H. CIN1 medicine & M. cervical cancer treatment vaccine

Treatment or early examination
of cervical diseases
‘First in Class’
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    Efficacy Test

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    Toxicity Test

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    Clinical Test

Platform technology HumaMAX® MucoMAX®
Target
disease
CIN1(BLS-H01) CIN2/3
(BLS-M07)
Stage of
disease progress
Normal/HPV
infected
HSIL 2)
LSIL 2)
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Treatment mechanism HumaMAX®
Cells infected by the HPV Virus
→ Prevents virus proliferation byusing BLS-H01 which has an antivirus effect
MucoMAX®
Virus-infected cervical epithelial cells create abnormal cells as time passes,even leading to deformation of the intraepithelial tissues
→ Disease treatment via inducing immunoreactions
  • LSIL : Low-grade squamous intraepithelial lesions
  • HSIL: High-grade squamous intraepithelial lesions

Clinical Test


BLS-M07

Outcome

  • Since August 2017, Clinical Phase 2b has been in progress with 16 testing agencies
  • Goal of clinical tests : To prove the effectiveness of the medicine developed by BL, compared to the above drug
  • Currently in a stage to check whether or not there is 75% treatment effectiveness, shown from Phase 1 and 2a, is meaningful from a statistical point of view

Market scale

  • The global market estimated to be worth KRW 3.5 trillion, ‘First-in-class’ globally innovative new medicine
  • Currently, no treatment options other than "conization" exist for stage 3 cervical cancer and, if a woman becomes pregnant after a conization procedure, the likelihood of side effects such as premature birth and miscarriage as well as recurrences of cancer are high, which makes the development of an effective medicine a pressing issue

Competitiveness

  • The best “First-in-its-Class” medicine among a group of similar drugs
  • mmunotherapy-based oral intestinal coating capsule : Convenience in administration and reduced psychological burden on the patients in the face of a treatment
  • Mechanism to induce mucosal CTL immunity, which is the most ideal means by which to treat cervical mucosal disease : "Inducing antigen-specific immunity" by absorbing antigens into a body through intestinal mucosa with lactic acid bacteria as the transporter

Strategy

  • Achieve meaningful effects during Clinical Phase 2b and then proceed with global clinical trials
  • About 250,000 people around the world die from cervical cancer every year
  • IN1 medicine [BLS-H01] and cervical cancer treatment vaccines [BLS-M07] are a Total Solution for HPV infections