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Agilent’s MMR IHC Panel pharmDx (Dako Omnis) Receives European IVDR Certification as a Companion Diagnostic Test for Colorectal Cancer

On September 2, 2025 Agilent Technologies Inc. (NYSE: A) reported that its MMR IHC Panel pharmDx (Dako Omnis) has received class C companion diagnostic (CDx) certification under EU in vitro diagnostic regulation (IVDR)1 as a CDx test for colorectal cancer (Press release, Agilent, SEP 2, 2025, View Source [SID1234655681]). MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify mismatch repair (MMR) deficient CRC patients eligible for treatment with OPDIVO (nivolumab) in combination with YERVOY (ipilimumab). MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

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The MMR pathway corrects DNA replication errors to maintain genomic stability2. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency (dMMR), leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition3.

MMR IHC Panel pharmDx (Dako Omnis) is an immunohistochemical panel specifically developed and validated to detect the loss of function of any of the four MMR proteins in formalin-fixed paraffin-embedded colorectal cancer tissue. Agilent’s panel is the only companion diagnostic IHC panel IVDR approved to diagnose colorectal cancer patients eligible for treatment with OPDIVO in combination with YERVOY.

Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division remarked: "The approval of MMR IHC Panel pharmDx will provide physicians in Europe with critical information to inform treatment decisions for patients with mismatch repair deficiency (dMMR). This endorsement underscores Agilent’s leadership in the development of companion diagnostics for groundbreaking therapies."

Agilent collaborated with Bristol Myers Squibb Company to develop the MMR IHC Panel pharmDx (Dako Omnis).

OPDIVO and YERVOY are registered trademarks of Bristol-Myers Squibb Company.

Puma Biotechnology to Present at the H.C. Wainwright 27th Annual Global Investment Conference

On September 2, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 1:00 p.m. EDT on Monday, September 8, at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Puma Biotechnology, SEP 2, 2025, View Source [SID1234655679]). The conference will be held September 8–10, 2025 at the Lotte New York Palace Hotel in New York City.

A live webcast of the presentation will be available on the Company’s website at View Source The presentation will be archived on the website and available for 30 days.

Brenus Pharma Announces First Patients Dosed in its First-in-Human Trial Evaluating STC-1010, a Next-Generation Immunotherapy

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.

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.

Study Published in Cell Reports Medicine Showcases BostonGene’s Multimodal AI Solutions to Stratify PD-1 and VEGF Immunotherapy Outcomes in Kidney Cancer

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.

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."

Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

On September 2, 2025 Akeso (9926.HK) reported the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1) (Press release, Akeso Biopharma, SEP 2, 2025, View Source [SID1234655673]). This Phase III trial is being conducted in China.

Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab’s strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation.

Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:

Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):

First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
First-line squamous NSCLC (versus tislelizumab + chemotherapy)
NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)
Phase III trials for core immuno-oncology indications (first-line therapy ):

First-line biliary tract cancer (versus durvalumab + chemotherapy)
First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab
Phase III trials for cold tumors and more:

First-line triple-negative breast cancer (TNBC)
First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
First-line pancreatic cancer
Additional global Phase III trials are in advanced stages of planning
An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide.

Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.

For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.