Apogee Therapeutics, an I&I biologics maker that quickly went public in 2023, said Monday it’s headed toward a Dupixent face-off next year as it looks to become the next “generational” biotech.
The San Francisco company expects its lead drug APG777, an IL-13 targeting monoclonal antibody, can eventually generate more than $10 billion in sales, CEO Michael Henderson told
Endpoints News
in a preview of Apogee’s R&D day on Monday.
The plan is to launch the medicine by the end of this decade, Henderson said.
“Historically, people have thought about us as a YTE antibody, a longer-acting version of another antibody,” Henderson said, “and we’ve been making investments to become so much more than that, which is what we’re really excited to show at our R&D day.”
Part of those grand ambitions are pinned on a combination future in inflammation and immunology. The I&I field has become one of the industry’s fastest-growing areas of R&D as drugmakers sling deals left and right for a market that Henderson said is only second in breadth to obesity.
Apogee’s first big combination test will come next year as it pairs APG777 with its OX40L-targeting mAb called APG990. By way of a co-formulation, those experimental medicines will go up against Dupixent in 50 to 75 patients with moderate-to-severe atopic dermatitis in a Phase 1b, Apogee said. The readout is slated for the second half of 2026.
“Everyone says, ‘Oh, we’re going to be better. It should be better,’” Henderson said. “No one ever actually runs that head-to-head study.”
Dupixent has become a
cornerstone
of Sanofi and Regeneron’s I&I pipelines, with the medicine projected to break the $14 billion sales milestone this year. It also became the
first biologic
to get FDA approval for chronic obstructive pulmonary disease, or COPD, this fall.
Apogee isn’t daunted. Its half-life technology, born out of its parent company Paragon Therapeutics, could allow for dosing every three or six months versus every two to four weeks for many other I&I therapies like Dupixent and Eli Lilly’s Ebglyss.
Eventually, as part of lifecycle management, Henderson envisions a once-yearly dosing schedule. In 12-month Phase 1 data on Monday, Apogee said APG777 had a half-life of 77 days and “near complete” inhibition of pSTAT6 for up to 12 months with just one administration of the drug.
“If we look at psoriasis, you have Skyrizi dosed every three months, and that started with an every two-week paradigm with Humira and then the IL-17s came out every four weeks,” Henderson said. “It’s too early to comment on price, of course, but in those cases, you see the price staying the same or even being higher with fewer injections because the better disease control and improved patient experience.”
Enrollment is going so much faster than anticipated in Apogee’s Phase 2 trial of APG777 in atopic dermatitis that the company now plans to unveil 16-week Part A data from the study in mid-2025. That’s “months” earlier than the previously guided second half of next year, Henderson said.
As a monotherapy, APG777 will also enter a Phase 1b in asthma by next summer, a Phase 2b in asthma in the second half of next year and a Phase 2 in eosinophilic esophagitis in 2026.
The company’s combination plans also include pairing up APG777 with APG333, a mAb that goes after TSLP, which is targeted by Amgen’s Tezspire and candidates from a
cohort
of other
biotechs
. While Apogee plans to evaluate APG333 alone in a Phase 1b in asthma, its future relies on combinations with APG777 in asthma and COPD.
“TSLP as a mono we are not excited about. People are doing that. It’s OK. But it’s crowded. It really is a combination that we get excited” about, Henderson said. Sanofi has an IL-13 and TSLP-targeting bispecific called lunsekimig, and Johnson & Johnson
paid $850 million upfront
for Proteologix and its bispecific in the arena.
Apogee also said its Phase 1 healthy volunteer trial showed its drug APG808 had a half-life of about 55 days, which could translate to every two or three-month maintenance doses. The investigational IL-4Rα drug is also in a Phase 1b in asthma, with a readout planned for the first half of 2025.
Apogee raised more than $400 million in a public offering in March on the back of interim Phase 1 healthy volunteer data. Will the company do it again after its R&D day?
“We think that we’re incredibly undervalued right now, especially after the recent pullback in the market,” Henderson said. If the Phase 2 data are what Apogee is hoping for, then the company “should be able to access a much lower cost of capital than we’re at today,” he added.
Apogee’s share price
$APGE
is down about 17% over the past month, but up 61% year-to-date.
Henderson thinks the biotech is headed toward becoming a “generational” drugmaker like Vertex or Gilead.
“They refuse to stop at good enough. They pursue combinations. They look to cannibalize their own markets,” Henderson said.