New Cancer Vaccine under Investigation by ReGen Factor

Table of Contents

1. What is the WT1 Anti-Cancer Peptide

2. Clinical Evidence Related to WT1

3. Approval Status by International Regulatory Bodies

4. WT1 Injection Process

1. What is the WT1 Anti-Cancer Peptide

Background 1: Alarming Cancer Incidence Rates in China

China has entered a high-incidence phase of cancer. In February 2022, the National Cancer Center released the latest national cancer statistics, showing:

• 4.064 million new cases

• 2.414 million deaths

• More than 7 people diagnosed with cancer every minute on average.

Background 2: Evolution of Cancer Treatment Methods

• Surgery

• Radiotherapy

• Chemotherapy

• Hormone Therapy

• Targeted Therapy

Tumor Immunotherapy: History and Prospects

1. Bacterial toxin treatment for tumors

2. First human tumor-associated TAA (tumor-associated antigen)

3. Provenge approved by FDA

4. New antigens against cancer: Peptides, mRNA

5. DC cells: Development of mRNA tumor immune prevention by 2030, potentially FDA approved.

 The Importance of Synthetic Peptides

• Nearly all cancer cells have genetic alterations (missense, deletions, frameshift, and gene fusion mutations), leading to tumor neo-epitopes.

• Preparing personalized tumor prevention candidate new antigens.

2. Clinical Evidence Related to WT1

• WT1 is highly expressed in more than twenty types of cancers including both hematological and solid tumors.

• WT1 peptide can be used for dendritic cell immunotherapy for nearly all cancers.

• Studies and clinical trials show that WT1 peptides are safe and tolerable for almost all patients with late-stage malignant tumors, achieving significant therapeutic effects.

Examples of Cancer Types Treated:

• Acute Myeloid Leukemia (AML)

• Acute Lymphoblastic Leukemia (ALL)

• Esophageal Cancer

• Chronic Myeloid Leukemia (CML)

• Gastric Cancer

• Pancreatic Cancer

• Gallbladder and Bile Duct Cancer

• Multiple Myeloma

• Colorectal Cancer

• Brain Tumors

• Renal Cancer

• Bladder Cancer

• Gynecological Tumors

• Malignant Melanoma

Clinical Outcomes:

• Complete remission observed in some acute myeloid leukemia patients after WT1 peptide vaccination.

• WT1-specific antibodies induced and maintained in patients.

3. Approval Status by International Regulatory Bodies

• WT1 vaccines (Galinpepimut-S, DSP-7888) are in various clinical stages in the US and Japan.

• FDA and EU have designated WT1 as an “orphan drug,” granting policy and financial support for its development.

4. WT1 Injection Process

At this time, our Chief Scientist and his team are conducting trials in Hong Kong and China.

Package Description:

• Three injections over six months, with appointments in Hong Kong.

Service Flow and Advantages:

• Comprehensive health assessment in Shenzhen or through provided reports.

• VIP service to Hong Kong with professional medical consultation and follow-ups.