PIPELINE

Pharmaceutical Solutions Based on
Long-acting Technology

Pipeline

이뮤노포지㈜는 반감기 연장 플랫폼 기술 기반의 파이프라인을 보유한 신약개발 회사입니다.

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주요 파이프라인 현황

Identification Indication Target Discovery Non-clinical Phase I Phase II 비고
ELP
Platform		 PF1801 Polymyositis (PM)/
Dermatomyositis (DM)

GLP-1*(Weekly)

* Sarcopenia
related Patent
FDA ODD
Duchenne Muscular
Dystrophy (DMD)
FDA ODD
Inclusion Body
Myositis (IBM)
Senile Sarcopenia
PF1804 Cardiomyopathy(DMD),
Heart Failure, Cystic Fibrosis		 VIP
FDA ODD
PF1805 Achondroplasia CNP
PF1806 Short Bowel Syndrome (SBS) GLP-2 (Weekly)
PF1807 Sarcopenia GLP-1 (Monthly)
PF1808
PF1802 Amyotrophic Lateral
Sclerosis (ALS),
Parkinson’s Disease		 Undisclosed
PF1803 Osteoarthritis (OA) OSCAR+
KF1601 Drug Resistant Chronic
Myeloid Leukemia (CML)		 BCR-ABL1 T315I
FDA ODD
PF1801
  • Biological – A novellong acting GLP-1(glucagon-like peptide-1)receptor agonist
  • Elastin-Like Polypeptide (ELP) half-life extension technology platform enables once weekly injection
  • Safety profile based on clinical data from phase 2b study in type 2 diabetes (20 weeks)
  • Drugre-positioningglobaldevelopmentstrategy :
    Targeting various indications that involve muscle atrophies including DMD, BMD and Polymyositis
  • Stage :
    IND submission for phase IIa in DMD
  • FDA ODD for DMD (Dec. 2020)
    FDA ODD for PM (Aug. 2021)

DMD (Duchenne Muscular Dystrophy)
BMD (Becker Muscular Dystrophy)

  • DMD and BMD are genetic disorders characterized by the progressive loss of muscle
Symptoms
  • Difficulty rising from a lying or sitting position
  • Large calf muscle, walking on toes
  • BMD is a milder version of DMD
Causes
  • The mutated DMD gene fails to produce virtually any functional dystrophin
  • BMD genetic mutations make partially functional dystrophin
Standard Therapy
  • High dose glucocorticoids

Polymyositis (다발성근염) / Dermatomyositis (피부근염)

  • A rare, idiopathic, inflammatory myopathy
Symptoms
  • Symmetric proximal muscle weakness
  • In severe cases, causes dysphagia or dysphonia
  • Serious threat to the quality of daily life
Causes
  • Auto-immune responses in skeletal muscle
  • Lymphocyte infiltration in the muscle
Standard Therapy
  • High dose glucocorticoids
  • Glucocorticoid-induced toxicity

IBM (Inclusion body myositis, 봉입체 근염)

  • A complex disease with degenerative pathological mechanisms as well as autoimmune mediated by
    T lymphocytes
Symptoms
  • Progressive muscle weakness in distal finger flexor muscles and the quadriceps
  • Unlike other myositis, asymmetric and distal muscle weakness are likely to appear with slow disease progression
Causes
  • Inflammatory cells invade the muscle tissue and concentrate between the muscle fibers presenting multiple inclusion bodies that contain cellular material of dead tissue
Standard Therapy
  • Immunosuppressant drugs
  • Corticosteroid doesn’t work for IBM

Senile Sarcopenia (노인성 근감소증)

  • Senile sarcopenia is the loss of muscle mass due to the natural aging process
Symptoms
  • Loss of lean muscle mass and decreased muscle size
  • Reduced strength, functional decline and increased risk of falling
Causes
  • Senile sarcopenia is likely the result of multiple interacting factors such as changes in hormones, age-related muscle changes, nutrition, and lifestyle
Standard Therapy
  • Currently there are no medication to treat senile sarcopenia
PF1802
BBB penetration and bio-availability enhanced first-in-classALS therapeutic candidate
BBB penetration and bio-availability enhanced first-in-classALS therapeutic candidate
BBB penetration and bio-availability enhanced first-in-classALS therapeutic candidate
  • Indication
    : ALS (Amyotrophic lateral sclerosis)
    (also known as Lou Gehrig's disease, Or motor neurone disease)
  • ALS is a devastating neurodegenerative disease that results in progressive loss of motoneurons, motor weakness and deathwithin 3-5 years after disease onset.
  • Class : Biologics, Dual ligand Fc fusion protein
  • Global market size expectation : USD 800 million in 2026
  • Stage :
    Non-clinical study
PF1803
  • First-in-class new biologic drug: dual function fusion protein
  • Indication: Osteoarthritis
  • Most common degenerative joint disease with extreme pain from joint cartilage destruction or regression
  • Novel Disease-modifying osteoarthritis drug (DMOAD)
  • Stage :
    Stable cell line development
PF1804
  • PF1804 is engineered with an ELP biopolymer to provide once-weekly dosing. However, our ELP biopolymers can also be designed to provide faster or slower uptake from the injection site, enabling the development of convenient and patient-friendly dosing regimens.
  • Stage :
    Planning Phase 2 Clinical trials for DMD Cardiomyopathy
    In-vivo animal testing data secured
  • FDA ODD (May. 2014)
PF1805
  • CNP-ELP once weekly product candidate for achondroplasia.
    A weekly CNP could significantly improve patient adherence compared to a daily injection, leading to improved outcomes.
    Pre-clinical data with CNP-ELP demonstrated a robust effect on linear growth in mice.
  • Indication : Achondroplasia
  • C-type natriuretic peptide (CNP) is a regulator of bone growth and can rescue defects in fibroblast growth factor 3 that cause achondroplasia resulting in dwarfism.
    Native CNP has a half-life of less than three minutes, limiting its use as a direct therapeutic.
    We are developing our CNP-ELP product candidate to deliver therapeutic levels of CNP with once weekly subcutaneous injections.
    In a mouse model, we observed a statistically significant effect on linear growth when our CNP-ELP product candidate was injected once every four days.
PF1806
  • Once-weekly ELP product candidate for short bowel syndrome. A weekly GLP-2 (teduglutide genetically fused to ELP) could significantly improve patient
    acceptability and adherence for patients with short bowel syndrome.
    Preclinical data with GLP-2-ELP demonstrated a significantly greater effect on the small intestine in normal rats than with teduglutide.
  • Indication : Short Bowel Syndrome
  • Glucagon-like peptide-2 (GLP-2) stimulates growth of intestinal villi, increasing their ability to absorb nutrients.
    GLP-2 is a potential treatment for patients with short bowel syndrome, Crohn’s disease or mucositis in patients undergoing cancer treatment.
    Teduglutide, currently marketed under the brand name Gattex, is an FDA-approved therapy based on GLP-2 that requires daily injections.
    In animal models, our GLP-2-ELP product candidate provided sustained levels of GLP-2, resulting in greater efficacy than teduglutide with less frequent dosing.
PF1807
  • Once monthly product candidate for Sarcopenia.
KF1601
New Chemical Entity
  • KF1601 is a rationally designed BCR-ALB inhibitor with activity against the
    common resistance mutation T315I
  • Developmental Strategy
  • Ponatinib is the first licensed BCR-ABL inhibitor with activity against T315I, but has significant side effects, including cardiac and vascular events
  • KF1601 has been developing to overcome the side effects of ponatinib
  • Stage :
    Non-clinical study
  • FDA ODD(Jan. 2023)