Amgen and Entera to Collaborate on Orally Administered Biologics

Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.

Entera will use its proprietary platform to develop the formulations, first for 1 preclinical large-molecule product that Amgen has selected. Amgen also retains an option for up to 2 additional programs to be included in the collaboration.

Entera, an Israel-based clinical-stage biotech company, says that its technology consists of 2 components: a small molecule that enhances absorption of large-molecule therapeutics, and a component that protects the large molecule from digestion in the gastrointestinal tract. This system, it says, increase oral bioavailability and decreases variability associated with oral administration of large molecules.

“We are excited to leverage our proprietary oral drug delivery platform in collaboration with Amgen, a leader in the development of large molecule and biologic treatments in inflammatory disease and numerous other disorders,” said Phillip Schwartz, PhD, CEO of Entera, in a statement. “This collaboration is an important validation of our platform technology.”

Under the terms of the agreement, Entera will receive an access fee from Amgen and will undertake preclinical development of the proposed product at Amgen’s expense. As it achieves various clinical and commercial milestones, Entera will be eligible to receive up to $270 million from Amgen in aggregate payments, plus tiered royalties.

Entera and Amgen are not the first to venture into the world of oral biologics; a fellow Israel-based company, Protalix BioTherapeutics, Inc, announced in March of this year that its OPRX-106, an orally administered biologic, had met its key efficacy end points in a phase 2 clinical trial. Protalix’s proposed drug is a plant cell—expressed recombinant human tumor necrosis factor (TNF) receptor II fused to an IgG1 Fc domain that is intended to treat inflammatory bowel disease.

Protalix says that the plant cells in its drug act as a delivery vehicle and have a unique attribute of a cellulose cell wall that allows them to resist the degradation that is inherent to proteins produced via mammalian expression as they pass through the digestive tract.

At least 1 other developer has attempted to produce an oral TNF inhibitor; in 2016, Avaxia Biologics reported positive results of a first-in-human trial of its AVX-470, a polyclonal bovine-derived anti-TNF drug, in patients with ulcerative colitis, saying that the agent was safe and well tolerated in the trial. However, Circle33 LLC, which later acquired the patent on the product, had not reported further developments.