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.

Logo - https://mma.prnewswire.com/media/966600/DarwinHealth_Logo.jpg

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