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Home » Pipeline

Pipeline

January 4, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Kentucky BioProcessing KBP-COVID-19 COVID-19 vaccine IND approved by the FDA
Hepion Pharmaceuticals CRV431 treatment of COVID-19 IND approved by the FDA
Innovation Pharmaceuticals Brilacidin hospitalized patients with COVID-19 IND approved by the FDA
Emergent BioSolutions

Mount Sinai Health System
COVID-19 Human Hyperimmune Globulin (COVID-HIG) postexposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2 initiation of phase 1 trial
Ology Bioservices ADM03820, anti-SARS-CoV-2 monoclonal antibodies COVID-19 patient dosing commenced in phase 1 trial
Vasomune AV-001 patients hospitalized with COVID-19 patient dosing commenced in phase 1 trial
Serum Institute of India

Dynavax
adjuvanted COVID-19 vaccine with Dynavax’s CpG 1018 prevention of COVID-19 first patients dosed in phase 1/2 trial
Aldeyra Therapeutics ADX-629 COVID-19 initiation of phase 2 trial
Acticor Biotech glenzocimab COVID-19-related acute respiratory distress syndrome (ARDS) first patient enrolled in phase 2 trial
Algernon Pharmaceuticals NP-120 (Ifenprodil) COVID-19 last patient treated in phase 2b portion of phase 2b/3 trial
NeuroRx

Relief Therapeutics
Zyesami (RLF-100: aviptadil) respiratory failure in patients with critical COVID-19 patient enrollment complete in phase 2b/3 trial
CureVac CVnCoV COVID-19 vaccine first patient dosed in phase 3 trial
EUSA Pharma siltuximab hospitalized patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection-associated case of ARDS first patient enrolled in phase 3 trial
Novavax NVX-CoV2373 COVID-19 vaccine candidate initiation of phase 3 trial
Shenyang Tonglian Group carrimycin severe COVID-19 in hospitalized patients approval by the FDA to proceed with phase 3 trial
Vir Biotech

GlaxoSmithKline
VIR-7831 (GSK4182136) hospitalized adults with COVID-19 first patient dosed in a new subtrial of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program phase 3 trial
Moderna mRNA-1273 COVID-19 vaccine Emergency Use Authorization granted by the FDA
Other Trials and Actions
AlloVir ALVR106 allogeneic and autologous hematopoietic stem-cell transplant patients with respiratory infections caused by RSV, influenza, PIV or hMPV IND approved by the FDA
Cerecor CERC-007 Still’s disease IND approved by the FDA
LyGenesis novel cell therapy end-stage liver disease IND approved by the FDA
Moebius Medical MM-II pain-in-knee osteoarthritis IND approved by the FDA
Onconova Therapeutics ON 123300 patients with relapsed/refractory advanced cancer IND approved by the FDA
Senhwa Biosciences CX-5461 solid tumors with BRCA2 or PALB2 mutations IND approved by the FDA
Ziopharm

Eden BioCell
patient-derived CD19-specific CAR-T patients with relapsed CD19+ leukemias and lymphomas IND approved in Taiwan
BioInvent

Transgene
BT-001 solid tumors clinical trial approved to begin in Belgium
Polyphor murepavadin inhaled antibiotic pseudomonas aeruginosa lung infections in people with cystic fibrosis clinical trial approved by the UK Medicines and Healthcare products Regulatory Agency
Amphivena Therapeutics AMV564 selected solid tumors first patients dosed in phase 1 trial
BioEclipse Therapeutics CRX100 refractory solid tumors first patients enrolled in phase 1 trial
Ascletis Pharma/Gannex ASC42 nonalcoholic steatohepatitis first patient dosed in phase 1 trial
Humanigen ifabotuzumab recurrent glioblastoma multiforme enrollment complete in phase 1 trial
Mustang Bio MB-101 (autologous IL13R?2-CAR T-cells) leptomeningeal brain tumors initiation of phase 1 trial
Gannex/Ascletis ASC41 nonalcoholic steatohepatitis first patients dosed in phase 1b trial
MODAG anle138b mild-to-moderate Parkinson´s disease initiation of phase 1b trial
ORIC Pharmaceuticals ORIC-101 advanced solid tumors initiation of second dose expansion portion of phase 1b trial
aTyr Pharma ATYR1923 pulmonary sarcoidosis patient enrollment complete in phase 1b/2a trial
Evaxion Biotech EVX-02 adjuvant therapy in patients with advanced melanoma first patient dosed in phase 1/2 trial
Aldeyra Therapeutics ADX-629 adults with mild asthma induced by bronchial asthma challenge initiation of phase 2 trial
Aldeyra Therapeutics ADX-629 adults with mild-to-moderate plaque psoriasis initiation of phase 2 trial
Altimmune HepTcell chronic hepatitis B initiation of phase 2 trial
Athersys

Memorial Hermann-Texas Medical Center
MultiStem cell therapy early treatment of traumatic injuries and subsequent complications first patient enrolled in phase 2 trial
Brainstorm Cell Therapeutics NurOwn (MSC-NTF cells) progressive multiple sclerosis patient dosing complete in phase 2 trials
Ultimovacs UV1 universal cancer vaccine patients with recurrent or metastatic head and neck cancer initiation of phase 2 trial
Annexon ANX005 Guillain-Barré syndrome first patients dosed in phase 2/3 trial
Albireo Pharma odevixibat Alagille syndrome initiation of phase 3 trial
Fibrogen pamrevlumab idiopathic pulmonary fibrosis first patient dosed in phase 3 trial
Neurana Pharmaceutical tolperisone symptoms associated with acute and painful muscle spasms of the back first patient enrolled in phase 3 trial
Oncopeptides melflufen plus dexamethasone and subcutaneous daratumumab patients with relapsed, refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents first patients dosed in phase 3 trial
Novaremed NRD135S.E1 painful diabetic peripheral neuropathy Fast-Track designation granted by the FDA
Moleculin Biotech annamycin soft-tissue sarcomas Orphan Drug designation granted by the FDA
Sigilon SIG-005 mucopolysaccharidosis type I Orphan Drug designation granted by the FDA
Antengene

Karyopharm
oral Xpovio (selinexor) patients with multiple myeloma who have received at least one prior therapy approved by the FDA for expanded indication
AstraZeneca Tagrisso (osimertinib) adjuvant treatment for patients with nonsmall-cell lung cancer whose tumors have a specific type of genetic mutation approved by the FDA for expanded indication
Almirall

Athenex
Klisyri (tirbanibulin) topical treatment of actinic keratosis of the face or scalp approved by the FDA
Bracco Diagnostics ProHance (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging children under two years for visualization of areas with disrupted blood-brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues approved by the FDA
Genentech Ocrevus (ocrelizumab) shorter, two-hour infusion time for relapsing and primary progressive multiple sclerosis approved by the FDA for new formulation
Integrum AB Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System adults who have transfemoral amputations approved by the FDA
Myovant Sciences Orgovyx (relugolix) adults with advanced prostate cancer approved by the FDA
Ridgeback Therapeutics Ebanga (ansuvimab-zykl) Zaire ebolavirus infection in adults and children approved by the FDA
Urovant Sciences Gemtesa (vibegron) overactive bladder approved by the FDA

 

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