On April 28, 2025 The Management Board of 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A14KL72) reported by the European Medicines Agency (EMA) that, based on the review of the final data and the company’s responses to the Day-180 Assessment Report, 4SC has been invited to an oral discussion before the Committee for Medicinal Products for Human Use (CHMP) at its meeting in late May (Press release, 4SC, APR 28, 2025, View Source [SID1234652255]). Following this meeting, the CHMP is expected to issue a decision on whether to issue a positive or negative recommendation on the company’s Marketing Authorization Application (MAA) for resminostat (Kinselby) in the EU.

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Information and explanations of the issuer regarding this announcement:

Future-oriented information
This release contains certain forward-looking statements that involve risks and uncertainties and reflect 4SC’s assessment as of the date hereof. Such forward-looking statements are neither promises nor guarantees, but are subject to numerous risks and uncertainties, many of which are beyond 4SC’s control, which could cause actual results to differ materially from those contemplated by such forward-looking statements. 4SC expressly disclaims any obligation to update or revise any forward-looking statements to reflect changed expectations or new events, conditions, or circumstances on which any such statements are based.

On April 28, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported the presentation of preclinical data on GNX1021, its lead antibody-drug conjugate (ADC) program, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, GlycoNex, APR 28, 2025, View Source [SID1234652270]). The presentation is part of a poster session held on April 28, 2025, at McCormick Place in Chicago.

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GNX1021 is a novel ADC that targets branched Lewis B/Y (bLeB/Y), a tumor-associated glycan highly expressed in gastric cancer and other solid tumors. The target has a distinct expression profile compared to HER2 and CLDN18—two well-known markers in gastric cancer—allowing GNX1021 to potentially treat patients who are not eligible for current HER2- or CLDN18-targeted therapies.

The poster presents preclinical data showing GNX1021’s antitumor activity in gastric cancer models with high bLeB/Y expression, along with a favorable safety profile in nonclinical studies. Findings suggest that GNX1021 may offer a differentiated therapeutic option for gastric cancer patients with limited targeted treatment choices.

"These data demonstrate the potential of GNX1021 to expand the treatment landscape for gastric cancer by targeting a glycan biomarker not addressed by existing therapies," said Dr. Mei-Chun Yang, CEO of GlycoNex. "As a first-in-class anti-glycan ADC, GNX1021 exemplifies our approach to developing next-generation oncology therapeutics designed to overcome tumor heterogeneity and drug resistance."

GlycoNex is advancing GNX1021 through IND-enabling preclinical development, with an IND submission planned for Q1 2026 and Phase 1 trial initiation expected in Q2 2026.

Presentation Details:

Event:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025

Session Category:

Experimental and Molecular Therapeutics

Session:

Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 1

Abstract Title: (#2932)

GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety

Date and Time:

April 28, 2025; 2:00 pm CDT

Location:

McCormick Place Convention Center, Chicago

Poster Section 17, Poster Board 6

On April 28, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the acceptance of an abstract for an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting taking place May 13-17, 2025, in New Orleans, LA (Press release, Adicet Bio, APR 28, 2025, View Source [SID1234652286]).

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Details of the oral presentation are as follows:

Title: ADI-270, an Armored Allogeneic Anti-CD70 CAR γδ T Cell Therapy, Demonstrates Robust CAR-Directed and -Independent Anti-Tumor Activity Against Hematologic and Solid Tumor Models Compared to Conventional CAR αβ T Cells
Session Name: Engineered Immune Effector Cells for Solid Tumors
Presenting Author: Melinda Au
Date and Time: May 17, 2025; 11:45 a.m. – 12:00 p.m. CT

On April 28, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported data that demonstrate the potential of its DEL Foundation Model to enable the rapid in silico identification of novel binders for a broad range of therapeutically relevant proteins, addressing a key barrier in the discovery and development of small molecule drugs (Press release, Nurix Therapeutics, APR 28, 2025, View Source [SID1234652239]). These results were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL, which is being held from April 25-30, 2025.

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"Nurix’s DEL-AI platform has the potential to accelerate the discovery of breakthrough small molecule drugs—whether they be protein degraders, molecular glues, or inhibitors—by enabling ready-access to tractable chemical matter for an expansive set of proteins, especially those previously considered beyond the reach of drug discovery organizations," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "Our team has leveraged the rich datasets generated from rigorously controlled screenings of our customize collection of over five billion unique DEL compounds against hundreds of disease targets and E3 ligase proteins to construct a powerful suite of machine learning models and tools. By directly integrating the sampling density provided by DEL compound repertoires with primary protein sequence information, our model can learn a generalizable structure activity relationship capable of predicting novel binders for nearly any disease-relevant protein target."

"Our DEL-AI engine is a potential game changer, allowing us to substantially accelerate drug discovery workflows and efficiently identify therapeutic candidates for our wholly owned pipeline and our current and future discovery partnerships," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "This powerful research engine is a result of our significant expertise and strategic investments in DEL methodology and our machine learning platform."

Nurix’s presentation at the AACR (Free AACR Whitepaper) 2025 Annual Meeting, titled: "DEL-AI: Proteome-wide in silico screening of multi-billion compound libraries using machine learning foundation models," described the development of a first-in-class foundation model that was trained on the Company’s high quality, proprietary DEL data. Nurix’s DEL Foundation Model is able to perform virtual DEL experiments on prospective protein target sequences to accurately predict novel binders to a large proportion of therapeutically relevant targets, including many targets considered undruggable. In plots of virtually predicted vs. experimentally-derived DEL screens against therapeutically relevant proteins, Nurix’s DEL Foundation Model demonstrated the ability to accurately predict the experimental results, including experimentally validated binders. Success of the DEL Foundation Model was found to correlate to the degree of similarity of query sequences to proteins within the DEL training set, and data demonstrated that the current model requires as little as 50% amino acid sequence similarity of a query protein to training data to enable binder prediction. Nurix’s model was also capable of inferring binders from chemical space not represented in the training set, suggesting that the model is capable of both protein sequence and chemical structure generalizations.

The development of the DEL Foundation Model was led by Nurix in collaboration with Loka, a Silicon Valley-based software development firm, and supported by Amazon Web Services (AWS), leveraging AWS SageMaker and AWS managed MLflow to provide enterprise-grade reliability and scalable infrastructure.

About DEL-AI

DEL-AI is Nurix’s discovery platform which employs advanced machine learning to enable all aspects of Nurix’s discovery engine, starting with DNA encoded library (DEL) hit-finding and degrader design, followed by automated chemistry synthesis and direct-to-biology screening and optimization, to rapidly generate degraders and degrader antibody conjugates (DACs) as new chemical entity drug candidates. By leveraging hundreds of billions of DEL compound binding signatures derived from thousands of DEL affinity screens collected from a diverse set of highly validated protein targets, Nurix’s DEL-AI platform can prospectively identify binders as starting points for drug discovery for virtually any pharmaceutically relevant target.

On April 28, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that data from the investigator sponsored NEOASIS study were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Agenus, APR 28, 2025, View Source [SID1234652256]). This represents the third clinical study evaluating botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting, with outcomes reported in mismatch repair–proficient (pMMR/MSS) and mismatch repair–deficient (dMMR/MSI-H) solid tumors. These findings include the first reported outcomes with BOT/BAL outside colorectal cancer in the neoadjuvant setting.

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"These initial results from the NEOASIS study indicate that botensilimab and balstilimab can induce pathological responses in patients with a variety of solid tumors, including triple-negative breast cancer, after just two doses," said Myriam Chalabi, MD, of the Netherlands Cancer Institute. "The observed response rates—achieved without dose-limiting toxicities or surgical delays—are notable."

NEOASIS Phase 2 Neoadjuvant BOT/BAL in Early-Stage Solid Tumors (NCT06279130)

Study Design:

The safety run-in enrolled patients with non-metastatic solid tumors, divided into two cohorts of 10 patients each: dMMR/MSI-H and pMMR/MSS. Patients received a single dose of BOT (25 mg or 50 mg) combined with BAL (450 mg) on Day 1 and again on Day 22.

Results:

dMMR/MSI-H Cohort (9 colorectal, 1 duodenal cancer):
Pathological response rate: 90%
Major pathological response (MPR): 80%
Pathological complete response (pCR): 70%
pMMR/MSS Cohort (6 triple-negative breast cancer, 2 ER+ breast cancer, 1 merkel cell carcinoma, 1 sarcoma):
Pathological response rate: 80%
Major pathological response (MPR): 70%
Pathological complete response (pCR): 20%
Triple-negative breast cancer subgroup (n=6): 63% achieved MPR
No dose-limiting toxicities were observed at either dose level, and all patients proceeded to surgery on schedule. Enrollment in the efficacy phase of the study continues.

"The NEOASIS study data reinforces earlier evidence of profound clinical activity with the BOT/BAL combination in the neoadjuvant treatment of solid tumors, including those traditionally resistant to immunotherapy," said Steven O’Day, MD, Chief Medical Officer at Agenus. "These findings substantiate the importance of this immunotherapy in early treatment settings and highlight the broad potential utility of this combination."

Presentation Details:

Title: Neoadjuvant botensilimab plus balstilimab in MMR proficient and deficient early-stage cancers: First results of the pan-cancer NEOASIS study (NCT06279130)
Presenter:Myriam Chalabi, MD, Netherlands Cancer Institute
Session:Aiming for Cure: Adjuvant and Neoadjuvant Approaches
Date and Time:April 28, 2025; 2:30 PM – 4:30 PM CT
Abstract Number:CT130
Visit View Source for more information.

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.