- Exclusive global license outside of Greater China for SHR-4849, a Phase 1
DLL3-targeting Topo-I-payload antibody drug conjugate (ADC)
- DLL3 highly expressed in Small Cell Lung Cancer (SCLC) and
Neuroendocrine Tumors (NETs), respectively 85% and 20-40%
- Rational combination opportunities with IDEAYA's DNA Damage
Repair (DDR) clinical pipeline, including Phase 1 PARG inhibitor
IDE161
- Targeting US IND filing for SHR-4849 in H1 2025
SOUTH
SAN FRANCISCO, Calif. and SHANGHAI, Dec. 29,
2024 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(NASDAQ: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
that it has entered into an exclusive license agreement for
SHR-4849, a novel DLL3-targeting Topo-I-payload ADC program with
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, SHA:
600276), an innovative global pharmaceutical company headquartered
in China focused on unmet clinical
needs. Under the terms of the agreement, IDEAYA will develop and
commercialize SHR-4849 worldwide outside of Greater
China.
"There is significant unmet medical need in DLL3-expressing
solid tumors, and we are excited by the opportunity to develop
SHR-4849, which has monotherapy potential in SCLC and NETs.
SHR-4849 is competitively well positioned with first-in-class
potential in the DLL3 topo-I-payload ADC field, a therapeutic area
that has demonstrated preliminary monotherapy clinical validation
in SCLC," said Yujiro S. Hata, Chief Executive Officer and
Founder, IDEAYA Biosciences. "In addition, SHR-4849 accelerates
IDEAYA's strategic objective to develop rational clinical
combinations of topo-payload based ADCs with our PARG inhibitor
IDE161, where we observe enhanced preclinical combination efficacy
versus evaluated topo-payload ADCs alone," said Daniel A.
Simon, Chief Business Officer, IDEAYA Biosciences.
Frank Jiang, Chief Strategy
Officer and Board Director, Hengrui Pharma, said "SHR-4849 is a
novel DLL3 targeting ADC showing encouraging early clinical signals
in small-cell lung cancer with a manageable safety profile. We are
delighted to partner with IDEAYA to support the development of this
ADC globally, which furthers our goal of delivering innovative
medicines for the benefit of patients around the world."
SHR-4849 has shown promising antitumor activity in preclinical
studies, including tumor regression as a monotherapy in multiple
models. This drug is currently being evaluated in a Phase 1
clinical trial for advanced solid tumors in China (NCT06443489). In the ongoing Phase 1
dose escalation, SHR-4849 has reached therapeutic dose levels where
multiple partial responses have been observed as of the data
cut-off date of December 10, 2024.
Among 11 evaluable small cell lung cancer (SCLC) subjects treated
at therapeutic dose levels, 8 partial responses by RECIST 1.1 were
observed, resulting in an overall response rate of ~73% (including
both confirmed and unconfirmed responses, all unconfirmed responses
were pending further evaluation). As of the data cut-off
date, treatment related adverse events (TRAEs) were predominantly
Grade 1 or 2, and the Phase 1 dose escalation is ongoing with no
reported drug-related discontinuations, and the maximum tolerated
dose has not yet been reached. The most common TRAEs observed
were white blood cell count decreased, anemia, neutrophil count
decreased, nausea and platelet count decreased.
IDEAYA is targeting to file a US IND for SHR-4849 in the first
half of 2025.
DLL3 has been reported to be expressed in multiple solid tumor
types, including in SCLC and Neuroendocrine Tumors at approximately
85% and 20-40%, respectively, based on the Human Protein Atlas
database. DLL3 has limited extracellular expression in normal
tissues, making it a promising therapeutic target in these tumor
types, for which there remains significant unmet medical need.
Under the terms of the agreement, Hengrui Pharma is eligible to
receive upfront and milestone payments totaling $1.045 billion, including a $75m upfront fee, up to $200m in development and regulatory milestone
payments, plus commercial success-based milestones. Hengrui is also
eligible to receive mid-single to low-double digit royalties on net
sales outside of Greater China.
The upfront and projected research and development costs, including
potential milestone payments, does not change the earlier provided
IDEAYA guided cash out runway of at least 2028.
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 early research and drug discovery
capabilities to synthetic lethality – which represents an emerging
class of precision medicine targets.
About Hengrui Pharma
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an
innovative global pharmaceutical company focused on unmet clinical
needs, with a strong track record of scientific and technological
innovation. Since its first innovative drug approval in 2011,
Hengrui Pharma has invested more than $5.4
billion in R&D and set up 14 R&D centers in
Lianyungang, Shanghai, the U.S.,
and Europe. It has 9 major
manufacturing sites and a global R&D team of more than 5,000
professionals. Hengrui Pharma has independently established a
number of leading technology platforms such as its ADC platform,
proteolysis targeting chimera (PROTAC), molecular gels,
bi/multi-specific antibodies, and AI molecular design, which
provide a strong foundation for innovative R&D. Hengrui strives
for continued innovation and collaboration with global partners to
serve a healthy China and benefit
patients around the world.
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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