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."

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.

On January 25, 2022 SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, reported that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for SNIPR001 (Press release, SNIPR Biome, JAN 25, 2022, View Source [SID1234606793]). SNIPR001 is the company’s first development candidate targeting E. coli in patients with hematological malignancy at risk of neutropenia. This announcement comes only a few weeks after the FDA approved the Investigational New Drug (IND) Application paving the way initiating the first clinical trial in humans.

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"At SNIPR BIOME, we are extremely proud to have been granted Fast Track designation by the FDA. It underlines SNIPR001’s potential to be a game-changer for hematological cancer patients at increased risk of life-threatening bloodstream infections caused by E. coli" says Dr. Christian Grøndahl, Co-founder & CEO and continues, "E. coli was recently highlighted as one of the leading pathogens associated with anti-microbial-resistance (AMR) and death in a systematic review published by the scientific journal The Lancet, so there is an urgent need for new medicines targeting E. coli."

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.

Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome, adds: "With the FDA’s Fast Track designation, we have reached yet another milestone and we are very pleased, that the FDA shares our view on the need to target AMR. Now, all our attention is directed towards initiating our first clinical trial, which is expected in H1 2022."

SNIPR001 is being developed in collaboration with the non-profit organisation CARB-X. The aim is to target E. coli bacteria in the gut, and thereby prevent translocation of these bacteria from the gut into the bloodstream, while leaving the commensal bacteria in the patient’s microbiome unaffected.

This precision medicine approach is harnessing a novel application of SNIPR BIOME’s proprietary CRISPR/Cas technology, hereby potentially transforming the way E. coli infections are prevented and treated, especially in the cancer ward.

Today, there are no approved therapies for prophylactic therapy in this setting.  

On January 25, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be releasing its preliminary results for the full year ended 30 September 2021 on 27 January 2022 (Press release, Redx Pharma, JAN 25, 2022, View Source [SID1234606762]).

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A live webcast for analysts and investors will be held at1.00pm GMT (8.00am ET) on 27 January 2022. To join the webcast, please register in advance at https://bit.ly/3IobDLs

A recording of the webcast will be made available on Redx’s website following the results meeting.

On January 25, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their ongoing collaboration with Monte Rosa Therapeutics to develop a cellular systems pharmacology model for cereblon (CRBN)-based molecular glue degraders (MGDs) targeting GSPT1 (Press release, Applied BioMath, JAN 25, 2022, View Source [SID1234606794]). The model will be used to predict and explain CRBN-based GSPT1 target degradation in various cellular disease settings and to answer mechanistic questions.

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"We chose to work with Applied BioMath based on their scientific expertise across various modalities and disease areas," said Sharon Townson, PhD, Chief Technology Officer at Monte Rosa Therapeutics. "Our hope is that the cellular systems pharmacology model we develop will accelerate our understanding of small molecule MGDs and we look forward to leveraging this advantage."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "A fit-for-purpose mechanistic model allows our partners to gain better insight into their therapeutic’s mechanism of action in various disease conditions more quickly than with traditional experimental approaches," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Monte Rosa Therapeutics is doing novel work and we’re excited to partner with them on this project."

To learn more about Applied BioMath’s solutions, visit View Source