Cellworks Expands into Precision Pharma to Accelerate the Development of Cancer Drugs and Revive Shelved Pharmaceutical Assets

Leader in Personalized Therapy Biosimulation Applies its Platform to Precision Drug Development

SOUTH SAN FRANCISCO, January 9, 2023 – Cellworks Group Inc., a leader in Personalized Therapy Biosimulation, today announced the launch of its Precision Drug Development business units aimed at accelerating time-to-market for drug development and reviving previously studied but unapproved pharmaceutical assets through predictive biosimulation. The two new business units will use Cellworks’ biosimulation platform and Computational Biology Model (CBM) to predict responses to pharmaceutical interventions in silico, thereby streamlining the clinical trial process by identifying the right patients more rapidly, which in turn reduces the time and expense of developing successful pharmaceutical agents.

“Drug development today is a time-consuming and expensive process - it can take a decade or longer to take a new drug to market and cost hundreds of millions of dollars,” said Brian Battey, COO of Cellworks Group. “But in many instances, the Cellworks Platform has the ability to predict the human clinical response to drug candidates years earlier than traditional development pipelines. By predicting human clinical response much earlier in the drug development cycle, we can help pharmaceutical companies shave years off drug development timelines, expand the diseases explored, reduce the cost of thoroughly investigating pharmaceutical assets and get new therapies to patients faster.”

Cellworks Precision Drug Development: Pre-clinical Stage

Biomarker Development: Cellworks uses cell line data and retrospective patient data to discover novel biomarkers for investigational agents, which can improve drug success rates by prospectively identifying patients who will respond to an agent. Biomarkers can be associated with response or non-response and range from a single-gene biomarker to multi-gene signature.

Companion Molecule Development: The Cellworks Platform may be able to expand the utility of a drug by discovering companion molecules that increase performance when administered in combination with the investigational agent. Cellworks leverages hundreds of models from its Drug Library to iteratively add desired agents to a combination and calculate the efficacy for each combination. All combinations that show efficacy are then filtered for further evaluation.

Indication Expansion: The Cellworks Platform can potentially identify additional indications where an investigational drug may be effective by leveraging the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell-lines to evaluate the efficacy of the agent in other indications. Cellworks biosimulation results may provide guidance for additional indications to target for clinical development.

“Ninety percent of drug candidates fail to make it to the marketplace because of failed clinical development strategies,” said Dr. Michael Castro, M.D., Chief Medical Officer at Cellworks Group. “Low efficacy is often not because the drug fails to hit its target, but is more often a consequence of a molecularly naïve approach to a heterogenous and complex disease. The Cellworks platform uses computational biosimulation to model signaling pathways, master regulators, hallmark behaviors of cancer, and drug interactions with each patient’s unique disease network. Biosimulation stratifies treatment options according therapeutic impact and enables precision clinical trials that promises to transform the drug development process with fewer failures. Even a modest doubling of successful drug development from 10 to 20% would reduce the development costs for an agent reaching the marketplace by half.”

Cellworks Precision Drug Development: Clinical Stage

Clinical Trial Biosimulation: By biosimulating clinical trials, the Cellworks Platform may be able to predict human clinical response to pharmaceutical agents in just weeks, delivering critical insights years ahead of a traditional clinical trial. Patient cohorts are selected from the Cellworks patient database of 100,000+ omics profiles of patients based on guidance from the client. Cellworks creates an in silico model of the drug or drug combination. The impact of the drug(s) is biosimulated with the cohort. Cellworks biosimulation results may provide guidance on the indications to target for clinical development.

Drug Revival and Repurposing: The Cellworks Platform aims to predict why specific drugs cause response, or not, which may be used to determine if shelved assets can be revived through appropriate patient selection or identification of non-obvious indications. Cellworks collaborates with pharma and biotech partners on certain assets to enhance development efforts and accelerate commercialization by applying the Cellworks Platform to assets owned by the partner or through in-licensing assets that the partner prefers to have an external innovation partner take on the clinical development and financial responsibilities.

Cellworks Platform and Computational Biology Model (CBM)

The Cellworks Platform biosimulates the impact of specific drug compounds on an individual patient or class of patients using their genomic profile. Multi-omic data from a patient or cohort is used as input to the Cellworks Computational Biology Model (CBM) to generate a personalized or cohort-specific disease model. The CBM is a highly curated mechanistic network of 6,000+ human genes, 30,000 molecular species and 600,000 molecular interactions. This model along with associated drug models are used to biosimulate the impact of specific compounds or combinations of drugs on the patient or cohort and produce therapy response predictions.

The Cellworks CBM has been tested and applied against various clinical datasets with results provided in over 125 presentations and publications with global collaborators. In studies such as iCare1, a prospective observational trial in AML and MDS published in Blood Advances, the Cellworks Platform has shown it can more reliably predict response compared to physician choice alone, identify the drugs in a multidrug regimen that are actually working --- not just adding toxicity, suggesting novel treatment regimens for patients who otherwise might have run out of options, and identify biomarkers associated with response and non-response.

New Leadership

Cellworks has recently added key members to its executive team to propel the company’s growth and commercialization strategy. Over the past six months, Dave Daly has supported the Cellworks business transformation as its CEO. Daly and Yatin Mundkur of Artiman Ventures, a Cellworks investor serving as Chief Technology Officer and Board Director, together lead the Cellworks Platform development strategy and model validation efforts. Other additions to the Cellworks leadership team include: Dr. Michael Castro as Chief Medical Officer; Brian Battey as Chief Operating Officer; James Wingrove, Ph.D. as Vice President of Clinical Services; and Duane Williams as Vice President Pharma Services. In addition, Philip Sawyer, Managing Partner at Bering Capital, has joined the Cellworks Board as a Director and Dr. Lee Newcomer, former Chief Medical Officer of UnitedHealth Group, is now Cellworks Chairman of the Board.

The new members of the Cellworks leadership team join Michele Dundas Macpherson, Cellworks Chief Business Officer, and Drew Watson, Ph.D., Cellworks Chief Biostatistician, as the company prepares for exponential growth in the Personalized Oncology and Precision Pharma markets.

“This exceptional team will continue to advance industry-leading decision support for personalized therapy selection, while also leveraging the same technology platform to provide precision pharma services that accelerate drug development to get new therapies to patients faster,” said Yatin Mundkur, Cellworks Chief Technology Officer and Board Director.

“Cellworks has a unique opportunity to bridge the gap between sequencing data and decision-making for therapy selection,” said Lee Newcomer, M.D., Cellworks Chairman of the Board. “Next Generation Sequencing (NGS) reports uncover genomic aberrations, but patients with multiple aberrations have hundreds of potential pathway disruptions that cannot be predicted without computational technology. The Cellworks Platform and Computational Biology Model use biosimulation to accurately predict the best clinical outcomes for a specific patient considering their full genomic profile.”

“Cellworks has assembled a powerhouse team skilled in diagnostic medicine, therapeutic decision making and drug development,” said Brian Battey, COO of Cellworks Group. “We are well-positioned to enhance clinical markets by addressing the significant unmet needs in both precision pharma and personalized oncology. I am looking forward to advancing Cellworks mission to improve patient outcomes through precision drug development and personalized therapy selection.”

About Cellworks Group

Cellworks Group, Inc. is a leader in Precision Drug Development and Personalized Therapy Biosimulation. The Cellworks Platform predicts therapy response for individual patients and patient cohorts using a breakthrough Computational Biology Model (CBM) and biosimulation technology. Backed by Artiman Ventures, Bering Capital, Sequoia Capital, UnitedHealth Group and Agilent Ventures, Cellworks has the world’s strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal – attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California with a research and development facility in Bangalore, India. For more information, visit www.cellworks.life

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