Generon’s A-337 Antibody Is Entering Phase 1 Trial as Treatment for Solid Tumors

Generon’s A-337 Antibody Is Entering Phase 1 Trial as Treatment for Solid Tumors

The A-337 antibody that Generon Corporation developed to sic immune-system T-cells on cancer cells that express the surface protein EpCAM will be tested in a Phase 1 clinical trial in Australia.

The trial will evaluate the antibody dynamics and safety of escalating doses of A-337 in patients with advanced solid tumors.

An antibody is a protein the immune system uses to kill invaders. The antibody that A-337 puts into play is the CD3 protein. EpCAM is a protein linked to tumor development and the spread of cancer to other parts of the body.

“A-337 represents a next-generation, CD3-activating bi-specific antibody targeting EpCAM-expressing solid tumors,” Dr. David Lacey, chairman of Generon’s Scientific Advisory Board, said in a press release. Expression is the process by which information from a gene is used to create a functional product like a protein.

“The multivalency [dual nature] of the EpCAM portion of the molecule may enable [A-337] activity across a wide range of tumor EpCAM expressions, including tumors expressing lower levels,” Lacey added. “This potential advance presents an important option for patients who have failed previous lines of therapy.”

Generon used its proprietary ITab immunotherapy antibody platform to create A-337. That platform produces human antibodies that target two molecules instead of one.

The company’s scientists designed ITab-derived antibodies to bind with the CD3 protein that immune T-cells express and also to recognize tumor-associated proteins.

Previous studies have shown that Generon antibodies can pack 1,000 time the punch of antibodies that are monoclonal, or produced from a single type of cell.

A-337, the first ITab product to enter clinical trials, is designed to bind to CD3 and to the cancer cell surface protein EpCAM.

The bridge the antibody creates between T-cells and cancer cells activates the T-cells, leading to the production of signaling molecules that trigger cancer cell death.

Researchers said A-337 has shown strong anti-tumor activity in preclinical-trial studies. It also is safer than similar products, they said.

“A-337 is our first immunotherapeutic antibody entering clinical development,” said Dr. Xiao Qiang Yan, chairman and CEO of Generon. “This is another important milestone.”

The therapy “has demonstrated compelling advantages in pre-clinical safety studies over other CD3-activating bi-specific antibodies targeting EpCAM,” Xiao said. “We are committed to bringing innovative immunotherapy antibodies to treat cancer patients, providing them with more effective treatment options.”