Company

Product

Description

Indication

Status

Phase I

Cellectar Biosciences Inc., of Madison, Wis.

CLR-131

Radioiodinated phospholipid ether-drug conjugate therapy

Multiple myeloma

Updated interim results from phase Ib trial in 15 patients with relapsed/refractory MM show overall survival of 19.4 months

Clementia Pharmaceuticals Inc., of Montreal

Palovarotene

Eye drop formulated RAR-gamma agonist

Keratoconjunctivitis

Initiated test of safety, tolerability and pharmacokinetic profile of single and multiple ascending doses in healthy volunteers; will inform design of proof-of-concept trial evaluating drug in dry eye disease, expected to begin in 2019

Noxxon Pharma NV, of Berlin

NOX-A12

Targets CXCL12

Metastatic, microsatellite-stable pancreatic and colorectal cancer

Top-line data from part 1 of phase I/II trial showed the drug penetrates the tumor microenvironment in both types of cancer tissue, where it binds and neutralizes CXCL12; changes in cytokine signature indicate modulation of tumor microenvironment; induces immune-stimulatory Th1-like immune response in about 50% of patients with analyzable serial biopsies; statistically significant correlation between degree of target inhibition in tumor tissues and changes in cytokine and chemokine immune profiles; part 2 of study is testing NOX-A12 plus Keytruda (pembrolizumab, Merck & Co. Inc.)

VBI Vaccines Inc. of Cambridge, Mass.

VBI-1501

Enveloped virus-like particle cytomegalovirus vaccine

Cytomegalovirus infection

Safe and well-tolerated at all doses tested; shown to induce gB antibody binding titers at all dose levels, and at the highest dose tested (2 μg), produced a 100% neutralizing antibody seroconversion rate in fibroblast cells, and 31% seroconversion rate in epithelial cells after third immunization

Phase II

Arena Pharmaceuticals Inc., of San Diego

Ralinepag

Prostacyclin receptor agonist

Pulmonary arterial hypertension

Patients who continued on ralinepag in the open-label extension saw sustained improvements from baseline for pulmonary vascular resistance (219 dyn*s*cm -5 median reduction, p=0.002) and 6MWD (49.8 meters mean improvement; p=0.003)

Bionomics Ltd., of Adelaide, Australia

BNC-210

Alpha-7 nicotinic acetylcholine receptor

Post-traumatic stress disorder

Trial did not meet primary endpoint of decrease in PTSD symptoms as measured by CAPS-5 at 12 weeks

Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa.

MEDI-0457

VGX-3100, a DNA-based immunotherapy, plus interleukin-12

Head and neck cancer

Results published in Clinical Cancer Research showed patients treated with the drug achieved a sustained complete response (full remission) on treatment with a subsequent PD-1 checkpoint inhibitor

Rexahn Pharmaceuticals Inc., of Rockville, Md.

RX-3117

Small-molecule nucleoside

Metastatic pancreatic cancer

Favorable preliminary safety and efficacy data from the ongoing study with drug in combination with Abraxane (nab-paclitaxel, Celgene Corp.)

Takeda Oncology Inc., of Cambridge, Mass.

Alisertib

Aurora A kinase inhibitor 

Advanced neuroblastoma

Combined with chemotherapy, drug showed antitumor activity in children with high-risk, relapsed neuroblastoma; results published in Clinical Cancer Research

Phase III

Chiasma Inc., of Waltham, Mass.

Octreotide

Binds to somatostatin receptors

Maintenance therapy in acromegaly

Exceeded target enrollment, with 56 patients randomized in the OPTIMAL trial; top-line data expected in September 2019 vs. prior guidance of the fourth quarter of 2019

Eli Lilly and Co., of Indianapolis

Ultra Rapid Lispro 

Mealtime insulin

Diabetes type 1 and 2

Readouts from 2 trials met the primary efficacy endpoint of noninferior A1C reduction from baseline compared to Humalog (insulin lispro, Eli Lilly and Co.) and also demonstrated significantly improved postmeal glucose control 

Melinta Therapeutics Inc., of New Haven, Conn.

Vabomere (meropenem and vaborbactam)

Antibacterial

Complicated urinary tract infection, acute pyelonephritis, complicated intra-abdominal infection, hospital-acquired/ventilator-associated bacterial pneumonia, and bacteremia due to carbapenem-resistant Enterobacteriaceae

Vabomere monotherapy was associated with increased clinical cure, decreased mortality, and was well-tolerated compared to best available therapy; results published in Infectious Diseases and Therapy

Novo Nordisk A/S, of Bagsvaerd, Denmark

Tresiba (insulin degludec) 

Long-acting insulin

Diabetes type 1 and 2

Results of a post-hoc analysis show patients may achieve improved glycemic control vs. insulin glargine U100, without an increase in hypoglycemia 

Otonomy Inc., of San Diego

Otividex

Sustained-exposure formulation of dexamethasone

Ménière's disease

AVERTS-2 trial data will support submission for U.S. registration and provide basis for ongoing additional phase III trial

Roche Holding AG, of Basel, Switzerland

Ocrevus (ocrelizumab)

Targets cells that express the B lymphocyte antigen CD20

Relapsing and primary progressive multiple sclerosis

5-year efficacy and safety data reinforce importance of early initiation and continuation of treatment


Notes

For more information about individual companies and/or products, see Cortellis.

 

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