On September 28, 2019, Aileron Therapeutics, Inc. (“Aileron” or the “Company”) announced the presentation of interim results from its
ongoing Phase 2a clinical trial evaluating the combination of ALRN-6924 and Pfizer’s IBRANCE® (palbociclib) for the treatment of patients with tumors harboring wild-type p53 and MDM2
amplification or MDM2/CDK4 co-amplification at the 2019 Congress of the European Society for Medical Oncology (ESMO).
As of the data cutoff date of September 2, 2019, the trial had enrolled 26 patients. The reported safety results showed that the combination has been
very well-tolerated in the trial, with the most common non-hematological related adverse events grade £2 being nausea (46%) and fatigue (23%). Neutropenia was the
only grade ³3 hematological related AE occurring in >5% of patients (27%), while grade ³3 thrombocytopenia and leukopenia each were observed in only one
patient (3.8%).
The preliminary analysis of activity in the 17 evaluable patients with liposarcoma showed a disease control rate of 88% and a median
progression-free survival of 4.4 months with 53% censoring. No partial or complete responses have been observed. Patients who have had at least one post-baseline assessment and have MDM2-amplified, TP53-WT
tumors were deemed evaluable.
The Company expects that the first indication for the combination of ALRN-6924 and palbociclib may be MDM2-amplified
sarcoma patients, for whom there exists a substantial unmet need across all lines of treatment for the estimated 15,000 patients worldwide diagnosed each year. In addition, these results have further encouraged the Company to expand enrollment to a
total of 35 patients in order to evaluate the combination on the treatment of other MDM2-amplified cancers. The Company expects to announce a final data readout in the second quarter of 2020.
Forward-Looking Statements
Statements in this report
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 preliminary or interim results from a clinical trial will be indicative of the final results of the trial; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron’s product candidates
will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of
Aileron’s quarterly report on Form 10-Q for the period ended June 30, 2019, filed on August 6, 2019, and risks described in other filings that Aileron may make with the Securities and Exchange
Commission. Any forward-looking statements contained in this report speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or
otherwise.
