#4D MOLECULAR THERAPEUTICS LOGO TRIAL#

The aerosol delivery procedure for 4D-710 was well tolerated.4D-710 was well tolerated, with no 4D-710-related adverse events following aerosol delivery.

#4D MOLECULAR THERAPEUTICS LOGO TRIAL#

The Cohort 1 clinical trial data summarized below are as of the data cutoff date of October 7, 2022.A101 was invented at 4DMT through directed evolution (using our Therapeutic Vector Evolution platform) for aerosol delivery throughout the lungs, penetration of the mucus barrier, resistance to pre-existing antibodies in humans, and efficient transduction and transgene expression in lung airway cells.The 4D-710 product candidate comprises the CFTR∆R transgene and the proprietary targeted and evolved synthetic capsid vector A101 for aerosol delivery.We look forward to continuing to enroll the study at the next dose level, as well as to additional follow-up with these study participants to assess clinical activity.” Delivery and expression of CFTR represents a critical and successful first step toward achieving our goal of benefiting people with CF who are not eligible for modulator therapy. Notably, expression was seen in 100% of lung tissue samples analyzed. The clinical data are the first to date to demonstrate, in the lungs of people with cystic fibrosis, successful delivery and expression of the CFTR transgene after aerosol delivery of a gene therapy. Taylor-Cousar added, “In our Phase 1/2 clinical trial, I’m very encouraged by the robust and widespread transgene expression demonstrated in all three participants’ lungs at this first dose level. Taylor-Cousar, Professor, Departments of Medicine and Pediatrics, and Co-Director, Adult Cystic Fibrosis Program Director, Cystic Fibrosis Foundation Therapeutics Development Center, National Jewish Health and the lead principal investigator on the 4D-710 phase 1/2 clinical trial, presented the clinical data at the NACFC 2022 conference.ĭr. Finally, these results further validate our Therapeutic Vector Evolution platform.”ĭr. These interim results underscore the encouraging potential of 4D-710 for patients with cystic fibrosis lung disease, and the potential of our proprietary A101 vector for other lung diseases. “These landmark CFTR expression data were achieved in the CF population with the highest unmet medical need, those who are not eligible for CFTR modulators. “We are honored by the selection of our late-breaking clinical data for presentation both in the NACFC symposium today and in the clinical plenary session tomorrow,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. 4D Molecular Therapeutics will host a conference call today, November 3, 2022, at 1:30 p.m. The presentation focused on safety, tolerability, and delivery and expression of the 4D-710 CFTR∆R transgene in lung tissue samples from patients enrolled in cohort 1 (n=3 1E15 vg). (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced that interim clinical data from the Phase 1/2 clinical trial of 4D-710 for cystic fibrosis lung disease were presented at the North American Cystic Fibrosis Conference (NACFC). 03, 2022 (GLOBE NEWSWIRE) - 4D Molecular Therapeutics, Inc. Conference call & webcast to be held today at 1:30 p.m.Cohort 1 enrollment completed Cohort 2 enrollment on-going.Cohort 1 safety and tolerability of 4D-710 demonstrated to date, with no drug-related adverse events following aerosol delivery.Cohort 1 lung bronchoscopy sample results demonstrate widespread delivery and expression of the 4D-710 CFTR∆R transgene in 100% of samples from all three patients.

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