On December 5, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported the full list of presentations by leading researchers and clinicians spanning multiple indications of blood cancer, leveraging the Tapestri Platform to advance therapeutic research and development at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Mission Bio, DEC 5, 2024, View Source [SID1234648848]). More than 20 presentations at the event, which takes place Dec. 7-10 in San Diego, will shine a spotlight on how Mission Bio’s customers are using Tapestri and associated products to gain a broader and deeper understanding of Multiple Myeloma, AML, Lymphoma, and CAR-T therapy development.

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Among these presentations, Mission Bio will showcase new datasets for the first time, demonstrating how the Tapestri Single-cell Multiple Myeloma Multiomics Solution, which became commercially available this year, can be used to integrate genomic, immunophenotypic, and clonotypic assessment to pinpoint disease-driving clones in Multiple Myeloma (MM). The team behind the data was led by Mission Bio CTO and co-founder Adam Sciambi.

"Our ongoing mission is to provide scientists with the means to understand hard-to-treat diseases like MM in ways that will lead to new, more effective treatments," Sciambi said. "We’re looking forward to sharing our findings on the role of rare clones in the progression from precursor conditions like monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to full-blown MM, as well as the comprehensive clonal architecture underlying relapse and treatment resistance. We’re equally excited to see what our customers are doing to advance research into other forms of cancer."

A new study from Heidelberg University Hospital will showcase the value of single-cell DNA+protein multiomics sequencing to refine minimal residual disease (MRD) assessment in acute myeloid leukemia (AML). Presented under the title "Clonal Dynamics of Leukemic and Clonal Hematopoiesis Mutations Predict Relapse in Single Cell MRD Analysis of AML in First Complete Remission," the research uses patient samples to demonstrate how this approach offers greater precision than current techniques, potentially establishing a way to redefine AML MRD.

Researchers from the University of Cincinnati will also introduce the first-ever data demonstrating the feasibility of integrating DNA and fusion profiling at the single-cell level as a multiomic approach. The presentation, titled "Single-Cell Multi-Omic Analysis of KMT2A-Rearranged Pediatric Acute Leukemia Clonal Evolution," is the first of its kind to utilize the combination of simultaneous molecular profiling and fusion identification at the single-cell level for pediatric leukemia.

Following a recent publication in the New England Journal of Medicine, new findings from Stanford University highlight the power of single-cell DNA sequencing to uncover critical genomic insights in chimeric antigen receptor (CAR) T-cell therapy, revealing myeloid predominance for TP53 clonal hematopoiesis in post-CAR therapy myeloid neoplasms (tMN) among non-Hodgkin lymphoma patients. These findings, presented under the title "Single Institution Analysis of Lymphoma Treatment Related Post-CAR Myeloid Neoplasms," underscore the potential of single-cell DNA sequencing to inform CAR T therapy development, enabling safer treatments by addressing risks tied to therapy-induced molecular changes.

Additional institutions included among the presentations at ASH (Free ASH Whitepaper) include the National Institutes of Health, Weill Cornell Medical College, University of Pennsylvania, Berlin Institute of Health, Oxford University Hospitals, University of Miami Miller School of Medicine, and University of Toronto. For the full list of poster and oral presentations, or to schedule a one-on-one meeting with the Mission Bio team at the 2024 ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source Attendees can also learn more about the Tapestri Platform and all of Mission Bio’s multiomics solutions by visiting booth #2112.

On December 5, 2024 Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, reported the launch of SHORTEN-ctDNA, a clinical trial at Columbia University (Press release, Foresight Diagnostics, DEC 5, 2024, View Source [SID1234648847]). The study aims to evaluate the ability to utilize Foresight CLARITY MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).

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Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.

"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY’s detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient’s actual response to treatment with a more dynamic and sensitive tool than imaging."

The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.

"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."

On December 5, 2024 Pixelgen Technologies, a leader in cell surface proteomics for single cells, reported upcoming participation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) in San Diego, Calif. from Dec. 7-10 at the San Diego Convention Center (Press release, Pixelgen Technologies, DEC 5, 2024, View Source [SID1234648846]). New data from collaborators will support the application of Pixelgen’s patented Molecular Pixelation (MPX) technology and kit across a broad range of scientific research, as the company expands into hematology.

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"With spatial mapping of cell surface proteins, hematology researchers can gain unprecedented insights into the organization and function of protein and protein complexes critical to blood cell function and disease," said Pixelgen CEO Simon Fredriksson, Ph.D. "This capability promises to advance diagnostics, enable personalized therapeutics, and support the development of next-generation treatments for blood cancers, immune dysregulation, and hematopoietic disorders. We’re excited to be participating in ASH (Free ASH Whitepaper) for the first time and sharing our groundbreaking technology with the hematology community."

Pixelgen will be featured in two sessions:

Dr. Fredriksson will give an industry presentation titled "The Spatial Organization of Surface Proteins of Single Cells in Myelodysplastic Syndrome for Diagnostics and Drug Target Discovery By Molecular Pixelation," featuring data from Dr. Aaron Viny, Columbia University, on Dec. 7 from 3:30-3:45 p.m., in Room 5B. Dr. Fredriksson will be joined by Dr. Viny.
Dr. Jessica Nordlund, Associate Professor at the Molecular Precision Medicine research group at Uppsala University, along with Dr. Maria Globisch, has a poster titled "Mapping the Spatial Proteome of Individual Leukemia Cells Undergoing Fludarabine Treatment," from 5:30-9:30 p.m. on Dec. 7, session number 803, in Halls G-H.
Pixelgen will be at Booth #2852 showcasing its product and technology. Representatives will be available to discuss the company’s latest data on identifying CAR-T cells and mapping their cell surface proteome for detailed mechanism of action studies. To support the company’s work in hematology, Pixelgen has developed an Application Note, in collaboration with Illumina, looking at cancer specific protein patterns of blood cancer cells.

On December 5, 2024 EpicentRx reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the oncolytic adenovirus-delivered transforming growth factor beta (TGFβ) inhibitor, AdAPT-001, plus the anti-PD-1, nivolumab, or anti-PD-L1, atezolizumab, to treat recurrent or refractory advanced or metastatic soft tissue sarcoma (STS) with disease progression after at least one prior line of therapy (Press release, EpicentRx, DEC 5, 2024, View Source [SID1234648845]). The purpose of Fast Track designation is to facilitate the development and approval process of drugs like AdAPT-001 that treat a serious condition or meet an unmet need such as STS, a rare tumor type with high heterogeneity, low chemo-, radio- and immunosensitivity, and a poor prognosis.

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The Fast Track designation was based on the promising potential of AdAPT-001 to sensitize STS tumors to checkpoint inhibitors like nivolumab or atezolizumab that they previously received and failed or never previously received because of low levels of both tumor mutation burden (TMB) and T-cell inflamed gene expression profiles (GEP) that predicted for non-response. Supporting evidence for Fast Track designation came from Phase 1 and 2 clinical trials and an ASCO (Free ASCO Whitepaper) podium presentation where the activity, safety, and durability of response (progression free survival of ~8.5 months) in patients with STS and other tumor types either alone or in combination with checkpoint inhibition were on full display.

According to EpicentRx CEO and viro-oncologist, Dr. Tony Reid, MD, PhD, "Checkpoint blockade immunotherapies have revolutionized cancer therapy for many patients and prolonged the lives of millions. But efficacy depends on 1) the presence of an immune infiltrate, which is often absent or immunosuppressive, and 2) low levels of immunosuppressive factors like TGFβ, which are frequently overexpressed. AdAPT-001 is designed both to inflame the tumor microenvironment and to combat immunosuppression by neutralization of TGFβ through the expression of a TGFβ trap. Fast Track designation is a terrific acknowledgement of the potential of AdAPT-001 to make a meaningful difference for STS patients who desperately require new treatment options."

About AdAPT-001
AdAPT-001, EpicentRx’s proprietary 2-in-1 biologic, whose activity was highlighted in a 2024 ASCO (Free ASCO Whitepaper) podium presentation, is designed to express a potent TGFβR inhibitor for local TGFβ neutralization, decreased Treg cell function, and superior therapeutic responses in combination with checkpoint inhibitors for several tumor types including STS, colorectal cancer, breast cancer and hepatocellular carcinoma.

On December 5, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported new preclinical data demonstrating the combination potential of EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC), with VEGFR2 or PD-1 inhibitors (Press release, Elevation Oncology, DEC 5, 2024, View Source [SID1234648844]). The data will be presented in a poster session at the European Society for Medical Oncology Immuno-Oncology Annual Congress 2024 (ESMO-IO), being held December 11-13, 2024, in Geneva, Switzerland.

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"We are pleased to share preclinical data supporting our planned evaluation of EO-3021 in combination with VEGFR2 or PD-1 inhibitors," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "The data demonstrate enhanced anti-tumor activity for both regimens, highlighting the potential benefits of a combination approach. This is particularly encouraging given our previously announced, promising initial clinical data from our Phase 1 clinical trial of single-agent EO-3021, which suggest EO-3021 potentially offers competitive efficacy and differentiated safety profile, including minimal payload-associated toxicity. We look forward to initiating dosing in the combination portion of our ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter and unlocking the full potential of EO-3021 as an active, more combinable Claudin 18.2 ADC."

In a poster titled, "Combination potential of EO-3021, a CLDN18.2 vc-MMAE ADC, with VEGFR2 or PD-1 inhibition in preclinical models of CLDN18.2-expressing cancers," Elevation Oncology will present new in vivo data from preclinical studies evaluating the anti-tumor activity of EO-3021 with a VEGFR2 or PD-1 inhibitor. The data show:

Treatment with EO-3021 and DC101, a surrogate of the VEGFR2 inhibitor ramucirumab, exhibited statistically superior tumor growth inhibition (TGI) compared to treatment with either EO-3021 or DC101 alone (TGI: 88.2% for EO-3021 in combination with DC101, compared to 20.1% for EO-3021 and 59.2% for DC101 alone).
Treatment with EO-3021 and a PD-1 inhibitor exhibited statistically superior TGI compared to treatment with either EO-3021 or a PD-1 inhibitor alone (TGI: 79.9% for EO-3021 in combination with a PD-1 inhibitor, compared to 33.8% for EO-3021 and 25.0% for a PD-1 inhibitor alone). 92% (11/12) of mice treated with the combination of EO-3021 and a PD-1 inhibitor achieved a complete response (CR), compared to 50% (6/12) mice treated with EO-3021 monotherapy and 17% (2/12) mice treated with a PD-1 inhibitor alone.
Elevation Oncology expects to initiate dosing in the combination portion of its ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024. Following clinical supply agreements with Lilly and GSK, the combination cohorts will evaluate EO-3021 and ramucirumab, a VEGFR2 inhibitor, in patients with gastric/GEJ cancer in the second-line setting, and EO-3021 and dostarlimab, a PD-1 inhibitor, in the front-line setting. Additionally, Elevation Oncology continues to enroll patients in the monotherapy dose expansion portion of its ongoing Phase 1 clinical trial and expects to report additional monotherapy data in the first half of 2025. In August 2024, Elevation Oncology reported initial clinical data from the dose escalation portion of the monotherapy study, demonstrating an objective response rate of 42.8% in patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+, with differentiated safety profile, including minimal hematological toxicity or hepatotoxicity, and no peripheral neuropathy/hypoesthesia.

The ESMO (Free ESMO Whitepaper)-IO poster presentation will be available in the "Publications" section of Elevation Oncology’s website starting December 12, 2024.

About EO-3021

EO-3021 is a differentiated, clinical-stage, potentially best-in-class ADC comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/GEJ adenocarcinoma that express Claudin 18.2. Following recently signed clinical supply agreements with Lilly and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting.

In September 2024, EO-3021 was granted Fast Track designation by the FDA for the treatment of patients with advanced or metastatic gastric/GEJ cancer expressing Claudin 18.2 that has progressed on or after prior therapy. EO-3021 was granted orphan drug designation by the FDA for the treatment of gastric cancer (including cancer of gastroesophageal junction) in November 2020 and for the treatment of pancreatic cancer in May 2021.

Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China.