On September 22, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025 (Press release, Anixa Biosciences, SEP 22, 2025, View Source [SID1234656160]).

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The trial, conducted at Cleveland Clinic and funded by a grant from the U.S. Department of Defense, evaluated the safety and immunogenicity of an alpha-lactalbumin (aLA) vaccine for breast cancer. The presentation, titled "Final Results of a Phase I Trial of alpha-lactalbumin (aLA) Vaccine for Breast Cancer," will be delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the vaccine technology.

With the trial now complete and comprehensive analyses of blood and tissue samples underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to the U.S. Department of Defense, which funded the study, and separately to the U.S. Food and Drug Administration (FDA) to inform upcoming Phase 2 planning discussions.

Presentation Details:

Abstract Number: 765
Presentation Number: PS4-06-19
Presentation Title: Final Results of a Phase I Trial of an Alpha-lactalbumin (aLA) Vaccine for Breast Cancer
Poster Presentation: Thursday, December 11, 2025, 5:00–6:30 PM CST
"We are very encouraged by the data generated in this human clinical trial, which continues to exceed our expectations," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This vaccine builds on decades of pioneering preclinical work led by the late Vincent Tuohy, Ph.D. and his team at Cleveland Clinic. His visionary research, has brought us to this pivotal moment—one that has the potential to transform the future of breast cancer prevention and treatment."

On September 22, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) reported that the U.S. Food and Drug Administration (FDA) has approved its first-in-human Investigational New Drug (IND) application for LBL-047 on September 19, 2025 (Press release, Nanjing Leads Biolabs, SEP 22, 2025, View Source [SID1234656159]). LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain independently developed by Leads Biolabs. There are currently no approved clinical trials of drugs targeting both BDCA2 and TACI worldwide. With this unique mechanism of action, LBL-047 holds strong first-in-class potential.

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Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "Autoimmune diseases often require lifelong management and represent the third most common chronic illness after cardiovascular diseases and cancer, underscoring the urgent need for safe and effective long-term therapies. LBL-047, our first autoimmune therapeutic candidate to enter the clinic, represents a major milestone in translating foundational immunology research into clinical development. This achievement also marks the expansion of our pipeline beyond oncology into autoimmune diseases."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "In addition to our leading focus on oncology, we are committed to leveraging our immunology expertise to address chronic, underserved diseases such as autoimmune disorders. Our approach to antibody-based therapeutics is guided by a deep understanding of disease pathogenesis and powered by our advanced engineering platforms. LBL-047, along with our other autoimmune candidate LBL-051, reflects our strategy of developing bi- and tri-specific antibody modalities to rapidly deliver meaningful clinical benefit to patients worldwide.".

About LBL-047

B cells and plasmacytoid dendritic cells (pDCs) are both central drivers of autoimmune disease pathogenesis. BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand) are key cytokines that promote the differentiation, maturation, and function of B cells and plasma cells. An engineered TACI domain can be used to trap BAFF and APRIL, thereby inhibiting their signaling. pDCs can produce large amounts of type I interferons (IFN-I, including IFN-α/β), activate T and B cells, and participate in autoimmune pathogenesis. BDCA2, a receptor uniquely expressed on pDCs, effectively inhibits IFN-I release and downstream effects upon activation.‌‌

By targeting both BDCA2 and BAFF/APRIL, LBL-047 is designed to simultaneously inhibit pDC activity and B-cell maturation, providing a synergistic approach to treating autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren’s syndrome. LBL-047 is further optimized with glycosylation modifications to enhance antibody-dependent cellular cytotoxicity (ADCC) and Fc engineering for an extended half-life.

On September 22, 2025 SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, reported an expansion of its collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) from the World CB & CDx Summit in Boston (Press release, AstraZeneca, SEP 22, 2025, View Source [SID1234656158]). The companies aim to improve the diagnosis and treatment of breast and prostate cancer by developing an optimized next generation sequencing (NGS) solution that leverages SOPHiA GENETICS’s AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway.

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The PIK3CA/AKT1/PTEN pathway is a key molecular signaling network that regulates how cells grow and survive, and its disruption is linked to the development of many cancers, including breast and prostate cancer. The PTEN gene, when altered, can contribute to cancer development and resistance to treatment. As part of this collaboration, the companies have developed an optimized NGS solution that deploys AI agents to analyze and detect genomic mutations across the full PTEN gene. A prototype of the enhanced solution has already demonstrated improved sensitivity in its ability to detect complex mutations across the pathway.

As part of the agreement, SOPHiA GENETICS will roll out a Privileged Access Program to selected clinical laboratories specializing in breast and prostate cancer research to validate sensitivity in a real-world setting, with broader commercial availability expected in 2026, alongside a multi-center real-world evidence study to further test its effectiveness. SOPHiA GENETICS’s global network will also help drive adoption of advanced PIK3CA/AKT1/PTEN testing in both tissue and liquid biopsy to expand patient access to precision therapies.

"Each day brings new insights that transform our understanding of cancer. Partnering with innovative biopharma leaders like AstraZeneca allows us to translate these discoveries into action for breast and prostate cancer patients worldwide, representing another step forward in our mission to democratize data-driven medicine." said Ross Muken, President, SOPHiA GENETICS.

The expanded partnership highlights the shared commitment of SOPHiA GENETICS and AstraZeneca to drive innovation in precision oncology and to ensure that patients across the globe can benefit from advanced genomic testing and targeted treatments. To learn more, connect with SOPHiA GENETICS at the World CB & CDx Summit in Boston, MA from September 22-25, 2025.

On September 22, 2025 Servier, an independent international pharmaceutical group governed by a foundation, reported that the European Commission (EC) has approved VORANIGO (vorasidenib) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy (Press release, Servier, SEP 22, 2025, View Source [SID1234656157]). The decision to approve VORANIGO as the first targeted therapy to treat Grade 2 IDH-mutant glioma follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2025.

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Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age. Historically, treatment options have been limited, and tumors continue to grow and infiltrate normal brain tissue without treatment.1,2,3

"Today’s EU approval of VORANIGO is a landmark moment for people in the EU living with IDH-mutated glioma who have been waiting more than two decades for new treatment options. VORANIGO is the first EMA-approved therapy specifically designed to target mutant IDH enzymes in Grade 2 glioma and represents a long-awaited shift in the treatment paradigm. As a leader in precision medicine, we’re grateful to the researchers, patients and advocates who have helped expand our understanding of IDH inhibition and bring this breakthrough to the EU," said Islam Hassan, Global Head of Development-Neuro-Oncology & Senior Director, LS/LCM at Servier.

Decisions by the EC are applicable in the 27 member states of the EU, as well as Norway, Liechtenstein, and Iceland.

The approval of VORANIGO is supported by results from the pivotal Phase 3 INDIGO clinical trial published in The New England Journal of Medicine and presented during the Plenary Session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which showed that VORANIGO significantly extended progression-free survival (PFS) and time to next intervention (TTNI) when compared to placebo. The INDIGO study showed that VORANIGO was well tolerated, and its safety profile was consistent with results from the Phase 1 studies. The most common (≥15%) adverse reactions were fatigue, COVID-19, musculoskeletal pain, diarrhea and seizure.4

VORANIGO has also been granted marketing authorization in the United States, Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, Switzerland, Brazil, the United Kingdom, and Japan. Servier has submitted marketing authorization applications in several other regions as well and reviews by the respective health authorities are ongoing.

On September 22, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that a new drug application (NDA) for the Company’s small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic non-small cell lung cancer (NSCLC) (Press release, Kelun, SEP 22, 2025, View Source [SID1234656156]). This acceptance for review is based on the positive results from the two pivotal Phase 2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC.

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Cohort 1 and 2, the Phase 2 stage of the KL400-I/II-01 study, evaluate the efficacy and safety of A400/EP0031 90mg orally once daily (QD) for the treatment of patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic NSCLC, respectively. Primary efficacy endpoints of the two pivotal cohorts were reached, where A400/EP0031 demonstrated favorable efficacy in pretreated and treatment-naïve NSCLC including patients with prior immunotherapy or brain metastases. A400/EP0031 also demonstrated an encouraging, manageable tolerability and safety profile.

Dr. Michael Ge, CEO of Kelun-Biotech said, "We are pleased to report positive results from the clinical study of A400/EP0031 in treating RET-fusion positive NSCLC, which gives us confidence in its future clinical potential. As a tumor agnostic precision therapy, A400/EP0031 represents our significant strategic positioning in the solid tumor field. We look forward to working closely with regulatory authorities to expedite the review process for A400/EP0031, bringing this innovative therapy to patients with RET-fusion positive NSCLC as soon as possible."

About RET-fusion positive NSCLC

RET gene fusions represent one of the rare yet significant driver mutation types in NSCLC. In Chinese NSCLC patients, the incidence of RET gene fusions ranges from 1.4% to 2.5%[1]. Patients with RET fusions derive limited benefit from conventional treatments. In recent years, the emergence of novel highly selective inhibitors has led to breakthroughs in the clinical management of advanced RET-fusion positive NSCLC patients. However, their therapeutic benefits are limited, in part, by acquired RET drug-resistant mutations and safety issues such as hypertension and hematological toxicity, underscoring the need for novel selective RET inhibitors with improved safety and better efficacy against drug-resistant mutations.

About A400/EP0031

A400/EP0031 is a novel next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The Company is currently conducting a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. The results from the Phase 1 study of A400/EP0031 in patients with advanced RET-mutant MTC were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the United States, United Kingdom, Europe and United Arab Emirates.