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Oregovomab:A Novel Mechanism of Action

Neo Antigen – a novel tumor antigen specific immunotherapy

CA125 is a key biomarker of ovarian cancer

Antigen Specific Immunity/Immunization
Antigen Specific Immunotherapeutic Antibody

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  • Target Therapeutic
  • ●  The antibody directly binds to the surface antigen, thus generating antitumor activities that can eliminate tumor cells and deliver antiproliferative effects
  • ●  Antibodies Requiring High Doses

    Herceptin (6-8 mg/kg) : >500mg/dose

    Opdivo (PD-1) : >500mg/dose

    Avastin (10 mg/kg) : 750 mg/dose

  • Target Immunogenic
  • ●  The antibody oregovomab and the target (tumor antigen) bind into neoantigen
  • ●  The neoantigen gets absorbed by dendritic cells, leading to the CA125-specific immune

    response from cytotoxic CD8+ T-cells

  • ●  Antibodies Requiring Low Doses

    Oregovomab : 2 mg/dose

    AR20.5 (MUC1) : 2 mg/dose

Oregovomab Can Potentially Fulfill an Urgent Clinical Need

VS
Limitations in current treatment
  • Carboplatin + paclitaxel, the standard first-line treatment for primary ovarian cancer has not changed in the past 16 years
  • Neoadjuvant chemotherapy was proven to be able to lower the mortality of surgically treated patients, but failed to demonstrate survival (OS) benefit
  • Bevacizumab + carboplatin/paclitaxel demonstrated a 3.5month improvement to PFS, but showed no significant survival (OS) benefit with increased toxicity
  • Immune checkpoint inhibitors (PD-1 inhibitor) have limited efficacy and clinical benefit to patients with ovarian cancer
  • PARP inhibitors are only efficacious in certain subgroup (BRAC 1/2, HRD) and are mainly used as late-line maintenance therapy
The Advantages of Oregovomab
  • In Phase II study, PFS was prolonged to 41.8 months (p=0.0027) from 12.2 months with just chemotherapy, thus showed potential as a much needed novel first-line treatment

  • Granted an Orphan Drug Designation by the U.S. FDA

Current Clinical Progress with oregovomab and its addressable ovarian cancer market in China

Global multicenter Phase III study of oregovomab
  • Initiated in

    August 2020

  • Enrollment Target

    602 patients worldwide

  • Current progress

    Global progress: Dosed the first patient at a trial center in the U.S. in Q4 2020. To date, the trial has been initiated at 130 centers across the globe and enrolled over 330 patients.

The 8th most common cause of death to women1

55,000+ new cases every year2
46% of patients in China reach a 5-year survival3

The status quo of ovarian cancer in China

1. World Cancer Research Fund International. Ovarian Cancer Statistics. September 2022.

2. WHO Globocan

3. Chinese Anti-Cancer Association Gynecological Oncology Committee. Guidelines for the Diagnosis and Treatment of Ovarian Malignant Tumors (2021 edition) [J]. Chinese Journal of Cancer, 2021, Vol. 31, No. 6.