PHILADELPHIA – Shanghai-based Epimab Biotherapeutics Inc. raised $74 million in a series B round to advance its phase I/II lead candidate, EMB-01, and expand its pipeline into immuno-oncology.
The round was co-led by SDIC Fund, one of China's largest private equity firms, and Sherpa Healthcare Partners, a Beijing-based venture capital firm. The round included investments from SCVC, other private investment entities, as well as the company's series A round investors. Epimab has raised more than $100 million to date.
The funds raised will advance EMB-01 through clinical trials. The bispecific EGFR/cMET receptor inhibitor is in a global phase I/II trial in solid tumors, Epimab Chief Operations Officer Stephan Lensky told BioWorld along the sidelines of the BIO International Convention.
The compound is competing with Johnson & Johnson's EGFR/cMET receptor inhibitor, JNJ-6372, which J&J flagged as one of 10 potential blockbusters it expects to be approved by 2023.
J&J is also in a phase I study, but Epimab said it hopes that its phase I/II adaptive trial design will give it more runway to be first out of the gate.
Using its Fabs-in-tandem immunoglobulin (FIT-Ig) platform, Epimab is developing a pipeline of bispecific molecules with antibody-like properties in immuno-oncology.
The platform combines two antibodies into one molecule by re-arranging the DNA sequence of the two monoclonal antibodies (MAbs) into three constructs and then co-expressing them.
Although bispecific antibodies provide more options for treating cancer, even minor modifications to a MAb can significantly change its properties, and Epimab has solved that by placing the second fab on top of the other to avoid mispairing, so that the six peptide chains align correctly, he said.
"Bispecific antibodies bind to two different antigens, and they're in tandem on each side. The key idea was to maintain structural elements of the antibody so the full size Fab isn't degraded," Lensky said, noting that the two antibodies are bound together on the same cell surface.
The privately owned company submitted INDs in China and the U.S. simultaneously, and received a record clinical trial authorization in China in 45 days. The phase I/II global trial is being run under one protocol with sites in China and the U.S.
"Because we had such broad activity, the FDA wanted us to go for solid tumors, and we'll likely expand into non-small-cell lung cancer," Lensky said.
He said he expects to see a phase I readout by the end of the year, and the phase II readout by the end of next year.
Epimab was founded in 2015, and with its lead candidate moving into the clinic in only four years, the speed at which the company has been able to move is impressive, he said.
Lensky attributed much of that success to the culture of the company, which encourages innovation and creativity.
Founder and CEO Chengbin Wu is one of the pioneers in the bispecific area and was the primary inventor of Abbvie's VDI-IG technology, one of the first bispecific antibody platforms that made it to the clinic, Lensky said.
The funds raised will help transform Epimab into a midsize company, "rapidly growing and advancing a pipeline based on our own discovery efforts," said Wu.
More assets are moving to the clinic. One is a dual checkpoint inhibitor.
Epimab will also expand its current capacity by adding a new manufacturing site in Suzhou for manufacturing clinical material to support its fast-moving pipeline. The Chinese government is supporting those economic develop zones in new areas to expand outside China's larger cities, Lensky said.
Dongfang Li from SDIC Fund and Cheng Xing from Sherpa will join the board of Epimab.
"Epimab has been emerging as one of the most innovative Shanghai-based biotech companies with a global vision," said Dongfang Li.
"We have followed and recognized Epimab's rapid growth and progress in the past few years," said Cheng Xing.