SHANGHAI, China & GAITHERSBURG, Md.—I-Mab, a company focused on novel biologics, has reported the signing of two new collaborations that will set in motion a discovery initiative meant to create innovative therapies and pipeline growth.
“The discovery initiative is part of our long-term strategy to continue to drive innovation and scientific leadership in immuno-oncology,” said Dr. Taylor Guo, chief scientific officer of I-Mab. “We remain laser focused on delivering against key clinical milestones as we look to strengthen our pipeline. Collaborations with Complix and Affinity are first of many that will propel the discovery engine to generate the next wave of cancer therapeutics with transformative potential and drive future pipeline growth.”
The collaborations with EU-based Complix and Shanghai-based Affinity will allow I-Mab access to cutting edge technology platforms to create the next generation of novel and highly differentiated drug candidates — including Cell Penetrating Alphabodies (CPAB) for otherwise intractable intracellular drug targets, and masked antibodies for targeted tumor-site activation.
“We are pleased to have signed this important collaboration with I-Mab. We look forward to sharing our scientific capabilities and expertise in the CPAB platform technology to uncover revolutionary therapeutics that can address intractable targets that have remained undruggable with existing drug formats,” added Dr. Mark Vaeck, CEO of Complix.
These new agreements are said to complement I-Mab’s existing clinical programs. The company has built a successful portfolio of novel and highly differentiated monoclonal and bispecific antibodies that are currently advancing towards late-stage clinical development and biologic license application (BLA). Both partner companies will receive undisclosed milestone fees stipulated in the agreements.
“We are excited at the prospect of working together with I-Mab to create a set of novel masked antibodies designed for specific tumor-site activation,” noted Dr. Cheng Liu, CEO of Affinity. “This collaboration leverages I-Mab’s expertise and existing antibody sequences in immuno-oncology and our proprietary antibody engineering platform to synergize our discovery and development efforts for innovation.”
I-Mab also recently announced the first patient dosed in the company’s Phase 3 pivotal trial (TALLER) for eftansomatropin alfa — also known as TJ101 — as a weekly treatment for pediatric growth hormone deficiency (PGHD) in China.
“We look forward to the start of this pivotal trial. A successful result would have significant implications in the quality of life of the patients,” stated Professor Xiaoping Luo, a national thought leader in PGHD, principal investigator of the study, and chairman of the Department of Pediatrics at Wuhan Tongji Hospital.
Eftansomatropin alfa is a long-acting recombinant human growth hormone (rhGH) with a novel molecular format which utilizes Genexine’s patented half-life extension hyFc fusion technology. Most rhGHs need to be injected daily, which can hamper patient compliance and adversely affect clinical outcomes. Eftansomatropin alfa could have long-term safety advantages over the conventional pegylated rhGH drugs, and its longer-acting regimen may offer advantages over daily injections.
In previous clinical trials, including a Phase 2 study in Europe, eftansomatropin alfa was demonstrated to be safe and well-tolerated. The clinical efficacy of weekly or biweekly regimens was comparable to that of the daily injected rhGH (genotropin).
“In China where there are more than 3.4 million children with growth hormone deficiency and only a small percentage of them receiving treatment, I-Mab is well positioned to address this significant unmet need. With the initiation of this pivotal trial, we hope to bring a highly differentiated growth hormone replacement therapy to our children,” reported Dr. Joan Shen, CEO of I-Mab, in a press release.