On June 3, 2022 Caris Life Sciences (Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported its Caris Assure liquid biopsy assay at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Booth #22081) (Press release, Caris Life Sciences, JUN 3, 2022, View Source [SID1234615604]).

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"Caris Assure establishes a new standard for liquid biopsy testing," said David D. Halbert, Chairman, Founder and CEO of Caris Life Sciences. "Current liquid biopsy offerings examine smaller panels of genes, which lack the versatility for the identification of novel predictive markers and signatures that are only possible through the whole exome and whole transcriptome approach unique to Caris. With Caris Assure, we have created the most extensive sequencing assay available to ensure we leave no stone unturned in properly guiding treatment selection and ongoing cancer care management."

Caris Assure is a blood-based molecular profiling assay that uses a novel circulating nucleic acids sequencing (cNAS) approach to analyze the Whole Exome (cfDNA) and Whole Transcriptome (cfRNA) of 22,000 genes, including Loss of Heterozygosity (LOH), Microsatellite Instability (MSI) and Tumor Mutational Burden (TMB) from a simple blood sample. This unique assay includes characterization of somatic tumor alterations, somatic Clonal Hematopoiesis of Indeterminate Potential (CHIP) alterations and identification of incidental germline findings. The assay further enables minimally invasive serial monitoring for detection of tumor heterogeneity and emergence of resistance mutations.

"We have applied the same industry leading, multi-cancer profiling technology used in our tissue assay to blood," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. "Our broad, 22,000 gene WES and WTS analysis ensures we render the most accurate results and findings for physicians seeking to properly diagnose, treat and monitor cancer patients. We are excited to bring this assay to the market and provide physicians with a new and comprehensive multi-cancer blood assay to add to their cancer diagnoses and treatment strategies."

Caris Assure sequences the largest panel of genes across both cfDNA (Whole Exome) and cfRNA (Whole Transcriptome), which helps overcome many of the shedding problems that plague cfDNA-only assays. By including DNA and RNA coverage across somatic tumor, somatic CHIP and germline alterations, Caris Assure captures more tumor-informed material, leading to improved performance and comprehensive molecular profiling results for the physician and patient. The approach also results in fewer missed mutations due to more tumor derived material inputs and concordance to tissue, as well as fewer false positives due to the analysis of CHIP mutations.

In an initial performance validation study of this first-of-its-kind whole exome, whole transcriptome (22,000 gene) blood assay, Caris Assure demonstrated more than 95 percent sensitivity for variant frequencies greater than 0.5 percent, while maintaining greater than 99.99 percent specificity. Additional validation data will be released in the coming months.

Caris Assure will be commercially available in the second half of calendar year 2022, with limited availability in the third quarter and expanding availability in Q4 and 2023.

On June 3, 2022 Patrys reported that share news that the Telethon Kids Institute has been awarded significant funding from the Cure Brain Cancer Foundation to support research for Patrys’ PAT-DX1 and PAT-DX3 programs (Press release, Patrys, JUN 3, 2022, View Source [SID1234615602]).

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The grant will be used to investigate Patrys’ deoxymab assets PAT-DX1 and PAT-DX3 in both in vitro and in vivo studies of high grade glioma (HGG), by combining with standard of care (SOC) treatments such as radiotherapy and temozolomide to determine efficacy.

Based within the Perth Children’s Hospital, the Telethon Kids Institute conducts translational research focused on improving treatments for the health and wellbeing of children. The research will be led by Professor Terrance Johns, who is at the forefront of Australian brain cancer research.

Patrys CEO and Managing Director, Dr James Campbell, said:

"This is one of our most exciting collaborations to date. Professor Terrance Johns and his team are pivotal in the brain cancer space in Australia. We gratefully acknowledge the Cure Brain Cancer Foundation Clinical Accelerator grant scheme for providing funding for therapeutic products with the potential to improve the pathway to the clinic."

On June 3, 2022 NanoMosaic, the pioneer and leader of nanoneedle technology (MosaicNeedle) for proteomics and multi-omics, is increasing its capabilities in neurology companion diagnostics (CDx) and future diagnostic tests, by offering a novel, reported that highly sensitive site-specific conjugated antibody against phosphorylated Tau (Phospho-Thr217) (Press release, BrickBio, JUN 3, 2022, View Source [SID1234615554]). The novel antibody has been designed to have higher affinities and enhanced performance on NanoMosaic’s Tessie platform.

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The demand from pharmaceutical partners for a highly sensitive, wide dynamic range, proteomics platform in neurology, utilizing a fully automated sample preparation solution on a standard liquid handler, initiated the collaboration between NanoMosaic and BrickBio, the leader in unnatural amino acid (UAA) incorporation and site-specific conjugation. BrickBio has designed a novel Phospho-Thr217 antibody, and using its Site-Select Panel will rapidly procure variants of the antibody conjugated with proprietary NanoMosaic moieties at optimal performance enhancing sites. The final sites chosen will significantly emphasize key properties of the antibody’s performance, while working in conjunction with the surface chemistry dynamics on the NanoChip, that will result in a sensitive, label-free, robust proteomic neurology solution with digital quantitation.

"NanoMosaic’s unique approach to high-sensitivity detection is significantly enhanced by expanding our conjugation strategies," said Josh Ritchey, VP of Product Development at NanoMosaic. "Utilizing proprietary moieties to enable these unique binding modes truly places NanoMosaic at the forefront of proteomic assay performance," Ritchey concluded.

"The site-specific introduction of stable conjugation handles across the entire antibody scaffold, powered by BrickBio’s Site-Select Panel, continues to expand the repertoire of previously inaccessible applications," said James Italia, VP of Commercial Development at BrickBio. "No other technology enables the breadth of conjugation site flexibility necessary to drive spatially oriented surface functionalization with unprecedented control," Italia concluded.

"The collaboration between BrickBio and NanoMosaic to develop a novel Phospho-Thr217 antibody, for pharmaceutical partners developing CDx assays and future IVD, in vitro diagnostic, applications will enable unprecedented, fully automated workflow advantages that provide precise digital measurements at the highest throughput with the widest dynamic range, in comparison to any current commercial proteomics system," stated John Boyce, Co-Founder of Tiger Gene. "These development and measurement advantages may translate to a significant increase in efficacious treatments for patients," Boyce concluded.

On June 3, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the Company plans to hold a clinical update call on June 13 after the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA 2022) as the data is subject to meeting’s embargo policy until June 12 (Press release, Gracell Biotechnologies, JUN 3, 2022, View Source [SID1234615552]).

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The management team intends to highlight clinical data from three investigator-initiated trials (IIT) for its BCMA/CD19 dual-targeting FasTCAR-T candidate GC012F and allogeneic TruUCAR-T candidate GC502 that will be presented at 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022) Annual Meeting and EHA (Free EHA Whitepaper) 2022 as follows:

Updated clinical data from a multicenter IIT evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in oral abstract presentations on June 5 at ASCO (Free ASCO Whitepaper) 2022 and on June 12 at EHA (Free EHA Whitepaper) 2022
Initial clinical data from an ongoing IIT evaluating GC012F for the treatment of relapsed/refractory B-NHL in a poster presentation on June 10 at EHA (Free EHA Whitepaper) 2022
Updated data with longer follow-up of GC502 in relapsed/refractory B-ALL in a poster presentation on June 10 at EHA (Free EHA Whitepaper) 2022

On June 3, 2022 Hackensack Meridian John Theurer Cancer Center investigators participated in the large phase III multicenter SHINE study, which reported that using the drug ibrutinib (Imbruvica) in combination with standard bendamustine and rituximab (BR) therapy as initial treatment for mantle cell lymphoma (MCL) slowed disease growth by 52% in older people newly diagnosed with the disease (Press release, Hackensack Meridian Health, JUN 3, 2022, View Source [SID1234615551]). The treatment could become the new standard of care for older people with MCL, who may not be able to tolerate more intensive treatment regimens. The study was published in the New England Journal of Medicine on June 3, 2022.

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"The field of mantle cell lymphoma treatment continues to evolve. The standard of care for elderly patients — who account for more than half of all people diagnosed with mantle cell lymphoma and who are not eligible for high-dose therapy upfront — has most frequently been chemoimmunotherapy with bendamustine and rituximab. Over time, however, most patients relapse," explained Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center, who led the center’s participation in the SHINE study. "Ibrutinib was the first inhibitor of the BTK protein approved for MCL, and it has been a game changer for patients with relapsed or persistent disease. Logically, the next step was to bring it to the frontline setting, which was the subject of the SHINE clinical trial."

In this study, previously untreated MCL patients aged 65 and older were randomly assigned to receive six cycles of BR with either ibrutinib (261 patients) or a placebo (262 patients). Patients who responded to treatment received up to 12 additional doses of rituximab as maintenance therapy. Researchers compared progression-free survival (PFS, the time it took for the cancer to continue growing) between the two groups.

Adding ibrutinib to BR dramatically improved the outcome. After a median follow-up of 7 years, PFS was 6.7 years in the BR+ibrutinib arm versus 4.4 years for the BR+placebo group. Concluded Dr. Goy, "This is highly significant and could easily translate into BR+ibrutinib becoming the next standard of care."