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
Froniglutide Dermatomyositis (DM)/
Polymyositis (PM)

GLP-1R* (Weekly)

* Sarcopenia
related Patent

FDA ,
식약처 ODD
Duchenne Muscular
Dystrophy (DMD)
FDA ODD
Inclusion Body
Myositis (IBM)
Senile Sarcopenia
Pemziviptadil Cardiomyopathy(DMD),
Heart Failure, Cystic Fibrosis
VPAC2
FDA ODD
PF1805 Achondroplasia NPR-B (Weekly)
PF1806 Short Bowel Syndrome (SBS) GLP-2R (Weekly)
PF1807 Sarcopenia GLP-1R (Monthly)
PF1809 L/O
PF1802 Amyotrophic Lateral
Sclerosis (ALS),
Parkinson’s Disease
Bifunctional
PF1803 Osteoarthritis (OA) Bifunctional
OSCAR +
KF1601 Drug Resistant Chronic
Myeloid Leukemia (CML)
BCR-ABL1 (T315I)
FDA ODD
Froniglutide
  • 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 :
    Phase 2 Clinical trials for DM/PM in progress
    IND approval for phase 2a in DMD
  • FDA ODD for DMD (Dec. 2020)
    FDA ODD for PM (Aug. 2021)
    MFDS ODD for DM/PM (Sep. 2023)

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 :
    Non-clinical study
Pemziviptadil
  • Pemziviptadil 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 :
    DMD Cardiomyopathy Phase 2 IND-ready
    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 :
    Preclinical / IND-ready
  • FDA ODD(Jan. 2023)