...we knew of the importance of the timeline for AveXis in this gene therapy application, an important new area of development for AveXis as well as G-CON.
COLLEGE STATION, Texas (PRWEB) October 23, 2017
G-CON today announced the completion and delivery of a G-CON POD® system to AveXis, Inc., a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. AveXis will produce AVXS-101, a treatment for patients with spinal muscular atrophy (SMA) Type 1, pursuant to its Good Manufacturing Practice (GMP) commercial manufacturing process in the PODs, for its pivotal trial of AVXS-101. The POD-based facility is the production site to supply the pivotal and future trials and, should AVXS-101 be approved for marketing, will be capable of meeting projected commercial demand.
The PODs form the Upstream, Downstream, and Filling unit operations as well as labs, connecting corridors and material air locks. The clean room classifications of the PODs include ISO 8/Grade D and ISO 7/Grade C spaces, Grade B spaces, and ISO 5/Grade A classifications. The PODs will include their own independent once through HVAC systems, internal electrical power distribution, controls (POD Automation controls for temp, humidity and pressure control), fire suppression (FM-200), and utility panels/distribution piping within the POD structure.
After surveying the market for flexible and re-purposeable cleanroom options, AveXis chose G-CON’s POD® technology for their processing needs, as it provided the most comprehensive as well as time and cost efficient solution.
Maik Jornitz, President and CEO of G-CON Manufacturing stated: “We committed to an aggressive timeframe for delivery and installation of our largest project to date because we knew of the importance of the timeline for AveXis in this gene therapy application, an important new area of development for AveXis as well as G-CON. We were further motivated by the potential importance of this therapy. Our team worked hard to make sure that we provided the quality and functionality required so that this clinical work could be successfully completed on the customer’s timeframe.”
AVXS-101 is a proprietary gene therapy candidate of a one-time treatment for SMA Types 1 and 2, designed to address the monogenic root cause of SMA and prevent further muscle degeneration by addressing the defective and/or loss of the primary SMN gene. AVXS-101 also targets motor neurons, providing rapid onset of effect and crossing the blood brain barrier to allow targeting of both central and systemic features.
About AveXis, Inc.
AveXis is a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. The company’s initial proprietary gene therapy candidate, AVXS-101, is in the pivotal phase of study for the treatment of SMA Type 1. The company also intends to expand the study of gene therapy into SMA Type 2 and two additional rare neurological monogenic disorders: Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.
For additional information, please visit http://www.avexis.com.
About G-CON Manufacturing
G-CON Manufacturing designs, builds and installs prefabricated, autonomous cleanroom PODs®. G-CON’s cleanroom POD® portfolio provides a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. The POD® cleanroom units surpass traditional cleanroom structures by virtue of their scalability, mobility and the possibility of repurposing the PODs® once the production process reaches its lifecycle end. For more information, please visit the G-CON’s website at http://www.gconbio.com.
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, AveXis’ research, development and regulatory plans for AVXS-101 for the treatment of patients with SMA Type 1. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the scope, progress, expansion, and costs of developing and commercializing AVXS-101, as well as other factors discussed in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of AveXis’ Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 16, 2017, and AveXis’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed with the SEC on August 10, 2017. In addition to the risks described above and in AveXis’ other filings with the SEC, other unknown or unpredictable factors also could affect AveXis’ results. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Investors are cautioned not to rely too heavily on the forward-looking statements in this release. These forward-looking statements speak only as of the date of this press release. Forward-looking statements will not be publicly updated or revised, whether as a result of new information, future events or otherwise, except as required by law.