Agreement marks first of its kind
for Advancium, a public charity launched by Deerfield
Management and the Deerfield Foundation
Advancium will evaluate ALRN-6924 as a
potential therapy for retinoblastoma, a rare but devastating
pediatric cancer of the eye
AUSTIN,
Texas and NEW YORK,
Oct. 31,
2024 /PRNewswire/ -- Aileron Therapeutics, Inc.
("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a
novel pipeline of first-in-class medicines to address significant
unmet medical needs in orphan pulmonary and fibrosis indications,
and Advancium Health Network ("Advancium"), a public charity
founded by Deerfield Management and the Deerfield Foundation to
meet the needs of underserved patient populations, today announced
entry into an exclusive option agreement for the acquisition of
ALRN-6924, a clinical-stage oncology agent developed by Aileron
prior to its 2023 merger with Lung Therapeutics, Inc.
During the option period, Advancium intends to evaluate
ALRN-6924 as a potential therapy for retinoblastoma (RB), a rare
but devastating cancer of the eye, with around 300 cases diagnosed
in the United States and 9,000
cases worldwide each year, nearly all in children [1]. With early
intervention the disease is rarely fatal; however, non-selective
chemotherapy with its attendant side effects remains the usual
treatment strategy, and removal of the affected eye(s) is a
frequent outcome. In contrast to chemotherapy, ALRN-6924
selectively targets MDM2 and MDMX, the endogenous inhibitors of the
regulatory protein p53, to activate p53-mediated tumor suppression
in cancer cells [2]. Previous studies have implicated the MDMX
protein as a key driver of RB tumorigenesis [3], and ALRN-6924 is
the first and only clinical-stage drug that acts on MDMX. ALRN-6924
has previously been studied in preclinical models of RB, where it
showed potent, on-mechanism anti-proliferative activity in RB cell
lines and was found to be highly soluble and compatible with
intraocular injection [4].
Under the terms of the option agreement, Advancium paid Aileron
a non-refundable fee for the exclusive option to acquire ALRN-6924
and related assets. If Advancium exercises its option, Aileron will
receive an exercise payment with potential for additional
development, regulatory and commercial milestone payments and sales
royalties.
"This agreement is a significant landmark for our work at
Advancium, as it is the first drug opportunity we are pursuing in
our mission as a public charity to develop much-needed therapies
for children with cancer," said Mark
Veich, Chief Executive Officer of Advancium and Vice
President of Philanthropy and Executive Director of the Deerfield
Foundation. "We look forward to evaluating ALRN-6924 as a potential
treatment for children with retinoblastoma who currently have
limited care options."
"Aileron is a strong supporter of Advancium's cause," said
Brian Windsor, Ph.D., President and
Chief Executive Officer of Aileron. "Although we remain focused on
developing novel therapies for the treatment of orphan pulmonary
and fibrosis indications, we are honored that they have chosen to
partner with us in this important step towards their goal of
delivering therapies to pediatric patients with high unmet
need."
References
[1] Cobrinik, D. "Retinoblastoma Origins and Destinations" N
Engl J Med. 2024 Apr 18;390(15):1408-1419
[2] Guerlavais, V. et al, "Discovery of Sulanemadlin
(ALRN-6924), the First Cell-Permeating, Stabilized α-Helical
Peptide in Clinical Development" J Med Chem, 2023; 66:9401–9417
[3] Laurie, N. A. et al, "Inactivation of the p53 pathway in
retinoblastoma" Nature. 2006 Nov
2;444(7115):61-6
[4] Wilson, M. W. et al, "Intraocular MDMX Inhibition by
ALRN-6924: A Targeted Strategy to Reactivate p53 in
Retinoblastoma." Investigative Ophthalmology & Visual Science,
2023 June;64(8): 1272
About Aileron Therapeutics
Aileron Therapeutics is a biopharmaceutical company
advancing a novel pipeline of first-in-class medicines to address
significant unmet medical needs in orphan pulmonary and fibrosis
indications. Aileron's lead product candidate, LTI-03, is a novel,
synthetic peptide with a dual mechanism targeting alveolar
epithelial cell survival as well as inhibition of profibrotic
signaling. Currently, LTI-03 is being evaluated in a Phase
1b clinical trial for the treatment
of idiopathic pulmonary fibrosis. Aileron's second product
candidate, LTI-01, is a proenzyme that has completed Phase
1b and Phase 2a clinical trials for
the treatment of loculated pleural effusions. LTI-01 has received
Orphan Drug Designation in the US and EU and Fast Track Designation
in the US.
About Advancium Health Network
Advancium Health Network is a mission-driven public charity
pioneering ways to overcome barriers in healthcare through a unique
model that combines for-profit infrastructure with non-profit
ideals. Advancium forges bonds between a diverse body of industry
partners, experts, and philanthropic support to leverage its
collective expertise and resources. From early-stage innovation to
pediatric MedTech and rare diseases, we are confronting
healthcare's most daunting hurdles for underserved patients and
catalyzing a positive impact on human health.
Forward-Looking Statements
This press release may contain forward-looking statements of
Aileron Therapeutics, Inc. ("Aileron", the "Company", "we", "our"
or "us") within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements with respect to: the terms
of the option agreement between Advancium and the Company; the
exercise of the option to acquire ALRN-6924 pursuant to the option
agreement; and the potential of the Company to receive a future
option exercise payment, milestone payments and royalties pursuant
to the option agreement with Advancium. We use words such as
"anticipate," "believe," "estimate," "expect," "hope," "intend,"
"may," "plan," "predict," "project," "target," "potential,"
"would," "can," "could," "should," "continue," and other words and
terms of similar meaning to help 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 risks and uncertainties
related to, changes in applicable laws or regulations, the
possibility that the Company may be adversely affected by other
economic, business, and/or competitive factors, including risks
inherent in pharmaceutical research and development, such as:
adverse results in the Company's drug discovery, preclinical and
clinical development activities, the risk that the results of
preclinical studies and early clinical trials may not be replicated
in later clinical trials or that partial results of a trial such as
the Cohort 1 results from the Company's ongoing Phase 1b clinical trial will be indicative of the full
results of the trial, the Company's ability to enroll patients in
its clinical trials, and the risk that any of its clinical trials
may not commence, continue or be completed on time, or at all;
decisions made by the U.S. Food and Drug Administration and other
regulatory authorities, investigational review boards at clinical
trial sites and publication review bodies with respect to our
development candidates; uncertainty as to whether or when the
option will be exercised, whether the development of ALRN-6924 as a
potential therapy for retinoblastoma will be successful, and
whether the Company will receive any meaningful payments under the
Company's option agreement with Advancium ; as well as the risks
and uncertainties discussed in the "Risk Factors" section of the
Company's Annual Report on Form 10-K for the year
ended December 31, 2023 and Quarterly Report on Form 10-Q
for the quarter ended June 30, 2024, which are on file with
the United States Securities and Exchange Commission (the
"SEC"), and in subsequent filings that the Company makes with
the SEC. These forward-looking statements should not be relied
upon as representing the Company's view as of any date subsequent
to the date of this press release, and we expressly disclaim any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Aileron Investor Relations & Media Contact:
Argot
Partners
aileron@argotpartners.com
212-600-1902
Advancium Investor Relations & Media
Contact:
Jyoti Patel
media@advanciumhealth.org
646-771-0699
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SOURCE Aileron Therapeutics, Inc.; Advancium Health Network