Merck KGaA and its Merck Serono division announced that they have entered a worldwide alliance with Lpath, Inc. of the United States to develop and commercialize ASONEP, a phase I monoclonal antibody currently being evaluated for the treatment of various cancer types.
ASONEP is a humanized monoclonal antibody that neutralizes S1P, a bioactive lipid that stimulates tumour cell migration, invasion and survival and also promotes angiogenesis, i.e. growth of new blood vessels. S1P has been highly correlated with the development of drug resistance in various cancer types.
Under the terms of the agreement, Merck Serono will provide Lpath up to $23 million of upfront payments and R&D funding to support Lpath's completion of the phase I clinical trial. If Merck Serono accepts the responsibility to develop ASONEP beyond phase I, it will pay Lpath an additional $28 million and will fund all continuing development activities. Further payments will be made on achievement of development, regulatory, and sales milestones that could total up to $422 million should ASONEP be approved in multiple indications.
As part of the alliance, Merck Serono now has exclusive, worldwide rights to develop and commercialize ASONEP across all indications and Lpath will receive royalties on commercial sales of the product.
"This alliance is a promising strategic fit for Merck Serono's business model and culture, benefiting from our broad expertise in developing monoclonal antibodies," said Vincent Aurentz, executive vice president Portfolio Development at Merck Serono. "ASONEP is an innovative drug candidate and the first monoclonal antibody targeting a bioactive lipid to be tested in clinical trials. We believe that S1P, the bioactive-lipid target of ASONEP, plays an important role in cancer."
Scott Pancoast, president and chief executive officer of Lpath, commented: "Merck Serono, which has distinguished itself as an outstanding developer and marketer of innovative drugs in key therapeutic areas, is an ideal partner for ASONEP and for Lpath. We expect this alliance to further validate the importance of bioactive-lipidtargeted therapeutics and extend Lpath's leadership position in this exciting new field."
ASONEP is a unique humanized antibody that binds to and inhibits S1P, a bioactive lipid that has multiple effects on cells including cell proliferation, migration and survival. S1P, which is up-regulated in tumour cells, also promotes tumour and endothelial-cell growth, angiogenesis and inflammation, and, importantly, it prevents apoptosis (cell death). S1P is associated with several pathologies, including cancer, ocular disorders, autoimmune disease, and inflammatory- and fibrosis-related disorders. Further, S1P has been highly correlated with drug resistance across a wide array of tumour types, as well as with increased mortality of patients with many different types of cancer. By inhibiting S1P activity, ASONEP may be able to increase survival in cancer patients, not only via its anti-angiogenic and anti-tumorigenic effects, but also via its ability to help patients overcome drug resistance. ASONEP is the systemic version of sonepcizumab, which is the humanized version of Sphingomab.
Lpath, Inc., headquartered in San Diego, California, is the category leader in bioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases.