Aileron Therapeutics Announces FDA Acceptance of IND for ALRN-6924 as a Myelopreservation Agent in Patients with p53-mutant Cancer Treated with Chemotherapy
“We are excited to advance another application for ALRN-6924 into the clinic. In preclinical studies ALRN-6924 has been shown to trigger a transient, dose-dependent cell-cycle arrest in normal bone marrow cells with normal p53. As others have shown, triggering cell-cycle arrest in rapidly dividing normal cells, such as bone marrow cells, can protect them from toxic effects of chemotherapy. In the clinic we plan to use a precision medicine approach to treat patients with cancers harboring p53 mutations (approximately 50% of all cancers). ALRN-6924 does not induce cell-cycle arrest in p53-mutant cancer cells, and leaves them vulnerable to chemotherapy. While our first myelopreservation clinical trial will be in small cell lung cancer patients treated with topotecan, we plan to develop ALRN-6924 as a tumor type-agnostic myelopreservation drug,” stated Dr.
“The FDA acceptance of our IND application represents an important milestone for ALRN-6924 and keeps us on schedule to commence our first clinical trial in myelopreservation as planned in September 2019,” said Dr.
The Company expects to enroll up to 40 patients in the Phase 1b portion of the planned Phase 1b/2 trial to evaluate the safety, tolerability, and efficacy of ALRN-6924 with topotecan as a 2nd line therapy for small cell lung cancer patients. The study will use existing standard gene tests, such as the ‘Foundation One’ panel, to screen patients for p53-mutation.
ALRN-6924 is a first-in-class, stabilized cell-permeating alpha-helical peptide that mimics the p53 tumor suppressor protein to disrupt its interactions with both its endogenous inhibitors, MDMX and MDM2. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of a variety of cancers, including cancers with MDM2-amplified tumors. For information about Aileron’s clinical trials, please visit www.clinicaltrials.gov.
Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides that address the most important intracellular targets in oncology and other therapeutic areas. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in drug candidates like ALRN-6924. Our current focus is to improve the standard of care for patients with cancer by developing safe and effective therapies that leverage our proprietary peptide platform. For more information, visit www.aileronrx.com, and for more information about our clinical trials please visit www.clinicaltrials.gov.
Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company’s strategy and clinical development plans. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Aileron’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the
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Source: Aileron Therapeutics, Inc.