Alpine Immune Sciences’ lupus drug candidate now has AbbVie lined up to continue the compound’s development.
The drug, ALPN-101, is ready for Phase 2 testing, which will be conducted by Seattle-based Alpine. The deal announced Thursday grants AbbVie (NYSE: [[ticker:ABBV]]) an exclusive option to license the drug after that study. The North Chicago, IL-based pharmaceutical company is paying its new partner $60 million up front for that option and, if the drug achieves clinical and regulatory milestones, will be responsible for up to $805 million more. If the drug reaches the market, Alpine is also eligible for royalties from sales.
Shares of Alpine (NASDAQ: [[ticker:ALPN]]) opened Thursday at $14.05 per share, a more than 188 percent increase over Wednesday’s closing price.
Lupus causes the immune system to attack the body’s own tissues and organs. The autoimmune disorder affects more than 1.5 million Americans, disproportionately women—particularly women of color, according to the Lupus Foundation of America. Symptoms include pain, fatigue, hair loss, and physical and cognitive impairment. The disease has few FDA-approved treatments.
The Alpine drug is a fusion of two different proteins that together are designed to simultaneously block CD28 and ICOS, two molecules believed to play critical roles in autoimmune and inflammatory diseases. The drug is engineered using “directed evolution,” a proprietary Alpine process in which a protein is engineered to offer a desired therapeutic function.
In preclinical testing, Alpine reported that this dual approach was better than blocking either pathway alone. In the Phase 1 tests, the company says the drug was safe and well tolerated by healthy volunteers.
Now it’s on to Phase 2, which will be financed with the upfront payment from AbbVie, Alpine CEO Mitch Gold said on a conference call Thursday. If AbbVie exercises its option for the drug, the company will be responsible for further development and commercialization expenses. Gold said that Alpine discussed potential collaborations with multiple companies, but AbbVie stood out as the “premier partner in immunology.”
“This was a highly competitive process, and AbbVie won out because of their commitment to lupus and their ability to be a transformative partner with us as we look to develop ALPN-101 in lupus and other inflammatory diseases,” he said.
AbbVie has extensive experience with autoimmune disease drugs. Its top seller, adalimumab (Humira), is approved for treating a number of autoimmune disorders and it accounted for more than $19 billion in revenue last year, according to the company’s annual report. But the biologic drug now faces biosimilar competition and AbbVie has turned to dealmaking as means of supplementing its portfolio of commercialized products and building its pipeline of drug candidates. Last month, the company closed its $63 billion acquisition of Allergan.
The milestone payments due to Alpine under its agreement with AbbVie aren’t all weighted toward the back end of the deal. Alpine is eligible for up to $75 million before AbbVie exercises its option on APLN-101, Remy Durand, Alpine’s senior vice president of business development and corporate strategy, said on the call.
Gold said that the deal provides validation for his company’s technology platform, which has also yielded two other compounds so far: ALPN-202, a cancer drug currently in Phase 1 testing, and ALPN-303, in preclinical development for inflammatory diseases. Those drugs aren’t covered by the partnership but Gold said that the payment from AbbVie enables the company to advance both drugs to the point of reporting clinical data.
Image: iStock/LoweStock
