Pipeline

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