Merck Announces Second-Quarter 2022 Dividend

On January 25, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the second quarter of 2022 (Press release, Merck & Co, JAN 25, 2022, View Source [SID1234606776]). Payment will be made on April 7, 2022 to shareholders of record at the close of business on March 15, 2022.

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ViewRay® to Participate in the B. Riley Securities Oncology Conference

On January 25, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will participate in the B. Riley Securities Oncology Conference. Scott Drake, President and Chief Executive Officer, and Zach Stassen, Chief Financial Officer, will participate in a fireside chat at 1:00 p.m. Eastern Time on Friday, January 28, 2022 (Press release, ViewRay, JAN 25, 2022, View Source [SID1234606792]).

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An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

AmerisourceBergen and TrakCel Launch Integrated Platform to Support Cell and Gene Therapies

On January 25, 2022 AmerisourceBergen, a global healthcare solutions leader, and TrakCel, the leading innovator of cellular orchestration solutions, reported an integrated technology platform designed to accelerate patient access to prescribed cell and gene therapies and deliver complete visibility throughout the treatment journey (Press release, TrakCel, JAN 25, 2022, View Source [SID1234607618]). The enhanced offering combines two platforms—OCELLOS, TrakCel’s advanced therapy orchestration platform, and Fusion, a customer relationship management and patient support ecosystem powered by AmerisourceBergen’s Lash Group, a market leader in patient support services.

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The platform increases connectivity between hub patient services and providers, resulting in a seamless and timely exchange of benefits and eligibility information which expedites patient enrollment and support, ultimately helping patients start on therapies sooner. The new offering adds to AmerisourceBergen’s robust portfolio of services and solutions that support the needs of cell and gene therapy innovators, providers and patients throughout the product and treatment journey—from pre-clinical and commercial logistics to market access and reimbursement consulting and patient support services.

"The fast-growing pipeline of cell and gene therapies represents immense hope for patients around the world, but their unique nature can pose challenges throughout the patient journey, such as eligibility and coverage barriers that can delay access to the treatment," said Willis Chandler, president of Manufacturer Services and Commercial Solutions at AmerisourceBergen. "By combining the capabilities of Fusion and OCELLOS, we’re streamlining the path to care, improving speed-to-therapy and creating a heightened level of connectivity across the supply chain. This represents an important step in AmerisourceBergen’s ongoing commitment to build an end-to-end service offering that supports innovators in enhancing patient access to these critical therapies."

TrakCel’s OCELLOS streamlines the orchestration of clinical and commercial stage therapies, from subject enrollment to treatment and administration, ensuring chain of custody and chain of identity are managed at each step of the patient journey. Fusion leverages emerging technologies, such as artificial intelligence and machine learning, for benefit verification, prior authorization, and multi-channel communication between payers, providers, and patients.

Through this integrated platform, the bi-directional flow of data starts when a provider creates a patient account and captures enrollment information within OCELLOS. The data is then securely delivered to the patient hub, where Fusion’s advanced technology begins to determine patients’ eligibility through benefits verification. If needed, a Lash Group coordinator will initiate benefits investigation and prior authorization. Providers receive a near real-time response of the patient’s coverage determination in OCELLOS and can take the next steps to move the prescribed treatment process forward.

"Ensuring that medicines are delivered efficiently and safely to patients is of utmost priority and progressing treatment pathways smoothly and quickly is critical both to successful treatment and to a good patient experience," said Ravi Nalliah, Chief Product and Strategy Officer for TrakCel. "These goals can only be achieved if data is shared securely, accurately and in real-time."

The integrated platform serves as the latest collaboration between AmerisourceBergen and TrakCel to support advanced therapy developers. AmerisourceBergen’s global specialty logistics provider, World Courier, collaborates with multiple orchestration platform providers, including TrakCel, to deliver systems that enable stakeholders to maintain chain of custody, chain of identity and traceability throughout shipments.

For more information on the integrated platform and AmerisourceBergen’s solutions to support cell and gene therapy manufacturers, visit View Source

New study published in Translational Medicine highlights cell avidity’s power as a functional biomarker for improved CAR-T design in preventing tumor escape

On January 25, 2022 LUMICKS, a next generation life science tools company, reported that research findings from a consortium, led by researchers at Cancer Center Amsterdam, Amsterdam University Medical Centers, published in Science Translational Medicine, detailed a novel design strategy for preventing tumor escape through improved chimeric antigen receptor (CAR) T cell therapy for common blood cancers (Press release, LUMICKS, JAN 25, 2022, View Source;utm_medium=rss&utm_campaign=new-study-published-by-group-of-maria-themeli-cell-aviditys-power-as-a-functional-biomarker-for-improved-car-t-design-in-preventing-tumor-relapse [SID1234606761]).

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Using both cell avidity measurements, as provided by LUMICKS’ z-Movi Cell Avidity Analyzer, and traditional immuno-assays, the researchers successfully demonstrated that co-expression of costimulatory receptors (CCR) along with an FDA approved BCMA and CD19 CAR can improve both durability of potential treatments as well as sensitivity to recognize and lyse various variants of multiple myeloma and acute lymphoblastic leukemia with low antigen density. This innovative dual-targeting approach provides an exciting new avenue for next-generation therapies that may overcome many common problems of current approved therapies, including high rates of relapse. The study was published in the December 2021 issue of Science Translational Medicine.

In the study profiled, the researchers set out to characterize the dual targeting system through co-expression of high-affinity engagement of co-stimulatory molecules with a BCMA CAR. Using LUMICKS’ z-Movi Analyzer, the researchers were able to determine that dual targeting with CD38-binding CCR enhanced the cytotoxicity of BCMA-CAR-T cells by increasing their binding avidity. This increasing activity improved the overall sensitivity of these cells as compared to other approved therapies. The measurement of cell avidity’s power as a functional biomarker provided strong support for the mechanism of action underlying these results and a rational basis for ongoing efforts to improve next-generation CARs for enhanced therapeutic efficacy.

"The z-Movi platform’s distinct ability to measure and quantify avidity provides a powerful tool for immuno-oncologists," said Maria Themeli, M.D., Ph.D. Assistant Professor at Amsterdam UMC and corresponding author of the study. "The instrument provided an essential piece of evidence in our investigation, giving us critical insight into how these engineered cells work and what is ultimately responsible for their changes in behavior with this new dual-targeting strategy. Understanding mechanism of action is fundamentally important for any effective drug development study."

The LUMICKS z-Movi platform provides the unique ability to measure the avidity of hundreds of cells in parallel using an intuitive and convenient workflow based on the application of acoustic force. The strength of interaction between single targeting (first generation) and double-targeting T cells and MM1.S target cells was measured in the study. Statistically robust differences in avidity were measured between the two CAR designs, demonstrating the underlying cause of the enhanced cytotoxicity of the dual targeting system.

"This innovative new work, highlighting LUMICKS’ z-Movi as a critical tool to enable CAR-T developers to precisely understand fundamental principles of therapy design, is both exciting and important," said Andrea Candelli, Ph.D., Chief Scientific Officer and co-founder of LUMICKS. "This is the first step in our mission to demonstrate and validate the power of cell avidity as the biomarker for immuno-oncology research and development."

ORIC Pharmaceuticals Announces Regulatory Clearance of Clinical Trial Application for ORIC-114 in Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications

On January 25, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported clearance of its Clinical Trial Application (CTA) by the regulatory authorities of the Republic of Korea for ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations (Press release, ORIC Pharmaceuticals, JAN 25, 2022, View Source [SID1234606777]).

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"This marks our third IND/CTA regulatory clearance in the last eight months and further demonstrates the productivity and commitment of our team as we expand our clinical portfolio to advance our mission on behalf of patients," said Jacob M. Chacko, M.D., president and chief executive officer. "We are encouraged by the brain penetrant properties and selectivity that ORIC-114 has demonstrated in preclinical studies, and we look forward to advancing the program into a Phase 1 study in the coming months. As we enter 2022, we are well positioned with five expected clinical updates across four clinical programs through the first half of 2023, and with cash and investments to fund our operating plan into the first half of 2024."

About ORIC-114

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated systemic tumor regressions and strong intracranial antitumor activity in various EGFR exon 20 insertion NSCLC and HER2-positive breast cancer models. ORIC-114 also compares favorably in head to head in vivo studies versus multiple approved and clinical stage EGFR exon 20 and HER2 inhibitors. The company plans to initiate a Phase 1b single agent study in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial data from this trial in the first half of 2023.