AmpliPhi’s wholly owned GMP facility now capable of producing material for over 100,000 doses from each drug substance batch of AB-SA01, sufficient to support clinical trial requirements
PUBLIC COMPANY INFORMATION:
SAN DIEGO–(BUSINESS WIRE)–AmpliPhi Biosciences Corporation (NYSE AMERICAN: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for patients with serious and life-threatening antibiotic-resistant bacterial infections, today announced a 10-fold increase in yield from its manufacturing process, the result of a continuous and ongoing effort to enhance manufacturing efficiencies for AB-SA01, the company’s clinical stage lead drug product candidate. AB-SA01 is a targeted bacteriophage therapeutic in clinical development for the treatment of serious and life-threatening S. aureus infections, including those that do not respond to antibiotic therapy.
“The improved manufacturing productivity that we have achieved for AB-SA01 is an important milestone for AmpliPhi as we seek to develop our bacteriophage therapeutics for patients suffering from life-threatening bacterial infections,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “We believe our GMP manufacturing facility now has the capacity to produce AB-SA01 needed for our planned clinical trials, and through the potential filing of a biologics license application and regulatory approval.”
Each drug substance batch produced at AmpliPhi’s wholly owned GMP facility can now provide material for over 100,000 doses, an increase in yield of approximately 10-fold compared to its previous manufacturing process capability.
During 2017-2018, over 1,000 doses of bacteriophage therapeutics from AmpliPhi’s facility were provided to patients with life-threatening infections not responding to antibiotics, under emergency treatment protocols as part of the company’s expanded access program.
In September 2018, AmpliPhi announced that the U.S. Food and Drug Administration (FDA) was in general agreement with the company’s trial designs for Phase 1/2 clinical trials for AB-SA01 in patients with S. aureusbacteremia and, separately, in patients with a hip or knee prosthetic joint infection due to S. aureus as an adjunct to surgical treatment. AmpliPhi intends to initiate the S. aureus bacteremia clinical trial in 2019.
AB-SA01 is a clinical stage targeted bacteriophage therapeutic candidate in clinical development for the treatment of serious and life-threatening S. aureus infections, including those that do not respond to any antibiotics. In preclinical studies, AB-SA01 demonstrated broad activity against 95% of global S. aureusmultidrug-resistant clinical isolates. AB-SA01 is manufactured in a GMP-certified facility dedicated to the production of bacteriophage products for human use.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on discovering and developing targeted therapeutics for patients with serious and life-threatening infectious diseases, including bacterial infections that are resistant to all antibiotics. AmpliPhi’s lead investigational product candidates are bacteriophage therapeutics that target Staphylococcus aureus and Pseudomonas aeruginosa, which are included as High and Critical on the WHO Priority Pathogens List. Bacteriophage therapeutics are uniquely positioned to address the threat of antibiotic resistance as they can be precisely targeted to kill pathogenic bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilm, and have been shown to restore antibiotic sensitivity to drug-resistant bacteria.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding: AmpliPhi’s intention to initiate a clinical trial of AB-SA01 for S. aureus bacteremia in 2019; the capacity of AmpliPhi’s manufacturing facility to produce sufficient quantities of AB-SA01 for its planned clinical trials, and through the potential filing of a biologics license application and regulatory approval; the potential benefits of phage therapy; and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics or are associated with biofilms. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with manufacturing bacteriophage product candidates; bacteriophage product candidate development, generally, through expanded access regulations, and in the clinic; AmpliPhi’s financial condition; and other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission (SEC), and AmpliPhi’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.