Wednesday, January 25, 2012

BARDA biothreat contract could bring $40M to Tetraphase

By Lori Valigra

Synthetic chemistry company Tetraphase Pharmaceuticals Inc. of Watertown could get $40 million from a federal contract to develop an antibiotic to potentially treat illnesses resulting from biological threats such as anthrax, tularemia or pestis, the company told Mass High Tech in an interview.

The money is part of a $67.2 million, five-year contract awarded to Tetraphase and its partner CUBRC Inc. of Buffalo, N.Y., from the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA). The contract is to develop Tetraphase’s lead compound, TP-434, to treat abdominal infections arising from biothreats. It follows a contract awarded last October worth a potential $36 million from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health. That contract is to develop Tetraphase’s antibiotic candidate TP-271 into a defense against lung infections caused by biothreats.

“This is a significant award,” Tetraphase CFO David Lubner said of the BARDA monies. “It’s an opportunity to take in non-dilutive funding and take the product to the next phase of development.” He said the money will pay for a significant number of Phase 1 trials and a Phase 2 trial.

The contract is for $11.4 million in the first year, with the potential for a four-year extension to a total value of $67.2 million. The contract, funded under the Broad Spectrum Antimicrobials Program led by BARDA, supports drug testing in clinical and animal studies, as well as fine-tuning of drug manufacturing. It also supports development of both oral and intravenous formulations. Tetraphase is currently developing TP-434 to treat complicated intra-abdominal infections.

Lubner said CUBRC will handle preclinical work on the drug’s efficacy and toxicity, while Tetraphase is responsible for manufacturing and clinical development, which will bring in about $40 million of the total $67 million pie.

Tetraphase is looking toward a growth spurt this year, depending on the results of a Phase 2 trial of TP-434 for intra-abdominal infections expected in the second quarter. “We would then look at a variety of financing, including private money, an IPO or a partnership,” Lubner said. The company last took in venture funding through a $45 million Series C round in June 2010. It was led by Excel Venture Management. Return backers CMEA Ventures, Flagship Ventures, Fidelity Biosciences, Mediphase Venture Partners and Skyline Ventures also participated in the round.

Guy Macdonald, CEO of Tetraphase, described TP-434 as a broad-spectrum antibiotic that can be given both orally and by injection. He explained that an injection could get the drug into a patient faster than oral administration, and that in the early stages, patients can be so sick they cannot swallow pills. Once they improve, then can take antibiotics orally.

So far, the results of early tests have been promising, he noted. “Preclinical data shows good activity against gram positive bacteria and against multi-drug resistant gram negative bacteria,” he said, adding that this is the first time a fully synthetic antibiotic has been made. Synthetic antibiotics have the potential to have novel profiles that can overcome antibiotic resistance, which has remained a challenge to antibiotic makers because bacteria change so quickly, he said.

TP-434 is one of four antibiotic drug candidates under development by Tetraphase, which was spun out of Harvard University in November 2006 and raised $25 million in a Series A financing. The company’s development efforts are based on fundamental technology developed by Professor Andrew Myers and his colleagues in Harvard’s Department of Chemistry and Chemical Biology. The Myers technology overcomes a key barrier to developing new tetracyclines by enabling their total synthesis from basic building blocks, according to the company.

TP-271 is still in preclinical efficacy studies, with a goal to get it into Phase 1 studies in the later stage of the government contract, Lubner said. TP-2758 is in the first stages of a Phase 1 trial in urinary tract infections that is expected to be completed in the first half of this year. And TP-834 is for community-acquired pneumonia, and investigational new drug work has just been completed, Macdonald added.

The company currently has 30 employees, and will add about 10 people selectively in chemistry and biology to advance compounds through contracts over the next two to four years, Lubner said. He added that the end to the TP-434 trial is “an important milestone that is approaching. Depending on the outcome, it could transform the company.”