New Pipeline Updates from Forbius, Inovio and Janssen

March 11, 2019

Company Drug/Device Medical Condition Status
AOBiome Therapeutics, Inc. B244 pediatric patients with atopic dermatitis (eczema) Phase Ib trial initiated enrolling 36 subjects aged 2 to 17 years
Forbius AVID200 diffuse cutaneous systemic sclerosis (SSc) Phase Ib trial initiated
I-Mab Biopharma TJ107 (HyLeukin) advanced solid tumors Phase Ib/IIa trial initiated enrolling 58 subjects in China
Odonate Therapeutics, Inc. tesetaxel locally advanced or metastatic breast cancer (LA/MBC) Phase II trial initiated enrolling 125 subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease who have not previously received a taxane
Eidos Therapeutics, Inc. AG10 transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) Phase III trial initiated enrolling 510 subjects with symptomatic ATTR-CM, associated with either wild-type or mutant TTR, with New York Heart Association Class I-III symptoms
Inovio VGX-3100 cervical dysplasia caused by human papillomavirus (HPV) Phase III trial initiated enrolling adult female subjects with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3
Acceleron Pharma, Inc. ACE-083 Charcot-Marie-Tooth disease (CMT) Orphan Drug designation granted by the FDA
Mitochon Pharmaceuticals MP-101 Huntington’s Disease Orphan Drug designation granted by the FDA
Celgene Corporation fedratinib myelofibrosis Priority Review granted by the FDA
NKMax America SNK01 refractory cancer IND approval granted by the FDA
Breckenridge Pharmaceutical, Inc. Imatinib Mesylate Tablets cancer ANDA approval granted by the FDA
Janssen Spravato major depressive disorder Approval granted by the FDA
Baxter International, Inc. eptifibatide acute coronary syndrome (ACS) Approval granted by the FDA
Adlon Therapeutics, L.P.m Adhansia XR (methylpheni-date hydrochloride) extended-release capsules CII Attention-Deficit/Hyperactivity Disorder (ADHD) Approval granted by the FDA