On April 25, 2025 CDR-Life reported the presentation of data for its novel T cell engager (TCE) programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago (Press release, CDR-Life, APR 25, 2025, View Source [SID1234652171]). The presentations showcase the company’s proprietary M-gager platform-derived TCE candidates, with a focus on CDR404, currently in Phase 1 clinical trials for MAGE-A4-positive solid tumors.

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"The data presented at AACR (Free AACR Whitepaper) highlight the potential advantages of our antibody-based approach to T cell engagement against highly tumor-specific targets," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "CDR404 demonstrated superior potency and durability in preclinical models, which align with the encouraging early signals we’re seeing in our ongoing Phase 1 trial."

Key Findings for CDR404 in MAGE-A4-Positive Tumors (Abstract #3494)
The poster, "Durable and potent in vitro T cell activity with repeated exposure to CDR404, a potential best-in-class T cell engager targeting MAGE-A4" demonstrated several advantages of CDR404 compared to a TCR-based TCE:

Superior Potency and Durability: CDR404 showed more potent killing of MAGE-A4-positive cancer cell lines across multiple indications, even at low effector-to-target cell ratios which mimic a "cold" tumor environment, compared to a TCR-based competitor
Enhanced T Cell Fitness: After multiple rounds of serial killing, T cells exposed to CDR404 maintained significantly better fitness, with lower levels of crucial T cell exhaustion markers compared to the TCR-based approach
Favorable Cytokine Profile: CDR404 demonstrated a more favorable cytokine release profile, potentially offering safety advantages in the clinical setting
Effective Across Multiple Cancer Types: CDR404 showed strong activity against MAGE-A4-positive tumor cells from different cancer types, including lung adenocarcinoma and squamous cell carcinoma, and melanomas
The data presented in the poster align well with early emerging data from the ongoing Phase 1 trial of CDR404 (NCT06402201). CDR404 has shown clear signals of immunological activity and preliminary evidence of anti-tumor activity, including at the pharmacokinetic model-derived starting dose. Use of this innovative model created an elevator to a higher starting dose, potentially shortening overall trial duration by enabling a starting dose closer to the efficacious dosing range while maintaining patient safety. Dose escalation is ongoing and patient data from the early stages of the Phase 1 trial will be reported later this year.

Second T Cell Engager for KK-LC-1-Positive Tumors (Abstract #3493)
In the poster, "A novel T cell engager antibody for the treatment of HLA-A01/KK-LC-1-positive tumors," CDR-Life presented data on CDR505, a novel antibody-based TCE targeting the Kita-Kyushu lung cancer antigen-1 (KK-LC-1) presented on HLA-A01:01.

Key findings for CDR505 included:

Potent and Selective: CDR505 demonstrated potent and selective killing of KK-LC-1-positive cancer cells.
Preferential T Cell Activation: The molecule showed preferential activation of CD8+ T cells, confirming the intended mechanism of action.
High Target Specificity: CDR505 exhibited high specificity for the KK-LC-1 peptide/HLA-A*01:01 complex, demonstrating low risk for off-target binding.
Desirable Pharmaceutical Properties: The molecule demonstrated excellent manufacturability, solubility and stability characteristics, supporting its feasibility for subcutaneous formulation.
Broad Patient Potential
Both TCE candidates have the potential to address significant patient populations:

CDR404 targets MAGE-A4-positive tumors in HLA-A02:01-positive patients. MAGE-A4 is expressed in up to 63% of ovarian cancers, 62% of head and neck cancers and 52% of squamous lung cancers.
CDR505 is the only TCE in development targeting KK-LC-1-positive tumors in HLA-A*01:01-positive patients. KK-LC-1 is expressed in 75% of colorectal and gastric carcinoma cancers and 60% of pancreatic ductal adenocarcinoma cancers.
"With CDR505, we’re breaking new ground in targeting previously inaccessible cancer antigens through our innovative M-gager platform," added Dr. Leisner. "This first-in-class molecule demonstrates how we’re tackling difficult targets with precision, particularly in tumor types where traditional approaches have shown limited success. The widespread expression of KK-LC-1 across gastrointestinal cancers positions CDR505 to potentially address some of medicine’s most challenging malignancies with a novel immunotherapeutic approach."

On April 25, 2025 Baylink Biosciences reported data from its Antibody Drug Conjugate portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL (Press release, Baylink Biosciences, APR 25, 2025, View Source [SID1234652139]). The data presented for BLB-101, an antibody drug conjugate targeting Claudin 6 and 9 delivering exatecan, represents a potential best-in-class profile. In addition, Baylink presented data demonstrating its novel next-generation ADC linker technology is able to overcome key challenges in ADC development.

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"The data presented today at AACR (Free AACR Whitepaper) provides strong evidence of BLB-101’s best-in-class profile. We believe BLB-101 is the only ADC with dual targeting of Claudin 6 and 9, with the ability to impact heterogenous tumors and benefit more patients with ovarian and other CLDN6/9+ tumor types. We plan to file an IND for this exciting candidate in 2026," said Alice Chen, PhD, Chief Scientific Officer and Founder of Baylink. "In addition, our scientists presented data at the meeting showcasing our innovative linker technology which has been designed to overcome a number of key challenges in the ADC field. In particular, our linker technology enables the delivery of new payload classes such as degraders and the delivery of two modalities in a dual payload ADC format, approaches that we believe will help to overcome resistance to chemotherapy, a significant unmet need."

Presentation Highlights

Preclinical evaluation of BLB-101, a topoisomerase-inhibitor-based anti-CLDN6/9 antibody-drug conjugate featuring a proprietary hydrophilic linker

Poster number：1578

Session Date and Time: April 28, 2025, 9:00 AM – 12:00 PM

BLB-101 is an antibody drug conjugate designed to target Claudin 6/9 and deliver the topoisomerase 1 inhibitor, exatecan in a highly efficient manner with a drug to antibody ratio of 8. Claudin 6 (CLDN6) is a tight junction protein that is highly expressed in various human cancers, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC), but is absent in normal adult tissues. Claudin 9 (CLDN9), which shares high homology with CLDN6, exhibits a similar expression pattern—being nearly undetectable in normal tissues but upregulated in ovarian and endometrial cancers. The compelling preclinical activity profile supports BLB-101 development for Claudin 6/9 positive tumors. An investigational new drug submission is planned for 2026.

Key Results:

We successfully identified a high-affinity antibody, 2D5S, that specifically binds to CLDN6 and CLDN9 while avoiding interaction with other Claudin family members. BLB-101 is an antibody-drug conjugate (ADC) candidate that incorporates 2D5S (CLDN6/9 Ab) and the topoisomerase I inhibitor, exatecan as payload, along with our proprietary hydrophilic linker, BL001. BLB-101 demonstrates excellent biological activity, favorable in vivo pharmacokinetics (PK), and excellent developability. It exhibits strong cytotoxic effects across multiple antigen-positive cancer cell lines. In xenograft models expressing CLDN6 or CLDN9, BLB-101 achieved tumor elimination at low doses. Additionally, BLB-101 was well tolerated in non-human primates. Collectively, these findings provide strong support for the continued clinical development of BLB-101.

• 2D5S Ab binds with high affinity to CLDN6 and CLDN9 while sparing other claudin

family members.

• 2D5S demonstrates stronger internalization compared to a benchmark antibody.

• BLB-101 is a DAR8 ADC featuring a topoisomerase 1-inhibitor-based payload with a

proprietary hydrophilic linker, BL001.

• BLB-101 exhibits strong in vitro cytotoxic and bystander killing effects.

• In xenograft models, BLB-101 treatment resulted in robust tumor elimination at dose as low as 1 mg/kg.

• BLB-101 demonstrated outstanding plasma stability and favorable PK in cynomolgus monkey.

• BLB-101 is well-tolerated in cynomolgus monkeys up to 40 mg/kg, suggesting an

extended therapeutic window.

A linker platform for antibody drug conjugates (ADCs): expanding the therapeutic window

Poster number：7463

Session Date and Time: April 30, 2025, 9:00 AM – 12:00 PM

Key Results:

Our novel linker designs offer significant advantages, with features that could expand the therapeutic window of current ADCs by improving their hydrophilicity and stability, and reducing off–target effects while maintaining efficacy. The linkers have been applied to several projects with the frontrunner project scheduled to enter a phase 1clinical trial in 2026. We are also expanding the utility of this class of linkers to enable innovative design of dual–payload–ADC and Degrader–Antibody–Conjugates.

• Baylink’s proprietary linker BL001 improves hydrophilicity and stability of ADC

• BL001 linker reduced non-specific uptake of ADC into non-cancerous cells via macropinocytosis

• BL001 linker utilized in a trastuzumab exatecan ADC showed superior antitumor effect to GGFG based ADC delivering Dxd.

• BL001 linker utilized in BLB-101 candidate showed excellent PK and tolerability in cynomolgus monkeys, predicting an enhanced therapeutic index.

Copies of the poster presentations will be available on the Baylink Biosciences website at www.Baylinkbio.com/blog following the AACR (Free AACR Whitepaper) meeting.

On April 25, 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 has released results from four preclinical studies in poster presentations at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2025) (Press release, Antengene, APR 25, 2025, View Source [SID1234652155]). These four posters feature Antengene’s four highly differentiated and high-potential programs, including ATG-201 (CD19 x CD3 TCE) and ATG-042 (MTAPnull-selective PRMT5 Inhibitor), which are poised to enter clinical development in the second half of 2025; ATG-110 (LY6G6D x CD3 TCE), which was developed on the AnTenGagerTM TCE 2.0 platform for the treatment of microsatellite stable colorectal cancer; and a companion diagnostic antibody developed to assess CD24 expression and guide clinical studies of CD24-targeted therapies.

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Details of the Poster Presentations:
ATG-201 (CD19 x CD3 T cell engager)
Title: ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases
Abstract Number: 7326
Session Category: Immunology
Session Title: T Cell Engagers and Novel Antibody-Based Therapies
Date: April 30, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, April 30, 2025 – 1:00 AM, May 1, 2025 (Beijing Time)
Location: Poster Section 40
• Introduction: By depleting autoreactive B cells, CD19-targeted CAR-T have shown early yet promising efficacy in treating patients with B cell-driven autoimmune diseases. However, the clinical application of TCE continues to be greatly hindered by the unfavorable pharmacokinetics and toxicity associated with cytokine release syndrome. To overcome these limitations, Antengene developed ATG-201, a "2+1" CD19 x CD3 TCE, which was evaluated in a series of in vitro studies for binding affinity, T cell dependent cytotoxicity (TDCC) cytokine release, and drug developability. The in vivo anti-lymphoma efficacy and pharmacodynamic effect were evaluated in Raji xenograft model. The tissue resident B cell depletion was assessed in CD34+ hematopoietic stem cells humanized mice. Pharmacokinetic parameters of ATG-201 were evaluated in normal Balb/c mice.
• Results: ATG-201 demonstrated high affinity binding to CD19, limited T cell binding before CD19 crosslinking, highly potent CD19-dependent T cell cytotoxicity against CD19+ B cells, as well as enhanced naïve B cell depletion with reduced cytokine release compared to clinical benchmarks. In lymphoma models, the study observed potent in vivo efficacy with reduced cytokine release. In CD34+ hematopoietic stem cells humanized mice, ATG-201 was able to induce complete B cell depletion with reduced cytokine release. ATG-201 has a mAb-like pharmacokinetic profile in wild type mice and good drug developability. Moreover, surrogate CD19 x CD3 AnTenGager TCE displayed potent efficacy in MRL/lpr spontaneous systemic lupus erythematosus (SLE) mouse models and MOG-Induced EAE models.
• Conclusions: ATG-201 demonstrated CD19-dependent CD3 binding and activation, inducing effective B cell depletion in vitro and in vivo with low cytokine release, which provides potential for the treatment of B cell malignancies and B cell related autoimmune diseases. ATG-201 is poised to enter clinical development in the second half of 2025.

ATG-042 (MTAPnull-selective PRMT5 Inhibitor)
Title: Preclinical characterization of ATG-042, a novel MTAPnull-selective PRMT5 inhibitor
Abstract Number: 4230
Session Category: Experimental and Molecular Therapeutics
Session Title: HDAC and Methyltransferase Inhibitors
Date: April 29, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, April 29, 2025 – 1:00 AM, April 30, 2025 (Beijing Time)
Location: Poster Section 16
• Introduction: Targeting the PRMT5-MTA complex has become a promising strategy for treating MTAPnull cancer in a synthetically lethal manner, avoiding on-target-off-tumor hematological toxicity when using first-generation, non-selective PRMT5 inhibitors. Herein, Antengene developed ATG-042, a novel MTAPnull-selective PRMT5 small molecule inhibitor with good brain penetration. In this study, the in vitro activity and MTAP selectivity of ATG-042 were profiled using HCT116 MTAP wild type (wt) cells, HCT116 MTAP knock out (ko) cells and multiple endogenous MTAPnull cell lines. The in vivo efficacy was tested in cell derived xenograft (CDX) mouse models with HCT116 MTAP wt cells, HCT116 MTAP ko cells, LU99 cells (MTAPnull) and U87MG-luc (MTAPnull). The pharmacokinetic and toxicological properties were assessed with corresponding assay methods.
• Results: ATG-042 showed excellent anti-proliferative activities on multiple endogenous MTAPnull cell lines with IC50 values between 10nM and 100nM. ATG-042 demonstrated high permeability, good metabolic stability, and low risk of drug-drug interaction. In vivo PK study shows that ATG-042 is well absorbed, with a dose-dependent increase in plasma distribution and high oral bioavailability in mice, SD rats and beagle dogs. Furthermore, ATG-042 is brain-penetrable (B/P ratio=51% in mice; KPuubrain=0.73 in rats). ATG-042 showed robust in vivo efficacy in both subcutaneous CDX models (HCT116 -MTAP ko, LU99) and orthotopic CDX model (U87MG-luc) as a single agent. In addition, ATG-042 also exhibited potential synergy in combination with other drugs for antitumor therapy.
• Conclusions: ATG-042 is an oral MTAPnull-selective PRMT5 inhibitor with potent efficacy against MTAPnull tumor. It also demonstrated good tolerability and brain penetrability. ATG-042 is poised to enter clinical development in the second half of 2025.

ATG-110 (LY6G6D x CD3 T cell engager)
Title: ATG-110, a novel "2+1" LY6G6D-targeted T-cell Engager (TCE) with high potency for the treatment of MSS colorectal cancer
Abstract Number: 3509
Session Category: Immunology
Session Title: T Cell Engagers
Date: April 28, 2025
Time: 2:00 PM – 5:00 PM (Central Time)
3:00 AM – 6:00 AM, April 29, 2025 (Beijing Time)
Location: Poster Section 38
• Introduction: Colorectal cancer (CRC) is one of the most common cancers worldwide and requires more effective and safer therapies to improve the poor survival outcome, particularly in patients with microsatellite stable (MSS) colorectal cancer, who exhibit primary resistance to immune checkpoint inhibitors and lack effective treatment options. T cell engagers have shown encouraging efficacy in treating hematological malignancies, while exhibiting suboptimal clinical efficacies in solid tumors. The risk of cytokine release syndrome (CRS) remains as a significant challenge clinically. ATG-110 is a novel "2+1" LY6G6D x CD3 TCE developed by Antengene. In this study, ATG-110 was evaluated in a series of preclinical in vitro studies for binding affinity, T cell activation and cytokine release, T cell dependent cytotoxicity (TDCC), and drug developability. The in vivo anti-tumor efficacy was evaluated in PBMC-humanized immunodeficient NDG mice engrafted with LY6G6Dmedium-expression HT55 or LY6G6Dvery low-expression SW480 MSS CRC cells.
• Results: ATG-110 binds to LY6G6D-positive cell lines, including LY6G6D-overexpression 293T and HT55 with the nanomolar grade EC50. The CD3 binding site of ATG-110 is concealed by the LY6G6D Fab arm before binding to LY6G6D, due to the steric hindrance. Therefore, ATG-110 demonstrated limited binding capability to CD3+ cells before LY6G6D crosslinking. It activates T cells and induces cytokine release only in the presence of LY6G6D+ cells. In vitro, ATG-110 resulted in potent T cell dependent cytotoxicity with single-digit pM IC50 values on HT55 cells. ATG-110 also showed highly potent in vitro efficacy against LY6G6Dlow-expression cells. ATG-110 exhibited a low risk of inducing cytokine release syndrome. ATG-110 demonstrated potent anti-tumor activity in PBMC-humanized HT55 xenograft model. Furthermore, ATG-110 also demonstrated good drug developability.
• Conclusions: ATG-110 demonstrated LY6G6D-dependent CD3 binding and activation with low risk of CRS. It showed powerful in vitro and in vivo anti-tumor efficacy against colorectal cancer, which warrants further clinical evaluation.

ATG-1144 (CD24 CDx Antibody)
Title: Development of a diagnostic antibody for CD24 targeted therapy
Abstract Number: 671
Session Category: Clinical Research
Session Title: Diagnostic Biomarkers 2
Date: April 27, 2025
Time: 2:00 PM – 5:00 PM (Central Time)
3:00 AM – 6:00 AM, April 28, 2025 (Beijing Time)
Location: Poster Section 29
• Introduction: CD24 has emerged as a promising therapeutic target for anti-cancer treatment. Several clinical trials are being conducted to evaluate the safety and efficacy of CD24-targeted therapies. Here, Antengene developed and characterized an anti-CD24 diagnostic antibody to enhance the screening and selection of patients based on CD24 expression. In this study, the authors described the discovery of the diagnostic antibody, and the evaluation of accuracy, sensitivity (selectivity), specificity, and assay precision of the antibody.
• Results: Monoclonal antibody clone ATG-1144 binds to the hCD24 core peptide in ELISA with an EC50 of 0.06 nM. Distinct membrane staining on human normal esophageal tissue FFPE specimens can also be observed with IHC staining using ATG-1144. For accuracy assessment, six CDX and twenty human specimens, comprising both positive and negative specimens (including solid tumors and B-cell non-Hodgkin lymphomas), were validated. Samples exhibiting high, medium, and low CD24 expression levels were evaluated for sensitivity and specificity, and the interpreted results aligned with the reference outcomes. FFPE tissues from three distinct patients were evaluated for assay precision assessment. The TMA IHC staining result revealed that 50-80% of patients with lung, breast, bladder, ovarian, or liver cancer have CD24 expression on tumor cell surface with low expression in the para-cancerous normal tissue.
• Conclusions: ATG-1144 specifically binds to human CD24 with high sensitivity as demonstrated by IHC staining. The development and validation of the method have been finalized using Leica Bond III platforms. These data suggest a potential diagnostic use of ATG-1144 for identifying CD24+ patients.

On April 25, 2025 Talus Bioscience, a technology-enabled therapeutics company, reported new preclinical data from programs targeting transcription factors in chordoma, non-small cell lung cancer, and advanced prostate cancer (Press release, Talus Bioscience, APR 25, 2025, View Source [SID1234652172]). The data, presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 25-30, support Talus Bio’s first-in-class approach to target previously undruggable transcription factors using regulome-scale discovery in live human cells.

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"We built our platform to systematically address transcription factors, a target class long considered out of reach for small-molecule therapeutics," said Alex Federation, PhD, CEO and Co-Founder of Talus Bio. "The data we’re presenting at AACR (Free AACR Whitepaper) show that the approach is working. Our platform has already logged over 50 million protein-compound interactions this year. These results validate our strategy in two difficult oncology indications. Our Brachyury molecules are on track for candidate nomination, and new compounds targeting NONO and AR-V7 show real promise for metastatic castration-resistant prostate cancer. We now have a repeatable model for discovering tractable starting points across transcription factor targets once thought undruggable."

Talus Bio’s technology profiles the regulome, providing a quantitative readout of active transcription factors and other DNA-bound regulators in live, unmodified human cells. The platform can measure over 10,000 regulomes per month and is being deployed to discover and optimize small molecules that modulate transcription factor activity in their native context.

Data presented at AACR (Free AACR Whitepaper) on lead drug candidates highlight the strength of this approach. By combining high-throughput transcription factor profiling with AI-guided chemistry, Talus Bio is accelerating the discovery of modulators for transcription factor targets.

Presentation Highlights

Poster 4036 / 2: Selective inhibition of the transcription factor Brachyury in chordoma and non-small cell lung cancer

Preclinical data presented by Gaelle Mercenne at AACR (Free AACR Whitepaper) showcase the ability of a novel covalent small molecule, TAL61, to effectively modulate Brachyury activity in patient-derived xenograft (PDX) models of chordoma:

TAL61 demonstrated significant efficacy in reducing tumor burden in PDX chordoma models with durable tumor suppression post-treatment
TAL61 exhibited low toxicity and high tolerability with daily dosing
Additionally, TAL61 decreased tumor burden by more than 50% in in vivo models of Brachyury-positive non-small cell lung cancer (NSCLC)
Poster 6991 / 20: Targeting NONO as a therapeutic strategy for metastatic castration-resistant prostate cancer (CRPC)

Preclinical data presented by Brian McEllin support an emerging modality targeting NONO to disrupt both AR and ARv7 transcription as an emerging treatment for metastatic castration-resistant prostate cancer:

A targeted search of Talus Bio’s proprietary compound database identified covalent small molecules for lead optimization
Compound treatment reduced mRNA and protein levels of AR and ARv7 in prostate cancer cells
Active compounds show abrogate AR and ARv7 gene expression programs in castration-resistant prostate cancer models
Poster 4496 / 7: Small molecule inhibition of previously "undruggable" transcription factors with AI-guided functional proteomics

Data presented by Alex Federation at AACR (Free AACR Whitepaper) highlight the regulome sequencing platform as a drug discovery engine for previously intractable transcription factors:

The assay provides a quantitative, time-resolved readout of drug-induced changes in transcription factor activity, capturing protein:genome interactions for thousands of proteins simultaneously
This approach enables small molecule screening in physiologically relevant contexts, where transcription factors fold, assemble, and function as they do in human disease
AI-guided hit discovery using this technology has enabled discovery and optimization for inhibitors of Brachyury, AR-V7, and STAT3
Talus Bio’s foundational AI model has helped identify over 30 tractable compounds against validated transcription factor targets in cancer and other diseases. The company is actively pursuing co-development opportunities with partners to accelerate these discoveries into the clinic. Connect with the team to learn more about partnerships and collaborations.

On April 25, 2025 CatalYm reported the presentation of the first preclinical data demonstrating that the company’s clinical-stage antibody visugromab can improve the anti-tumor activity of antibody-drug conjugates (ADCs). The data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place in Chicago, IL, April 25-30, 2025 (Press release, Catalym, APR 25, 2025, View Source [SID1234652140]). The poster will highlight the potential of targeting Growth Differentiation Factor 15 (GDF-15) to enhance the activity and overcome resistance to ADC therapies, which are increasingly used as frontline treatments in several solid tumor indications. The full abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting website.

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The study showed that several clinically validated ADCs, including topoisomerase I and microtubule inhibitor-based regimens, consistently triggered GDF-15 expression, suggesting a potential resistance mechanism to ADC therapy. Across in vitro and in vivo models of multiple solid tumor types, ADC treatment induced GDF-15 release from tumor cells, leading to elevated serum levels and reduced ADC efficacy. Combining ADC treatment with GDF-15 neutralization improved anti-tumor responses, resulting in reduced tumor growth and enhanced infiltration and activation of T cells and myeloid cells in the tumor microenvironment.

"We are building a broader understanding of GDF-15 as a key resistance mechanism activated by targeted approaches like ADCs as well as the leading immunotherapies like PD-1 inhibitors," said Christine Schuberth-Wagner, PhD, Chief Scientific Officer at CatalYm. "By blocking GDF-15, visugromab restores anti-tumor immune activity and enhances treatment efficacy, underscoring its potential as a versatile combination partner across a broad spectrum of cancer therapies beyond immunotherapies."

"ADCs continue to demonstrate potent and specific therapeutic impact, nevertheless resistance is a significant challenge for long-term patient benefit. In addition to our Phase 2 clinical development program, CatalYm will continue to investigate how our GDF-15 neutralizing antibody visugromab can create a novel path to address cancer resistance effectively," added Scott Clarke, Chief Executive Officer at CatalYm.

The preclinical findings build on clinical evidence from the GDFATHER-1/2a trial (GDF-15 Antibody-mediaTed Human Effector T Cell Relocation Phase 1/2a Trial; NCT04725474), that was recently published in Nature. The data show that visugromab induces deep and durable responses in patients with relapsed or refractory solid tumors who had progressed on prior anti-PD-1/PD-L1 therapies. In addition to restoring anti-tumor immune responses, visugromab also demonstrated the potential to mitigate cancer-associated cachexia. CatalYm is currently conducting a broad, global Phase 2b clinical development program for visugromab, evaluating its effectiveness in earlier treatment lines of non-squamous non-small-cell lung cancer and hepatocellular carcinoma, as well as neoadjuvant treatment in urothelial cancer in combination with standard of care.

Poster details

Session title: "PO.IM01.03 – Antibodies and Antibody-Drug Conjugates"

Abstract title: "GDF-15 neutralization enhances the therapeutic activity of antibody-drug conjugates"

Abstract number: 4777/13

Location: Section 36

Date and time: April 29, 2025, 9:00 AM – 12 PM CT/ 4:00 PM – 7:00 PM CEST

About Visugromab
Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ.