On April 14, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported the publication of a comprehensive review in JAMA Oncology that strengthens the evidence supporting the Oncotype DX Breast Recurrence Score test (Press release, Exact Sciences, APR 14, 2025, View Source [SID1234651912]). The peer-reviewed article titled, "Genomic Assays for Breast Cancer in Diverse Populations: Prognostic and Predictive Insights," affirms that the Oncotype DX test provides accurate and reliable information to help guide breast cancer treatment decisions across all racial and ethnic groups.

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While breast cancer mortality has declined overall, non-Hispanic Black women continue to face a 40% higher mortality rate compared to non-Hispanic White womenI. The publication acknowledges these disparities and the need to better understand the complex factors behind them. Despite the prognostic differences between racial and ethnic minority groups, the Oncoytpe DX Breast Recurrence Score test accurately predicts chemotherapy benefit regardless of race or ethnicity. While these disparities highlight the need for broader systemic change, advancing precision oncology remains critical and tools like the Oncotype DX Breast Recurrence Score test ensure treatment decisions are guided by reliable data for every patient.

The largest real-world SEER registry analysis to date—spanning more than 171,000 breast cancer patients and presented at ASCO (Free ASCO Whitepaper) 2024—provides powerful new evidence that the Oncotype DX test accurately predicts chemotherapy benefit across all racial and ethnic groups. In this study, which is not part of the JAMA Oncology review, the Recurrence Score result predicted chemotherapy benefit in Hispanic, non-Hispanic Black and non-Hispanic White patientsII. These findings add to the body of evidence from key clinical trials—including NSABP*-B20 and SWOG†-8814—which confirm that Oncotype DX is the only genomic test proven to predict chemotherapy benefit, the utility of which was further confirmed in randomized clinical trials including TAILORx and RxPONDER III,IV. With no racial or ethnic differences shown in its predictive value, the Oncotype DX test remains a trusted tool to help guide breast cancer treatment decisions for all patients.

"This study helps deepen our understanding of the multifaceted factors driving disparities in breast cancer outcomes," said Dr. Yara Abdou, assistant professor of medicine and breast cancer clinical trial program leader at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill and the first author of the paper. "By building on insights from landmark clinical trials, we further validate the utility of genomic tests across diverse populations. Our findings reinforce the value of using genomic assays to help guide treatment decisions for all racial and ethnic groups."

Key Highlights:

This publication reinforces the Oncotype DX test’s value in helping guide treatment decisions—providing precise estimates of distant recurrence risk and accurately identifying which breast cancer patients may or may not benefit from chemotherapy, regardless of race or ethnicity.
Secondary analyses of TAILORx and RxPONDER, which included the Oncotype DX Breast Recurrence Score test, confirm consistent chemotherapy benefit across racial and ethnic groups, highlighting that worse prognostic outcomes do not necessarily translate to greater chemotherapy benefitV.
The paper suggests that continued research is essential to understanding the biological, social, and systemic drivers of disparities in breast cancer outcomes—and to ensuring equitable access to genomic tools like the Oncotype DX test.
"At Exact Sciences, we’re proud that the Oncotype DX test continues to stand alone as the only genomic test validated to predict chemotherapy benefit in randomized trials—and that it performs consistently across racial and ethnic groupsV," said Dr. Rick Baehner, chief medical officer of Precision Oncology at Exact Sciences. "We remain deeply committed to partnering with global clinical leaders to reduce disparities and ensure every patient has access to the Oncotype DX test."

* National Surgical Adjuvant Breast and Bowel Project
† SWOG is part of the National Cancer Institute’s National Clinical Trials Network

On April 14, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, reported dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma (Press release, Aulos Bioscience, APR 14, 2025, View Source [SID1234651905]). This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer.

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Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress.

"We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma."

AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells.

Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting later this month.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About AU-007
AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On April 14, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application covering its chimeric antigen receptor-T cell (CAR-T) technology (Press release, Anixa Biosciences, APR 14, 2025, View Source [SID1234651904]).

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The allowed claims in this patent encompass core methods and compositions that are fundamental to Anixa’s innovative CAR-T approach. Anixa’s CAR-T platform is specifically designed to address the long-standing challenges of applying CAR-T therapies to solid tumors, positioning the program as a potential breakthrough in immuno-oncology. This patent, along with others, was granted to The Wistar Institute and exclusively licensed to Anixa Biosciences. Anixa’s CAR-T technology is currently in a clinical trial at Moffitt Cancer Center, treating recurrent ovarian cancer patients.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "This Notice of Allowance further strengthens our growing intellectual property portfolio and reinforces the potential of our robust CAR-T program. Securing foundational patent protection is a vital step in supporting the program’s future success and in driving the development of next-generation immunotherapies with the potential to deliver transformative outcomes for patients."

On April 13, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported $18M in Australian Federal Government Funding from the Medical Research Future Fund (MRFF) Frontiers Initiative for ‘Defeating Prostate Cancer with Targeted Alpha Therapy’ (Press release, Advancell, APR 13, 2025, View Source [SID1234651896]).

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One out of eight men develops prostate cancer. With the support from the Medical Research Future Fund (MRFF) Frontiers Initiative, the goal of the multidisciplinary multi-institutional investigator team is to transform the clinical management of prostate cancer by leveraging leading therapeutic radiopharmaceutical technology paired innovative clinical development and a deep understanding of tumour biology to improve the lives of patients with prostate cancer.

The research program is enabled by AdvanCell’s proprietary (Lead-212) 212Pb alpha isotope production technology along with the delivery of a first-in-field clinical platform trial to accelerate the translation of 212Pb-based targeted alpha therapies, one of the most exciting breakthroughs in cancer treatment.

Dr. Anna Karmann MD PhD, AdvanCell Chief Medical Officer said: "On behalf of all Co-Investigators, I would like to thank the Australian Government and MRFF Frontiers Initiative committee for this prestigious award. Targeted alpha therapies are among the most promising in oncology. We believe this MRFF-funded research can be practice changing and have a lasting positive impact on the lives of patients with prostate cancer. We highly value the support and opportunity this funding provides to fast-track translation and accelerate the development of novel combination therapies in an industry-academic partnership."

AdvanCell is collaborating with world-leading experts in Australia and globally, underpinning the transformative nature of the important clinical research. The clinical PIs include internationally renowned physician scientists Prof. Louise Emmett (St Vincent’s Hospital, Sydney and University of New South Wales) and Prof. Shahneen Sandhu (Peter MacCallum Cancer Centre, Melbourne).

Prof. Louise Emmett: "This collaborative Frontiers grant gives us the tools to deeply evaluate optimal combinations with targeted alpha therapy in prostate cancer – aiming for longer better lives using great technology in a smart way."

Prof. Shahneen Sandhu: "Our MRFF grant will accelerate the development of innovative targeted alpha therapy combinations designed to enhance patient care and clinical outcomes."

Scientific investigators include Prof. Richard Payne (The University of Sydney), Prof. Matt Trau, Dr. Alain Wuethrich, Dr. Kevin Koo (The University of Queensland), Dr. Scott Lovell (University of Bath), A/Prof. Serigne Lo (Melanoma Institute Australia) and Dr. Thomas Kryza and Dr. Simon Puttick (AdvanCell).

Prof. Stephen Rose, Head of Translational Medicine and Clinical Science at AdvanCell, highlighted the importance of the MRFF funding. "The MRFF funding supports Australian innovation to drive the establishment of sovereign manufacturing capabilities to accelerate clinical translation of 212Pb-targeted alpha therapy."

On April 12, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that results from a Phase 3 registrational clinical study evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) for the treatment of adult patients with advanced triple-negative breast cancer (TNBC) and results from an early Phase I/II clinical study of sac-TMT for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) were published in the top international medical journal Nature Medicine (Impact Factor (IF)= 58.7) (Press release, Kelun, APR 12, 2025, View Source [SID1234651895]).

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Results

TNBC: Based on the results of the multicenter, randomized, controlled Phase III OptiTROP-Breast01 (NCT05347134) clinical study, the current publication reports on the efficacy and safety of sac-TMT versus investigator’s choice chemotherapy for the treatment of patients with locally advanced, recurrent or metastatic TNBC. The results of the study showed that sac-TMT demonstrated statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice chemotherapy. Based on this study, sac-TMT was approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). The data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

NSCLC: Based on the results of two early clinical studies of sac-TMT, the article reports on the efficacy and safety of sac-TMT in previously treated advanced NSCLC with or without epidermal growth factor receptor (EGFR) mutations. The article also explored in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumor activity of TROP2 ADCs.

Dr. Michael Ge, CEO of Kelun-Biotech said, "These successful publications in Nature Medicine mark the international academic community’s recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC. The Company’s novel product, sac-TMT, has been marketed in China for two indications. Meanwhile, the Company is also actively promoting the registrational clinical studies of sac-TMT in multiple indications, including breast cancer and lung cancer. Kelun-Biotech has always been committed to promoting innovation and leadership, and we look forward to continuing our research in the field of ADCs in partnership with MSD."

About sac-TMT (佳泰莱)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.