July 28, 2026

Cyagen's ProF Humanized Mouse Platform Supports FDA IND Clearance for Chimigen's Cancer Immunotherapy

Cyagen's huHSC-NKG-ProF mouse model provided critical preclinical efficacy data for KMV002, a first-in-class immune priming therapy (IPT), accelerating its path to clinical trials.

Guangzhou, China, July 28, 2026 - Cyagen Biosciences announced that KMV002, a first-in-class cancer immunotherapy developed by Chimigen Biomedical, has received clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for metastatic castration-resistant prostate cancer (mCRPC).

As part of the program's IND-enabling preclinical development, Cyagen provided efficacy evaluation and translational profiling services using its proprietary huHSC-NKG-ProF humanized mouse platform, supporting comprehensive assessment of the therapeutic's immune activation and antitumor activity.

The milestone represents another successful example of Cyagen's integrated humanized model and pharmacology platform supporting innovative immunotherapy programs progressing from preclinical research toward global clinical development.

Supporting Next-Generation Cancer Immunotherapy Through Translational Humanized Models

KMV002 is Chimigen's lead immunotherapy candidate built on its proprietary SynNeogen® platform.

Unlike conventional immunotherapies that struggle against typically "cold" tumors like prostate cancer, KMV002 employs an Immune Priming Therapy (IPT) strategy. By precisely targeting dendritic cells (DCs) and inducing robust CD8⁺ T-cell responses, it aims to convert a treatment-resistant "cold" tumor into a treatable "hot" one.

To support KMV002's IND-enabling studies, Cyagen provided comprehensive in vivo efficacy evaluation and translational profiling services using its proprietary huHSC-NKG-ProF humanized mouse model. This model reconstructs a functional human immune system via CD34⁺ hematopoietic stem cell (HSC) engraftment. The platform enabled investigators to evaluate therapeutic activity, immune-cell activation, and tumor microenvironment remodeling within a single integrated preclinical model.

Expanding Applications: Evaluating In Vivo CAR Therapeutics

Beyond immune priming therapies like KMV002, the multilineage immune reconstitution of the huHSC-NKG-ProF model makes it an ideal platform for evaluating other emerging modalities, particularly in vivo CAR-T and CAR-NK therapies. The model allows developers to reliably assess critical parameters such as delivery vehicle selectivity, in vivo CAR cell expansion, tissue distribution, and safety-related immune responses.

Explore how this model supports next-generation cell therapies, read: In Vivo CAR-T Enters Clinical Validation: How It Works and What Comes Next.

Accelerating IND Success Through Integrated Pharmacology Services

Cyagen provides integrated IND-enabling pharmacology solutions covering study design, humanized model development, efficacy evaluation, biomarker analysis, flow cytometry, tissue pathology, and translational immune profiling.

By combining proprietary humanized mouse platforms with standardized pharmacology workflows and experienced scientific teams, Cyagen continues to help global biotechnology companies generate high-quality preclinical evidence supporting regulatory submissions and clinical development.

The successful progression of Chimigen's KMV002 program into U.S. clinical trials further demonstrates how translationally relevant humanized models can help reduce development risk and accelerate innovative immunotherapy programs toward patients.

About huHSC-NKG-ProF

Cyagen's huHSC-NKG-ProF mouse is an enhanced CD34⁺ HSC-humanized model optimized for translational immunology research.

The model supports robust human immune-cell reconstitution and is widely applicable to:

Cancer vaccines
In vivo CAR-T
CAR-NK
Bispecific antibodies
Immune checkpoint therapies
Cytokine therapeutics
Cell and gene therapies

Making it an ideal platform for IND-enabling pharmacology studies.

About Cyagen Biosciences

Founded in 2006, Cyagen Biosciences is an AI-enabled biotechnology company dedicated to accelerating biomedical innovation through proprietary gene-editing technologies, advanced disease models, computational platforms, and integrated preclinical research solutions.

Cyagen develops and applies cutting-edge technologies in gene editing, humanized models, AAV engineering, and AI-driven biological research to support global drug discovery and translational medicine programs. The company's research capabilities span multiple therapeutic areas, including ophthalmology, oncology, neuroscience, metabolic diseases, autoimmune disorders, and other fields.

With advanced research platforms and global collaboration networks, Cyagen is committed to empowering researchers and biopharmaceutical companies with innovative solutions that bridge scientific discovery and therapeutic development.