On September 2, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported the publication of a collaborative study*, "AI-driven multimodal algorithm predicts immunotherapy and targeted therapy outcomes in clear cell renal cell carcinoma," in Cell Reports Medicine (Press release, BostonGene, SEP 2, 2025, View Source [SID1234655677]). The study introduced the largest harmonized transcriptomic and clinical dataset in kidney cancer and presents a model of how advanced multimodal AI solutions can identify previously unknown determinants of response to combinations of immunotherapy and VEGF inhibitors in solid tumors.

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While immune checkpoint inhibitors (ICIs) and VEGF inhibitor specific tyrosine kinase inhibitors (TKIs) have transformed care, treatment for metastatic clear cell renal cell carcinoma (ccRCC) remains challenged by variable responses, frequent progression and therapy-related toxicities and a lack of guidance on when to apply combination versus single agent therapy. Previous predictive models showed promise, but lacked reproducibility and biological interpretability across independent cohorts.

Leveraging more than 3,600 patient samples and harmonized clinical data, researchers developed a multimodal foundation model trained on extensive real-world datasets that integrates genomics, transcriptomics and tumor microenvironment (TME) profiling. The digital twin-like model generated representations of patient biology. It uncovered five novel Harmonized Immune Tumor Microenvironment (HiTME) subtypes — distinct categories of ccRCC defined by unique immune infiltration patterns, genomic alterations and prognostic outcomes. Importantly, these subtypes were validated with spatial proteomics, ensuring predictions mapped directly to tumor biology rather than functioning as a "black box."

Using the HiTME subtypes, researchers generated clinically interpretable responder scores that correlated with survival outcomes for both ICIs and TKIs across independent cohorts. This led to a decision-tree tool that stratified patients into ICI-preferred, TKI-preferred or non-responder categories, establishing a data-driven methodology to stratify patients by underlying immune and tumor biology, enabling new insights for drug development and clinical research. The framework also revealed a therapy-resistant subgroup characterized by immune-desert phenotypes and angiogenic signaling–highlighting urgent unmet needs and new therapeutic avenues.

"This study demonstrates how multimodal foundation models can reshape oncology," said Nathan Fowler MD, Chief Medical Officer at BostonGene "By grounding predictions in tumor biology rather than opaque algorithms, we enable clinicians to understand why patients may or may not respond to treatment — making AI both clinically actionable and scientifically trustworthy."

On September 2, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported that members of management will present at the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025 (Press release, Aligos Therapeutics, SEP 2, 2025, View Source [SID1234655629]).

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A webcast of the on demand presentation will be accessible by visiting the Presentation & Events section on the "Investors" page of Aligos’ website at www.aligos.com. A replay of the webcast will be available following the presentation for at least 30 days.

On September 2, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, reported that members of its senior management team will present and participate in the following investor conferences (Press release, Lyell Immunopharma, SEP 2, 2025, View Source [SID1234655647]):

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Morgan Stanley 23rd Annual Global Healthcare Conference on Monday, September 8th at 9:15 am Eastern Time
H.C. Wainwright 27th Annual Global Investment Conference on Wednesday, September 10th at 8:00 am Eastern Time

A live webcast of the presentation can be accessed through the Investors section of the Company’s website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company’s website following the presentation date.

On September 2, 2025 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura) reported they have received a notice from Astellas Pharma Inc. ("Astellas") to exercise the option right granted under a Research Collaboration Agreement, executed on June 17th 2024 (Press release, Alivexis, SEP 2, 2025, View Source [SID1234655631]). This agreement focused on identifying small molecule compounds targeting a new drug target selected by Astellas, utilizing Alivexis’ drug discovery platform ModBind and other advanced technologies.

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The joint research collaboration aimed to accelerate the discovery of novel functional modulators for a previously uncharacterized drug target selected by Astellas. Leveraging our computational drug discovery platform, including ModBind, the Alivexis team led the integrated drug discovery researching, including conducting in silico evaluations and developing experimental assays to evaluate compound efficacy. Under the terms of the collaboration agreement, Astellas was granted the option to acquire rights to the research deliverables.

About ModBind.
Alivexis has established a computational drug discovery platform that greatly accelerates small molecule drug discovery, which includes physics-based molecular dynamics simulations using GPUs (Graphics Processing Units), large-scale virtual screening algorithms, and deep learning models. With the help of their computational drug discovery platform, Alivexis has already delivered several clinical candidate molecules for both in-house drug discovery projects and external collaborations. Among Alivexis’ various computational drug discovery tools, the newly developed ModBind is a molecular simulations-based algorithm that can predict the efficacy of drug candidate compounds with high accuracy, yet performs hundreds to thousands of times faster than the other state-of-the-art technologies in the field. ModBind is based on a theoretical approach that is fundamentally different from industry standard simulations-based prediction technologies. One significant advantage of ModBind is that it is an absolute predictor of ligand efficacy and does not require known reference compounds, which are usually necessary for other methodologies. Therefore, ModBind is useful in all stages of preclinical drug discovery – from screening large random chemical libraries for initial hit finding to delivering clinical candidates in the lead-optimization stage. This capability has already been proven by Alivexis’ in-house research and external collaborations and is contributing to the progression of many drug discovery projects.

【CEO S. Roy Kimura’s Comments】
"We are extremely pleased that Astellas Pharma has elected to exercise its option to obtain the rights for the small molecule compounds that were discovered through our ModBind drug discovery collaboration. Despite being a difficult target with no previously reported lead compounds, our ModBind simulation technology has successfully identified compounds worth further study. This result further demonstrates the power of our ModBind platform to rapidly identify promising drug lead compounds. Beyond identifying new drug candidates for other promising disease targets, we are currently applying ModBind to develop a foundation AI model for drug discovery and generate very large synthetic datasets to train target-specific generative AI models. We believe that the combination of simulation and AI (ModBindxAI) is the key to unlocking efficient drug discovery. "

On September 2, 2025 Brenus Pharma reported that first patients have been successfully dosed in its first-in-human clinical trial evaluating STC-1010, the company’s lead in vivo immunotherapy candidate developed through its proprietary off-the-shelf platform (Press release, Brenus Pharma, SEP 2, 2025, View Source [SID1234655678]). Three patients have already been enrolled in the study. The first completed eight weeks of treatment with no adverse events attributed to the investigational therapy. This trial targets patients with unresectable, locally advanced or metastatic colorectal cancer (CRC) — the second leading cause of cancer-related death worldwide — for whom chemotherapy remains the predominant treatment option.

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This international "BreAK CRC-001"1 Phase I/IIa, open-label, multicenter trial aims to assess the safety, tolerability, and preliminary efficacy of STC-1010 in over 80 patients in combination with an immunostimulatory regimen (GM-CSF low-dose and cyclophosphamide) and standard-of-care chemotherapy (mFOLFOX6 ± bevacizumab). First results are expected in the first half of 2026.

"This marks a pivotal step for Brenus and the future of new modalities in oncology with the potential to improve outcomes, with more accessible and scalable solution for patients who desperately need it," said Paul Bravetti, CEO of Brenus Pharma.

"Treating the first patient represents more than a scientific milestone — It’s a profoundly meaningful moment, marking the start of broader clinical and pharmaceutical deployment," said Benoit Pinteur, co-founder and CSO of Brenus Pharma.

"CRC remains challenging, as current immunotherapies are only effective in dMMR/MSI-H ‘hot’ tumors. For pMMR/MSS patients, there’s a strong need for drugs that can ‘heat up’ cold tumors. BreAK-CRC is eagerly awaited, and we’re excited to explore STC-1010’s potential in first-line combination," said François Ghiringhelli, M.D., Ph.D., CGFL. Director of early clinical unit and study coordinator.

First sites are already open in France : CGFL, Dijon; Institut Bergonié, Bordeaux; ICM, Montpellier; and HCL, Lyon. Additional centers will open in 2026 in France and Belgium. Further centers will join the study for Phase II with an international U.S. expansion.