyeth, acquired by Pfizer in 2009, Barrett successfully led, co-chaired or served as the senior marketing executive on teams that focused on infectious diseases, oncology, transplantation, and hemophilia. He brings to Synthetic Biologics his expertise in U.S. and global strategy, domestic and global branding, clinical development, medical affairs, supply chain, business development and strategic alliance management. He built the brand and led global commercialization efforts for Wyeth’s in-line IV antibiotic, Zosyn/Tazocin (the second IV antibiotic to achieve more than $1 billion in sales), and managed the U.S. launch of Wyeth’s broad-spectrum IV antibiotic, Tygacil. In 2010, Barrett formed LL Barrett Biopharmaceutical Consulting LLC, providing consulting to the life sciences field with a particular focus on brand strategy, lifecycle strategy, business development, and strategic communications.

“Acinetobacter has consistently demonstrated its ability to rapidly develop resistance to antibiotics,” Barrett said. “We believe the threat of this pathogen coupled with a scarcity of new antibiotics creates a perfect storm … I look forward to working with the Company as they work toward developing new therapeutic candidates for a field of medicine where the availability of effective interventions has declined.”

Acting as the body’s army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. MAbs can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient’s own immune system by providing the means to specifically and rapidly neutralize or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to use Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs for human testing and use to specifically treat certain infectious diseases for which current therapies are unavailable or inadequate.

More at www.syntheticbiologics.com.

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