January 2019

Pipeline

New Pipeline Updates from AgeneBio, Second Genome and Imperative Care

January 28, 2019

Company Drug/Device Medical Condition Status
Ironwood Pharmaceuticals IW-6463 serious and orphan Central Nervous System (CNS) disorders Phase I trial initiated enrolling healthy volunteer subjects
Concert Pharmaceuticals CTP-692 adjunctive treatment for schizophrenia Phase I trial initiated
Curis, Inc. CA-170 (oral dual inhibitor of VISTA and PDL1) mesothelioma Phase I trial initiated
Second Genome, Inc. SGM-1019 nonalcoholic steatohepatitis (NASH) Phase II trial initiated enrolling 100 subjects in the U.S.
Bio-Thera Solutions BAT1806 (tocilizumab biosimilar) Rheumatoid Arthritis (RA) Phase III trial initiated enrolling more than 600 subjects around the world
AgeneBio AGB101 amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) Phase III trial initiated enrolling 830 subjects in the U.S., Canada and Europe
Daiichi Sankyo Company, Limited [fam-] trastuzumab deruxtecan (DS-8201) HER2 low, unresectable and/or metastatic breast cancer Phase III trial initiated enrolling 540 subjects at approximately 160 sites in regions including, but not limited to, North America, Western Europe and Asia
Imperative Care, Inc. neurovascular access catheters minimally invasive neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions 510(k) clearance granted by the FDA
Rebound Therapeutics Corporation AURORA Surgiscope System single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy 510(k) clearance granted by the FDA
Aerie Pharmaceuticals, Inc. AR-1105 (dexamethasone intravitreal implant) macular edema due to Retinal Vein Occlusion (RVO) IND approval granted by the FDA
I-Mab Biopharma TJD5 (TJ004309) advanced solid tumors IND approval granted by the FDA
Nexus Pharmaceuticals, Inc. Busulfan Injection chronic myelogenous leukemia ANDA approval granted by the FDA
Biom’up HEMOBLAST Bellows Laparoscopic Applicator minimally-invasive procedures PMA approval granted by the FDA
Sanofi Pasteur 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to children age 6 through 35 months influenza Approval granted by the FDA

 

CWMarketplace

January 2019: Top 10 Industry Provider Profiles

January 28, 2019

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Features

Centralized Monitoring in Practice — Lessons Learned from Early Implementers

January 21, 2019

A survey conducted recently by Metrics Champion Consortium shows most of the responding sponsors — 90 percent — indicate they are implementing ICH’s new centralized monitoring approach to risk management, but only about a third of that number say they have fully integrated it into their trials operations. See Figure 1.

Almost all (93 percent) cited detecting risks to subjects and data integrity as the primary reason to conduct centralized monitoring, and three quarters of respondents said it was both a good predictor of the need for individual site visits and detector of potential fraud and/or misconduct among trial staff.

“Onsite monitors are not able to see how their sites compare to others in the same study — whether their performance, data trends, etc., are outliers compared to other sites,” says MCC Executive Director Linda Sullivan. A particular benefit of centralized monitoring is the ability to identify whether data is being fabricated, Sullivan says, something very difficult for an onsite monitor to do. See Figure 2.

Briefs

FDA to Accelerate Gene, Cell Therapy Approvals

January 21, 2019

The FDA expects to receive some 200 new gene and cell therapy INDs in the next two years and plans to expedite their processing by hiring up to 50 extra staffers to handle review and other tasks. The agency also is considering new guidances focusing on regenerative therapies.

Pipeline

New Pipeline Updates from OSSIO, TransEnterix and Abbott

January 21, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-601 advanced or metastatic solid tumors Phase I trial initiated enrolling 75 subjects
Mirati Therapeutics, Inc. MRTX849 advanced solid tumors that harbor KRAS G12C mutations Phase I/II trial initiated
Promentis Pharmaceuticals, Inc. SXC-2023 moderate to severe trichotillomania in adults Phase II trial initiated enrolling 100 subjects in the U.S.
Innovent Biologics, Inc. Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) in combination with capecitabine and oxaliplatin advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) Phase III trial initiated enrolling 650 subjects in China
TransEnterix Senhance Ultrasonic System minimally invasive surgery 510(k) clearance granted by the FDA
OSSIO OSSIOfiber Bone Pin stability and secure bone fixation during the orthopedic healing process 510(k) clearance granted by the FDA
Mundipharma International Flutiform pMDI asthma treatment in children five years of age or older Approval granted by the EMA
Bristol-Myers Squibb Company Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC) Approval granted by the EMA
iSchemaView RAPID neuroimaging platform stroke patients who are likely to benefit from endovascular thrombectomy (clot removal) 510(k) clearance granted by the FDA
Novartis crizanlizumab (SEG101) prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD) Breakthrough Therapy Designation granted by the FDA
Exelixis, Inc. CABOMETYX (cabozantinib) tablets hepatocellular carcinoma (HCC) NDA approval granted by the FDA
AIVITA Biomedical anti-PD1 monoclonal antibodies in combination with AV-MEL-1 metastatic melanoma IND approval granted by the FDA
NeoImmuneTech, Inc. and Genexine Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) high-risk skin cancers IND approval granted by the FDA
Zydus Cadila Amlodipine in combination with Atorvastatin high blood pressure and lowering cholesterol ANDA approval granted by the FDA
Amneal Pharmaceuticals, Inc. generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours mild to moderate dementia caused by Alzheimer’s or Parkinson’s disease ANDA approval granted by the FDA
Abbott Amplatzer Piccolo Occluder patent ductus arteriosus (PDA) in premature babies and newborns Approval granted by the FDA
Sanofi Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) repeat vaccination to help protect against tetanus, diphtheria and pertussis Approval granted by the FDA