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BioFactura’s Ustekinumab Biosimilar To Be Trialed As ‘Robotic’ Pill

US-Based Firm Signs Agreement With CA-Based Rani Therapeutics

Executive Summary

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

BioFactura is joining forces with Rani Therapeutics Holdings, Inc. to assess BioFactura’s BFI-751 biosimilar Stelara (ustekinumab) candidate with Rani’s RaniPill platform technology, which intends to replace subcutaneous or intravenous injection of biologics with pain-free oral dosing, in the form of a ‘robotic’ pill.

According to the California-based biotech, the RaniPill platform technology enables the drug to navigate through the patient’s stomach and enter the small intestine. The RaniPill capsule then goes through a transformation and aligns itself to inject the drug into the intestinal wall.

“Rani will conduct preclinical studies to determine whether BFI-751 can successfully be delivered into the bloodstream, when administered orally via the RaniPill capsule,” BioFactura noted.

The company’s chairman and chief medical officer, Jeffrey Hausfeld, said it was “very exciting being on the cutting edge of technology. Bringing together our Stelara biosimilar with Rani's oral platform is a good example of BioFactura’s mission to continuously innovate, provide patients with high quality products, and offer improved value and accessibility.”

US-based biologics firm BioFactura earlier this year became the latest to join the crowd of biosimilars developers targeting Janssen’s $8bn Stelara brand, announcing the start of Phase I trials for the BFI-751 version of the inflammatory diseases treatment that is being developed by its BioFactura Australia arm. (Also see "BioFactura Joins Stelara Biosimilar Crowd" - Generics Bulletin, 26 May, 2021.)

Billing the Phase I study for BFI-751 as the “first clinical trial from BioFactura’s pipeline of high-value biosimilar and biodefense drugs,” the company said the candidate – developed using the firm’spatented StableFast platform – would undergo a pivotal pharmacokinetics assessment to assess its effects on healthy human volunteers compared to EU- and US-licensed Stelara following a single dose under the skin.

The randomized, double-blind trial will also assess the safety and tolerability of BFI-751 in 210 healthy volunteers and their immune response.

“This is the first time BFI-751 has been administered to humans, as authorized by the ethics committees in both Australia and New Zealand,” the firm noted at the time, adding that “the first three sentinel groups have been dosed with no significant adverse events reported to date.”

Last month, Rani Therapeutics conducted an initial public offering, raising around $73m in new capital that was, ultimately, short of its $100m target. Ahead of its public listing, the company had raised more than $200m in venture funding, including $69m through a Series E round in December last year. (Also see "Finance Watch: VC Mega-Rounds Fund Wide Array, From Respiratory To Rare Diseases" - Scrip, 10 Dec, 2020.)

The company has already conducted early human studies with AbbVie’s inflammatory disease blockbuster Humira (adalimumab), AstraZeneca’s diabetes drug Bydureon (exenatide) and the synthetic hormone Novartis’s Sandostatin (ocreotide) in which the RaniPills have shown bioavailability similar to the subcutaneous injections.

Among a crowded field of developers, Hikma recently announced an agreement worth up to $150m to in-license Bio-Thera Solutions’ BAT2206 biosimilar ustekinumab candidate in the US (see sidebar).

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