On September 22, 2025 OGT, a leading global provider of genomic diagnostic and research solutions, reported that the U.S. Food and Drug Administration (FDA) has granted their De Novo Classification Request for the CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ (revumenib) (Press release, Sysmex, SEP 22, 2025, View Source [SID1234656163]). Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.

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OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukaemia, providing a robust, accessible, rapid turnaround test for KMT2Ar detection that will maximize the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj. It is estimated that more than 95% of patients with KMT2Ar acute leukaemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.

"We are delighted that our CytoCell KMT2A Breakapart FISH Probe Kit PDx has received marketing authorization as a CDx for Revuforj." said Dr. Leila Luheshi, VP of Pharma Partnering at OGT. "The development and subsequent authorization of this new CDx is an important demonstration of the skill and commitment of our clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukaemia."

Steve Chatters, OGT’s EVP of Regulatory and Medical Affairs noted "Our strong foundation in haematology diagnostics has been a key factor in our success bringing the KMT2Ar CDx to market as a Class II device, as opposed to the more common Class III classification for companion diagnostics. We have decades of experience developing regulated FISH products, gained from our prior development of IVDR-certified and FDA-cleared FISH probes. Combined with our extensive customer partnerships in haematology labs in the USA, we have refined insights into the application of these products and are able to access a wealth of real-world data across a multitude of clinical and analytical factors, which is invaluable for product development. This is a core pillar of our success."

The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues for potentially improving outcomes for patients with these challenging acute leukaemia cases.

"Accurately identifying acute leukaemia patients with KMT2Ar is a key factor in selecting appropriate therapeutic options for a group of patients who have traditionally had a very poor prognosis" said Adrian Smith, CEO of OGT. "We are optimistic that the authorization of OGT’s CDx will help this underserved patient group benefit from developments in precision oncology."

On September 22, 2025 Tubulis reported that its late-breaking abstract covering first clinical data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for oral presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held October 17-21, 2025, in Berlin (Press release, Tubulis, SEP 22, 2025, View Source [SID1234656162]). The presentation by the principal investigator of the study, Dr. Antonio Gonzalez-Martin, will provide interim data from the dose escalation part of the ovarian cancer cohort in the first-in-human study with TUB-040. Tubulis’ lead antibody-drug conjugate (ADC), TUB-040 is a next-generation NaPi2b-targeting ADC developed using Tubulis’ proprietary Tubutecan linker-payload platform. It combines the company’s P5 conjugation system with an exatecan payload enabling the development of stable, highly targeted ADCs, optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. In a range of preclinical models, including ovarian cancer, TUB-040 demonstrated superior biophysical properties as well as effective and durable responses.

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Details of the oral presentation:

Title: NAPISTAR 1-01: A Phase 1 dose escalation study of TUB-040, a novel NaPi2b-targeting exatecan antibody-drug conjugate (ADC) in patients with platinum-resistant ovarian (PROC) high-grade serous carcinoma (HGSC)
Presenter: Dr. Antonio Gonzalez-Martin, Director Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra
Session Category and Title: Mini Oral session: Gynaecological cancers
Session Date and Time: October 19, 2025; 10:15 – 11:45 am CEST
Lecture Time: 10:38 – 10:43 am CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: #5520

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

On September 22, 2025 Akeso Inc. (9926.HK) reported that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab (PD-1/VEGF bispecific antibody), for treating locally advanced or metastatic pancreatic cancer in patients who have failed up to two prior lines of systemic therapy (Press release, Akeso Biopharma, SEP 22, 2025, View Source;bifunctional-antibody-fusion-protein-ak130-combined-with-ivonescimab-for-advanced-pancreatic-cancer-302562663.html [SID1234656161]).

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AK130 is the world’s first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development. The initiation of the AK130-202 study marks a significant milestone in Akeso’s strategy approach of "IO2.0 + IO2.0" combinations. This clinical development strengthens Akeso’s leadership position in the emerging global IO 2.0 cancer therapy landscape.

To date, Akeso has nine self-developed bispecific antibodies or bispecific antibody-drug conjugates (ADCs) in clinical development or received regulatory approval. Leveraging its proprietary bispecific antibody technology platform, Akeso has multiple advanced combination therapy research programs that include commercially approved therapies such as ivonescimab and cadonilimab (PD-1/CTLA-4 bispecific antibody), as well as potentially first -in-class candidates such as AK130 and AK146D1 (Trop2/Nectin4 bispecific ADC).

Preclinical studies indicate that dual blockade of the PD-1/VEGF and TIGIT/TGF-β pathways has synergistic therapeutic potential. This combination could remodel the tumor immune microenvironment and enhance anti-tumor immune responses. Prior clinical data from ivonescimab monotherapy in first-line pancreatic cancer has shown strong efficacy potential. The combination of AK130 and ivonescimab is expected to further improve the therapeutic benefit in this challenging malignancy.

About AK130 (Bifunctional Antibody Fusion Protein)

AK130 is Akeso’s entirely in-house developed bifunctional antibody fusion protein. It combines an anti-TIGIT monoclonal antibody with the extracellular domain of the human TGF-β receptor II. TIGIT is an emerging immune checkpoint, and blocking TIGIT-CD155 interactions can relieve suppression of tumor-infiltrating CD8+ T cells and NK cells, thereby enhancing their anti-tumor activity. TGF-β signaling contributes to immunosuppression, immune evasion, and resistance to checkpoint inhibitors. By blocking both TIGIT and TGF-β, AK130 can activate T-cell responses while reducing the immunosuppressive activity of Tregs, leading to enhanced anti-tumor effects.

As the first and only TIGIT/TGF-β bifunctional antibody fusion protein in registrational clinical development globally, AK130 has now been administered to the first patient in its combination therapy study with ivonescimab for advanced pancreatic cancer. Additional clinical trials are ongoing to evaluate AK130 as a monotherapy for advanced solid tumors and in combination with ivonescimab for advanced hepatocellular carcinoma.

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.