Barely six months after launching, Paragon Therapeutics’ first spinout has set its sights on the public markets as well as taking on some of the biggest names in immunology and inflammation.
In a Securities and Exchange Commission filing submitted yesterday, Apogee Therapeutics announced its intention to list on the Nasdaq—although the price has yet to be confirmed—and shared more details of its intriguing preclinical pipeline.
The San Francisco-based biotech unveiled at the end of last year with $169 million to advance at least four of Paragon’s candidates designed to treat inflammatory and immunological disorders, although the company remained tight-lipped on the details.
Now, Apogee has shed more light on its lead candidate APG777, a monoclonal antibody that the biotech is touting as a potential rival to Dupixent. Like Regeneron and Sanofi’s blockbuster, APG777 is designed to inhibit IL-13 signaling, although Dupixent also inhibits IL-4 signaling.
In preclinical studies, APG777 has already demonstrated “equivalent or superior” IL-13 inhibition than another IL-13 drug, Eli Lilly’s investigational therapy lebrikizumab, the biotech said.
Apogee expects to investigate APG777 in similar indications to Dupixent and lebrikizumab, namely atopic dermatitis and asthma. A phase 1 trial in healthy volunteers is planned in Australia for the second half of this year, which is designed to set up phase 2 and 3 studies in atopic dermatitis. Those data may in turn influence a potential midstage trial in asthma as well as open the door to other inflammation and immunology indications like alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis and prurigo nodularis.
Next up is the IL-4Rα inhibitor APG808, which Apogee has been putting head-to-head with Dupixent in preclinical studies and is happy with the results. APG808’s key differentiator with the first generation of IL-4 antibodies is that it only needs to be administered every six weeks as opposed to every two, the biotech said. The company hopes to get the candidate into human trials for COPD.
Apogee is also working on an inhibitor of OX40L to treat atopic dermatitis. As the molecule’s role occurs higher in the inflammatory pathway than either IL-13 or IL-4Rα, the company hopes this approach “could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments,” it said in the filing.
Finally, there’s APG222, which is aimed at targeting both IL-13 and OX40L as a potential treatment for atopic dermatitis.
The company ended March with $141.3 million in cash and equivalents, which it expects to last for at least the next 12 months. But Apogee clearly has ambitions beyond that, with plans to use the net proceeds from an IPO to fund its preclinical and clinical studies of its four programs. Any remaining funds will be channeled to “additional research and development activities, as well as for capital expenditures, working capital and general corporate purposes,” according to the biotech.