RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology
DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics.

Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors.

The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through 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 various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. 

- Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth

"The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," 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-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies."

As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies.

"The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies."

- Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth.

These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. Importantly, these discoveries can rapidly mature into precision biomarker-driven human clinical trials and commercial development.

About DarwinHealth, Inc.
DarwinHealth: Precision Therapeutics for Cancer Medicine is a cancer frontier biotechnology-focused company, co-founded by CEO Gideon Bosker, MD, and Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems Biology and Chair of the Department of Systems Biology from Columbia University. The company's technology was developed by Califano's laboratory over the past 14 years and is exclusively licensed by Columbia University. DarwinHealth technology has been developed to identify mechanistic and biomarker-driven, processable and often unforeseen alignments at the proteomic level between small molecules and specific tumor subtypes / patient cohorts and is therefore positioned to accelerate the development of oncology pipelines.

About Prelude Therapeutics
Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

Spotlight

Since the time of blockbuster drugs and mirrored sales teams a decade ago, pharmaceutical reps’ access to physicians continues to decline each year. Studies indicate that between 36.5% - 44% of physicians are now being designated as “no access.”1 Despite this declining access trend, the industry continues to allocate most of its total sales and marketing budgets to its sales forces, reaching estimates of $12 billion in 2016. With so much at stake, the industry can ill afford to arm its sales force with inadequate sales reports. Yet, the reporting function continues to fall short.

Related News

PHARMACY MARKET

AIkido Pharma Announces Strategic Interest in ASP Isotopes Inc.

AIkido Pharma Inc. | December 07, 2021

AIkido Pharma Inc. announced that the Company secured a strategic equity interest in ASP Isotopes, Inc., which focuses on the non-nuclear supply of enriched isotopes. ASP Isotopes' Aerodynamic Separation Process is a method of enriching molybdenum-100 which is a stable isotope of molybdenum. Technetium-99m is the most used radioisotope in the nuclear imaging industry, but the supply chain, which involves the radioactive decay of molybdenum-99 has been fraught with problems during the last 20 years. Mo-100 can be converted into Technetium-99m closer to the point of care thus eliminating the complex supply chain that currently exists and the risk of a supply interruption to the hospital and radiological pharmacy. ASP Isotopes is currently constructing a 20 Kg/year production plant in South Africa during 2021/22. There has been significant interest from potential customers for volumes exceeding 100% of the capacity of the first manufacturing plant. The company intends to enter into "take or pay" style offtake agreements with customers and by 2028, ASP Isotopes Inc intends to be a leading supplier of non-nuclear enriched isotopes generating over $150 million in EBITDA per annum. "The ASP Technology has been developed over the last 18 years. Following this capital raise, we believe that we are in a strong position to complete our first manufacturing plant for Molybdenun-100. Given the inherent challenging nature of the current supply chain, there has been considerable interest from potential customers, and we look forward to beginning commercial operations in the future. We would like to thank AIkido Pharma for their strategic investment in ASP Isotopes and we look forward to delivering extraordinary shareholder returns during the next several years". Paul Mann, Chairman and CEO of ASP Isotopes Anthony Hayes, CEO of AIkido, noted, "This clearly exemplifies another high growth opportunity for us with a potential monetization event in the first half of 2022. ASP's unique technology, large market opportunity, notable investors and well accomplished management team are what initially attracted us to this opportunity. Our strategic investment in ASP Isotopes is exciting as they may have the best solution to help solve the current supply chain issue of a potential supply side shock with their Aerodynamic Separation Process. The Mo-99 market is currently estimated to be valued at $3.8 billion per year but with nine out of ten facilities expected to close within 10 years many governments and companies are exploring alternative methods of producing MO-99. We remain focused on continuing to acquire assets in our space that we believe will create shareholder value and possible monetization in the next 6-9 months." About ASP Isotopes Inc. ASP Isotopes Inc. was incorporated in 2021 and is an isotope enrichment company. The company utilizes technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The company's first commercial product will be Molybdenum 100, which has the potential to replace Molybdenum 99, a commonly used product in the diagnostic imaging market. About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer and prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus. Additionally, the Company has interests in high growth opportunities in diverse sectors with potential near term monetization events.

Read More

PHARMA TECH

KSP Specialty Pharmacy now offers access to non-oncology drugs and launches new website featuring pharmacy patient portal

Karmanos Cancer Institute | October 05, 2021

The Barbara Ann Karmanos Cancer Institute and KSP Specialty Pharmacy (KSP) are pleased to announce the launch of new services and a new website: www.ksppharmacy.org. The new site features provider resources and information for payers and pharmaceutical companies. Most notably, the site includes an online portal where patients can refill their prescriptions. This tool also allows patients to see their list of medications, get reminders and interact with their pharmacist. A portal for patient education and tips is forthcoming. Additionally, KSP has begun offering non-oncology specialty drugs to serve providers and patients throughout the McLaren Health Care network. KSP is a specialty pharmacy within the McLaren Health Care Network, serving the needs of patients with complex disease states and high-cost therapeutic treatments. KSP began as an extension of the Barbara Ann Karmanos Cancer Institute in 2019 and has since grown to assist with specialty medication needs of patients throughout the McLaren system in Michigan, Ohio and Indiana. Additionally, the Karmanos ambulatory pharmacy, which provides non-specialty medication, has launched a portal with similar functionality. Those undergoing cancer treatment at Karmanos can now access their prescription information and request refills on the Karmanos pharmacy web page. We are continually striving to provide our patients with tools and convenience to help them understand their treatment. The new website and app will provide the outstanding service we offer over the phone and in person on a new, convenient platform, - Stephen Smith, RPh, MS, FASHP, Chief Pharmacy Officer. KSP provides patient care and customer service through a panel of expert clinical pharmacy specialists that can assist in drug education and management of not only a patient's specialty prescriptions, but their entire prescription portfolio. The pharmacy team has direct access to the patient's medical records and providers to ensure the time to delivery of the first dose is swift. In fact, the average rate to the first dose at KSP during fiscal year 2021 is 3.92 days, while the industry standard is more than ten days. A primary goal is to ensure that our in-house social worker and account resolution team find unique programs to allow patients access to high-cost medications without being financially burdened. This allows patients to stay adherent and compliant with their prescribed therapies and start a path to faster healing and recovery. Specialty medications are used to treat complex health conditions that include hepatitis C, multiple sclerosis, cancer, rheumatoid arthritis, organ transplant, migraines and others. KSP Specialty Pharmacy's expanded services include the ability to dispense medications for patients within the McLaren Health System who face these disease states. These medications may need to be administered by a health care professional, self-injected or taken by mouth, which may require clinical monitoring. Specialty medications often require special handling, delivery and storage requirements. KSP is accredited by the Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC). URAC designation was earned in 2020 and allows for the provision of agents in other specialized areas, such as HIV, gastroenterology, neurology and many others. About the Barbara Ann Karmanos Cancer Institute Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment and compassion. Our vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in the state of Michigan. For more than 75 years, our administrative and research headquarters, along with our premier specialty cancer hospital, have been located in downtown Detroit. Our 15 network sites throughout the state deliver market-leading cancer care and clinical trials conveniently to the communities where many of our patients live. Karmanos is recognized by the National Cancer Institute as one of the best cancer centers in the nation. Our academic partnership with the Wayne State University School of Medicine provides the framework for cancer research and education – defining new standards of care and improving survivorship.

Read More

BUSINESS INSIGHTS

CEM Corporation and AmbioPharm enter into US partnership for GMP peptide production

CEM Corporation | September 16, 2021

CEM Corporation and AmbioPharm, Inc. are pleased to announce the formation of a partnership to produce GMP peptides for the global market. The partnership includes the exclusive 1Use of CEM's microwave peptide synthesis technology on a large scale for the production of GMP peptides up to several kilograms using its own scalable reactors. The main advantages of this new relationship are the extremely short production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable the rapid and efficient production of new chemical peptide entities (NCEs) using the latest available technologies. With this agreement, AmbioPharm has started peptide synthesis at its North Augusta facility to better serve customers with fast microwave synthesis processes. CEM's peptide production technology utilizes automated, large-scale microwave solid phase peptide synthesis systems (SPPS) that have been proven to improve peptide purity and minimize excess reagents. In addition, the CEM has developed proprietary coupling methods optimized for reactions at elevated temperatures 2 , a unique way to combine the coupling and deprotection reactions in a single step 3 , and established the use of more environmentally friendly solvents that are more accessible at elevated temperatures 4 . These unique technological advantages are licensed to AmbioPharm for GMP production. AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 people and recently completed a major expansion of its headquarters in South Carolina, USA, adding nearly 56,000 square feet of additional peptide manufacturing capacity. The production plant has a cleaning capacity of up to 30 kg / batch and a freeze-drying capacity of up to 1,000 liters. The CEM Liberty Pro Synthesizer offers different reactor sizes (3, 8 and 15 liters) that allow the synthesis of batches from 5 g to 500 g of the final peptide. Peptide-based drugs have enormous potential for the future and we are pleased to be able to help improve their production process. AmbioPharm is an ideal partner and we believe this relationship will enhance the opportunities for the manufacturing of peptide therapeutics. - Michael J. Collins, Ph.D., President and CEO of CEM Corporation. With the addition of CEM's microwave technology to our GMP peptide manufacturing options, we can offer even better service in terms of faster delivery for our partners' products and unique opportunities to make longer and more complex peptides accessible using microwave methods. - Chris Bai, Ph.D., CEO of AmbioPharm Inc. About CEM CEM Corporation, a privately held company based in Matthews, North Carolina, is a leading provider of laboratory instruments. The company has subsidiaries in the UK, Germany, Italy, France, Japan and Singapore and a worldwide network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company's products are used in many industries, including the pharmaceutical, biotech, chemical and food industries, as well as academic research. About AmbioPharm, Inc . AmbioPharm, part of the Ambio Pharmaceuticals Group, is a leading, innovation-driven company that specializes in the development and manufacture of peptides and peptide-like products. AmbioPharm offers a comprehensive range of services and produces customized products for research, clinical development and commercial use for pharmaceutical and biotechnology companies worldwide. AmbioPharm operates internationally, has its headquarters in the USA, locations in Europe, the USA and Asia and has more than 14 years of experience and expertise.

Read More

Spotlight

Since the time of blockbuster drugs and mirrored sales teams a decade ago, pharmaceutical reps’ access to physicians continues to decline each year. Studies indicate that between 36.5% - 44% of physicians are now being designated as “no access.”1 Despite this declining access trend, the industry continues to allocate most of its total sales and marketing budgets to its sales forces, reaching estimates of $12 billion in 2016. With so much at stake, the industry can ill afford to arm its sales force with inadequate sales reports. Yet, the reporting function continues to fall short.