On April 25, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported that 18 abstracts, including one oral presentation, have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, on April 25 – 30 in Chicago (Press release, Tempus, APR 25, 2025, View Source [SID1234652176]). Tempus researchers will showcase scientific and clinical research that highlight the transformative impact of AI on oncology treatment and patient outcomes.

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"Tempus is proud to showcase a comprehensive collection of scientific research this year, highlighting the impact of our multimodal dataset and AI-enabled diagnostic solutions on cancer research," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "AACR stands as a leading forum for cancer research, and we look forward to presenting our findings alongside our collaborators in Tempus’ home city of Chicago."

Research highlights include:

Oral Presentation: Investigating the clinical landscape and biological impact of SF3B1 hotspot mutations in breast cancer
Date/Time: April 27, 2025; 4:40 PM – 4:45 PM CT
Location: To be announced

Overview: This study examines the implications of SF3B1 hotspot mutations in breast cancer, focusing on genetic profile, survival outcomes, and biological impacts, by analyzing de-identified data from Tempus’ multimodal real-world database consisting of 420 breast cancer patients with SF3B1 mutations. Innovative genome editing in isogenic breast cell lines revealed that SF3B1 mutations negatively impact cell growth and tumor development. The findings support the utility of SF3B1 mutations as potential therapeutic targets and underscore the importance of understanding their role in cancer biology, with ongoing research aimed at uncovering the mechanisms behind hotspot-specific effects.
Poster Presentation: Genetic and clinical landscape of NUTM1 structural variants
Date/Time: April 28, 2025; 2:00 PM – 5:00 PM CT
Location: Section 34
Overview: Within Tempus’ multimodal real-world database, researchers identified 59 patients with a primary diagnosis of NUT carcinoma—an aggressive cancer—81% of whom had a confirmed NUTM1 fusion. Notably, there were 106 additional patients who had a NUTM1 fusion without a corresponding initial NUT carcinoma diagnosis, suggesting a potentially significant underdiagnosis rate. The study found a variety of fusion gene partners, with certain cancer types showing enrichment of specific fusions. With a median overall survival of just over 5 months, the findings suggest that certain cancer types with a high enrichment of NUTM1 fusions may benefit from universal next-generation sequencing to ensure accurate diagnosis and potentially improve outcomes for patients with high-risk cancer types.
Poster Presentation: A longitudinal, circulating tumor molecular response biomarker as a predictor of clinical outcomes in a real-world cohort of patients with advanced solid tumors treated with tyrosine kinase inhibitors
Date/Time: April 29, 2025; 9:00 AM – 12:00 PM CT

Location: Section 45

Overview: In a study analyzing advanced cancer patients, researchers evaluated the prognostic value of changes in circulating tumor DNA tumor fraction (ctDNA TF) during tyrosine kinase inhibitor (TKi) therapy. The study, which consisted of 109 patients from Tempus’ multimodal real-world database, found that molecular responders had significantly longer real-world overall survival (rwOS) than molecular non-responders across various cancer types. The findings suggest that ctDNA TF may serve as a biomarker to predict molecular response to TKi therapy, potentially guiding treatment decisions and improving patient outcomes in a real-world setting.
Collaborator-led Poster Presentation: Enhancing TCR-T with a Fas-based switch receptor boosts T cell engraftment, persistence, and anti-tumor activity in models of hard-to-treat PRAME solid tumor indications
Date/Time: April 29, 2025; 9:00 AM – 12:00 PM CT

Location: Section 39

Overview: T-knife Therapeutics is developing a FAS-based switch receptor (FAS-TNFR) to target PRAME-positive solid tumors, designed to enhance T cell activity and overcome the hostile tumor microenvironment. Utilizing Tempus multi-modal data, T-Knife analyzed a large database of tumor samples to identify the inhibitory ligands most frequently found in PRAME-expressing indications and to understand in depth the pattern of expression of PRAME and inhibitory ligands in different patient populations. These insights provided by Tempus were crucial for T-knife to select the optimal switch receptor from their armoring toolbox and determine appropriate target populations for their upcoming clinical trials (Figures 1A, 2D, and 3A-C present Tempus-driven data and insights).

On April 25, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported solid tumor regression data from Bantam’s lead product candidate, BTM-3566 (Press release, Bantam Pharmaceutical, APR 25, 2025, View Source [SID1234652160]). These preclinical data will be shared in a poster presentation during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held from April 25-30, 2025 at the McCormick Place Convention Center in Chicago, Illinois. The poster highlights evidence of robust anti-tumor activity in a broad range of solid tumor models, as well as introduces FAM210B, a mitochondrial protein, as a potential biomarker for response.

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BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets difficult-to-treat, aggressive tumors by activating OMA1-ATF4 Integrated Stress Response (ISR), a newly described mitochondrial homeostasis pathway. Previously, BTM-3566 was shown to have strong single-agent activity in both cell line and patient-derived xenograft (PDX) models of mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL), regardless of cell of origin (COO) or genotype. The new data extend these findings to solid tumors and demonstrate that BTM-3566 has in vitro and in vivo activity across tumor types.

Key findings include:

BTM-3566 exhibits in vitro and in vivo activity in a broad range of solid tumor models
BTM-3566 drives tumor regression in models with low FAM210B RNA expression, supporting the use of FAM210B as a potential biomarker for response
Ectopic expression of FAM210B blocks drug activity in multiple models, suggesting a mechanistic role for the protein in mediating response
BTM-3566 demonstrates additive and synergistic activity in combination with other agents from multiple classes in preclinical models, including BH3 mimetics, supporting future combination strategies
"These findings provide important insight into the unique mechanism of our lead compound and support the potential for future patient selection using FAM210B expression," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "We believe BTM-3566 holds promise not only as a monotherapy but also in combination with numerous approved anti-cancer agents, potentially expanding treatment options for patients with aggressive, hard-to-treat tumors. We intend to further explore these relationships as product development progresses."

Poster Presentation Details

Title: Selective pharmacological activation of the mitochondrial protease OMA1 inhibits tumor growth and induces regression in tumors expressing low levels of FAM210B
Presenter: Matthew Kostura, PhD, Chief Scientific Officer, Bantam Pharmaceutical
Session: Experimental and Molecular Therapeutics
Date/Time: Monday, April 28th at 3 p.m. to 6 p.m. ET
Abstract Number: 3032

The poster presentation will be available under the News & Resources section of the company’s website shortly after the event.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.

Currently, Bantam is conducting an ongoing Phase 1 clinical trial in both the U.S. and Canada evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. For more information about the U.S. trial, visit ClinicalTrials.gov and search NCT06792734.

On April 25, 2025 Incyte (Nasdaq:INCY) reported that the Company will present new early-stage data from its oncology portfolio at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, IL, from April 25–30 (Press release, Incyte, APR 25, 2025, View Source [SID1234652177]).

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"At AACR (Free AACR Whitepaper) we will be presenting data from early-stage programs across our oncology portfolio, including for patients with myeloproliferative neoplasms, ovarian cancer and other solid tumors," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "These data will guide our approach as we advance our pipeline and seek to transform the treatment landscape for patients with cancer and myeloproliferative neoplasms."

Abstracts accepted for presentation at AACR (Free AACR Whitepaper) include:

Mini Symposium

INCB177054

INCB177054: A Novel, Potent, Orally Bioavailable DGKα/ζ Dual Inhibitor Enhances T-Cell Function and Demonstrates Potent Antitumor Activity
(Session Title: Novel Antitumor Agents. April 28, 4:50 p.m. – 5:05 p.m. ET (3:50 p.m. – 4:05 p.m. CT). Abstract #3789.))

Poster Presentations

INCA33890

INCA33890 Increases CD8+ T-Cell Effector Function Compared with pembrolizumab as Assessed by Single-Cell RNA Sequencing in Human PD-1xTGFβR2 Knock-In Mouse Model (Session Title: Immune Fitness and Metabolic Regulation of Cancer Immunity​. April 29, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT). Abstract #4861.))

INCA33890, a Bispecific Antibody Targeting PD-1 and TGFβR2, Shows Enhanced Immune Responses in Models of Ovarian Cancer
(Session Title: Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators. April 29, 3:00 p.m. – 6:00 p.m. ET (2:00 – 5:00 p.m. CT). Abstract #6074.))

PD-1xTGFβR2 Bispecific Biclonics Antibody INCA33890 Augments Human T-Cell Effector Functions In Vitro and Ex Vivo
(Session Title: Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators​. April 29, 3:00 p.m. – 6:00 p.m. ET (2:00 – 5:00 p.m. CT). Abstract #6071.))

INCB057643

INCB057643, a Bromodomain and Extra-Terminal (BET) Protein Inhibitor, Improved Bone Marrow Function and Shifted Megakaryopoiesis to Erythropoiesis in Patients with Myeloproliferative Neoplasms (MPNs)
(Session Title: Molecular Genetics and Epigenetics of Tumors​. April 30, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT). Abstract #7188.))

Novel Role of INCB057643, a Bromodomain and Extra-Terminal (BET) Protein Inhibitor, in Myeloid Cell Regulation and Immunosuppressive Tumor Environment Remodeling in Myelofibrosis (MF)
(Session Title: Molecular Genetics and Epigenetics of Tumors​. April 30, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT). Abstract #7184.))

Association of Cyclin E1 Expression with Genomic Instability in Ovarian Cancer
(Session Title: Origins and Mechanisms of Genomic Instability​. April 28, 3:00 p.m. – 6:00 p.m. ET (2:00 – 5:00 p.m. CT). Abstract #2846.))

On April 25, 2025 NETRIS Pharma, a clinical-stage private biopharmaceutical company developing a new class of therapeutics targeting Netrin-1, reported positive interim results from the ongoing ImmunoNET Phase II trial of its lead candidate NP137 (Press release, Netris Pharma, APR 25, 2025, View Source [SID1234652145]). The multicenter, open-label, proof of concept study is designed to evaluate the clinical and biological activity of NP137 as an add-on therapy in patients with advanced or metastatic Head & Neck Cancer and Non-Small Cell Lung Cancer (NSCLC) who have progressed under standard immunotherapies.

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The interim analysis met both the primary and key secondary endpoints in secondary refractory patients. Such analysis confirms NP137 excellent safety profile and its potential to overcome secondary resistance to leading immunotherapies. Clinical benefits were observed in half of the patients with Head & Neck and NSCLC cancers who had previously progressed under approved immunotherapy.

« These interim results mark a major milestone in our mission to develop drugs that overcome therapy resistance » said Patrick Mehlen, CEO of NETRIS Pharma. « We are excited by the potential of NP137 to restore patients sensitivity to immunotherapy-based treatments and to deliver a new treatment solution for patients with limited options ».

Upcoming Data Presentations

Comprehensive study design and interim results will be presented at two of the world’s leading oncology congresses: the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in 2025, underscoring the global significance of these findings.

« We look foward to sharing these important data with the oncology community at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper), and to advancing NP137 into the next phase of development » added Dr. Jérome Fayette, Medical Oncologist at Centre Léon Bérard and Principal Investigator of the ImmunoNet study.

About NP137

NP137 is a humanized monoclonal antibody (IgG1) targeting netrin-1, a protein overexpressed in a large proportion of human cancers and associated with disease severity and resistance to therapy. By blocking netrin-1, NP137 is designed to restore apoptosis and reverse epithelial-to-mesenchymal transition (EMT), addressing critical mechanisms of resistance that limit the effectiveness of immune checkpoint inhibitors. Preclinical and early clinical studies have shown that NP137 has anti-cancer effects both as a monotherapy and in combination with chemotherapy or immunotherapy, with a favorable safety profile.

On April 25, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, reported an upcoming clinical plenary oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Marengo Therapeutics, APR 25, 2025, View Source [SID1234652161]). The presentation will report updated clinical and translational findings from the ongoing Phase 1/2 trial (STARt-001) evaluating invikafusp alfa (STAR0602) in patients with anti-PD(L)1-resistant, antigen-rich solid tumors.

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The results highlight clinical pharmacology, selective immune activation, and RP2D selection in addition to demonstrating clinically meaningful anti-tumor activity and a well-characterized safety profile. The data also further support the advancement of the lead asset into Phase 2 development and confirm clinical efficacy.

"These encouraging data represent the first clinical proof of our precision T cell agonist approach to overcome anti-PD(L)1-resistant cancer, a therapeutic area with significant unmet need. Importantly, invikafusp monotherapy not only selectively engaged and expanded a key T cell subset in immunotherapy-resistant tumors, but also reinvigorated anti-tumor responses," said Ke Liu, M.D. Ph.D., Chief Development Officer of Marengo Therapeutics. "Based on the initial disease control and tumor regression rates observed, invikafusp has the potential to offer a promising new class of immunotherapy for patients who have exhausted checkpoint inhibitor therapy options."

"The initial clinical activity of invikafusp monotherapy in PD-1 resistant tumors is novel and important as a new approach to immunotherapy," said Bruce A. Chabner, M.D., Clinical Director Emeritus at Massachusetts General Hospital. "The ability of invikafusp to activate a specific subset of T cells in heavily pretreated cancer patients and achieve objective responses in tumors that have failed PD-1 inhibitors is clinically meaningful. These results may mark the beginning of a new class of novel T cell agonists in treating checkpoint resistant cancers with precision immune activation."

Invikafusp alfa is Marengo’s first-in-class, dual T cell agonist with a bi-specific antibody design to selectively activate the Vβ6 and Vβ10 subsets of T cells in vivo.

Key Findings from the Abstract (CT205):

Initial Clinical Activity (TMB-H subgroup at optimal biologic dose):
Six of the initial nine efficacy evaluable patients (67%) achieved disease control (2 confirmed partial responses (cPRs) and 4 with stable disease)
The cPRs were in MSS colorectal cancer with one response lasting ~12 months
Plenary oral presentation to include updated clinical results from initial data cut and additional patients
Clinical Pharmacology and Recommended Phase 2 Dose (RP2D):
RP2D was determined as 0.08 mg/kg Q2W, selected based on pharmacokinetics, pharmacodynamics, safety, and activity
Dose-dependent, selective expansion of peripheral CD8+ Vβ6/Vβ10 T cells, with ~600% average peak expansion at RP2D
Expanded Vβ T cells exhibited a memory phenotype and expressed cytotoxic effector molecules
Soluble markers of T cell activation (e.g., IFN-γ, sCD25) increased post-dosing; inflammatory cytokines (e.g., TNF-α, IL-6) remained limited below RP2D
Based on initial clinical and preclinical results, the U.S. Food and Drug Administration granted Fast Track Designation to invikafusp alfa for the treatment of patients with TMB-high colorectal cancer. The STARt-001 Phase 2 portion of the trial is ongoing and actively enrolling, focused on expanding into other antigen-rich tumors, including MSI-H and TMB-H tissue agnostic solid tumors.

Presentation Details

Title: Updated clinical results, recommended Phase 2 dose (RP2D) determination and translational study results for START-001: a Phase 1/2 trial of invikafusp alfa, a first-in-class TCR β chain-targeted bispecific antibody in patients with anti-PD(L)1-resistant, antigen-rich solid tumors
Abstract Number: CT205 (Late-breaking)
Session Title: Clinical Trials Plenary: Biologics and T-cell Engagers
Session Date and Time: Tuesday, April 29, 2025, 10:15 AM – 12:15 PM CT
Presenter: Ryan J. Sullivan, M.D., Massachusetts General Hospital