On November 12, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported favorable preclinical results supporting the development of SOT106, its antibody-drug conjugate for the treatment of sarcoma, at the Connective Tissue Oncology Society (CTOS) Annual Meeting taking place November 12-15, 2025, in Boca Raton, FL.

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Data presented in SOTIO’s poster indicate that SOT106 is a potent and well-tolerated LRRC15-targeted ADC, showing strong potential for the treatment of sarcomas and other LRRC15-positive malignancies.

Specific results include:

SOT106 induces potent, antigen-specific cytotoxicity in vitro with nanomolar activity and a pronounced bystander effect.
In vivo, SOT106 drives dose-dependent tumor regression, including complete responses at 1 mg/kg, and surpasses benchmarks in both soft tissue sarcoma and osteosarcoma patient-derived xenograft (PDX) models, including those with low-to-medium LRRC15 expression and in orthotopic osteosarcoma.
In an exploratory non-human primate (NHP) study, SOT106 had a favorable pharmacokinetic profile and a high therapeutic index; dose-limiting toxicities aligned with known MMAE effects.
"Sarcomas continue to represent a significant unmet medical need, with limited therapeutic progress over the past several decades. LRRC15 is a clinically validated target broadly expressed across sarcoma subtypes, making it an ideal candidate for a differentiated ADC approach," said Amy Jensen-Smith, chief scientific officer of SOTIO. "These NHP data reinforce our confidence in SOT106’s therapeutic potential and mark a critical step toward delivering a novel treatment option for patients facing these aggressive diseases."

SOTIO is advancing SOT106 through IND-enabling studies toward an anticipated IND filing in Q4 2026. The company has additionally developed and validated a proprietary, highly sensitive, and specific LRRC15 immunohistochemistry assay to guide patient selection in upcoming clinical trials.

Poster presentation and Q&A details:

Poster Title: "Targeting leucine-rich repeat-containing protein 15 (LRRC15): SOT106 antibody-drug conjugate for soft tissue sarcoma and osteosarcoma treatment"
Presenter: Lenka Palova Jelinkova, Ph.D.
Date & Time: Thursday, Nov. 13, 2025, 5:30-6:30pm EST
Location: Grand Ballroom, The Boca Raton

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, NOV 12, 2025, View Source [SID1234659858])

On November 12, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that data from multiple pipeline programs, including long-term and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option, will be presented during the CTOS Annual Meeting 2025, taking place November 12-15 in Boca Raton, Florida.

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"We are excited about the breadth of data we’re presenting at CTOS this year, which underscore the strong progress we continue to sustain across our pipeline," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "We look forward to sharing encore data from our Phase 3 MOTION study of vimseltinib and providing updates on our DCC-3009 Phase 1 program, which demonstrate how we can expand our GIST treatment capabilities by targeting known primary and secondary drug-resistant mutations spanning multiple KIT exons."

Oral and Poster presentation details are as follows:

Title: Long-Term Efficacy and Safety of Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT): Results from the MOTION Phase 3 Trial
Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Dei Tumori
Session Title: Session 8: TGCT & Desmoid Tumor
Session Date: Friday, November 14, 2025
Session Time: 2:30 – 3:30 PM ET

Title: Impact of Expert-Led Education Programs on Health Care Provider (HCP) Knowledge of Gastrointestinal Stromal Tumor (GIST)
Presenter: Mark Agulnik, M.D., USC Norris Comprehensive Cancer Center, University of Southern California
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Efficacy with Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT) and Prior Colony-Stimulating Factor 1 (CSF1) Inhibitor Therapy: A Phase 2 Case Series
Presenter: Andrew J. Wagner, M.D., Ph.D., Harvard Medical School, Dana-Farber Cancer Institute
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Effect of a High-Fat Meal on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Effect of Itraconazole (ITX) and Rabeprazole (RBP) on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: An Open-Label Phase 1/2 Study of DCC-3009 Monotherapy in Patients (Pts) with Advanced Gastrointestinal Stromal Tumor (GIST)
Presenter: Suzanne George, M.D., Division of Sarcoma, Dana-Farber Cancer Institute – Sarcoma Center
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

On November 12, 2025 LabGenius Therapeutics ("LabGenius"), a drug discovery company combining artificial intelligence (AI) and high-throughput experimentation to advance next-generation multispecific antibodies for solid tumours, reported a scientific poster will be presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, being held December 10 – 12, 2025, at the Queen Elizabeth II Centre in London, United Kingdom. LabGenius’ presentation will debut the pre-clinical in vivo efficacy (>90% tumour growth inhibition) and tolerability data for their lead asset, a highly tumour selective bispecific T-cell engager (TCE).

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Poster Presentation Details

Title

Novel Selectivity-Enhanced Bispecific T-cell Engager Utilises Avidity to Overcome On-target, Off-tumour Toxicity

Date and time

Wednesday, December 10, 2025, 08:00 (GMT)

Poster number

309P

Location

The Churchill Room, Queen Elizabeth II Centre, London

Bispecific TCE Overview

For the selected target, LabGenius has developed a selectivity-enhanced TCE. The company’s lead optimisation platform, EVA, was used to discover and concomitantly optimise a TCE with improved killing selectivity, potency, efficacy, and manufacturability. The biological mechanism underlying this enhanced selectivity is based on the principle of avidity. By harnessing avidity-driven selectivity, the optimised TCE can distinguish between healthy and diseased cells based on differential tumour-associated antigen expression.

(Press release, LabGenius Therapeutics, NOV 12, 2025, View Source [SID1234659856])

On November 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,472,205 on November 18, 2025, covering key aspects of the Company’s breast cancer vaccine technology. The patent protects novel methods of inducing an immune response to α-lactalbumin protein—a protein typically found only in normal breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies. The co-inventors of the patent are the late Dr. Vincent Tuohy, and Dr. Justin Johnson of Cleveland Clinic.

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"Our breast cancer vaccine program is a cornerstone of our strategy to develop next-generation preventive immunotherapies," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This new patent meaningfully extends the duration of our intellectual property protection and reinforces our commitment to addressing a disease that affects hundreds of thousands of women each year. With a strong and growing global patent portfolio, we are well-positioned to advance a vaccine that could fundamentally change how we prevent breast cancer in healthy women."

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. This patent issuance builds upon the Company’s broad and expanding intellectual property portfolio, strengthening foundational patent protection for the breast cancer vaccine program into the mid-2040s.

Despite significant progress in breast cancer treatment, the disease remains the most commonly diagnosed cancer among women worldwide. In the United States alone, over 297,000 new cases of invasive breast cancer are projected in 2025, with approximately 43,000 women expected to die from the disease. No FDA-approved vaccine currently exists to prevent breast cancer, representing a major and unmet need in the field of preventive oncology.

Anixa’s investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin—while sparing normal tissue. By targeting this "retired" protein, which is generally absent from healthy tissue except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

(Press release, Anixa Biosciences, NOV 12, 2025, View Source [SID1234659855])

On November 12, 2025 Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Humane Genomics, a biotechnology company developing oncolytic viral therapies, reported a partnership for process transfer and cGMP manufacturing of HGI627, a novel therapy targeting pediatric liver cancer (hepatoblastoma).

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Humane Genomics uses its proprietary synthetic RNA virus platform to rapidly design and engineer RNA viruses with precise anti-cancer capabilities. Through a two-factor selectivity mechanism, these therapies infect and replicate only in targeted cancer cells, leaving healthy tissue unharmed. The company’s platform powers a growing pipeline of next-generation viral therapies across multiple cancer types, including their lead candidate, HGI627.

Under this collaboration, Genezen will perform technology transfer, process development, and cGMP manufacturing of the VSV-based HGI627 therapy.

"Genezen is excited to partner with Humane Genomics on this novel cancer treatment and provide our best-in-class manufacturing expertise to bring this critical therapy to life for pediatric patients," said Steve Favaloro, chairman and chief executive officer of Genezen. "This partnership reinforces our commitment to supporting innovators at every stage of development and highlights the deep technical expertise and commitment to patients of the Genezen team."

Peter Weijmarshausen, co-founder and chief executive officer of Humane Genomics, added, "We are thrilled to partner with Genezen. Their experienced, dynamic team and state-of-the-art facilities make them a perfect match to turn our groundbreaking science into real therapies for patients."

(Press release, Genezen, NOV 12, 2025, View Source [SID1234659854])