Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced that it has initiated plans to lease a build-to-suit 21,000 square foot current Good Manufacturing Practices (cGMP) manufacturing and quality control facility adjacent to its Florida facility to prepare for anticipated late-stage development of its X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) programs. Build-out of this cGMP facility, which is expected to be completed in the second half of 2022, is part of the Company’s strategy to enable more rapid filing of a Biologics Licensing Application and commercial launch of its XLRP candidate upon potential United States Food and Drug Administration (FDA) approval. The cGMP facility is also expected to support more rapid advancement of the Company’s product pipeline while providing supply chain redundancy and reducing manufacturing risk.
“This manufacturing build-out reinforces our commitment to the advancement of our XLRP candidate through a Phase 2/3 clinical trial and, if approved, eventual commercialization. We are taking steps to increase control over our cGMP manufacturing and analytical release to ensure that we can meet anticipated future demand for our current clinical candidates and our exciting pre-clinical opportunities,” said Sue Washer, President and Chief Executive Officer of AGTC. “This state-of-the-art manufacturing facility will provide us with the flexibility to pursue additional indications that have large patient populations and/or require substantially higher doses to provide efficacy.”
The Company presented new data from two studies related to improvements in the manufacturing process for its XLRP gene therapy candidate on May 11, 2021 at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting, which was held virtually May 11-14, 2021. These improvements will support manufacturing and quality release for the Phase 2/3 Vista trial by our current manufacturing partners, and potential late-stage trials for ACHM as the Company works toward finalizing a commercial manufacturing process that could meet potential market demand.
On May 6, 2021, AGTC reported new data from its ongoing Phase 1/2 XLRP clinical trial that further support the best-in-class potential of its XLRP candidate. The updated data among patients who met the inclusion criteria for the Skyline and Vista trials show a 50% response rate in Groups 5 and 6 at month 12 based on improvements in visual sensitivity; a statistically significant difference with respect to visual acuity in treated compared with untreated eyes for patients in Groups 2, 4, 5 and 6 and month 12; and continued durability of response at month 24 in two of three Group 4 patients available for evaluation at the time point. The complete 12-month data will be presented at the American Academy of Ophthalmology annual meeting in November 2021 and the Company remains on track to report 3-month masked interim Skyline data in the fourth quarter of 2021, 12-month Skyline data in the third quarter of 2022, and 6-month masked interim Vista the fourth quarter of 2022.
“We are confident that our expanding body of data supports the unparalleled potential of our XLRP product candidate, and we are moving quickly to advance commercialization plans on multiple fronts,” said David R. Knop, Ph.D., Vice President of Process Development at AGTC. “We have developed a robust, reproducible, scalable and highly productive AAV manufacturing process and associated analytics, which allows for a modest sized facility to fulfill supply requirements through commercialization.”
The Company plans to support its cGMP manufacturing and quality control strategic investment through a combination of robust tenant improvement allowances and tiered rental rates during construction of the build-to-suite facility. Equally as important, on May 13, 2021, the Company amended its Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (NYSE: HTGC). Under the amended Loan Agreement, a second term loan advance of $10.0 million was authorized and advanced to the Company. Additionally, the interest-only period and loan maturity date were extended to March 31, 2022 and April 1, 2024, respectively, and, in the event that the Company meets certain conditions, including achievement of performance milestones, the Company has the ability to further extend those dates. The Company also has the right, subject to the lenders’ sole discretion, to receive additional term loan advances of up to $5.0 million prior to April 1, 2022 or, if certain conditions are satisfied, then prior to January 1, 2023. All other material terms of the Loan Agreement were unchanged.
“This additional funding from Hercules Capital will support AGTC’s investment in internal manufacturing capabilities, while further advancing its clinical pipeline. We are pleased to be able to amend our current debt facility and provide the additional growth capital to support these efforts,” said Bryan Jadot, Senior Managing Director and Life Sciences Group Head for Hercules.