Rain Therapeutics Initiates Phase 3 MANTRA Clinical Trial of Milademetan for De-differentiated Liposarcoma and Provides Patie...
July 20 2021 - 8:00AM
Rain Therapeutics Inc., a clinical-stage company developing
precision oncology therapeutics, today announced that the first
patient has been randomized in the multicenter, open-label, Phase 3
registrational study (MANTRA) evaluating milademetan (RAIN-32), an
oral mouse double minute 2 (MDM2) inhibitor, for the treatment of
DD LPS.
“The start of our Phase 3 MANTRA study evaluating milademetan
marks an important step forward in addressing a high unmet need for
patients with DD LPS,” said Richard Bryce, MBChB, Chief Medical
Officer at Rain Therapeutics. “We are proud to have advanced
milademetan into a pivotal study less than 12 months after
acquiring the program, and believe it has the potential to be the
best-in-class MDM2 inhibitor.”
The MANTRA trial, a randomized, multicenter, open-label, Phase 3
registrational study, is designed to evaluate the safety and
efficacy of RAIN-32 compared to trabectedin, a current standard of
care, in patients with unresectable or metastatic DD LPS with or
without a well-differentiated (WD) LPS component that has
progressed on one or more prior systemic therapies, including at
least one anthracycline-based therapy. Approximately 160 patients
are expected to be randomized in a 1:1 ratio to receive milademetan
or trabectedin. The primary objective of the trial is to compare
progression-free survival (PFS) by blinded independent review
between the milademetan treatment arm and the trabectedin control
arm. Secondary endpoints include overall survival, PFS by
investigator assessment, objective response rate, duration of
response, disease control rate, safety and patient reported
outcomes.
The Company also provided an update on patients continuing to
receive RAIN-32 monotherapy from the previously concluded Phase 1
dose escalation and expansion study. As of July 1, 2021, three
WD/DD LPS patients received therapy with milademetan monotherapy
for greater than 51 months. Two of these patients continue to
receive therapy with durations now at 51 and 57 months without
disease progression, and an additional patient received therapy for
greater than 59 months before discontinuation in the second quarter
of 2021. This highlights the potential for a favorable milademetan
long-term tolerability and safety profile.
About Well-Differentiated/Dedifferentiated
LiposarcomaLiposarcoma is a rare cancer originating from
fat cells located in the soft tissues of the body. It is a
malignant cancer that can spread to other parts of the body.
Well-differentiated LPS is less aggressive and tends to be a large
painless mass found in deeper tissues. Dedifferentiated (DD) LPS is
more aggressive, arising from WD LPS, and is usually found in
tissue behind the abdominal area or the extremities. WD/DD LPS are
the most frequent subtypes of LPS and share common genomic
abnormalities, predominately MDM2 gene amplification. The incidence
of LPS is estimated at approximately 3,000 patients annually in the
U.S. for which there are few effective treatment options.
About RAIN-32Milademetan (RAIN-32) is a small
molecule, oral inhibitor of MDM2, which is oncogenic in numerous
cancers. Milademetan has already demonstrated meaningful antitumor
activity in an MDM2-amplified subtype of LPS and other solid tumors
in a Phase 1 clinical trial, validating a rationally-designed
dosing schedule to mitigate safety concerns and widen the
therapeutic window of MDM2 inhibition. In addition to the ongoing
Phase 3 clinical trial evaluating milademetan in patients with LPS,
Rain Therapeutics anticipates commencing a Phase 2 tumor-agnostic
basket trial in certain solid tumors in the second half of 2021 and
a Phase 2 trial in intimal sarcoma by early 2022. Milademetan has
received U.S. Food and Drug Administration Orphan Drug Designation
for patients with LPS.
About Rain Therapeutics Inc.Rain Therapeutics
Inc. is a clinical-stage precision oncology company developing
therapies that target oncogenic drivers for which it is able to
genetically select patients it believes will most likely benefit.
This approach includes using a tumor-agnostic strategy to select
patients based on their tumors’ underlying genetics rather than
histology. Rain’s lead product candidate, milademetan (RAIN-32), is
a small molecule, oral inhibitor of MDM2, which is oncogenic in
numerous cancers. In addition to milademetan, Rain is also
developing a preclinical program that is focused on inducing
synthetic lethality in cancer cells by inhibiting RAD52. For more
information, visit www.rainthera.com.
Forward Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include statements regarding, among
other things, Rain’s ongoing and planned studies for RAIN-32
(milademetan). Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as “plans,” “will”, “anticipates,” “goal,” “potential,” “expects”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Rain’s
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with Rain’s business in general and limited operating history,
difficulty enrolling patients in our clinical trials given the
relatively small LPS patient population, Rain’s reliance on third
parties to conduct and support its preclinical studies and clinical
trials, and the other risks described in Rain’s filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. Rain undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
Media Contact for Rain:Grace FotiadesLifeSci
Communications+1.646.876.5026gfotiades@lifescicomms.com
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