Many of our patient community have requested information about the COVID-19 vaccines and concerns related to the potential to develop cross-reactive antibodies to the AAV used in gene therapy.

In response to our questions, Audentes Therapeutics, the pharmaceutical company who are responsible for developing the AT132 gene therapy for x-linked myotubular myopathy, would like us to share the following information with you.

1. The Audentes team shares in the global optimism that safe, effective, approved vaccines will soon be available to protect against the SARS-CoV-2 virus, the cause of the COVID-19 pandemic.

2. There are many different vaccine strategies being investigated simultaneously, including some that transfer COVID-19 DNA or RNA using viral or non-viral vectors.

3. The use of viral vectors as a vaccine strategy against COVID-19 has raised questions about vector-directed immune responses in recipients of future approved vaccines and implications regarding future candidacy for gene therapies using similar viral vectors.

4. Some COVID-19 vaccines deliver mRNA via lipid nanoparticles, and would not be expected to result in cross-reactivity with an AAV-based therapy
Other vaccines being investigated use adenovirus, which is a different virus than adeno-associated virus (AAV) and would not be expected to result in cross-reactivity.

5. At this time, we do not anticipate changing the inclusion/exclusion criteria for our clinical trials based upon vaccine status.

6. Audentes continues to monitor the COVID-19 vaccine development landscape, detailed information about emerging vaccine candidates, as well as other expert guidance.

7. Should concerns in these matters arise about a particular vaccine candidate, Audentes will communicate this to the patient community

8. Patients and families should speak with their healthcare professional to have an informed discussion about this topic.

9. If your healthcare professional has any questions related to how approved vaccines or treatments involving AAV vectors might impact future eligibility for our investigational therapies, your healthcare professional is welcome to email our Medical Affairs team at medinfo@audentestx.com

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COVID19 Vaccine Q&A 18DEC2020 Portuguese and Brazil

In case you would like more information, Parent Project Muscular Dystrophy recently hosted a webinar on this topic, which you can view here: https://www.parentprojectmd.org/aiovg_videos/covid-19-vaccination-duchenne-what-you-need-to-know-december-11-2020/