- Nominated IDE034 (BCG034) as a development candidate, a
potential first-in-class B7H3/PTK7 topo-I-payload bispecific
antibody drug conjugate (BsADC)
- Option exercised for an exclusive worldwide license for IDE034
from Biocytogen
- Targeting an IND-filing for IDE034 in 2025 to enable
first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload
BsADC program
- IDE034 has the potential to be developed as a monotherapy and
in combination with IDEAYA's PARG inhibitor IDE161
- B7H3/PTK7 co-expression in lung, colorectal, and head and neck
cancer, has been reported at approximately 30%, 46% and 27%,
respectively
SOUTH
SAN FRANCISCO, Calif. and BEIJING, Nov. 11,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
the selection of IDE034, a potential first-in-class B7H3/PTK7
topo-I-payload BsADC, as a development candidate and the exercise
of its option for an exclusive worldwide license from Biocytogen
Pharmaceuticals (Beijing) Co.,
Ltd. (Biocytogen, HKEX: 02315) for potential first-in-class
B7H3/PTK7 BsADC program.
"We are pleased to nominate development candidate IDE034, a
promising potential first-in class B7H3/PTK7 topo-I-payload
bispecific ADC, which has demonstrated robust monotherapy tumor
regressions in multiple preclinical models. The co-expression of
B7H3/PTK7 in several solid tumors, including double-digit percent
prevalence in lung, colorectal, and head and neck cancers,
highlights the potential addressable market, both as monotherapy
and in combination with PARG inhibitor IDE161," said Michael White, Ph.D., Chief Scientific Officer
of IDEAYA Biosciences. "We are excited to nominate our
6th development candidate in IDE034 and this program
achieves several strategic objectives for IDEAYA, including the
potential for monotherapy activity, application in multiple
priority solid tumor types of lung and colorectal cancer, and the
ability to enable wholly-owned rational combinations with our
internal pipeline," said Yujiro S.
Hata, Chief Executive Officer and Founder, IDEAYA
Biosciences.
"We are excited to have IDEAYA exercise their option to license
the worldwide rights to our B7H3/PTK7 BsADC IDE034 with a
proprietary topoisomerase linker-payload. This important milestone
in our partnership further validates Biocytogen's
RenLite® platform and brings us one step closer to
making an impact on patients with solid tumors. We look forward to
our continued partnership with IDEAYA as they advance this program
to the clinic," added Dr. Yuelei Shen, President and CEO of
Biocytogen.
IDEAYA is targeting an Investigational New Drug (IND) submission
to the U.S. Food and Drug Administration (FDA) in 2025 for IDE034,
subject to satisfactory completion of ongoing preclinical and
IND-enabling studies, to enable first-in-human study
initiation.
The option was exercised for an exclusive worldwide license from
Biocytogen pursuant to the option and license agreement between
IDEAYA and Biocytogen. IDEAYA will pay Biocytogen upfront and
option exercise fees, along with additional development and
regulatory milestone payments, commercial milestone payments, and
royalties on net sales, totaling $406.5
million, including up to $100
million in development and regulatory milestone
payments.
B7H3/PTK7 has been reported to be co-expressed in multiple solid
tumor types, including in lung, colorectal, and head and neck
cancers at approximately 30%, 46% and 27%, respectively, based on
the Human Protein Atlas database.
About IDEAYA Biosciences
IDEAYA is a precision
medicine oncology company committed to the discovery and
development of targeted therapeutics for patient populations
selected using molecular diagnostics. IDEAYA's approach integrates
capabilities in identifying and validating translational biomarkers
with drug discovery to select patient populations most likely to
benefit from its targeted therapies. IDEAYA is applying its
research and drug discovery capabilities to synthetic lethality –
which represents an emerging class of precision medicine
targets.
About Biocytogen
Biocytogen (HKEX: 02315) is a global
biotechnology company that drives the research and development of
novel antibody-based drugs with innovative technologies. Founded on
gene editing technology, Biocytogen leverages genetically
engineered proprietary RenMice® (RenMab™/ RenLite®/ RenNano®/
RenTCR-mimic™ ) platforms for fully human
monoclonal/bispecific/multispecific antibody discovery, bispecific
antibody-drug conjugate discovery, nanobody discovery and TCR-mimic
antibody discovery, and has established a sub-brand, RenBiologics™,
to explore global partnerships for an off-the-shelf library of
>400,000 fully human antibody sequences against approximately
1000 targets for worldwide collaboration. As of June 30, 2024, approximately 150 therapeutic
antibody and multiple clinical asset
co-development/out-licensing/transfer agreements and nearly 50
target-nominated RenMice® licensing projects have been
established with over 60 global pharmaceutical and biotech
companies, including several partnerships with multinational
pharmaceutical companies (MNCs). Biocytogen pioneered the
generation of drug target knock-in humanized models for preclinical
research, and currently provides a few thousand off-the-shelf
animal and cell models under the company's sub-brand, BioMice™,
along with preclinical pharmacology and gene-editing services for
clients worldwide. Headquartered in Beijing, Biocytogen has branches in
China (Haimen Jiangsu,
Shanghai), USA (Boston,
San Francisco), and Germany (Heidelberg). For more information,
please visit http://en.biocytogen.com.cn.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to (i) the timing of a potential IND filing,
(ii) potential development strategies, (iii) the estimated
potential addressable market and (iv) the potential therapeutic
benefits of IDEAYA therapeutics. Such forward-looking statements
involve substantial risks and uncertainties that could cause
IDEAYA's preclinical and clinical development programs, future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the drug development process, including IDEAYA's
programs' early stage of development, the process of designing and
conducting preclinical and clinical trials, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, IDEAYA's ability to
successfully establish, protect and defend its intellectual
property, and other matters that could affect the sufficiency of
existing cash to fund operations. IDEAYA undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of IDEAYA in
general, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.