Ask the Expert: Examining and Reporting Safety Information

November 18, 2019

This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This month features two WCG pharmacovigilance experts, WCG Vigilare Vice President Angela Pittwood and Jim Bannon, president of the scientific and regulatory review division of WCG Clinical.

Up and Coming from AZTherapies, Holon Solutions and Noxopharm

November 18, 2019

This feature highlights changes in clinical research organizations’ personnel.

ADC Therapeutics
ADC Therapeutics SA has named Jennifer Herron its first chief commercial officer. Herron recently served as executive vice president and CCO at Immunogen.

New Pipeline Updates from Triple-Gene LLC, Aptinyx Inc. and Celgene Corporation

November 18, 2019

Company Drug/Device Medical Condition Status
Triple-Gene LLC INXN-4001 heart failure Phase 1 trial initiated enrolling 12 stable subjects with implanted Left Ventricular Assist Device (LVAD)
Cerveau Technologies Inc. [F18]MK-6240 neurodegenerative diseases Phase 1 trial initiated enrolling healthy volunteers and subjects with Mild Cognitive Impairment (MCI) and with Alzheimer’s Disease (AD) at Kobe City Medical Center General Hospital in Japan

Aravive, Inc.


AVB-500 in combination with durvalumab platinum-resistant, recurrent epithelial ovarian cancer Phase 1/2 trial initiated
Turning Point Therapeutics, Inc. TPX-0046 advanced solid tumors Phase 1/2 trial initiated enrolling 350 TKI-treatment naïve and -pretreated subjects with RET-altered non-small-cell lung, thyroid and other advanced cancers
Dragonfly Therapeutics, Inc. DF1001 advanced solid tumors Phase 1/2 trial initiated enrolling subjects with locally advanced or metastatic solid tumors who express HER2
Turning Point Therapeutics, Inc. repotrectinib solid tumors Phase 1/2 trial initiated enrolling 75 pediatric patients with ALK-, NTRK- and ROS1-positive solid tumors

VBI Vaccines

Brii Biosciences

BRII-179 (VBI-2601) chronic hepatitis B virus (HBV) infection Phase 1b/2a trial initiated enrolling 65 subjects
xBiotech USA, Inc. bermekimab severe Atopic Dermatitis (AD) Phase 2 trial initiated

AVEO Oncology

Biodesix, Inc.

ficlatuzumab in combination with high-dose cytarabine relapsed and refractory acute myeloid leukemia (AML) Phase 2 trial initiated enrolling 60 adult subjects with AML who failed induction chemotherapy or who achieved a complete response, but relapsed within one year
Aptinyx Inc. NYX-2925 painful diabetic peripheral neuropathy (DPN) Phase 2 trial initiated enrolling 200 subjects with advanced DPN
Aptinyx Inc. NYX-2925 fibromyalgia Phase 2 trial initiated enrolling 300 subjects
Viracta Therapeutics, Inc. nanatinostat in combination with valganciclovir relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoid malignancies Fast Track designation granted by the FDA
X4 Pharmaceuticals, Inc. mavorixafor (X4P-001) WHIM (Warts, Hypogammaglobulinemia, Infections and Myelokathexis) syndrome Breakthrough Therapy Designation granted by the FDA
Celgene Corporation Reblozyl (luspatercept–aamt) anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions Approval granted by the FDA


Up and Coming from Albireo Pharma, Elysium Health and Santhera

November 11, 2019

This feature highlights changes in clinical research organizations’ personnel.

ACADIA Pharmaceuticals, Inc.
ACADIA Pharmaceuticals, Inc. has named Ponni Subbiah senior vice president, global head of medical affairs and chief medical officer. Subbiah recently served as CMO at Indivior.