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Home » Pipeline

Pipeline

December 8, 2019
Company Drug/Device Medical Condition Status

Cellectis

UCART22

relapsed/refractory B-cell acute lymphoblastic leukemia

Phase 1 trial initiated in subjects at the University of Texas MD Anderson Cancer Center

Innovent Biologics

Beijing Hanmi Pharmaceutical Co.

IBI315

HER2-expressing advanced solid malignancies

Phase 1 trial initiated enrolling subjects at sites in China

TFF Pharmaceuticals

voriconazole

antifungal drug for treating Invasive Pulmonary Aspergillosis

Phase 1 trial initiated enrolling 64 healthy subjects at one site in Canada

INmune Bio

XPro1595

Alzheimer's disease

Phase 1b trial initiated in 18 subjects with Alzheimer’s disease at multiple sites in England and Australia

QBiotics Group Limited

tigilanol tiglate

head and neck cancer

Phase 1/2 trial initiated in 40 subjects with head and neck squamous cell carcinoma (HNSCC) in at least four sites in India and Australia

Imbrium Therapeutics LP

Spine Thera

SX600

sciatica

Phase 1/2 trial initiated enrolling subjects

Cerevance

CVN424

Parkinson’s disease

Phase 2 trial initiated in 70 subjects with Parkinson’s disease and motor fluctuations who are currently being treated with levodopa

Ra Pharmaceuticals

Zilucoplan

immune-mediated necrotizing myopathy

Phase 2 trial initiated dosing 24 subjects with IMNM who are positive for anti-3-hydroxy-3-methylglutaryl-coenzyme a reductase or anti-signal recognition particle autoantibodies

MediWound

EscharEx

venous leg ulcers

Phase 2 trial initiated enrolling 174 subjects at 25 sites

Dermavant Sciences

cerdulatinib

vitiligo and atopic dermatitis

Phase 2a trial initiated enrolling 30 subjects aged 18-70 years old diagnosed with vitiligo

Theravance Biopharma

TD-8236

inflammatory lung diseases

Phase 2 trial initiated enrolling 21 subjects with mild asthma following an inhaled allergen challenge

Rafael Pharmaceuticals

CPI-613

Burkitt’s lymphoma and leukemia

Phase 2 expansion trial initiated enrolling subjects at Massachusetts General Hospital in Boston

Oragenics

AG013

oral mucositis

Phase 2 trial initiated enrolling 200 subjects undergoing traditional chemoradiation for the treatment of head and neck cancer

Concert Pharmaceuticals

CTP-692

schizophrenia

Phase 2 trial initiated enrolling 300 adult subjects with schizophrenia who are stable on an antipsychotic medication

Soligenix

SGX301

cutaneous T-cell lymphoma

Phase 3 trial initiated enrolling 169 subjects at multiple centers

Phathom Pharmaceuticals

vonoprazan

erosive esophagitis and heartburn

Phase 3 trial initiated enrolling 1,000 subjects with EE at multiple centers in the U.S. and Europe

Pluristem Therapeutics

PLX-PAD cells

muscle regeneration

Phase 3 trial initiated enrolling 240 subjects recovering from arthroplasty for hip fracture at multiple sites in the U.S., Europe and Israel

Prokarium

Entervax

Fever

Clinical trial authorization granted by the MHRA

SK Life Science

SKL24741

epilepsy

IND approval granted by the FDA

Bio-Thera Solutions

BAT2206

psoriatic arthritis

IND approval granted by the FDA

Personal Genome Diagnostics

PGDx elio

cancer

IDE approval granted by FDA

Amneal Pharmaceuticals

Carafate

duodenal ulcer

Abbreviated NDA granted by the FDA

ImmunityBio

N-803 (IL-15) super antagonist

non-muscle invasive bladder cancer

Breakthrough device designation granted by the FDA

Dr. Reddy’s Laboratories

Bortezomib

intravenous use only for the treatment of adult patients with multiple myeloma and for the treatment of mantle cell lymphoma

Approval granted by the FDA

Tusker Medical

Tula system

placement of tympanostomy tubes (commonly known as ear tubes) in the physician’s office without general anesthesia

Approval granted by the FDA

Genentech

Tecentriq plus chemotherapy

metastatic non-squamous non-small cell lung cancer

Approval granted by the FDA

Foundation Medicine

FoundationOne CDx as a Companion Diagnostic for Piqray (alpelisib)

hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer

Approval granted by the FDA

 

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