New Pipeline Updates from Seattle Genetics, Novartis, Vybion and Notal Vision

December 10, 2018

Company Drug/Device Medical Condition Status
Innovent Biologics, Inc. IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate Advanced solid tumors FDA approved Investigational New Drug (IND) application and plans to initiate Phase I clinical trial based on results from China Phase I trial
Sunny Pharmtech, Inc. and Vitruvius Therapeutics, Inc. Aminocaproic Acid Tablets 500 mg and 1000 mg tablets Fibrinolysis FDA approved Abbreviated New Drug Application (ANDA)
Vybion, Inc. INT41 Huntington’s disease FDA granted Orphan Drug designation
Ocular Therapeutix™, Inc. RP-L201 DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg Occular pain following eye surgery
Notal Vision, Ltd. Notal Vision Home-based Optical Coherence Tomography (OCT) System Home testing between doctor ntra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD) FDA granted Breakthrough Device designation
Mirati Therapeutics, Inc. MRTX849 Cancers driven by KRAS G12C mutations FDA has cleared the company’s Investigational New Drug (IND) application to initiate Phase I/II Trial
AbbVie Rovalpituzumab Tesirine (Rova-T) Second-line therapy for advanced small-cell lung cancer Halted Phase III trial due to shorter overall survival in the Rova-T arm
Genentech, Inc. Kadcyla® (ado-trastuzumab emtansine) HER2-positive early Breast cancer (EBC) Phase III KATHERINE trial met its primary end-point, significantly reducing risk of recurrence or death compared to Herceptin® (trastuzumab) as an adjuvant treatment
Global Blood Therapeutics Voxelotor Sickle cell disease in patients 12 and older Interim analysis of its Phase III HOPE study showed patients experienced “rapid, robust and sustained improvements in hemoglobin levels and measures of hemolysis with a favorable safety and tolerability profile”
Seattle Genetics Adcetris Previously untreated systemic anaplastic large cell lymphoma Granted approved by FDA
Novartis ligelizumab (QGE031) Chronic spontaneous urticartia (CSU) whose symptoms are inadequately controlled by H1-antihistamines Taking it into Phase III trials after a mid-stage trial showed out-performed Xolair
Janssen Pharmaceutical IMBRUVICA® (ibrutinib) plus rituximab Chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL) Phase III trial results: significantly prolonged PFS compared to FCR in previously untreated patients aged 70 years or younger with CLL/SLL
Exelixis, Inc. and IPSEN Cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) previously untreated advanced HCC Previously untreated advanced hepatocellular carcinoma (HCC) initiation of COSMIC-312, a Phase III pivotal trial of this med versus sorafenib