DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics to Develop Novel Biomarkers for Multiple Oncology Candidates
PR92264
NEW YORK, Oct. 13, 2021 /PRNewswire=KYODO JBN/ --
DarwinHealth, Inc. today announced a scientific research collaboration
employing its Biomarker Enrichment Strategies for Trials (BEST platform) to
elucidate novel biomarkers to guide translational trajectories for multiple
oncology molecules being developed by Prelude Therapeutics.
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Under the collaboration, DarwinHealth will use its proprietary, quantitative,
systems biology-based algorithms, CLIA-approved technologies, and validated
approaches focused on Master Regulator (MR) proteins and tumor checkpoints to
identify novel protein-based biomarkers that will add significant precision to
patient cohort selection for clinical trials to be conducted at Prelude's
discretion in both hematologic and solid tumors.
"The goal of this biomarker-focused collaboration," explained Professor Andrea
Califano, Clyde and Helen Wu Professor and Chair, Department of Systems
Biology, Columbia University and DarwinHealth Co-founder, "is to assess and
characterize overall and tumor-specific mechanisms-of-action of Prelude's
pipeline molecules in an attempt to identify novel biomarkers that may align
these agents with responsive patient cohorts. Additionally, the collaboration
will mechanistically characterize potential therapeutic opportunities for
Prelude's pipeline molecules targeting various oncogenic pathways across
multiple hematologic malignancies and solid tumor subtypes, as selected by
Prelude Therapeutics. The study will leverage the VIPER algorithm to
characterize the activity of these diverse compounds against key Master
Regulator (MR) protein modules (tumor checkpoints) necessary for
subtype-specific tumor viability."
"The BEST initiative will provide precise and actionable compound- and tumor
-specific information for assessing the potential of Prelude's pipeline
molecules to invert subtype-specific tumor checkpoint activity," explained Dr.
Mariano Alvarez, Chief Scientific Officer of DarwinHealth. "The purpose of such
studies is to generate a range of validated compound/tumor subtype/biomarker
alignments that represent evidence- and mechanism-based roadmaps for biomarker
development and patient selection to potentially accelerate clinical studies."
As part of the BEST initiative, DarwinHealth will provide a comprehensive
readout of the potential clinical value of select Prelude pipeline molecules
across a spectrum of tumor types. Through quantitative modeling and
biomarker-centric translational pathways, DarwinHealth will also assist in the
design of in vivo validation studies to leverage key opportunities that may not
be apparent using conventional technologies.
"The BEST collaboration addresses one of the critical unmet needs of the
biotechnology and biopharmaceutical spaces focused on cancer drug
discovery—that is, developing biomarkers highly predictive of clinical response
to compounds whose ultimate effectiveness may be the result of an incompletely
decipherable range of both on- and off-target drug effects directed at multiple
targets of regulatory programs underlying cancer dependencies," noted Dr.
Gideon Bosker, CEO and DarwinHealth Co-founder. "These uncertainties lend
themselves to extending the biomarker concept beyond a drug's primary (i.e.,
high-affinity) target, to multi-protein classifiers identified by our
integrative computational and experimental methodologies."
Notably, novel, multi-protein classifiers identified by the BEST platform have
been previously reported by DarwinHealth for Multiple Myeloma (N Engl J Med
2019;381:727-38. https://www.nejm.org/doi/full/10.1056/NEJMoa1903455 ) and
DLBCL (British Journal of Haematology; 02 August 2021,
https://doi.org/10.1111/bjh.17730).
These technologies are ideally suited for identifying mechanistic alignments
between drug candidates and cancer patients based on the ability of drugs to
inactivate the patient-specific MR proteins that are necessary for tumor state
maintenance. Importantly, these discoveries can be quickly matured to
precision, biomarker-driven clinical human testing and commercial development.
About DarwinHealth, Inc.
DarwinHealth: Precision Therapeutics for Cancer Medicine is a "frontiers of
cancer," technology-focused company, co-founded by CEO Gideon Bosker, MD, and
Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems
Biology and Chair, Department of Systems Biology at Columbia University. The
company's technology was developed by the Califano lab over the past 14 years
and is exclusively licensed from Columbia University. DarwinHealth technology
has been developed to identify actionable, and frequently unanticipated
mechanistic and biomarker-directed alignments at the proteomic level between
small molecules and specific tumor subtypes/patient cohorts and, therefore, it
positioned to accelerate development of oncology pipelines, both for small
molecule and immuno-oncology-based developmental pathways.
DarwinHealth utilizes proprietary, systems biology algorithms to match
virtually every cancer patient with the drugs and drug combinations that are
most likely to produce a successful treatment outcome. "Conversely, these same
algorithms also can prioritize investigational drugs and compound combinations
of unknown potential against a full spectrum of human malignancies, as well as
novel cancer targets," explained Dr. Bosker, "which make them invaluable for
pharmaceutical companies seeking to both optimize their compound pipelines and
discover mechanistically actionable, novel cancer targets and compound-tumor
alignments."
DarwinHealth's mission statement is to deploy novel technologies rooted in
systems biology to improve clinical outcomes of cancer treatment. Its core
technology, the VIPER algorithm, can identify tightly knit modules of master
regulator proteins that represent a new class of actionable therapeutic targets
in cancer. The methodology is applied along two complementary axes: First,
DarwinHealth's technologies support the systematic identification and
validation of druggable targets at a more foundational, deep state of the
cancer cell's regulatory logic so we and our scientific partners can exploit
next generation actionability based on fundamental and more universal tumor
dependencies and mechanisms. Second, from a drug development and discovery
perspective, the same technologies capable of identifying potentially druggable
novel targets based on master regulators, and upstream modulators of those
targets. This is where the DarwinHealth oncotectural approach, with its
emphasis on elucidating and targeting tumor checkpoints, provides its most
important solutions and repositioning roadmaps for advancing precision-focused
cancer drug discovery and therapeutics.
The proprietary, precision medicine-based methods employed by DarwinHealth are
supported by a deep body of scientific literature authored by its scientific
leadership, including DarwinHealth CSO, Mariano Alvarez, PhD, who co-developed
the company's critical computational infrastructure. These proprietary
strategies leverage the ability to reverse-engineer and analyze the genome-wide
regulatory and signaling logic of the cancer cell, by integrating data from in
silico, in vitro, and in vivo assays. This provides a fully integrated drug
characterization and discovery platform designed to elucidate, accelerate, and
validate precise developmental trajectories for pharmaceutical assets, so their
full clinical and commercial potential can be realized. For more information,
please visit: www.DarwinHealth.com.
About Prelude Therapeutics
Prelude Therapeutics is a clinical-stage precision oncology company developing
innovative drug candidates targeting critical cancer cell pathways. The
Company's lead product candidates are designed to be oral, potent, and
selective inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is
in Phase 1 development for advanced solid tumors and select myeloid
malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor
optimized for high brain exposure, in a Phase 1 clinical trial including
glioblastoma multiforme (GBM). The Company's pipeline also includes its third
clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1
development for patients with relapsed/refractory hematologic malignancies, and
its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and
PRT-SCA2, a SMARCA2 protein degrader.
Prelude Therapeutics Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act of
1995, including, but not limited to, anticipated discovery, preclinical and
clinical development activities, timing of availability and announcements of
clinical results, the timing of the expansion portion for its Phase 1 clinical
trial for PRT543 and PRT811, the timing of IND-related activities for PRT2527
and the potential benefits of the Company's product candidates and platform.
All statements other than statements of historical fact are statements that
could be deemed forward-looking statements. Although the Company believes that
the expectations reflected in such forward-looking statements are reasonable,
the Company cannot guarantee future events, results, actions, levels of
activity, performance or achievements, and the timing and results of
biotechnology development and potential regulatory approval is inherently
uncertain. Forward-looking statements are subject to risks and uncertainties
that may cause the Company's actual activities or results to differ
significantly from those expressed in any forward-looking statement, including
risks and uncertainties related to the Company's ability to advance its product
candidates, the receipt and timing of potential regulatory designations,
approvals and commercialization of product candidates, the impact of the
COVID-19 pandemic on the Company's business, clinical trial sites, supply chain
and manufacturing facilities, the Company's ability to maintain and recognize
the benefits of certain designations received by product candidates, the timing
and results of preclinical and clinical trials, the Company's ability to fund
development activities and achieve development goals, the Company's ability to
protect intellectual property, and other risks and uncertainties described
under the heading "Risk Factors" in documents the Company files from time to
time with the Securities and Exchange Commission. These forward-looking
statements speak only as of the date of this press release, and the Company
undertakes no obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date hereof.
SOURCE: DarwinHealth
CONTACT: Gideon Bosker, CEO DarwinHeallth, (503) 880-2207,
GBosker@DarwinHealth.com
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