ExSight Ventures (“EV”) joined a $10 million Series B financing round in 2C Tech Corporation Inc. (the “Company” or “2C Tech”), an early-stage biotechnology company. 2C Tech is developing nanoparticle technology to treat a number of retinal degenerative conditions. EV joins select investors Hoya Corp., InFocus Capital Partners and others. This investment will enable the Company’s pursuit of an early feasibility study (“EFS”) for the treatment of Retinitis Pigmentosa (“RP”).
Since 2C Tech’s founding they have sought to bring quantum dot (“QD”) technology to patients. The Company has accomplished much to date with a relatively modest amount of capital. 2C Tech has already conducted an ex-US Phase I clinical trial to assess the safety of their QD technology in humans. The Mexico City based trial was completed in 2016. The results were promising: QDs were shown to be safe for use in humans and preliminary data suggests the technology’s efficacy in improving vision damaged by retinitis pigmentosa.
2C Tech moves toward a clinical study on the accelerated EFS pathway. The Center for Devices and Radiological Health (CDRH) “EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation.” This device pathway promises a faster and less capital-intensive time to the clinic. The EFS pathway allows for the enrollment of a small number of subjects and is used to evaluate the device design concept with respect to initial clinical safety and device functionality.
The Company expects to submit an Investigational Device Exemption application (“IDE”) to the FDA in early 2020. Once approved 2C Tech will initiate the EFS clinical trials to demonstrate efficacy and product safety. The trial protocol will include the Ora-VNC™ mobility course as a primary endpoint, a functional vision metric specifically tailored for RP patients. The approach is similar in concept to that used in the successful Spark Therapeutics trials. The majority of clinical trial sites have already been identified and await the IDE approval to begin enrollment. The first patient should be treated by the middle of 2020 with results expected in the latter part of the year.
If successful with the EFS study 2C Tech has several options for rare and orphan disease pathways that could further accelerate and expedite time to market. The technology would represent a breakthrough in treating not only patients with retinitis pigmentosa but other blinding conditions as well. Other potential indications include AMD, glaucoma and diabetic retinopathy. Dr. Rahhal stated, "2C Tech is attempting this unique application of quantum dot technology, to quickly get treatment in the hands of clinicians, using routine, well-accepted, office-based intravitreal injection. 2C Tech could soon help large numbers of patients across the entire spectrum of RP and other retinal degenerations."
The combination of strong pre-clinical data, promising clinical data and a strong leadership team gives us confidence that 2C Tech will be able to bring their device to market and greatly impact the treatment of RP patients. We are excited to be part of the 2C Tech story.