- IVERIC bio Inc announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating the reduction in vision loss with ACP 2 mg versus sham treatment.
- The posthoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in the rate of vision loss with ACP 2 mg compared to sham treatment at 12 months.
- Results were consistent in the GATHER1 and GATHER2 clinical trials independently, signaling a 44% reduction and a 59% reduction, respectively, in the rate of vision loss with ACP 2 mg compared to sham over the first 12 months of treatment.
- In a combined analysis of GATHER1 and GATHER2, patients treated with ACP 2 mg experienced a 56% reduction in the rate of vision loss compared to sham over the first 12 months of treatment.
- Avacincaptad pegol (ACP) is under FDA evaluation for safety and efficacy, with a PDUFA Goal Date of August 19, 2023.
- The company plans to submit marketing authorization applications to the European Medicines Agency and the U.K. Medicines and Healthcare Regulatory Agency in 2023, subject to feedback from planned interactions with regulatory authorities in Europe, which is expected in 1H of 2023.
- ImmunoGen Inc announced a global, multi-target license and option agreement that granted Vertex Pharmaceuticals Incorporated rights for ImmunoGen's ADC technology to discover targeted conditioning agents for use with gene editing.
- After each target's research period, Vertex will have the option to obtain a worldwide, exclusive license to research, develop, and commercialize conditioning agents employing ImmunoGen's technology for that target.
- ImmunoGen will retain full rights to the ADC technology for all targets not covered by the Vertex license.
- Vertex will pay ImmunoGen an upfront payment of $15 million. ImmunoGen can receive up to $337 million in option exercise fees, development, and commercial milestone payments per target.
- Vertex is responsible for all research, development, commercialization, and related costs.
- The company reported Q4 revenues of $41.2 million compared to $28.0 million a year ago and the consensus of $17.23 million.
- ImmunoGen had $275.1 million in cash and cash equivalents.
- The company reported a Q4 EPS loss of $(0.23), compared to the consensus loss of $(0.30) and $(0.17) a year ago.
