On April 14, 2023 OncoOne, a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, reported two poster presentations highlighting new preclinical data from its oxMIF-targeting drug candidate pipeline at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, held from April 14-19, in Orlando, Florida (Press release, OncoOne, APR 14, 2023, View Source [SID1234630109]). The presentations will feature updated analyses for lead antibody candidate ON203 and first preclinical data from the company’s pre-targeted radioimmunotherapy program, ON-05, both of which demonstrated promising anti-tumor effects. ON203 and ON-05 target the oxidized macrophage migration inhibitory factor (oxMIF), a central regulator of innate immune cells in the tumor microenvironment (TME).

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"MIF’s disease-specific isoform oxMIF is an exciting target for cancer therapy across a range of drug modalities. The positive impact on the tumor microenvironment and the anti-tumor effects we are seeing with ON203, particularly in ex-vivo patient tumoroids, and the first presented data from our PreTarg-it program ON-05 clearly show the potential of this approach. We look forward to further investigating the individual benefits of each of our programs in a range of solid tumor indications," said Randolf Kerschbaumer, Ph.D., CEO of OncoOne.

Alexander Schinagl, Ph.D., CTO of OncoOne added: "We are pleased to see that our PreTarg-it program, ON-05, demonstrated such promising initial preclinical results including significant tumor regression. Our goal at OncoOne is to develop the right drug modality for each indication to broadly explore the value of oxMIF as a target for patients living with solid tumors."

Dr. Jennifer Guerriero, Assistant Professor at Harvard Medical School and Member of OncoOne’s Scientific Advisory Board added: "The preclinical ON203 data is especially encouraging given that it was collected from actual patient tumor material treated with the antibody. These ex-vivo data are extremely value-building for OncoOne as the company approaches the clinic because they provide more accurate analyses beyond what can be generated using standard animal models alone."

Data Summary and Presentation Details ON203
The poster entitled "Targeting the oxidized form of macrophage migration inhibitory factor (oxMIF) with antibody ON203 activates the tumor microenvironment" summarizes new preclinical results evaluating the anti-tumor and TME-modulating effects of the next-generation anti-oxMIF antibody ON203 in human tumoroids which retain an intact TME and are isolated from colorectal adenocarcinoma patients. The data build on and strengthen the excellent tumor penetration, tumor retention and reduced tumor proliferation preclinical data shown in previously analyzed mouse models. As outlined in the poster, ON203 demonstrated tumor cell killing effects in four out of five ON203-treated CRC tumoroids with substantial stimulation effects on immune cells. In responding tumoroids, ON203 activated Natural Killer (NK) and NK T cells (upregulation of Granzyme B and CD107a) and supported an anti-tumor M1 like polarization along with macrophage activation (upregulation of CD16 and HLA-DR). These preclinical data highlight the potential of ON203 to significantly modulate the TME towards immune-stimulating functions in tumor material collected from patients.

The poster #2974 will be presented on Monday April 17th in the poster session "Immunology / Therapeutic Antibodies 3 / Section 24 – Poster Board 21," from 1:30 PM to 5:00 PM ET.

Data Summary and Presentation Details PreTarg-it ON-05
The second poster, titled "Pretargeted radioimmunotherapy with a novel anti-oxMIF/HSG bispecific antibody and a 177Lu-loaded HSG radioligand results in significant tumorregression in murine models of cancer" presents the first preclinical data of OncoOne’s pre-targeted radioimmunotherapy program, ON-05. The PreTarg-it program ON-05 combines an anti-oxMIF/HSG bispecific antibody with a sequentially administered radioligand with high affinity for the bispecific antibody. By pre-targeting the tumor with the bispecific antibody, it can accumulate within the tumor prior to administering the radioactive payload reducing the radiation burden on normal tissues. The study results demonstrated the ability of the anti-oxMIF/HSG bispecific antibody to penetrate and accumulate in the tumor tissue with fast clearance in the circulation. In conjunction with the 177Lu-loaded HSG radioligand significant tumor growth inhibition and survival benefits were demonstrated in colorectal cancer and pancreatic cancer mouse models indicating PreTarg-it ON-05 as a novel therapeutic option for patients living with hard-to-treat tumors.

The poster #585 will be presented on Sunday, April 16th in the poster session "Experimental and Molecular Therapeutics / Targeting the Tumor Microenvironment / Section 20 – Poster Board 19," from 1:30 PM to 5:00 PM ET.

Both posters will be available on OncoOne’s website upon conclusion of the AACR (Free AACR Whitepaper) 2023 Annual Meeting.

About oxMIF
The founders of OncoOne discovered a disease-related isoform of the macrophage migration inhibitory factor (MIF), which they named "oxMIF" (oxidized MIF). OxMIF is generated by a post-translational modification of MIF in inflammatory processes and tumorigenesis. Unlike MIF, oxMIF can only be detected in inflamed tissue and solid tumors but not in healthy tissues. The post-translational modification leads to a structural transformation that exposes epitopes in the MIF homotrimer that are otherwise inaccessible to antibodies in the center of the trimer. Targeting oxMIF as the disease related isoform of MIF overcomes previous significant challenges associated with targeting MIF, making it an ideal candidate for therapeutic intervention in an array of high-need indications.

On April 14, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported the company will present one poster concerning Phase 1 clinical results for BAT1006 at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting taking place April 14 – April 19, 2023 in Orlando, Florida (Press release, BioThera Solutions, APR 14, 2023, View Source [SID1234630108]).

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The poster, entitled "A Phase I study of BAT1006, a Novel Anti-HER2 Antibody, in Patients with Locally Advanced/Metastatic Solid Tumors," will highlight Phase I clinical data demonstrating the safety and efficacy of BAT1006 in HER2-positive cancer patients. An abstract of the presentation will be available on AACR (Free AACR Whitepaper) website on the day of the presentation.

Presentation details are as follows:

Session Title:

Phase I Clinical Trials

Session Time:

Tuesday Apr 18, 2023 9:00 AM – 12:30 PM

Location:

Orange County Convention Center, Poster Section 46

Poster Board Number:

2

Abstract Number:

CT189

Copies of the poster will be made available on the Company’s website after they are presented.

About BAT1006

BAT1006 is a HER2 extracellular domain II-targetd monoclonal antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect aiming for HER2-positive locally advanced/metastatic solid tumors. After the dose escalation trial, dose expansion study of BAT1006 and combination therapy with other HER2-based therapy such as BAT8010 ADC will be initiated for the treatment of HER2-positive cancers.

On April 14, 2023 Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors, reported the presentation of six abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Orlando, Fla., April 14-19, 2023 (Press release, ArsenalBio, APR 14, 2023, View Source [SID1234630107]). These data demonstrate the company’s continued progress towards the enhancement and clinical development of its unique integrated circuit T cell approach for diseases beyond ovarian cancer, including kidney cancer and other solid tumors.

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"As we conduct our first clinical study on AB-1015, which leverages ArsenalBio’s integrated circuit T cells for the potential treatment of ovarian cancer, we continue to innovate as we explore improvements and future applications of our platform and develop new therapeutic candidates for kidney cancer and other areas of unmet medical need," said Ken Drazan, M.D., ArsenalBio’s Co-Founder and Chief Executive Officer. "These new data show the potency, power, and potential for integrated circuit T cells across multiple diseases."

ArsenalBio will disclose features and findings of AB-2100, a novel integrated circuit T cell therapeutic candidate engineered for the treatment of clear cell renal cell carcinoma. This is the company’s second pipeline program which is targeting the initiation of a phase 1 trial in 2024. The following abstracts will be presented as poster presentations during the AACR (Free AACR Whitepaper) annual meeting.

Abstract LB092: Identification of target antigens for logic gated CAR T-cell therapeutics for the treatment of clear cell renal cell carcinoma: an opportunity prime with PSMA and kill with CA9
Monday, April 17, 2023, 9 a.m. – 12:30 p.m.
Late-Breaking Research: Immunology 1 Poster Session

A bioinformatic discovery and wet-bench validation approach were used to identify target antigens enabling AB-2100, ArsenalBio’s sequential-AND logic gated ICT therapeutic, identifying PSMA as a promising priming antigen target expressed on tumor vascular endothelial cells and CA9 as a promising cytolytic antigen target expressed on tumor cells. These studies show that CA9 and PSMA are co-positive in >70% of ccRCC patient specimens in both primary and metastatic disease states, and suggest utility as target antigens for a sequential-AND logic gated integrated circuit T cell therapeutic.

Abstract 4088: A neovasculature-inducible CA9 CAR resistant to FASL and TGFb mediated suppression for the treatment of ccRCC
Tuesday, April 18, 2023, 9 a.m. – 12:30 p.m.
Immunology: CAR T-cell therapy 2

Carbonic anhydrase IX (CA9) is expressed at a high level on the majority of tumor cells in ccRCC samples, making it an attractive target antigen for CAR T-cell therapy. Previous attempts to develop CA9 CAR T cells were limited, however, by on-target, off-tumor toxicity. In order to reduce this risk and restrict CA9 CAR activity specifically to ccRCC tumors, ArsenalBio’s proprietary PrimeR logic gate technology was deployed to engineer a PSMA x CA9 sequential-AND logic gated therapeutic for the treatment of ccRCC, AB-2100. AB-2100 was shown to be specific in vivo and eliminated tumors in RCC-based xenograft models at doses so low that a CA9 CAR without enhancements had no anti-tumor effect. In this study, we confirmed the feasibility of killing ccRCC cells using this approach to selectively target antigens that cannot be safely targeted using conventional CARs and overcome multiple suppressive mechanisms in the tumor microenvironment in xenograft models.

Abstract 4073: Tunable STAT activation by synthetic pathway activators (SPAs) increases engineered T-cell potency and persistence
Tuesday, April 18, 2023, 9 a.m. – 12:30 p.m.
Immunology: Adoptive Cell and Natural Killer Cell Therapy

STAT signaling is known to govern T cell activation and differentiation. In these studies, ArsenalBio highlights the creation of a library of synthetic proteins (Synthetic Pathway Activators or SPAs), that can control STAT signaling without an external cytokine input. When expressed in integrated circuit T cells, SPAs result in significant enhancements in T-cell potency and expansion both in vitro and in murine xenograft tumor models. These studies demonstrate the effectiveness of the SPA platform as a novel, tunable, and T cell intrinsic approach for engineering cells that result in potent anti-tumor properties.

Abstract 1768: Multiplexed shRNA cassettes targeting orthogonal pathways (Fas/PTPN2/TGFBR) enhance the potency of Integrated Circuit T cells (ICTs) in multiple solid tumor models
Monday, April 17, 2023, 9 a.m. -12:30 p.m.
CAR T-cell Therapy 1

ArsenalBio has previously shown success in engineering dual shRNA cassettes that significantly increase the antitumor potency of integrated circuit T cells in ovarian cancer models. This study builds on these prior findings to develop a quadruple shRNA cassette that adds the ability to protect against inhibitory signals present in multiple solid tumor types, including renal cell carcinoma (RCC). Quadruple shRNA cassettes targeting Fas/PTPN2/TGFBR significantly enhance the antitumor activity of ICT cells in multiple xenograft tumor models, thereby demonstrating the utility of this multiplexed shRNA strategy.

Abstract 1783: High-throughput arrayed screening of logic gated CARs enables the selection of candidates for ccRCC with optimal potency and fidelity traits
Monday, April 17, 2023, 9 a.m. – 12:30 p.m.
CAR T-cell Therapy 1

The identification of synthetically engineered molecules, including chimeric antigen receptors (CARs), requires comprehensive screening to identify molecules with optimal attributes and activity. These studies demonstrate the utility of an ArsenalBio platform that permits the screening of hundreds of candidate constructs that enable to dual targeting of PS MA as a priming target and CA9 as a cytolytic target, to select an optimal sequential-AND logic gated integrated circuit T cell therapeutic candidate for ccRCC. From those initially screened independently, the top PSMA- and CA9-targeting compounds were combined and screened across T cells engineered from four human donors. The best-performing candidates were shown to be superior to CAR T cells in a long-term killing assay, showed potent cytotoxicity of low expressing antigen lines, and displayed background levels of cytotoxicity against single antigen targets.

Abstract 5329: High-throughput screening strategies in the development of logic gated cell therapies
Tuesday, April 18, 1:30 – 4:30 p.m. ET
High-throughput Screening, Lead Identification, and Optimization, and in Silico Drug Discovery

To overcome the limits of CAR T-cell therapy in the treatment of solid tumors, ArsenalBio tested multiple ways to engineer T cells to improve their fidelity and on-target functionality using cell lines co-cultured with CAR and PrimeR antigens or with just a single antigen. This study showed highly concordant results from pooled and array screens helping to define a small set of PrimeR binders that exhibited both high fidelity and on-target functionality for additional testing in in vivo models.

On April 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place April 14 – 19, 2023 (Press release, Natera, APR 14, 2023, View Source [SID1234630106]).

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Natera and its collaborators will present findings from five studies on Signatera in esophago-gastric adenocarcinoma, muscle-invasive bladder cancer (MIBC), colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Highlights include:

ctDNA prediction of tumor response and recurrence in patients with esophago-gastric carcinoma receiving FLOT + immunotherapy (avelumab) pre- and post-surgery
ctDNA prediction of tumor response and recurrence in patients with MIBC, with and without neoadjuvant therapy, with long term follow-up (median 68 months) after radical cystectomy
Genomic profiling of >13,000 patients with early (≤50 years old) vs late (≥60 years old) onset CRC
Potential of ctDNA to guide imaging-based surveillance strategies in patients after surgery for peritoneal metastases from CRC
ctDNA as a pharmacodynamic and predictive biomarker in patients with resectable HCC treated with immunotherapy (cemiplimab) pre- and post-surgery
"We are pleased to share additional Signatera data at this year’s AACR (Free AACR Whitepaper) annual meeting that continues to highlight the important role of personalized MRD testing in assessing treatment response and predicting relapse across a broad range of indications," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "These data presentations underscore Natera’s commitment to generating novel insights on MRD testing and genomic testing to help advance cancer care."

The full list of Signatera poster presentations at AACR (Free AACR Whitepaper) is below.

Abstract #2178 | April 17, 9:00 AM – 12:30 PM
Presenter: Thomas U. Marron, M.D., Ph.D. – Icahn School of Medicine at Mount Sinai
Circulating tumor DNA (ctDNA) correlates closely with tumor necrosis and relapse-free survival (RFS) in hepatocellular carcinoma (HCC) patients treated with perioperative cemiplimab

Abstract #5600 | April 18, 1:30 – 5:00 PM
Presenter: Sia Viborg Lindskrog – Aarhus University Hospital
Utility of circulating tumor DNA and transcriptomic profiling in predicting outcome in muscle invasive bladder cancer patients

Abstract #5591 | April 18, 1:30 – 5:00 PM
Presenter: Marco Gerlinger, M.D., FRCP – Barts Cancer Institute & St Bartholomew’s Hospital
Circulating tumor DNA for recurrence prediction and efficacy analysis in the ICONIC trial of peri-operative FLOT and avelumab (PD-L1) in localized esophago-gastric adenocarcinoma

Abstract #5604 | April 18, 1:30 – 5:00 PM
Presenter: Kevin Chang, M.S. – University of Iowa
Circulating tumor DNA for predicting peritoneal only disease recurrence in colon cancer

Abstract #6696 | April 19, 9:00 AM – 12:30 PM
Presenter: Eric Lander, M.D. – Vanderbilt University Medical Center
Genomic alterations associated with early-onset and late-onset colorectal cancer

The AACR (Free AACR Whitepaper) abstracts are available here.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

On April 14, 2023 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported the unveiling of MERSCOPE PanCancer Pathways Panel (Press release, Vizgen, APR 14, 2023, View Source [SID1234630105]). The company will be presenting data generated using the PanCancer Pathways Panel at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-19, 2023 in Orlando, Florida.

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The PanCancer Pathways Panel features a list of genes targeting canonical signaling pathways of cancer and is constructed using recognized oncology databases including OncoKB, MutSig, the Cancer Genome Atlas and Hallmarks of Cancer to ensure inclusion of critical cancer genes. The Panel provides a key tool for researchers to study tumor behavior at cellular and subcellular levels across multiple different types of cancers. The PanCancer Pathways Panel features:

Characterization of major oncology signaling pathways including RAS/RTK, PI3K, NOTCH, MYC, Cell Cycle, HIPPO
Inclusion of cell type markers to identify healthy and disease states
Compatibility across multiple cancer types
"While Vizgen is known for the customizability of our platform, this pre-designed panel along with our PanNeuro Cell Type Panel represent an ideal starting point for researchers who are looking for convenient off-the-shelf options to explore adding spatial genomic capabilities into their research," said Terry Lo, President and CEO of Vizgen. "We’re constantly developing new ways to help researchers use this technology to gain new insights, particularly in complex tissues such as solid tumors. These are the first of many panels to come in our product portfolio."

As part of AACR (Free AACR Whitepaper), Vizgen will be presenting four posters, one of which showcases data generated using the new MERSCOPE PanCancer Pathways Panel. The data demonstrates the ability of the MERSCOPE Platform to characterize individual cells in a wide range of human tumor types, including breast, colon, prostate, ovarian, lung and liver cancers. Analysis of expression patterns in tumor cells highlights the panels’ ability to accurately reproduce known transcriptional signatures of hepatocellular carcinoma. In addition to the posters presented by Vizgen, Jonathan Chen, MD, PhD (Broad Institute of MIT and Harvard) will be presenting findings from human lung cancer data generated on the MERSCOPE Platform.

Presentation Details

Title: Characterizing cancer-associated fibroblasts in prostate cancer using Vizgen’s MERSCOPE Platform
Date: Tuesday April 18
Time: 9:00 am – 12:30 pm EDT
Presenter: Ben Patterson, PhD, Vizgen
Poster Number: 4332
Location: Section 37

Title: Spatially resolved single-cell transcriptomic profiling in formalin-fixed paraffin-embedded (FFPE) tissues
Date: Tuesday April 18
Time: 9:00 am – 12:30 pm EDT
Presenter: Jiang He, PhD, Vizgen
Poster Number: 4195
Location: Section 28

Title: Interrogating immuno-oncological interactions in the tumor microenvironment
Date: Tuesday April 18
Time: 1:30 pm – 5:00 pm EDT
Presenter: Ben Patterson, PhD, Vizgen
Poster Number: 5148
Location: Section 23

Title: A pathway-centric approach to characterizing tumour heterogeneity and cell diversity across multiple cancer types
Date: Wednesday April 19
Time: 9:00 am – 12:30 pm EDT
Presenter: Leiam Colbert, PhD, Vizgen
Poster Number: 5885
Location: Section 4

Title: Spatial clustering reveals immune hub interaction with reservoir of stem- like CD8 T cells and predicts immunotherapy response in lung cancer patients
Date: Tuesday April 18
Time: 3:07 pm – 3:22 pm EDT
Presenter: Jonathan Chen, MD, PhD, Broad Institute
Poster Number: 5784
Location: Tangerine Ballroom 1 (WF1) – Convention Center

All presentations and posters will be available to registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website on April 14, 2023, beginning at 4:30 PM ET. Following release at AACR (Free AACR Whitepaper), Vizgen’s poster presentations will also be available in the Vizgen Resource Hub on the Vizgen website.