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.

On September 1, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Zai Laboratory, SEP 1, 2025, View Source [SID1234655613]).

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"Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China," said Andrew Zhu, Chief Commercial Officer, Greater China, Zai Lab. "Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited. TIVDAK, the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients. With our established commercial infrastructure for ZEJULA in Hong Kong, we are uniquely positioned to ensure TIVDAK reaches patients without delay."

TIVDAK is currently under regulatory review for its Biologics License Application by China’s National Medical Products Administration (NMPA), which was accepted in March 2025.

About TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).