Moderna and Thermo Fisher Scientific Announce Long-Term Strategic Collaboration

On February 23, 2022 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, reported a 15-year strategic collaboration agreement to enable dedicated large-scale manufacturing in the U.S. of Spikevax, Moderna’s COVID-19 vaccine, and other investigational mRNA medicines in its pipeline (Press release, Moderna Therapeutics, FEB 23, 2022, View Source [SID1234608911]).

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"Thermo Fisher continues to be a trusted partner, bringing a full range of products and services that have enabled us to deliver innovative medicines at an unprecedented speed and scale," said Juan Andres, Moderna’s chief technical operations and quality officer. "We are pleased to further expand our collaboration with Thermo Fisher as a long-term manufacturing partner that will enable us to continue to build on our mRNA platform and pipeline."

Over the past several years, Thermo Fisher has been partnering with Moderna to support its development pipeline with both clinical research and contract manufacturing services. This included the quick scale-up of aseptic fill-finish services and packaging of its COVID-19 vaccine. As part of this expanded agreement, Thermo Fisher will now provide dedicated capacity for a range of aseptic fill-finish services including lyophilized and liquid filling. In addition, the company will provide inspection, labeling and final packaging services.

"Moderna’s innovation in mRNA technology has been pivotal in the global response to the pandemic and we are proud and privileged to support Moderna over the last decade," said Michel Lagarde, executive vice president and chief operating officer of Thermo Fisher Scientific. "In expanding our strategic partnership, Moderna will further leverage our scale and depth of capabilities to continue to transform its mRNA platform and bring new breakthrough medicines to patients around the world."

American Oncology Network (AON) and VieCure Announce Strategic Collaboration to Accelerate Adoption of Precision Oncology and Personalized Cancer Care

On February 23, 2022 American Oncology Network, LLC (AON) , a high-growth medical oncology provider with a focus on supporting the long-term viability of oncology treatment in community-based settings, reported a strategic collaboration with VieCure, a national leader in the deployment of Artificial Intelligence (AI), codified clinical content and point-of-care clinical decision support in oncology (Press release, American Oncology Network, FEB 23, 2022, View Source [SID1234608910]). The collaboration is designed to facilitate the delivery of precision oncology and personalized care and treatment for patients across the ever-expanding AON network.

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Foundational to the future of oncology treatment is the execution of a vision for personalized medicine. Realizing this vision requires access to patients, oncologists and robust molecular information and patient outcomes data. This strategic collaboration will serve as a key vehicle to do just that. AON oncologists and staff will improve clinical decision-making at the individual patient level, while standardizing care plans and associated care delivery across the patient population to better outcomes. Longitudinal information which tracks the same type of information on the same patient at multiple times will be generated in real time as patients move throughout their complex cancer care journey. This information will be used to evaluate treatment approaches, create new value-based care funding options, improve overall treatment outcomes and provide insights into next generation prevention, screening, diagnostic and therapuetic opportunities. Given the value of the data and associated insights, AON and VieCure will work jointly with industry on transformational initiatives.

The parties have strategically aligned to accelerate the adoption of three critically important paradigm shifts that are currently underway in oncology, including: (1) the compliant use of next generation tumor sequencing, targeted therapy, immunotherapy and emerging therapies such as radio-ligands; (2) the transition to value-based care, and (3) increasing patient participation in the management of their care given more and more patients are living longer with their disease and being treated at home. While these transformational changes are improving overall survival and quality of life for patients, they are also driving the need for change at the point of care given oncologists are having to evaluate an ever growing amount of patient data and clinical evidence.

"Clinicians want to do what’s best for their patients, for their staff and for practices," said Dr. Stephen "Fred" Divers, Chairman of the AON Advisory Board and a practicing Medical Oncologist. "They want to make the right decisions at the right time, but they’re often overwhelmed by data which is poorly accessible and manageable, leading to clinical workflow burdens which get in the way of achieving the best outcomes for their patients. They need a technology solution that helps simplify cancer’s complexities and empowers them to do their best. At AON, we partner with physicians and their practices to help them navigate the complex oncologic landscape, improve quality of care and elevate oncology in community settings. VieCure aligns perfectly with that mission."

AON leadership recognized the need for 21st century clinical decision making tools and turned to VieCure to be their partner. The two entities will work together to codify AON’s unique clinical content including but not limited to therapeutic and drug contracts, commercial payer rules and clinical trials.

"We understand that knowledge is the secret to beating cancer," said Dr. Fred Ashbury, Chief Scientific Officer at VieCure. "That’s why we’re embracing the power of clinical inferencing to do what the human brain cannot, which is to enable clinicians to easily sift through the overwhelming amount of information to find the right answers for every patient, every time. At VieCure we’re about creating simplexity in cancer care, which means we use AI technology to cut through the dense fog of information that holds clinicians back; we help to superpower them to do their best work. By codifying the latest in clinical evidence and financial rules, we can envelop our clinicians with a halo of knowledge in real time which can be easily and quickly interpreted and actioned right at the point of care."

The multi-year strategic collaboration will not only serve to meet the clinical needs of the AON community today but will ensure the VieCure platform evolves over time. Together the parties have committed to:

Joint research and development, creating and deploying new features and technology innovations as the oncology landscape changes.
Advancing access to, and administration of, the latest codified content including national and international evidence, therapy (eg. drug/bio-similar) agreements, and phase I, II, and III clinical trials.
Centralization of precision oncology infrastructure including one-click order entry for next generation tumor sequencing and the return of relevant discrete data to facilitate real-time clinical inferencing of results to help guide treatment selection and management decisions.
Facilitation of joint/new partnerships with industry collaborators – clinical research, radiation therapy, radioligand, pharma and molecular diagnostic partners.
Facilitating clinical paradigm shifts and appropriate adoption of radioligand therapy, proteomics, biology guided radiotherapy, digital transformation at the patient/family level, and more.
Advancing value-based care in a personalized cancer care and precision oncology environment.

Cleveland Diagnostics Announces Publication of Real-World Study Demonstrating the Clinical Utility of IsoPSA® for Prostate Cancer Risk Assessment

On February 23, 2022 Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported the publication of a large real-world clinical utility study in Urology Practice, a peer-reviewed journal of the American Urological Association (Press release, Cleveland Diagnostics, FEB 23, 2022, View Source [SID1234608908]). The study, led by Dr. Eric Klein, Emeritus Professor and Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Cleveland Clinic Lerner College of Medicine, found that the use of IsoPSA led to significant provider behavior modification and a 55 percent net reduction in prostate biopsy recommendations.

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In the study, a diverse set of 38 providers from both community-based practices and academic locations within the Cleveland Clinic health system enrolled 900 men being evaluated for prostate cancer, readily adopted IsoPSA, and utilized IsoPSA results in their patient management decisions. IsoPSA results led to physicians changing their initial biopsy and MRI recommendations in two-thirds of the cases. In addition to the 55 percent reduction in biopsy recommendations subsequent to the test, IsoPSA also demonstrated both confirmatory and discriminatory power, most notably that providers changed their pre-test ‘biopsy’ recommendations to ‘no biopsy’ recommendations in 90 percent of the cases following receipt of patient IsoPSA results below the test’s threshold value.

"Caregivers are seeking better tools to help them determine with confidence which of their patients should or should not go on to biopsy," said Dr. Mark Stovsky, Chief Medical Officer at Cleveland Diagnostics. "We expect that IsoPSA, our novel blood-based prostate cancer test, may fundamentally shift the diagnostic paradigm of prostate cancer, and improve patient care and outcomes."

"We’re very pleased that providers are not only willing to insert IsoPSA into their current diagnostic workflow, but also change their behavior based on the test results," said Arnon Chait, Chief Executive Officer at Cleveland Diagnostics. "Given the significant reduction in biopsy recommendations observed in this real-world study, the downstream savings to Medicare and commercial payors, and ultimately, the clinical benefits to patients are expected to be substantial."

It is estimated that $4B is spent in the U.S. each year on unnecessary prostate biopsies. Given the results of this real-world study and previously published clinical validation and cost effectiveness studies, Cleveland Diagnostics believes that IsoPSA will reduce significantly the number of unnecessary procedures, thereby improving patient care while producing significant cost savings for the health care system.

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test (LDT) conducted at its high-complexity, CLIA-certified, CAP- accredited laboratory in Cleveland, Ohio.

Forma Therapeutics to Report Fourth Quarter and Year-end 2021 Financial Results and Provide Business Update on March 1, 2022

On February 23, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will release fourth quarter and year-end 2021 financial results Tuesday, March 1, 2022 (Press release, Forma Therapeutics, FEB 23, 2022, View Source [SID1234608907]). Forma management will host an investment community conference call at 8 a.m. Eastern Standard Time (EST), on March 1, 2022 to discuss these financial results and provide a business update.

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Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 3322907. A live webcast of the conference call will be available in the "News & Investors" section of Forma’s website at www.formatherapeutics.com.

4D pharma to Participate at the Chardan Metagenomics and Microbiome Medicines Summit

On February 23, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that Duncan Peyton, Chief Executive Officer, and Alex Stevenson, Chief Scientific Officer of 4D pharma, will participate in a fireside chat at the Chardan Metagenomics and Microbiome Medicines Summit on Tuesday, March 1, 2022 at 9:00 a.m. ET (2:00 p.m. GMT) (Press release, 4d Pharma, FEB 23, 2022, View Source [SID1234608906]).

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A webcast of the fireside chat will be available via the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com and will be available to replay for 90 days following the presentation.