Bicycle Therapeutics has filed to raise up to $86 million in a Nasdaq IPO. The British biotech wants the money to prepare for phase 2 and 3 clinical trials of its lead anticancer candidate, BT1718.
BT1718, like the rest of Bicycle’s pipeline, is based on a type of fully synthetic short peptide the company calls “Bicycles.” These peptides have low molecular weight and pharmacokinetic properties akin to those of small molecules. But their pharmacology is more in keeping with that of biologics, leading Bicycle to use them as the targeting mechanism in drug conjugates.
Bicycle thinks the combination will result in drugs that quickly penetrate tumors—and are retained by them—have a short systemic half-life and can carry a larger toxin payload than antibodies. A slew of organizations are persuaded by the potential, enabling Bicycle to raise money from the VC wings of GlaxoSmithKline and Novartis and strike deals with partners including AstraZeneca. But for now, there is limited clinical evidence to back up the predictions.
Bicycle moved BT1718, which pairs a DM1 cytotoxic payload to a MT1-MMP targeting mechanism, into a phase 1/2a trial on the strength of preclinical data showing it killed tumors, particularly those that expressed MT1-MMP. But its clinical data are limited to evidence that DM1 is entering and staying in tumors, plus early confirmation that the pharmacokinetics are consistent with the preclinical performance.
Bicycle expects to have preliminary data from the clinical trial in the second half of the year. Once Bicycle has identified a recommended dose based on the two tested in the 40-patient phase 1, it will move BT1718 into the 2a portion of the clinical trial.
The Nasdaq IPO is intended to fund Bicycle’s preparations for phase 2 and 3 development of the lead drug while leaving enough cash left over to move BT5528 and BT8009 through phase 1 and 2a trials.
BT5528 is a new test of the ability of the Bicycle peptides to improve on the antibodies typically used to guide cytotoxic payloads to tumors. The target of the drug, EphA2, has been pursued by multiple research groups, including AstraZeneca’s Medimmune. AstraZeneca took an antibody-drug conjugate against the target into the clinic, but the frequency of bleeding events and elevated liver enzymes put a stop to development. Bicycle thinks its peptides may have a better safety profile.
In disclosing information pertinent to potential investors, Bicycle revealed it was the victim of a cyberattack last year. The phishing attack led to the automatic forwarding of emails from two accounts to an unauthorized third party. Bicycle said the attack did not have a material impact on its business.