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Pipeline

New Pipeline Updates from Oncternal, Adrenomed and AbbVie

October 7, 2019

Company Drug/Device Medical Condition Status
Themis Bioscience and ZIKAVAX Second-generation Zika vaccine Zika virus Phase 1 study initiated enrolling 48 healthy subjects
Noveome Biotherapeutics, Inc. ST266 intraocular hypertension Phase 1 trial initiated enrolling subjects at the University of Pennsylvania who have been diagnosed with intraocular hypertension who have not yet developed optic nerve damage
Clover Biopharmaceuticals SCB-313 malignant ascites Phase 1 trial initiated enrolling subjects in China
Oncternal Cirmtuzumab in combination with Ibrutinib Mantel cell lymphoma (MCL) Phase 1b expansion cohort trial initiated to confirm the RDR
AVEO Oncology AstraZeneca Tivozanib (FOTIVDA) and Durvalumab (IMFINZI) hepatocellular carcinoma (HCC) Phase 1b/2 trial initiated enrolling 50 subjects with hepatocellular carcinoma (HCC) who have not received prior systemic therapy
Checkmate Pharmaceuticals Inc. CMP-001 in combination with BAVENCIO (avelumab), utomilumab (4-1BB agonist) and PF-04518600 (OX40 agonist) Squamous Cell Carcinoma of the Head and Neck (SCCHN) Phase 1b/2 trial initiated enrolling 60 subjects with Squamous Cell Cancer of the Head and Neck (SCCHN)
Adrenomed Adrecizumab septic shock Phase 2 trial initiated enrolling 300 subjects with early septic shock and elevated blood levels of Adrenomedullin
Oncopeptides AB melflufen with dexamethasone relapsed/refractory multiple myeloma (RRMM) Phase 2 trial initiated enrolling 150 subjects
North Sea Therapeutics Icosabutate NASH (Non-alcoholic Steatohepatitis) Phase 2b trial initiated enrolling 264 subjects
Immutep eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA(R) (or pembrolizumab, an anti-PD-1 therapy) Non-small cell lung cancer (NSCLC) Phase 2 expansion cohort trial initiated enrolling 19 subjects with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line in 13 study centers across the U.S., Europe and Australia
Cortexyme COR388 Alzheimer’s Disease Phase 2/3 trial initiated enrolling 570 subjects in U.S. and Europe
Incyte ruxolitinib cream vitiligo Phase 3 trial initiated enrolling 300 adolescent and adult subjects ages 12 and older who have been diagnosed with non-segmental vitiligo
Galmed Pharmaceuticals Ltd. SCD1 modulator Aramchol nonalcoholic steatohepatitis (“NASH”) and fibrosis Phase 3/4 trial initiated enrolling 2,000 subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes at 185 sites in the U.S., Europe, Latin America and Asia.
Luminex Corporation ARIES MRSA Assay methicillin-resistant Staphylococcus aureus (MRSA) 510 (k) clearance granted by the FDA
Exogenesis Corporation Exogenesis Hernia Mesh soft tissue repair, abdominal wall hernias and abdominal wall deficiencies 510 (k) clearance granted by the FDA
(LAS) Laser Associated Sciences FlowMet-R peripheral artery disease (PAD) 510 (k) clearance granted by the FDA
Janssen Pharmaceuticals INVOKANA (canagliflozin) Heart failure in patients with type 2 diabetes (T2D) and DKD Approval granted by the FDA
Janssen Pharmaceuticals Darzalex multiple myeloma Approval granted by the FDA
AbbVie MAVYRET (glecaprevir/pibrentasvir) naïve chronic hepatitis C (HCV) with
cirrhosis or with compensated cirrhosis
Approval granted by the FDA
Genentech Rituxan (rituximab) injection granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones) Approval granted by the FDA