Weight reduction achieved by the category of medicine referred to as GLP-1 receptor agonists has sparked new curiosity to find extra approaches to cardiometabolic illness, proven by current acquisition exercise. Startup i2O Therapeutics may set itself aside with cardiometabolic dysfunction medicine that provide the efficacy of biologic drugs however in oral formulations. The corporate has an opportunity to achieve the market sooner with a unique GLP-1 drug providing: a drug/gadget mixture product it just lately acquired. However commercialization is not any positive factor. The FDA has already turned down the product candidate twice.
The newly acquired expertise comes from Intarcia Therapeutics, an organization that developed an implantable gadget that slowly delivers its drug payload over an prolonged time frame. Intarcia’s ITCA 650 is a matchstick-sized gadget implanted twice a 12 months, administering the GLP-1 agonist exenatide for treating kind 2 diabetes.
This previous week, Boston-based i2O introduced it had acquired ITCA 650 in addition to Medici, the expertise platform that developed it. Monetary phrases weren’t disclosed, however i2O is freshly capitalized, backed by a $46 million Collection A financing. The startup additionally has a brand new CEO. Kurt Graves, previously Intarcia’s prime government, was appointed chairman, president and CEO of i2O. Graves had been government chairman of i2O’s board of administrators since 2021.
Intarcia initially sought FDA approval of ITCA 650 in 2016. The FDA rejected the corporate’s new drug software in 2017, citing manufacturing points. The company turned down Intarcia’s software once more in 2020, citing the chance of kidney harm. In line with FDA paperwork posted in 2021, ITCA 650’s pivotal research led to stories of acute kidney harm (AKI) in 14 topics in comparison with 4 topics within the placebo arm. The regulator famous that whereas different GLP-1 agonists have a danger of kidney harm, ITCA 650’s danger info is predicated on post-marketing occasion stories and never on scientific testing of those medicines.
“In distinction, the chance of AKI was clearly recognized within the ITCA 650 scientific trial knowledge,” the FDA stated. “This AKI danger for ITCA 650, in comparison with different members of the GLP-1 RA class, is especially regarding as a result of it was recognized from these satisfactory and well-controlled scientific trials, which represent stronger proof for assessing a drug’s security than spontaneous post-marketing opposed occasion stories.”
Intarcia’s appeals of the FDA rejections have been denied, as was a request for an FDA advisory committee assembly. An advisory assembly was lastly granted and is scheduled for Sept. 21.
The roots of i2O are at Harvard College and the analysis of Samir Mitragotri, a professor of bioengineering. The analysis centered on creating oral formulations of biologic and peptide medicine that should be administered as injections. The i2O expertise platform, licensed from Harvard, makes these medicine with a novel coating that permits the medicines to carry up within the digestive system till they attain the small gut the place the energetic drug is launched. With an preliminary concentrate 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 preliminary focus is in preclinical improvement. The startup has 5 different preclinical program for kind 2 diabetes, weight problems, and the fatty liver illness referred to as non-alcoholic steatohepatitis.
Right here’s a recap of different current biotech financings:
—Gene remedy startup Epigenic Therapeutics emerged with a $32 million Collection A spherical of funding. The Shanghai-based firm is creating what it describes as a next-generation gene modulation therapies for prevalent ailments. Reasonably than use gene-editing instruments that alter the DNA sequence, Epigenic says its expertise exactly modulates gene expression at epigenetic ranges. The corporate stated it can use the brand new capital to help preclinical improvement and early scientific validation of its two lead applications, whose targets weren’t disclosed. Epigenic’s financing was co-led by Qiming Enterprise Companions and OrbiMed. Earlier investor Morningside Enterprise Capital participated within the spherical.
—RA Capital Administration led the $33 million seed financing of Superluminal Medication, which joins a rising group of corporations discovering and creating medicine that focus on G protein-coupled receptors, or GPCRs. Many of those receptors are thought-about undruggable. Boston-based Superluminal has a expertise platform that makes use of generative biology and chemistry to find small molecules able to hitting these elusive targets. Superliminal hasn’t disclosed which GPCRs it’s concentrating on, however the startup says it can apply the capital towards deciding on a candidate for its lead program.
—Most cancers drug developer Fore Biotherapeutics raised $75 million to proceed a Section 2 research that would help a regulatory software. Philadelphia-based Fore is creating plixorafenib, a small molecule that blocks mutated variations of the BRAF protein whereas sparing regular variations which are discovered within the physique. The drug has reached Section 2 testing as a therapy for BRAF-altered strong and central nervous system tumors which have superior after earlier strains of therapy. The brand new capital will help this registrational trial. Fore’s Collection D spherical of funding was led by SR One and co-led by Medicxi.
—Cellares, a startup whose expertise employs robotics and software program to automates cell remedy manufacturing, raised $244 million in financing. South San Francisco-based Cellares will used the capital to construct a “good manufacturing facility” in Bridgewater, New Jersey. The 118,000 square-foot website may have the capability to make 40,000 cell remedy batches yearly—10 instances the manufacturing capability of a conventional contract manufacturing and improvement group facility, in accordance with the corporate. The New Jersey website is anticipated to be prepared to start out making cell therapies within the second half of 2024. The Collection C spherical of funding was led by new investor Koch Disruptive Applied sciences.
—Neuroscience startup Rapport Therapeutics raised $150 million for therapies that focus on particular areas of the mind moderately than performing broadly all through the mind and central nervous system. The corporate, which splits its operations between Boston and San Diego, is already within the clinic with a lead program for drug-resistant seizures. This program is anticipated to achieve Section 2 testing subsequent 12 months. Cormorant Asset Administration led Rapport’s Collection B financing.
—The factitious 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 most cancers targets. These targets stay undisclosed, however executives informed MedCity Information that the money will help plans to achieve the clinic “within the not-too-distant future.” Genesis’s Collection B financing was co-led by Andreesen Horowitz.
—Abcuro, a biotech that goals to deal with autoimmune ailments and most cancers by exactly modulating T cells and pure killer cells, raised $155 million. The Newton, Massachusetts-based firm will use the money to proceed pivotal testing of ABC008, an antibody drug that addresses a goal referred to as KLRG1 to deal with inclusion physique myositis, an inflammatory situation that causes muscle weak point. Abcuro’s Collection B financing was led by Redmile Group and Bain Capital Life Sciences.
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