Rain Therapeutics Presents Data on Milademetan (RAIN-32) at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics
October 07 2021 - 10:00AM
Rain Therapeutics Inc., (NasdaqGS: RAIN), (“Rain”), a late-stage
company developing precision oncology therapeutics, today announced
data on its oral mouse double minute 2 (MDM2) inhibitor,
milademetan, presented at the 2021 AACR-NCI-EORTC Virtual
International Conference on Molecular Targets and Cancer
Therapeutics held virtually October 7-10, 2021.
Three poster presentations detailed: 1) in vivo and in vitro
activity of milademetan using a rationally-derived MDM2 copy number
threshold as a predictive biomarker for patient selection, 2) in
vivo and in vitro activity of milademetan in Merkel cell carcinoma
(MCC) models and 3) results demonstrating milademetan induces
synthetic lethality of (ER)-positive breast tumors with GATA3
mutations.
Key findings from Rain’s presentations include:
- Milademetan demonstrated anti-tumor activity in patient-derived
organoid models and xenograft models consisting of genetically
selected tumors, representing many different histologies, using
MDM2 gene amplification (amp) and wild-type (WT) p53 as selection
criteria.
- Robust induction of p53 target genes including MIC-1, p21 and
PUMA was observed following milademetan treatment indicating
re-activation of p53 by milademetan.
- Milademetan inhibited MCC cell lines in patient-derived
xenograft models that lack TP53 mutations, representing the
majority of MCC cases, for which no approved targeted therapies are
available.
- MCC has low rates of p53 mutation and MDM2 dependence in MCC is
driven by polyoma virus-induced MDM2 expression in the majority of
cases.
- Milademetan inhibited proliferation of GATA3 frameshift (fs)
mutant ER+ breast cancers, demonstrating significant activity and
the potential to treat ER+, GATA3 mutant breast cancers that have
been unresponsive to the current standard of care.
- GATA3 fs mutations are mutually exclusive of p53 mutations in
ER+ breast cancer and are associated with higher expression of MDM2
and other genes in the MDM2/p53 axis associated with p53
inactivation.
“These data further support the potential of milademetan as a
targeted therapy in genetically pre-defined cancer patients beyond
our lead indication in liposarcoma,” said Robert Doebele, M.D.,
Ph.D., co-founder, president and chief scientific officer of Rain
Therapeutics. “These therapeutic opportunities represent areas of
unmet need where the tumors may exhibit MDM2 dependency and for
which milademetan therapy alone or in combination may lead to
clinically meaningful outcomes.”
Copies of each poster will be available by visiting the "Events
& Presentations" section of the Rain website.
About Milademetan Milademetan 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 late-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, 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.
Forward Looking Statements Statements 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. 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” 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 the risks
and uncertainties 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 ContactJordyn TemperatoLifeSci
Communications+1.646.876.5196jtemperato@lifescicomms.com
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