On April 23, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S (Press release, Innovent Biologics, APR 23, 2025, View Source [SID1234652067]).

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Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO (Free ESMO Whitepaper) Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO (Free ASCO Whitepaper), further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options."

Details on the abstracts are listed below:

Oral Presentation

1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma

Abstract Number: 2502
Session Type: Oral Abstract
Session Title: Developmental Therapeutics-Immunotherapy
Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT
Presenter: Jun Guo, MD, Beijing Cancer Hospital

2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer

Abstract Number: 104
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot"
Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT
Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC)

Abstract Number: 8509
Session Type: Oral Abstract
Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT
Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine

4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343

Abstract Number: 4017
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT
Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center

5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21)

Abstract Number: 7007
Session Type: Oral Abstract
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT
Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences

6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01)

Abstract Number: 3519
Session Type: Rapid Oral Abstract
Session Title: Gastrointestinal Cancer-Colorectal and Anal
Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT
Presenter：Changqing Jing, MD, Shandong Provincial Hospital

7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in nasopharyngeal carcinoma: The EP-STAR trial

Abstract Number: 6010
Session Type: Oral Abstract
Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer
Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT
Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center

Poster Presentation

1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress

Abstract Number: TPS9594
Session Type: Poster
Session Title: Melanoma/Skin Cancers
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute

2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial

Abstract Number: 5565
Session Type: Poster
Session Title: Gynecologic Cancer
Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT
Presenter: Jin Shu, MD, Chongqing University Cancer Hospital

3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study

Abstract Number: 1029
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research

4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study

Abstract Number: 1102
Session Type: Poster
Session Title: Breast Cancer—Metastatic
Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT
Presenter: Fan Wu, MD, Fujian Cancer Hospital

5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress

Abstract Number: TPS4201
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Lin Shen, MD, Beijing Cancer Hospital

6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases.

Abstract Number: 4050
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT
Presenter: Dan Sha, MD, Shandong Provincial Hospital

*Abstracts of TYVYT (sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007.

On April 23, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that it will release the latest clinical data of the CD73 small molecule inhibitor ATG-037 and the mTORC1/2 small molecule inhibitor ATG-008 in Poster Presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30th to June 3rd in Chicago, IL, the United States (Press release, Antengene, APR 23, 2025, View Source [SID1234652066]).

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Previously, Antengene entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) on the Phase I/IB STAMINA-01 trial evaluating ATG-037 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with anti-PD-1 resistant solid tumors, with encouraging preliminary results in melanoma and non-small cell lung cancer (NSCLC). Currently, the dose optimization and expansion portion of the study is enrolling in China and Australia.

Details of the Poster Presentations:

ATG-037 (CD73 Small Molecule Inhibitor)
Title: A first-in-human phase I/Ib study of ATG-037 monotherapy and combination therapy with pembrolizumab in patients with advanced solid tumors: STAMINA-01
Abstract: 3123
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date: June 2, 2025
Time: 1:30 PM – 4:30 PM (Central Time)
2:30 AM – 5:30 AM, June 3, 2025 (Beijing Time)

ATG-008 (mTORC1/2 Small Molecule Inhibitor)
Title: A TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced cervical cancers with prior anti-PD-(L)1 therapy
Abstract: 5540
Session: Gynecologic Cancer
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, June 1, 2025 – 1:00 AM, June 2, 2025 (Beijing Time)

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On April 23, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation (Press release, Verastem, APR 23, 2025, View Source [SID1234652065]). The Company expects to initiate a Phase 1/2a study in mid-2025 with plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

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The Company also announced the acceptance of an abstract, by our partner GenFleet Therapeutics, for rapid oral presentation of the preliminary dose escalation phase of the Phase 1/2 study of VS-7375 (also known as GFH375) conducted by GenFleet at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held on May 30-June 3, 2025, in Chicago, IL. The abstract is under embargo until May 22, 2025, at 5:00 pm EDT, when additional data will be released.

"We’re excited to advance the clinical program for VS-7375 in the U.S. and build on the initial dose escalation work conducted by GenFleet in China that demonstrated oral bioavailability and no dose-limiting toxicities across six dose levels, with partial responses achieved among multiple patients with both pancreatic and advanced lung cancers," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We believe there remains a significant opportunity to improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375’s dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents. We look forward to our partner GenFleet’s oral presentation that will include updated safety and efficacy data from the Phase 1 study at the ASCO (Free ASCO Whitepaper) annual meeting."

The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study is based on an efficacious dose identified in the initial data from the GenFleet study to accelerate the trial’s progress. Verastem plans to dose escalate across levels where cancer responses were observed in GenFleet’s study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers.

ASCO 2025 Presentation Details:

The abstract is under embargo until May 22, 2025, at 5:00 pm EDT.

Title: A First-in-Human Phase I/II Study of GFH375, a Highly Selective and Potent Oral KRAS G12D Inhibitor in Patients with KRAS G12D Mutant Advanced Solid Tumors
Abstract Number: 3013
Session: Rapid Oral Abstract Sessions: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date/Time: Monday, June 2, 2025, from 8:00 am to 9:30 am CDT
About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.

On April 23, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported three upcoming presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois (Press release, Agenus, APR 23, 2025, View Source [SID1234652064]). A poster presentation will highlight new translational data monitoring induced T-cell dynamics from the botensilimab and balstilimab (BOT/BAL) program in mismatch repair–proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer (mCRC). In addition, two trials-in-progress presentations will showcase the design and scientific rationale of ongoing clinical studies evaluating botensilimab-based combinations in advanced pancreatic cancer.

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Presentation Details:

Presentation Title: Monitoring botensilimab and balstilimab induced T cell dynamics in refractory mismatch repair proficient metastatic colorectal cancer.
Presenting Author: Dr. Gertjan Rasschaert
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: 3527
Poster Number: 196

Presentation Title: A phase 2 study of botensilimab and AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody, with or without chemotherapy in subjects with advanced pancreatic cancer. (NCT05632328)
Presenting Author: Dr. Bruno Bockorny
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: TPS423
Poster Number: 506a

Presentation Title: An open-label, phase 1 trial with expansion cohort of botensilimab (AGEN1181) + balstilimab (AGEN2034) + nab-paclitaxel + gemcitabine + cisplatin + chloroquine + celecoxib in adult patients with previously untreated metastatic pancreatic cancer. (NCT06076837)
Presenting Author: Dr. Dan Van Hoff
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: 507b
Poster Number: TPS4234

About Botensilimab (BOT)

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,100 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. For more information about botensilimab trials, visit www.clinicaltrials.gov.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

On April 23, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its latest advancements in cancer research tools at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30 at McCormick Place Convention Center in Chicago, IL (Press release, Bio-Techne, APR 23, 2025, View Source [SID1234652063]). Bio-Techne’s booths will feature its oncology research portfolio spanning early discovery, translational research, and cell and gene therapy development.

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AACR is recognized as one of the world’s most influential cancer research conferences, convening global experts to exchange groundbreaking discoveries and innovations in cancer science and medicine. Bio-Techne will engage with these researchers and industry professionals to highlight its cutting-edge solutions that empower scientific progress across the oncology landscape.

At booth #3049, Bio-Techne will feature its comprehensive portfolio, including high-performance proteins, antibodies, small molecules, cell culture reagents, immunoassays, automated proteomic analysis platforms, and spatial multiomic solutions. These technologies are designed to drive advancements in oncology research, accelerate immune cell therapy development, and support the creation of next-generation diagnostic tools. Advanced Cell Diagnostics (ACD), a Bio-Techne brand, will feature its complete solution for accelerating spatial multiomic research, including its protease-free workflows across the RNAscope spatial portfolio. To support the expanded capabilities for multiomic detection on the Leica Bond RX, we will showcase scientific posters and an evening reception on April 27th co-hosted by ACD, Leica Biosystems and Indica Labs.

At booth #3249, Lunaphore, one of Bio-Techne’s spatial biology brands, will present its enhanced end-to-end portfolio that offers high-value spatial biology solutions for the translational research community. Lunaphore’s latest advancements include the launch of the fully-automated, same-section multiomics application for fixed-frozen tissue. Additionally, Lunaphore will bring together the spatial biology community at an exclusive dinner reception on April 28, held in affiliation with AACR (Free AACR Whitepaper), providing a unique opportunity to connect with leaders in the field of multiomics, and explore Lunaphore’s upcoming releases, including innovative tools for HORIZON image analysis software.

"As cancer research advances at an unprecedented pace, Bio-Techne remains committed to providing scientists with the tools they need to drive discovery and innovation," said Kim Kelderman, Bio-Techne’s President and Chief Executive Officer. "Our solutions empower researchers at every stage—from fundamental science to translational applications—helping to shape the future of precision medicine and next-generation cancer therapies. We are excited to connect with the scientific community at AACR (Free AACR Whitepaper) to explore new possibilities in the fight against cancer."

Bio-Techne Presentations and Poster Presentations:

Protein Quantitation for Characterization of Potential Cancer Therapeutics in Early Discovery and Mechanism of Action Insights in Translational Studies
Tuesday, April 29 | 10:00 – 11:00 AM
Exhibit Hall, Spotlight Theater A

Evaluation of IDH1, EGFR, IGF1R, and Ki67 Biomarkers in Glioblastoma Using Lunaphore COMET Platform
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 29 | Abstract 2093
Presenter: Jennifer Jones, Sr. Product Marketing Specialist

Multiomic Co-Detection of Proteins, mRNA and Protein-Protein Interactions Reveal PD1-PDL1 Interactions in the Tumor Microenvironment of Bladder Cancer Patients Treated with anti-PD-L1
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 3 | Abstract 2179
Presenter: Ge-Ah Kim, Sr. Scientist

Multiomic Fluorescent Co-Detection of Biomarkers in the Tumor Microenvironment Using a New RNAscope Assay on Roche DISCOVERY ULTRA
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 28 | Abstract 2092
Presenter: Anushka Dikshit, Sr. Applications Manager

Identifying Immune Cell Phenotypes and Their Function by Using High Throughput Spatial Multiomics
Tuesday, April 29 | 2:00 PM – 5:00 PM
Poster Board 24 | Abstract 5318
Presenter: Anushka Dikshit, Sr. Applications Manager

Profiling the Tumor-Immune Landscape with a Same-Section Multiomics Assay
Tuesday, April 29 | 2:00 PM – 5:00 PM
Poster Board 10 | Abstract 5304
Presenter: Jacqueline Giliberti, PhD, Product Manager

Spatial Multiomics Reveals T-cell Activation and Exhaustion States in the Tumor Microenvironment
Wednesday, April 30 | 9:00 AM – 12:00 PM
Poster Board 12 | Abstract 6471
Presenter: Anushka Dikshit, Sr. Applications Manager

Poster Presentation In Collaboration
A Novel Protease-Free Workflow for Spatial Multiomics Analysis of the Tumor Microenvironment in Breast Cancer
Poster Board 21 | Abstract 170
Presenter: Dr. Tanni Rahman, HistoWiz

Dissecting the Immune Landscape in EBV+ Classical Hodgkin Lymphoma Following IL-23 Inhibition Using Single-Cell Hyperplex Immunofluorescence Analysis: A Case Report
Wednesday, April 30 | 9:00 AM – 12:00 PM
Poster Board 9 | Abstract 6468
Presenter: Dr. Janusz Franco-Barraza, Fox Chase Cancer Center

Translating clinically Validated Antibodies into a Multiplexed Immunofluorescent Panel for the Spatial Profiling of Lymphoid Malignancies
Monday, April 28 | 2:00 PM – 5:00 PM
Poster Board 4 | Abstract 2525
Presenter: Dr. Tania Pannellini, European Institute of Oncology (EIO)

For more information about Bio-Techne’s presence at AACR (Free AACR Whitepaper) 2025, visit View Source