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We have developed a family of monoclonal antibodies that have the same specificity based on a binding, complementarity determining region (“CDR”) sequence homology. Our lead product is a humanized monoclonal antibody (our “mAb” or “SIWA 318H”). It targets a SIWA-identified, naturally-occurring cell surface marker (our “SIWA Marker”) on both cancer cells and senescent cells (“SCs”), which cells are thereby destroyed and removed through normal processes. Our family of antibodies includes SIWA 318M, a murine homolog that we used in our early in vitro and in vivo studies.

SIWA has conducted several in vivo preclinical studies. which have shown that using SIWA 318 over a short period of time has been able to statistically significantly:

  • Reduce senescent cells as measured by p16INK4a
  • Increase muscle mass in a naturally aged mouse model
  • Inhibit metastatic lung foci in a 4T1 breast cancer model

Across these studies, no adverse effects from SIWA 318 were recorded.

 

318H In Vitro Binding Results

318H Binding to PANC-1 cells - Immunoflourescence

SIWA 318H Ab – labeled with GFP
SIWA 318H Ab – GFP + DAPI – Red square section magnified

318H Binding to Orthotopic PSN1 in Mouse – Immunohistochemistry

After staining, cancer cells are stained with peroxidase (brown) indicating binding to 318H and the 20X image corresponds to the red box in the 10X image.

318H binding to Patient Derived Pancreatic Cancer cells – immunohistochemistry

Patient derived pancreatic cancer (PDX 712) (stained with peroxidase (brown) indicates 318H binding )

318H binding to MCF-7 cells (Breast cancer) - Immunofluorescence

SIWA 318H – labeled with GFP 10x magnification
SIWA 318H – GFP + DAPI 10x magnification Red square section magnified 20x magnification

318H ─ Binding to HTB-14 Glioblastoma cells and nuclei from an ATCC glioma cell line panel

Glioblastoma Cells
318H was applied to HTB-14 Glioblastoma cells, followed by a secondary antibody labelled with Texas Red. Cell nuclei were counterstained with DAPI. 318H bound to all types of brain cancer cells in an ATCC glioma cell line panel which included astrocytoma cells, fibroblasts and metastatic glioblastoma cells.

318H In Vitro Binding Results

Design of the Proof-of-concept (POC)/ efficacy study for 318H in humanized mice for treatment of subcutaneous pancreatic cancer

Treatment administered ip every 3 days for 6 treatments

318H treatment reduced pancreatic tumor growth in humanized mice model

318H treatment reduced pancreatic tumor growth in humanized mice model

Increased Survival in humanized mice treated with 318H mAb

Increased Survival in humanized mice treated with 318H mAb

Complete remission* response in humanized mice treated with 318H

CompleteRemissionGraphA
Isotype Control SIWA 318H HD
Disease 15 10
Complete Remission 1 6
CompleteRemissionGraphB
 Isotype ControlSIWA 318H LD
Disease159
Complete Remission17

*Complete remission is defined as the disappearance of all signs of tumor presence in response to treatment

Efficacy In A Triple Negative Breast Cancer Metastasis Model

Design of the murine model for the treatment of metastasis in breast with 318M (mouse homolog)

Treatment administered iv twice daily for 3 weeks

318M (318H Mouse Homolog) Reduced metastasis in breast cancer model

Metastatic Foci
Treatment tolerability was assessed by body weight measurements and frequent observation for signs of treatment-related side effects. All treatment regimens were acceptably tolerated, with slight group mean body weight losses and no treatment related deaths.

Some Other Images of 318H Binding Results

Human Alzheimer Vascular Microglia
Human Alzheimer’s Vascular Microglia
PANC-1 Pancreatic Cancer cells
PANC-1 Pancreatic Cancer cells
Human Osteoarthritic Chondrocytes
Human Osteoarthritic Chondrocytes
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