Pipeline

March 15, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Kintor Pharmaceutical proxalutamide male COVID-19 outpatients IND approved by the FDA for phase 3 trial
Melior Pharmaceuticals tolimidone nonhospitalized patients recently diagnosed with COVID-19 IND approved by the FDA for phase 2 trial
AIM ImmunoTech intranasal Ampligen prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases first patient dosed in phase 1 trial
VBI Vaccines VBI-2902 COVID-19 vaccine first patients enrolled in phase 1/2 trial
Can-Fite Biopharma piclidenoson patients hospitalized with moderate- to-severe COVID-19 first patient enrolled in phase 2 trial
Other Trials and Actions
Alphamab Oncology KN046 thymic carcinoma IND approved by the FDA
TissueTech TTAX03 facet joint pain resulting from osteoarthritis IND approved by the FDA
Lee’s Pharma socazolimab extensive-stage small-cell lung cancer IND cleared by China’s National Medical Products Administration for a phase 3 trial
Alteogen Eylea Biosimilar (ALT-L9) neovascular (wet) age-related macular degeneration completion of phase 1 trial
BioEclipse Therapeutics CRX100 refractory solid tumors first patient dosed in phase 1 trial
American CryoStem autologous mesenchymal stem cell infusion therapy postconcussion syndrome phase 1 trial initiated
Impact Therapeutics Wee1 Inhibitor IMP7068 patients with advanced solid tumors first patient dosed in phase 1 trial
Adicet Bio ADI-001 allogeneic gamma delta T-cell therapy expressing a chimeric antigen receptor B-cell nonHodgkin lymphoma phase 1 trial initiated
BeiGene BGB-15025 hematopoietic progenitor kinase 1 (HPK1) inhibitor T-cell activated cancer growth phase 1 trial initiated
Oncoinvent Radspherin ovarian cancer patients with peritoneal carcinomatosis first patients enrolled in third-level dose cohort of phase 1 trial
DemeRx ibogaine HCl (DMX-1002) opioid use disorder phase 1/2a trial authorized in the UK
Aravive AVB-500 patients with advanced clear- cell renal cell carcinoma that have progressed on front-line treatment first patients dosed in phase 1b/2 trial
Metacrine MET642 nonalcoholic steatohepatitis first patient treated in phase 2a trial
OCON Health intrauterine drug delivery platform IUB SEAD abnormal uterine bleeding patient enrollment complete in phase 2a trial
AEON Biopharma BP-450 (prabotulinumtoxinA) injection preventive treatment of migraine initiation of phase 2 trial
Edesa Biotech EB01 chronic allergic contact dermatitis patient enrollment complete in first cohort of phase 2b trial
IRLAB Therapeutics mesdopetam levodopa-induced dyskinesias in Parkinson's disease first patients dosed in Europe in phase 2b/3 trial
Natera Signatera tumor-informed, personalized molecular residual disease test muscle-invasive urothelial carcinoma phase 3 trial initiated to test use of diagnostic tool prior to treatment with Genentech’s atezolizumab (Tecentriq)
Caladrius Biosciences CLBS12 Buerger’s disease Orphan Drug designation granted by the FDA
Sigilon Therapeutics SIG-007 Fabry disease Orphan Drug designation granted by the FDA
Steba Biotech Padeliporfin ImPACT adults with upper-tract urothelial cancer Orphan Drug designation granted by the FDA
Passage Bio PBGM01 GM1 gangliosidosis Fast-Track designation granted by the FDA
Passage Bio PBFT02 frontotemporal dementia with granulin mutations Fast-Track designation granted by the FDA
Passage Bio PBKR03 Krabbe disease Fast-Track designation granted by the FDA
Rocket Pharmaceuticals RP-L201 leukocyte adhesion deficiency-I (LAD-I) Regenerative Medicine Advanced Therapy designation granted by the FDA
Genentech Actemra (tocilizumab) subcutaneous injection systemic sclerosis-associated interstitial lung disease approved by the FDA
Kite Pharma Yescarta (axicabtagene ciloleucel) relapsed or refractory follicular lymphoma after two or more lines of systemic therapy approved by the FDA for expanded indication
Seqirus Flucelvax quadrivalent influenza vaccine approved by the FDA for expanded age indication
Roche Ventana ALK (D5F3) CDx Assay companion diagnostic to identify ALK-positive nonsmall-cell lung cancer patients eligible for treatment with Pfizer's Lorbrena (lorlatinib) approved by the FDA
Able Medical Devices Valkyrie Thoracic Fixation System stabilization and fixation of fractures of the chest wall approved by the FDA
Brain Scientific next-generation NeuroCap device electroencephalogram electrode array used to obtain rapid EEGs in routine clinical and research settings approved by the FDA

 

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