AUM Biosciences Pte. Ltd. (“AUM”), a global clinical-stage
biotechnology company focused on discovering and developing
precision oncology therapeutics, announced today that the first
patient has been dosed in its Phase 2 clinical trial evaluating
AUM001 for the treatment of metastatic colorectal cancer (MSS CRC).
AUM001 is a mRNA translation inhibitor that targets MNK 1/2 and the
chokepoint of multiple pro-oncogenic signalling pathways for the
treatment of MSS CRC.
“Dosing the first patient in AUM001’s Phase 2
trial is a major milestone in advancing our mission to build an
industry-leading portfolio of innovative therapies designed to
reverse cancer resistance,” said Vishal Doshi, Chairman and CEO of
AUM. "While colorectal cancer is the third most common cancer
globally, there are limited therapeutic options due to the
resistance associated with current treatments. AUM is leveraging
multi-faceted strategies, technologies, and targets to develop a
diversified pipeline of candidates that have distinct mechanisms of
action to overcome cancer drug resistance."
This randomized and open-label Phase 2 study is
designed to evaluate the safety, tolerability, and effectiveness of
AUM001 as a monotherapy and in combination with KEYTRUDA®
(pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1
therapy in MSS CRC, with a focus on the microsatellite stable (MSS)
subset. The study will be conducted in two modules. Module 1 is a
dose escalation run-in module to identify the Maximum Tolerable
Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of AUM001 to be
administered orally as monotherapy and in combination with
intravenous pembrolizumab or irinotecan. Module 2 consists of a
cohort expansion at the RP2D of AUM001 in combination with
intravenous pembrolizumab or irinotecan in patients with locally
advanced or MSS CRC to evaluate clinical activity and the safety of
AUM001. The first patient has been dosed in Module 1, Arm A, which
has multiple dose finding cohorts for the monotherapy, with AUM001
administered orally once every other day. Module 1 is expected to
enroll up to forty-eight patients, and top line readout from Module
1 is anticipated in the fourth quarter of 2023. The first patient
has been dosed at Pindara Private Hospital in Queensland,
Australia.
The global Phase 2 trial is being conducted in
collaboration with MSD, a tradename of Merck & Co., Inc.,
pursuant to a clinical trial collaboration and supply agreement for
KEYTRUDA®. Trial details can also be found on
www.clinicaltrials.gov under study ID: NCT05462236.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
As previously announced on October 20, 2022, AUM
entered into a definitive business combination agreement (the
“Agreement”) with Mountain Crest Acquisition Corp. V (Nasdaq: MCAG)
(“Mountain Crest”), a publicly-traded special purpose acquisition
company formed in Delaware, whose management team has an impressive
pedigree of successful SPAC transactions. Following the closing of
the business combination, AUM plans to operate its business as a
wholly owned subsidiary of AUM Biosciences Limited, a Cayman
Islands exempted company, and it is expected that the ordinary
shares of AUM Biosciences Limited will trade on the Nasdaq Stock
Market under the ticker symbol “AUMB.”
About AUM BiosciencesAUM is a
global clinical-stage oncology company focused on advancing a
pipeline of precision oncology therapeutics designed to deploy
multi-faceted inhibition strategies to reverse cancer resistance.
AUM is advancing a broad portfolio of precision oncology
therapeutics. AUM001 is a selective and synergistic MNK inhibitor
as shown in current studies, and has entered a Phase 2 clinical
trial for metastatic colorectal cancer. AUM601 is a promising
therapy for tropomyosin receptor kinase (TRK) fusions and mutations
within the kinase domain, and has received Orphan Drug Designation
from the United States Food and Drug Administration (the “FDA”) for
the treatment of solid tumors with the NTRK fusion gene. AUM302 is
a potentially first-in-class macrocyclic oral kinase inhibitor
rationally designed small molecule to uniquely combine pan-PIM
kinase, pan-PI3K and mTOR inhibition in a single agent, and has
received Orphan Drug Designation from the FDA for the treatment of
neuroblastoma, as well as a Rare Pediatric Disease Designation.
Comprised of pharma industry veterans with decades of research and
development experience, the AUM leadership team has an extensive
track record of selecting distinctive early-stage assets,
successfully exiting virtual biotech models, and has contributed to
over 50 INDs and over 150 oncology clinical trials, and development
of several currently marketed oncology treatments with annual peak
sales up to $3 billion.
About Mountain CrestMountain
Crest Acquisition Corp. V (Nasdaq: MCAG) is a blank check company
formed under the laws of the State of Delaware, for the purpose of
effecting a merger, share exchange, asset acquisition, share
purchase, reorganization or similar business combination with one
or more businesses.
Non-Solicitation
This press release shall not constitute a
solicitation of a proxy, consent, or authorization with respect to
any securities or in respect of the proposed business combination.
This press release shall also not constitute an offer to sell or
the solicitation of an offer to buy any securities, nor shall there
be any sale of securities in any states or jurisdictions in which
such offer, solicitation, or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended, or an exemption therefrom.
Important Information About the Proposed
Business Combination and Where to Find ItIn connection
with the proposed business combination, AUM and Mountain Crest have
caused AUM Biosciences Limited to file relevant materials with the
Securities and Exchange Commission (the “SEC”), including a
registration statement on Form F-4 containing a proxy
statement/prospectus (the “Registration Statement”). The
Registration Statement includes a proxy statement/prospectus to be
distributed to holders of Mountain Crest’s common stock in
connection with Mountain Crest’s solicitation of proxies for the
vote by Mountain Crest’s stockholders with respect to the proposed
transaction and other matters as described in the Registration
Statement, as well as the prospectus relating to the offer of
securities to be issued to AUM’s stockholders in connection with
the proposed business combination. As the Registration Statement
has been filed and declared effective, Mountain Crest is mailing a
definitive proxy statement to its stockholders. Copies of these
documents may be obtained free of charge at the SEC's website at
www.sec.gov. Stockholders of Mountain Crest are urged to read the
Registration Statement and the other relevant materials when they
become available before making any voting decision with respect to
the proposed business combination because they will contain
important information. The information contained on, or that may be
accessed through, the website referenced in this press release is
not incorporated by reference into, and is not a part of, this
press release.
Participants in the
SolicitationMountain Crest and its directors and executive
officers may be deemed participants in the solicitation of proxies
from Mountain Crest’s stockholders with respect to the business
combination. A list of the names of those directors and executive
officers and a description of their interests in Mountain Crest is
included in the Registration Statement for the proposed business
combination and is available at www.sec.gov. Additional information
regarding the interests of such participants is contained in the
Registration Statement for the proposed business combination.
Information about Mountain Crest’s directors and executive officers
and their ownership of Mountain Crest common stock is set forth in
Mountain Crest’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, as modified or supplemented by any Form 3
or Form 4 filed with the SEC since the date of such filing. Other
information regarding the interests of the participants in the
proxy solicitation is included in the Registration Statement
pertaining to the proposed business combination. These documents
can be obtained free of charge from the sources indicated
above.
AUM and its directors and executive officers may
also be deemed to be participants in the solicitation of proxies
from the stockholders of Mountain Crest in connection with the
proposed business combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed business combination is included in the
Registration Statement for the proposed business combination.
Forward-Looking StatementsThis
press release includes “forward-looking statements” within the
meaning of the “safe harbor” provisions of the United States
Private Securities Litigation Reform Act of 1995. Mountain Crest’s
and AUM’s actual results may differ from their expectations,
estimates, and projections and, consequently, you should not rely
on these forward-looking statements as predictions of future
events. Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue,” and
similar expressions (or the negative versions of such words or
expressions) are intended to identify such forward-looking
statements. These forward-looking statements include, without
limitation, Mountain Crest’s and AUM’s expectations with respect to
future performance and anticipated financial impacts of the
proposed business combination, the satisfaction of the closing
conditions to the proposed business combination, and the timing of
the completion of the proposed business combination.
These forward-looking statements involve
significant risks and uncertainties that could cause the actual
results to differ materially from those discussed in the
forward-looking statements. Most of these factors are outside
Mountain Crest’s and AUM’s control and are difficult to predict.
Factors that may cause such differences include, but are not
limited to: (1) the occurrence of any event, change, or other
circumstances that could give rise to the termination of the
Agreement; (2) the outcome of any legal proceedings that may be
instituted against Mountain Crest and AUM following the
announcement of the Agreement and the transactions contemplated
therein; (3) the inability to complete the proposed business
combination, including due to failure to obtain approval of the
stockholders of Mountain Crest and AUM, certain regulatory
approvals, or satisfy other conditions to closing in the Agreement;
(4) the occurrence of any event, change, or other circumstance that
could give rise to the termination of the Agreement or could
otherwise cause the transaction to fail to close; (5) the impact of
the COVID-19 pandemic on AUM’s business and/or the ability of the
parties to complete the proposed business combination; (6) the
inability to obtain the listing of Holdco’s ordinary shares on
Nasdaq following the proposed business combination; (7) the risk
that the proposed business combination disrupts current plans and
operations as a result of the announcement and consummation of the
proposed business combination; (8) the ability to recognize the
anticipated benefits of the proposed business combination, which
may be affected by, among other things, competition, the ability of
AUM to grow and manage growth profitably, and retain its key
employees; (9) costs related to the proposed business combination;
(10) changes in applicable laws or regulations; (11) the
possibility that Mountain Crest or AUM may be adversely affected by
other economic, business, and/or competitive factors; (12) risks
relating to the uncertainty of the projected financial information
with respect to AUM; (13) risks related to the organic and
inorganic growth of AUM’s business and the timing of expected
business milestones; (14) the risk that AUM001 or its other drug
candidates may fail to meet the safety or efficacy criteria
necessary for marketing approval; (15) the amount of redemption
requests made by Mountain Crest’s stockholders; and (16) other
risks and uncertainties indicated from time to time in the final
prospectus of Mountain Crest for its initial public offering and
the Registration Statement relating to the proposed business
combination, including those under “Risk Factors” therein, and in
Mountain Crest’s other filings with the SEC. Mountain Crest
cautions that the foregoing list of factors is not exclusive.
Mountain Crest and AUM caution readers not to place undue reliance
upon any forward-looking statements, which speak only as of the
date made. Mountain Crest and AUM do not undertake or accept any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements to reflect any change
in their expectations or any change in events, conditions, or
circumstances on which any such statement is based.
Contacts:
For AUM Biosciences Pte. Ltd.:Mr. Vishal DoshiCEO10 Anson Road,
24-16 A/B, Singapore, 079903
Investors:ICR WestwickeStephanie CarringtonT:
(646) 277-1282stephanie.carrington@westwicke.com
Media:FINN PartnersGlenn SilverT: (973)
818-8198glenn.silver@finnpartners.com
SPAG/FINNVerlynn
Heng+65-91861225verlynn.heng@spag.asia
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