On April 11, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine (Press release, Gilead Sciences, APR 11, 2022, View Source [SID1234611999]). The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial.

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With today’s decision from the FDA, enrollment in the U.S. can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Gilead, in close coordination with regulatory authorities, is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the U.S. The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold.

"Our confidence in the risk-benefit profile of magrolimab has been unwavering, and we continue to believe in the potential for this treatment to address the unmet medical needs faced by people living with MDS and AML," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "This is a significant milestone for Gilead and, more importantly, for patients diagnosed with these cancers. We look forward to continuing our work developing magrolimab and advancing this potential cancer treatment option."

During the partial clinical hold, patients already enrolled in the affected Gilead magrolimab studies, including the pivotal, Phase 3 ENHANCE study, continued receiving treatment. Prior to the trial hold, Gilead already met the pre-specified enrollment threshold required for the first interim analysis of the ENHANCE study. Based on this, Gilead is confident the readout for the first interim analysis remains on schedule for 2023.

Magrolimab was granted Breakthrough Therapy designation for the treatment of newly diagnosed MDS by the FDA in 2020. In addition to MDS and AML, magrolimab is being developed in several hematologic cancers and solid tumor malignancies. Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established.

About Myelodysplastic Syndrome (MDS)

MDS is a rare, often unrecognized, under-diagnosed, bone marrow disorder widely considered to be a form of cancer. In MDS, the body’s bone marrow does not make enough mature, healthy red blood cells, white blood cells and/or platelets. While many cases may go undiagnosed, current estimates show that ~100,000 new cases are diagnosed each year. Therapeutic advancement for higher-risk MDS has been limited in the last 15 years and stem cell transplant is the only potential cure, but those older than 65 or with other conditions are often not eligible.

One in three people with MDS will progress to AML, one of the most common types of leukemia in adults. Approximately 10,000 people die every year from AML in the U.S.

About Acute Myeloid Leukemia (AML)

AML is a type of cancer that starts in the bone marrow and can quickly move to the blood and other parts of the body, including the lymph nodes, spleen and central nervous system. AML most often develops from cells that would turn into red blood cells, neutrophils, and platelets but can also evolve from other blood disorders such as myelodysplastic syndromes. Approximately 20,000 Americans will be diagnosed with AML each year.

About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don’t eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) as well as solid tumor malignancies. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.

On April 11, 2022 Biognosys, a leader in next-generation proteomics solutions for drug discovery and development, reported a global strategic partnership agreement with NeoGenomics, Inc. (Nasdaq: NEO), a leading provider of oncology testing and global contract research services (Press release, Biognosys, APR 11, 2022, View Source [SID1234611998]). The strategic partnership will encompass multiple strategic and commercial initiatives, including NeoGenomics labs offering access to Biognosys proteomics platforms, medical and scientific affairs-joint presentations and discussions, along with joint scientific and technical initiatives.

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"At Biognosys, we continuously push the boundaries of what is possible with our proteomics solutions to address key challenges in drug development," said Kristina Beeler, Ph.D., Chief Business Officer, Biognosys. "Our platforms are transforming research from early drug discovery to clinical biomarker identification. We are excited to now combine our proteomics platforms with NeoGenomics’ immuno-profiling platform to advance our biopharma partners’ oncology drug development programs."

One of the first efforts of this collaboration saw Biognosys combining its TrueDiscovery proteomics platform with NeoGenomics’ MultiOmyx multiplexed immunofluorescence (mIF) spatial tissue analysis as a multimodal approach for analyzing the proteins of tumor samples from late-stage melanoma patients treated with immune-checkpoint inhibitors. The dual proteomic and mIF profiling approach allows for a comprehensive characterization of melanoma patients and pinpointed a specific set of biomarkers that may be used to predict a patient’s response to checkpoint inhibitors. The development and utility of this multimodal approach will be presented across two posters by Biognosys and NeoGenomics at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting this week. The multimodal offering will also be made available commercially for biopharma partners.

"The need of our pharma customers to access the next state-of-the-art technology to improve diagnostics and clinical trials is top priority for us," said Gina Wallar, Ph.D., President, Pharma Services, NeoGenomics Laboratories, Inc. "Partnering with Biognosys gives us the added advantage of expanding into proteomics, data analytics and subsequent actionable results, not only in early discovery and translational research but ultimately, in clinical trials impacting patient care."

AACR Posters

Abstract 3923: Ubiquitin ligases implicated as predictive biomarkers for poor outcome to immunotherapy in melanoma patients

In this poster presented by Biognosys on April 13, unbiased proteomic profiling with TrueDiscovery was used to characterize melanoma patients and their responses to PD1-targeted immunotherapy. The profiling was able to identify a set of 103 proteomic biomarkers associated with ubiquitination pathways that correlate with treatment outcomes. The results were cross analyzed with the spatial tissue analysis performed via the MultiOmyx platform. These findings need to be further confirmed in orthogonal cohorts, nevertheless the data point to the possibility of more precise targeting of melanoma patients for immunotherapy.

Abstract 1267: Dual approach using unbiased proteomics and multiplexed immunofluorescence for the detection of markers predictive for immunotherapy in melanoma patients

Despite clinical advances, durable responses to immune checkpoint inhibitors are not observed in 40-60% of melanoma patients, and current biomarkers do not clearly distinguish responders. In this study presented by NeoGenomics today, a dual proteomic and mIF profiling approach was able to comprehensively characterize melanoma patients and successfully stratify non-responders from responders based on a set of selected protein biomarkers.

To see Biognosys’ full presence at the AACR (Free AACR Whitepaper) 2022 annual meeting, please refer to this press release or visit biognosys.com/aacr22.

On April 11, 2022 Bruker Corporation (Nasdaq: BRKR) reported that launched and exhibited unique and novel capabilities for spatial multiomics, single-cell proteomics, and cell-line, tissue and plasma proteomics cancer research (Press release, Bruker, APR 11, 2022, View Source [SID1234611997]).

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Following up on Bruker’s recent strategic investment in AmberGen Inc., Bruker is announcing a partnership for the application of Ambergen Miralys peptide-code antibody kits for the Bruker timsTOF flex novel MALDI HiPLEX-IHC workflow for targeted protein expression profiling in tissue. By combining peptide-code mass-reporting antibody probes for protein recognition with Bruker’s comprehensive MALDI imaging workflows, researchers can produce highly multiplexed images of target proteins in a wide field-of-view up to a standard slide.

Bruker’s timsTOF fleX platform integrates MALDI HiPLEX-IHC protein mapping with unbiased small molecule imaging (lipids, glycans, metabolites, xenobiotics) from the same tissue section, a new and unique multiomics capability for cancer cell-line, tissue and TME imaging research from fresh frozen or formalin-fixed paraffin-embedded (FFPE) sections.

Dr. Michael L. Easterling, Bruker Director of Imaging Life Sciences Mass Spectrometry, commented: "Spatial protein expression mapping can elucidate processes in immuno-oncology, and in TME and metastasis research. The MALDI HiPLEX IHC workflow based on AmberGen’s peptide-encoded antibody panels provides targeted protein localization and adds the capability to map important lipids, glycan and metabolite markers on the same tissue section.

Additionally, Bruker demonstrated the new CellScapeTM instrument for high-precision targeted spatial proteomics, recently launched by their Canopy Biosciences division. Canopy Biosciences’ CellScape is the latest generation ChipCytometryTM instrument, which enables high-plex spatial imaging and quantification of protein biomarkers in a wide variety of sample types with single-cell and sub-cellular resolution. CellScape further improves spatial resolution, offers up to 8x higher throughput, and walkaway automation. CellScape is unique for quantitative biology with 8-log extremely high dynamic range (HDR) imaging to quantify both low and high expressing proteins in the same sample, solving a key challenge inherent in high-plex imaging. Applications in cancer biology are abundant and include spatial phenotyping of the diverse tumor and immune cell types in the tumor microenvironment (TME).

Canopy also featured their Spatial Immune Profiling kits for the ChipCytometry platform. The Spatial Immune Profiling kit is a quantitative, multiplexed assay for FFPE tissues developed to provide ready-to-use pre-validated antibody reagents for ChipCytometry researchers, e.g., for immuno-oncology. The kits enable researchers to skip assay development and move straight into performing their translational and clinical research assays.

On April 11, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported its co-authorship of a study with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 from April 8-13, 2022 (Press release, Personalis, APR 11, 2022, View Source [SID1234611996]).

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"Working with Merck KGaA, Darmstadt, Germany, and leveraging the combination of transcriptome and exome-based data generated by the ImmunoID NeXT Platform, we were able to explore promising, integrative approaches to complementing the previously demonstrated classification method for colorectal cancer. We are excited to see how this collaboration further unfolds," said Richard Chen, MD, chief medical officer and SVP of R&D for Personalis.

Details of the poster are as follows:

Title: Comprehensive next generation sequencing profiling in combination with transcriptomic-based tumor molecular subtyping and harmonized TMB calculation using paired specimens from late-stage CRC patients (Poster 5743)

Session Category: Molecular/Cellular Biology and Genetics

Session Title: Genomics

Overview: This study reaffirms existing RNA-seq based molecular subtyping methods in late-stage CRC. Novel integrative methods are introduced which extend RNA-sequencing based subtyping by incorporating DNA-sequencing based mutation profiles, revealing potential integrated methods for subtype identification. This approach may be further investigated in larger cohorts, and by associating subtypes with other characteristics such as tumor laterality.

On April 11, 2022 Seneca Therapeutics, Inc. (STI), a clinical-stage biopharmaceutical company dedicated to the development of novel immunotherapies for difficult to treat solid cancers reported positive preclinical data on the treatment and analysis of the checkpoint resistant pancreatic syngeneic murine tumor model, Pan02 (Press release, Seneca Biopharma, APR 11, 2022, View Source [SID1234611995]). The data presented demonstrated that the combination SVV-001 and checkpoint inhibitors anti-PD1 and anti-CTLA4 eradicated 83% of tumors and elicited long term survival in these mice.

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Further, mice with Pan02 tumors eradicated by the treatment rejected re-challenge of Pan02 cells, demonstrating a robust local and systemic anti-tumor immune response. Mechanistic studies demonstrated a major increase in CD8 positive T cells in tumors in mice treated with the combination. Animals treated with anti-PD1, anti-CTLA4, both anti-PD1 and anti-CTLA4, or SVV and either anti-PD1 or anti-CTLA4 failed to show any tumor eradications.

"The compelling data presented here supports our upcoming clinical trial for patients having difficult to treat neuroendocrine neoplasms. In this trial patients will receive SVV-001 in combination with anti-PD-1 and anti-CTLA4 checkpoint inhibitors said Dr. Paul Hallenbeck, presenter at the AACR (Free AACR Whitepaper) 2022 Annual Meeting and President and Chief Scientific Officer at Seneca Therapeutics.