Aileron Therapeutics, Inc. Plans Clinical Trial of ALRN-6924 in Patients with Advanced Non-Small Cell Lung Cancer
January 11, 2021 at 05:00 pm IST
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Aileron Therapeutics, Inc. announced the completion of its previously announced registered direct offering of 32,630,983 of its shares of common stock at a purchase price of $1.10 per share, for gross proceeds of $35.9 million, before deducting placement agent fees and other offering expenses payable by Aileron. Aileron is developing ALRN-6924 as a novel medicine to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s effects against cancer cells, a concept known as chemoprotection. New fundamental investors, including Acorn Bioventures, BVF Partners, L.P., Maven Investment Partners and Grand Oaks Capital, participated in the offering, in addition to several existing Aileron investors, including Satter Medical Technology Partners and Lincoln Park Capital Fund, LLC. JonesTrading Institutional Services LLC (JonesTrading) acted as the placement agent for the offering. In addition to the $35.9 million registered direct offering, between November 12, 2020 and January 5, 2021, Aileron sold an aggregate of 9,894,519 shares of its common stock in “at the market” offerings under the Capital on Demand Sales Agreement with JonesTrading resulting in aggregate gross proceeds of approximately $12.7 million. Gross proceeds combined from both offerings were $48.6 million before deducting commissions and fees. With the proceeds from these transactions, Aileron believes that its cash, cash equivalents and investments will enable it to fund its current strategic plan into the second half of 2023, including the planned clinical trial of ALRN-6924 in patients with advanced non-small cell lung cancer (NSCLC). Aileron plans to begin enrollment in a Phase 1b randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin doublet chemotherapy (with or without immune checkpoint inhibitors), in the second quarter of 2021. The planned Phase 1b NSCLC trial follows Aileron’s presentation in October 2020 of clinical data from its ongoing Phase 1b clinical trial of ALRN-6924 in small cell lung cancer (SCLC) demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan. Aileron anticipates reporting initial results from the trial late in the fourth quarter of 2021 and full results in mid-2022.
Aileron Therapeutics, Inc. is a biopharmaceutical company. The Company is advancing a pipeline of medicines to address unmet medical needs in orphan pulmonary and fibrosis indications. Its lead product candidate, LTI-03, is a synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 is being evaluated in a Phase Ib clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF). Its second product candidate, LTI-01, is a proenzyme, or zymogen, designed to slowly activate in the pleural space and break up the scar tissue, allowing for drainage of the pleural effusion. It has completed Phase Ib and Phase IIa clinical trials for the treatment of loculated pleural effusions.