TFF Pharmaceuticals, Felix Biotechnology sign LOI for collaboration, development and licence agreement

TFF Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, and Felix Biotechnology, a clinical stage, biotherapeutic-based antibiotic development company, jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties’ non-binding agreement in principle to negotiate and enter into a collaboration, development and licence agreement (CDLA).

Under this proposed CDLA agreement, Felix Biotechnology would obtain a worldwide license to TFF Pharmaceuticals’ Thin Film Freezing technology to develop and manufacture dry powder formulations of a novel, bacteriophage-based biotherapeutics for inhalation delivery directly to the lungs of patients.

Under the terms of the proposed CDLA and in exchange for the license to the TFF technology, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix biotherapeutics. A definitive CDLA is subject to the mutual agreement of the parties and a number of conditions, including Felix Biotechnology’s successful completion of a Series A financing.

“We are very excited to be pursuing an agreement with Felix Biotechnology, a company on the leading edge of developing bacteriophage therapies that initially are targeting bacterial lung infections,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

“We believe the reformulation of these unique, complex biologics using our TFF technology would represent a first-of-its-kind breakthrough and could provide a more effective and targeted delivery mechanism to the deep lung of patients. We look forward to working towards a final agreement and seeing this breakthrough technology advance into the clinic and beyond.”

“Our goal at Felix is not only to develop but also to deploy innovative solutions to tackle the growing and unmanaged challenge of antibiotic resistant bacterial infections. We currently deliver our generalized phage therapy directly to the lung via nebulization, and have done so successfully in humans. Our lead asset, targeting Pseudomonas infections in the lungs of CF patients is currently being evaluated in a double-blind, placebo-controlled trial at Yale in 36 patients,” said Rob McBride, CEO of Felix Biotechnology. “We are excited to continue developing cutting edge and effective phage delivery solutions to our patients and our collaboration with TFF represents an important next step for us on this path.”

“Bacteriophages, which are bacterial viruses that infect specific strains of a single bacteria species, are highly relevant as therapeutic alternatives to antibiotics because of the prevalence of multidrug resistance to antibiotics,” said Robert O. Williams III, Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and an inventor of TFF Pharmaceutical’s Thin Film Freezing technology.

“The challenge, historically, of delivering bacteriophages is that their formulations have not been well optimized, limiting their shelf-life and subsequent potency. Many of these formulations also require cold-chain storage,” continued Williams. “We have demonstrated that Thin Film Freezing can convert liquid bacteriophage into a dry powder that can be stored at typical room temperatures. This dry powder form of the bacteriophage can then be administered by intranasal/inhalation delivery to the lungs, or by injection after reconstitution at the point-of-use.”

In May of 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Felix Biotechnology supplied various phage product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Felix phage products, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included titer testing and neutralization testing, both parties agreed to begin negotiating a licensing arrangement.