Ambrx Announces NovoCodex’s Dosing of First Patient with ARX305, Ambrx’s Investigational Antibody Drug Conjugate Targeting CD70
09 November 2022 - 2:00PM
Business Wire
- ARX305 is being evaluated by Ambrx’s partner,
NovoCodex, in a Phase 1 clinical trial in various advanced tumors
-
- First patient dosing triggers milestone
payment to Ambrx -
- NovoCodex responsible for funding Ambrx’s
Phase 1 development of ARX305 -
Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using its proprietary Engineered
Precision Biologics (EPBs) platform to create antibody drug
conjugates (ADCs), today announced the first patient has been dosed
by Ambrx’s partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex)
in its Phase 1 trial of ARX305 in patients with advanced solid
tumors. ARX305 is the only anti-CD70 ADC in active development that
targets CD70, a protein that is overexpressed in a broad range of
solid and hematologic tumors, giving it the potential to treat a
range of liquid and solid tumor cancers, where CD70 is
overexpressed.
According to their development agreement, NovoCodex and Ambrx
will collaborate in the development of ARX305 up until the
completion of Phase 1 clinical trials. Under the terms of the
development agreement, Ambrx is eligible to receive up to $4.0
million in clinical milestones, as well as tiered royalties in the
low teens percentage range of aggregate net sales of ARX305 in
China from NovoCodex. As a result of the first patient being dosed
in NovaCodex’s Phase 1 clinical trial in China, Ambrx will now
receive a significant portion of the $4.0 million milestones
payments.
Ambrx plans to leverage the safety data from NovoCodex’s Phase 1
dose escalation clinical trial to inform its own Phase 1a trial,
thereby efficiently using the company’s cash and resources.
Specifically, using the data gained from NovoCodex’s dose
escalation trial, Ambrx can reduce the expense of conducting its
own initial dose escalation clinical trial. Building on the
NovoCodex Phase 1 data, Ambrx plans to expedite its Phase 1a trial
of ARX305 by starting at higher doses (i.e., doses closer to a
recommended Phase 2 dose). Following the completion of NovoCodex’s
Phase 1 clinical trial, Ambrx’s Phase 1a clinical trial for ARX305
is expected to initiate in the second half of 2023. NovoCodex is
also responsible for funding a majority of Ambrx’s development of
ARX305 through the end of Phase 1 clinical trials, up to a certain
cap, and will be able to leverage Ambrx’s data in its own
development of ARX305.
"The dosing of the first patient with ARX305 by NovoCodex
represents an important strategic benchmark that will not only
advance another Ambrx-generated ADC asset into the clinic, but also
will allow us to leverage findings from the study to inform our own
clinical trial,” said Daniel O’Connor, Chief Executive Officer of
Ambrx. “Leveraging partner data will both expedite internal
development and cut costs, establishing a strong foundation from
which to begin our own Phase 1 trial.”
Mr. O’Connor added, “CD70 is highly expressed on the surface of
a variety of hematological and solid tumor cells, and I believe the
stability of ARX305 conferred by our proprietary EBP platform
uniquely positions it as a potential best-in-class treatment for
CD70 expressing tumors. I want to thank NovoCodex for continuing
our strong partnership and look forward to continued progress as
they advance ARX305 through the clinic.”
About Ambrx Biopharma Inc. (Ambrx)
Ambrx is a clinical stage biopharmaceutical company using an
expanded genetic code technology platform to discover and develop
Engineered Precision Biologics. These include next generation
antibody drug conjugates (ADCs) and other engineered therapies to
modulate the immune system. Ambrx is advancing a focused portfolio
of clinical and preclinical programs designed to optimize efficacy
and safety in multiple cancer indications, including its lead
product candidate ARX517, a prostate-specific membrane antigen
(PSMA) targeting ADC. In addition, Ambrx has clinical
collaborations with multiple partners on drug candidates generated
using Ambrx technology. For more information, please visit
www.ambrx.com.
Forward-Looking Statements
This press release includes certain “forward-looking statements”
intended to qualify for the “safe harbor” from liability
established by the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements may be identified by
the words “anticipate,” believe,” “estimate,” “expect,” “intend,”
“plan,” “project,” “may,” “will,” “could,” “should,” “seek,”
“potential” and similar expressions, and include, without
limitation, express or implied statements regarding Ambrx’s beliefs
and expectations regarding the advancement and potential benefits
of its product candidates, clinical development and strategic
plans, and the timing of program updates and milestones related to
its product candidates. Forward-looking statements are based on
Ambrx’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Factors that could cause actual results to differ include, but are
not limited to, those risks and uncertainties associated with: the
continuing impact of the COVID-19 pandemic and other public
health-related risks and events on Ambrx’s business, operations,
strategy, goals and anticipated milestones; Ambrx’s ability to
execute on its strategy including with respect to the timing of its
R&D efforts, initiation of clinical trials and other
anticipated milestones; risks associated with development of novel
therapeutics, including potential delays in clinical trials and
regulatory submissions and the fact that future clinical trial
results may not be consistent with preliminary results or results
from prior preclinical studies or clinical trials; Ambrx’s ability
to fund operations as anticipated; and the additional risks and
uncertainties set forth more fully under the caption “Risk Factors”
in Ambrx’s Annual Report on Form 20-F filed with the United States
Securities and Exchange Commission (SEC) on April 26, 2022, and
elsewhere in Ambrx’s filings and reports with the SEC.
Forward-looking statements contained in this press release are made
as of this date, and Ambrx undertakes no duty to publicly update or
revise any forward looking statements, whether as a result of new
information, future events or otherwise, except as may be required
under applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221109005345/en/
INVESTORS Laurence Watts Managing Director Gilmartin Group, LLC.
619-916-7620 ir@ambrx.com
MEDIA Mike Tattory Account Supervisor LifeSci Communications
media@ambrx.com
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