After a poor 2016 and a slow start to 2017, biotech IPOs have started to pick up in recent months, and amid the ASCO madness two upstarts are looking to make their offering.
First up is Novartis, Lilly and Roche-backed Aileron, named after the French for “little wing” (and more known in aeronautical circles), and the older of the two having been founded back in 2006 and based in Cambridge, Massachusetts.
The biotech is targeting a range of cancers using stapled peptides, and filed on Friday with the SEC to raise up to $69 million, with plans to list on the Nasdaq under the symbol "ALRN." Pricing terms are yet to be made public.
Its lead product candidate is ALRN-6924, which targets the tumor suppressor p53 for the treatment of a variety of cancers. The experimental therapy is currently being tested across several trials, and works by reactivating p53-mediated tumor suppression by targeting the two primary p53 suppressor proteins, MDMX and MDM2.
There is a phase 1 in advanced solid tumors or lymphomas, as well as phase 2a in peripheral T-cell lymphoma, with other early stage test in other blood cancers.
As of the beginning of May this year, the company had given ALRN-6924 to 95 cancer patients, and of the 62 evaluable in its phase 1 trial for advanced solid tumors or lymphomas, just under half (30 patients) showed disease control, consisting of 2 patients who achieved complete responses, 2 patients who achieved partial responses, and 26 patients who achieved stable disease, with 46% of stable disease patients experiencing shrinkage of the tumor.
The company, a 2009 Fierce 15 winner, says in its SEC filing: “We believe that by using our proprietary stapled peptide drug platform, we can develop first-in-class molecules, like ALRN-6924, that contain a novel set of properties. As such, our stapled peptide drugs may be able to address historically undruggable targets and complex mechanisms, such as intracellular protein-protein interactions like p53, that underlie many diseases with high unmet medical need.
“We believe that stapled peptide therapeutics have the potential to become a major class of drugs, like small molecules and monoclonal antibodies, for oncology and other therapeutic areas, and may significantly improve treatment paradigms and clinical outcomes for patients.”
Apple Tree Partners are its current biggest stockholder, with 22.4% ownership, while Novartis’ venture arm is the second at just under 21%. Lilly and Roche’s venture arm are also in on the act, taking a 7.7% and 5.3% stake respectively, with Roche also in 2010 signing a research collaboration with the company.
And then there is the embryonic upstart Dova Pharmaceuticals, founded just last year, which is looking to sell an acquired drug candidate for low blood platelets, and also filed on Friday with the SEC to raise up to $75 million for its initial public offering.
The Durham, NC-based company also plans to list on the Nasdaq, under the symbol $DOVA. No pricing terms here as yet, either.
Its drug candidate, avatrombopag, was in fact bought up from Eisai last year and works as an orally administered thrombopoietin receptor agonist, or TPO-RA, that the biotech is working on for thrombocytopenia.
Getting hold of a later-stage asset has seen it spin quickly through the R&D cycle, and has recently finished off two pivotal phase 3 tests that looked at thrombocytopenia in patients with chronic liver disease. It hit its primary and secondary endpoints in each of these test, setting up its filing with the SEC.
And, based on these results, an NDA is also planned for the FDA in Q3. “We believe that avatrombopag’s efficacy and safety profile in combination with its convenient oral dosing could provide advantages over other treatments for patients with thrombocytopenia,” the company’s management says in the SEC form.
“We believe avatrombopag’s pharmacokinetic profile and pharmacodynamic profile as well as its metabolic characteristics are the core attributes that differentiate it from the currently marketed TPO-RAs and make it a compelling treatment option for patients with thrombocytopenia. To date, avatrombopag has been evaluated in more than 20 clinical trials [from Eisai] involving more than 1,100 subjects and has been observed to be generally well tolerated.
“We believe that avatrombopag may, therefore, have the potential to be used more broadly for patients with thrombocytopenia, including patients without CLD, and we are exploring regulatory and clinical development strategies that would support this expanded use.”
PBM Capital, which bought the drug and created the biotech for it, naturally owns the lion’s share of the company, 84.8%, while Perceptive Life Sciences Master Fund is the second largest with 5.4%.