Friday, September 22, 2023

Twice Rejected Diabetes Drug/Device Product Gets New Chance at Startup i2O – MedCity News

Weight loss achieved by the class of drugs called GLP-1 receptor agonists has sparked new interest in finding additional approaches to cardiometabolic disease, shown by recent acquisition activity. Startup i2O Therapeutics could set itself apart with cardiometabolic disorder drugs that offer the efficacy of biologic medications but in oral formulations. The company has a chance to reach the market sooner with a different GLP-1 drug offering: a drug/device combination product it recently acquired. But commercialization is no sure thing. The FDA has already turned down the product candidate twice.

The newly acquired technology comes from Intarcia Therapeutics, a company that developed an implantable device that slowly delivers its drug payload over an extended period of time. Intarcia’s ITCA 650 is a matchstick-sized device implanted twice a year, administering the GLP-1 agonist exenatide for treating type 2 diabetes.

This past week, Boston-based i2O announced it had acquired ITCA 650 as well as Medici, the technology platform that developed it. Financial terms were not disclosed, but i2O is freshly capitalized, backed by a $46 million Series A financing. The startup also has a new CEO. Kurt Graves, formerly Intarcia’s top executive, was appointed chairman, president and CEO of i2O. Graves had been executive chairman of i2O’s board of directors since 2021.

Intarcia initially sought FDA approval of ITCA 650 in 2016. The FDA rejected the company’s new drug application in 2017, citing manufacturing issues. The agency turned down Intarcia’s application again in 2020, citing the risk of kidney injury. According to FDA documents posted in 2021, ITCA 650’s pivotal study led to reports of acute kidney injury (AKI) in 14 subjects compared to four subjects in the placebo arm. The regulator noted that while other GLP-1 agonists have a risk of kidney injury, ITCA 650’s risk information is based on post-marketing event reports and not on clinical testing of these medicines.

“In contrast, the risk of AKI was clearly identified in the ITCA 650 clinical trial data,” the FDA said. “This AKI risk for ITCA 650, compared to other members of the GLP-1 RA class, is particularly concerning because it was identified from these adequate and well-controlled clinical trials, which constitute stronger evidence for assessing a drug’s safety than spontaneous post-marketing adverse event reports.”

Intarcia’s appeals of the FDA rejections were denied, as was a request for an FDA advisory committee meeting. An advisory meeting was finally granted and is scheduled for Sept. 21.

The roots of i2O are at Harvard University and the research of Samir Mitragotri, a professor of bioengineering. The research focused on developing oral formulations of biologic and peptide drugs that must be administered as injections. The i2O technology platform, licensed from Harvard, makes these drugs with a unique coating that enables the medicines to hold up in the digestive system until they reach the small intestine where the active drug is released. With an initial focus on oral GLP-1 agonists, i2O unveiled a $4 million seed financing in 2020 co-led by Sanofi Ventures and the JDRF T1D Fund.

The oral GLP-1 agonist that was i2O’s initial focus is in preclinical development. The startup has five other preclinical program for type 2 diabetes, obesity, and the fatty liver disease called non-alcoholic steatohepatitis.

Here’s a recap of other recent biotech financings:

—Gene therapy startup Epigenic Therapeutics emerged with a $32 million Series A round of funding. The Shanghai-based company is developing what it describes as a next-generation gene modulation therapies for prevalent diseases. Rather than use gene-editing tools that alter the DNA sequence, Epigenic says its technology precisely modulates gene expression at epigenetic levels. The company said it will use the new capital to support preclinical development and early clinical validation of its two lead programs, whose targets were not disclosed. Epigenic’s financing was co-led by Qiming Venture Partners and OrbiMed. Earlier investor Morningside Venture Capital participated in the round.

—RA Capital Management led the $33 million seed financing of Superluminal Medicine, which joins a growing group of companies discovering and developing drugs that target G protein-coupled receptors, or GPCRs. Many of these receptors are considered undruggable. Boston-based Superluminal has a technology platform that uses generative biology and chemistry to discover small molecules capable of hitting these elusive targets. Superliminal hasn’t disclosed which GPCRs it’s targeting, but the startup says it will apply the capital toward selecting a candidate for its lead program.

—Cancer drug developer Fore Biotherapeutics raised $75 million to continue a Phase 2 study that could support a regulatory application. Philadelphia-based Fore is developing plixorafenib, a small molecule that blocks mutated versions of the BRAF protein while sparing normal versions that are found in the body. The drug has reached Phase 2 testing as a treatment for BRAF-altered solid and central nervous system tumors that have advanced after earlier lines of treatment. The new capital will support this registrational trial. Fore’s Series D round of funding was led by SR One and co-led by Medicxi.

Cellares, a startup whose technology employs robotics and software to automates cell therapy manufacturing, raised $244 million in financing. South San Francisco-based Cellares will used the capital to build a “smart factory” in Bridgewater, New Jersey. The 118,000 square-foot site will have the capacity to make 40,000 cell therapy batches annually—10 times the production capacity of a traditional contract manufacturing and development organization facility, according to the company. The New Jersey site is expected to be ready to start making cell therapies in the second half of 2024. The Series C round of funding was led by new investor Koch Disruptive Technologies.

—Neuroscience startup Rapport Therapeutics raised $150 million for therapies that target specific regions of the brain rather than acting broadly throughout the brain and central nervous system. The company, which splits its operations between Boston and San Diego, is already in the clinic with a lead program for drug-resistant seizures. This program is expected to reach Phase 2 testing next year. Cormorant Asset Management led Rapport’s Series B financing.

—The artificial intelligence-powered drug discovery of Genesis Therapeutics is now bolstered by $200 million, which the startup will use to develop small molecules that hit protein cancer targets. Those targets remain undisclosed, but executives told MedCity News that the cash will support plans to reach the clinic “in the not-too-distant future.” Genesis’s Series B financing was co-led by Andreesen Horowitz.

—Abcuro, a biotech that aims to treat autoimmune diseases and cancer by precisely modulating T cells and natural killer cells, raised $155 million. The Newton, Massachusetts-based company will use the cash to continue pivotal testing of ABC008, an antibody drug that addresses a target called KLRG1 to treat inclusion body myositis, an inflammatory condition that causes muscle weakness. Abcuro’s Series B financing was led by Redmile Group and Bain Capital Life Sciences.

Photo: RomoloTavani, Getty Images 

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