ZIP CODE FOR 4D MOLECULAR THERAPEUTICS UPDATE
ZIP CODE FOR 4D MOLECULAR THERAPEUTICS FULL
ZIP CODE FOR 4D MOLECULAR THERAPEUTICS LICENSE

ZIP CODE FOR 4D MOLECULAR THERAPEUTICS FULL

We are pleased to regain full rights to our 4D-110 product candidate for choroideremia, and to develop it further within our wholly-owned ophthalmology product portfolio,” said David Kirn, M.D., Chief Executive Officer, President and Co-founder. We expect to release initial 4D-110 biologic activity data in the fourth quarter of this year when at least six months of follow-up are available for all currently enrolled patients, and after the 90-day transition period with Roche is completed. “We believe the initial clinical tolerability and adverse event profile data in twelve patients from our two intravitreal rare disease ophthalmology clinical trials, performed under 4DMT INDs, demonstrate the potential of our intravitreal product platform.

ZIP CODE FOR 4D MOLECULAR THERAPEUTICS UPDATE

4DMT will conclude the Roche-funded clinical trial under the collaboration and plans to subsequently transfer previously treated patients onto a 4DMT-sponsored long-term follow-up study to continue monitoring biologic activity endpoints, safety and tolerability.ĤDMT Rare Disease Ophthalmology Product Candidate Portfolio Update The company plans to submit to FDA safety and efficacy data from the completed Phase 1 clinical trial along with a new clinical study protocol as soon as possible. Based on the totality of the data generated to date, 4DMT intends to continue clinical development. As a result, 4DMT will regain full rights to 4D-110.ĤDMT has not changed its position on the potential of 4D-110 for choroideremia, a devastating blinding disease with no approved therapies.

ZIP CODE FOR 4D MOLECULAR THERAPEUTICS LICENSE

Subsequently, Roche sent a notice of termination without cause of the Collaboration and License Agreement, effective as of September 16, 2021.

Roche requested that 4DMT conclude the Roche-funded 4D-110 trial in advanced choroideremia patients as a result of Roche’s assessment of a change in the risk-benefit profile. Update on Roche Collaboration and License Agreement 4DMT will regain full-rights to 4D-110 as a result of Roche’s termination of the Collaboration and License Agreement under which 4DMT had licensed to Roche certain rights to 4D-110ĮMERYVILLE, Calif., J(GLOBE NEWSWIRE) - 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced an update on their rare disease ophthalmology product candidate portfolio including Phase 1 dose escalation clinical trial safety and tolerability data with 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa (XLRP) (n=12 patients total), and that the company received a notice of termination of the Collaboration and License Agreement by 4D-110 licensee Roche resulting in full rights to 4D-110 reverting to 4DMT.4D-125: Initial clinical safety data at both of the two dose levels in the Phase 1 portion of a Phase 1/2 clinical trial indicate that 4D-125 was well-tolerated and did not result in any dose-limiting toxicity (n=6 all patients followed between four and nine months).4D-110: Initial clinical safety data at both of the two dose levels in the Phase 1 clinical trial indicate that 4D-110 was well-tolerated and did not result in any dose-limiting toxicity (n=6 all patients followed between one and nine months).

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