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Pipeline

New Pipeline Updates from Genentech, Vaxart and Allergan

March 25, 2019

Company Drug/Device Medical Condition Status
Sutro Biopharma, Inc. STRO-002 ovarian and endometrial cancers Phase I trial initiated enrolling 160 female subjects with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer
Cytovation AS CyPep-1 HPV-induced warts Phase I trial initiated enrolling 58 subjects with cutaneous warts at the Centre for Human Drug Research in Leiden, the Netherlands
Innovent Biologics, Inc. IBI188 advanced malignant tumors Phase I trial initiated in China
I-Mab Biopharma TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) autoimmune and inflammatory diseases Phase I trial initiated enrolling 32 healthy subjects in the U.S.
Neurovive Pharmaceutical AB KL1333 mitochondrial disease Phase Ia/Ib trial initiated enrolling healthy subjects in the UK
Vaxart, Inc. norovirus GII.4 vaccine norovirus Phase Ib trial initiated enrolling 86 subjects
Infinity Pharmaceuticals, Inc. IPI-549 in combination with Tecentriq and Avastin (bevacizumab) front-line renal cell cancer (RCC) Phase II trial initiated
Infinity Pharmaceuticals, Inc. IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) front-line triple negative breast cancer (TNBC) Phase II trial initiated
Imugene Limited HER-Vaxx (IMU-131) HER-2 positive gastric cancer Phase II trial initiated enrolling 68 subjects with metastatic gastric cancer overexpressing the HER-2 protein at multiple sites across Asia, Eastern Europe and India
ImmunogenX Latiglutenase celiac disease Phase II trial initiated enrolling subjects at the Mayo Clinic in Rochester, MN
Xeris Pharmaceuticals, Inc. ready-to-use, room-temperature stable liquid glucagon Type 1 diabetes Phase II trial initiated enrolling 48 subjects with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia (EIH) who receive daily insulin treatment via a subcutaneous infusion pump
Via Surgical Ltd. FasTouch Absorbable Fixation System soft tissue repair 510(k) clearance granted by the FDA
Aptar Pharma Bidose nasal spray device depression Breakthrough Therapy designation granted by the FDA
Aimmune Therapeutics, Inc. AR101 peanut allergy BLA approval granted by the FDA
Allergan plc AVYCAZ (ceftazidime and avibactam) complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI) in pediatric patients three months and older sNDA approval granted by the FDA
Genentech Tecentriq (atezolizumab) in combination with carboplatin and etoposide (chemotherapy) extensive-stage small cell lung cancer (ES-SCLC) Approval granted by the FDA
Sage Therapeutics, Inc. Zulresso (brexanolone) injection postpartum depression (PPD) Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. and Sanofi Dupixent (dupilumab) adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable Approval granted by the FDA