Company Product Description Indication Status
Phase I
American Gene Technologies Inc., of Rockville, Md. AGT103-T Autologous cell product HIV infection First patient in study underwent leukapheresis to make the product
Corvus Pharmaceuticals Inc., of Burlingame, Calif. CPI-006 CD73 antagonist COVID-19 infection Fully enrolled trial in people hospitalized with coronavirus; results from 22 participants at cut-off date of Nov. 4, 2020, showed 4/4 evaluable who received 0.3-mg/kg dose had sustained high titers of IgG antibodies to trimeric spike protein to 84+ days; 3/3 developed antiviral antibody responses to day 56 that blocked infectivity of receptor bearing cells in pseudovirus neutralization assay
Curevac NV, of Tubingen, Germany CVnCoV mRNA based vaccine COVID-19 prophylaxis Data published on Medrxiv showed the vaccine produced an immune response comparable to patients who recovered from COVID-19
Denali Therapeutics Inc., of South San Francisco DNL-310 Fusion protein of iduronate 2-sulfatase and an Enzyme Transport Vehicle Hunter syndrome After 4 weeks of treatment, there was a 76% mean reduction in heparan sulfate in the cerebrospinal fluid (CSF) (p<0.001); normal healthy levels seen in 4 of 5 patients; treatment reduced dermatan sulfate in CSF by a mean of 53% (p<0.001)
Galapagos NV, of Mechelen, Belgium GLPG-3667 Small molecule with undisclosed mechanism of action Psoriasis Treated first of approximately 30 patients in phase Ib study testing 2 dose levels of the drug; primary endpoint is the change from baseline in Psoriasis Area Severity Index score at 4 weeks
Immunitybio Inc., of Culver City, Calif., and Nantkwest Inc., of El Segundo, Calif. hAd5-S-Fusion+N-ETSD vaccine Bivalent, human adenovirus COVID-19 vaccine COVID-19 prophylaxis First dose level administered with no serious adverse events; expansion cohort is ongoing
Immunophotonics Inc., of St. Louis IP-001 Carbohydrate polymer that triggers a tumor-specific systemic immune response Thermally ablated solid tumors First patient treated in the phase Ib/IIa study
Onxeo SA, of Paris AsiDNA DNA damage response inhibitor Metastatic solid tumors Interim results of patients treated with drug plus carboplatin or drug plus carboplatin and paclitaxel showed 4 of 7 patients experienced a partial response and/or longer durations of disease control than with previous lines of treatment
Rallybio LLC, of New Haven, Conn. RLYB-211 Plasma-derived hyperimmune globulin Healthy male participants (eventually fetal and neonatal alloimmune thrombocytopenia) Dosed first participant in phase I/II study to establish dose required to rapidly clear HPA-1a positive platelets transfused to HPA-1a negative participants
Phase II
Affibody AB, of Solna, Sweden ABY-035 IL-17A inhibitor Psoriatic arthritis Started the 52-week study in approximately 129 patients testing the efficacy of different dose regimens of ABY-035 as compared to placebo
Agenus Inc., of Lexington, Mass., and Merck & Co. Inc., of Kenilworth, N.J. MK-4830 ILT4 antibody PD-L1-positive advanced non-small-cell lung cancer Started study testing MK-4830 plus Keytruda (pembrolizumab)
Arena Pharmaceuticals Inc., of San Diego Etrasimod Sphingosine 1-phosphate receptor modulator Atopic dermatitis Phase IIb Advise trial in moderate to severe disease missed primary endpoint of EASI change from baseline at week 12 vs. placebo
Hepion Pharmaceuticals Inc., of Edison, N.J. CRV-431 Hepatitis B structural protein inhibitor; peptidyl-prolyl cis-trans isomerase A inhibitor Nonalcoholic steatohepatitis Final participant enrolled in 75-mg study drug cohort in phase IIa Ambition trial; data from cohort expected by year-end 2020
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Mavrilimumab GM-CSF receptor alpha antagonist Giant cell arteritis Primary efficacy endpoint of time-to-first adjudicated GCA flare by week 26 in all treated patients (p=0.0263) and secondary efficacy endpoint of sustained remission at week 26 in all treated patients (33.3 percentage point increase; p=0.0038) were statistically significant
PDS Biotechnology Corp., of Florham Park, N.J. PDS-0101 Versamune-based T-cell activating vaccine Head and neck cancer Versatile-002 trial opened to assess study drug + Keytruda (pembrolizumab, Merck & Co. Inc.) in first-line recurrent/metastatic HPV16-positive disease; primary efficacy endpoint is objective response rate at 9 months following treatment initiation
Revance Therapeutics Inc., of Newark, Calif. DaxibotulinumtoxinA (injectable) Botulinum toxin A stimulator Plantar fasciitis Neither dose (DAXI 80 U,  DAXI 120 U) met primary efficacy endpoint of statistically significant improvement from baseline (p=0.2135, p=0.2205, respectively) in Numeric Pain Rating Scale at week 8 vs. placebo
Sanifit Therapeutics SA, of Palma, Spain SNF-472 (myo-inositol hexaphosphate, intravenous) Calcium metabolism modulator  Vascular calcification Subgroup analyses from phase IIb Calipso study, published in Kidney International Reports, showed reduced progression of coronary artery calcium vs. placebo in people who received maintenance hemodialysis
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin, topical film-forming solution) Protein phosphatase 2A inhibitor External genital warts In Care-1 study, pooled results from 6- and 24-hour treatment exposures showed 35.1% (20/57) of treated participants achieved complete clearance of all treatable lesions at day 84 vs. 2.4% (1/42) for vehicle (p=0.0001); those who received study drug achieved statistically significantly larger reductions (6-hour, p< 0.0001; 24-hour, p=0.0003) in percent change from baseline in number of treatable lesions vs. vehicle at day 84; end-of-phase II meeting requested with FDA
Phase III
Astrazeneca plc, of Cambridge, U.K., and Amgen Inc., of Thousand Oaks, Calif. Tezepelumab Thymic stromal lymphopoietin ligand inhibitor Asthma Navigator trial met primary endpoint for study drug added to standard of care (SOC) with statistically significant reduction in annualized asthma exacerbation rate over 52 weeks in overall population with severe, uncontrolled disease vs. placebo added to SOC; trial also met primary endpoint in subgroup with baseline eosinophil counts <300 cells per microliter
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Voclosporin Calcineurin inhibitor; IL-2 receptor antagonist Lupus nephritis Integrated analysis of pivotal Aura-LV and Aurora trials showed statistically significant higher renal response rates of 43.7% for study drug vs. 23.3% for control at 1 year (p < 0.0001) and 31.7% vs. 20.3%, respectively, at 6 months (p=0.00080); 50% reduction in urine protein/creatine ratio (UPCR) from baseline at any time achieved by 93.7% who received voclosporin vs. 75.2% for placebo, with median time to 50% UPCR reduction of 29 days vs. 58 days, respectively; separate data from people with systemic lupus erythematosus showed study drug does not have meaningful drug-drug interaction co-administered with mycophenolate mofetil
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) + Yervoy (ipilimumab, Bristol Myers Squibb Co.) PD-1 inhibitor + CTLA4 inhibitor Non-small-cell lung cancer Keynote-598 trial in metastatic disease halted for futility after interim analysis showed no incremental benefit in co-primary endpoints of overall or progression-free survival for combination vs. Keytruda alone
Merck & Co. Inc., of Kenilworth, N.J., and Eisai Inc., unit of Eisai Co. Ltd., of Tokyo Keytruda (pembrolizumab) + Lenvima (lenvatinib)  PD-1 inhibitor + multiple receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Combination met primary endpoint of progression-free survival (PFS) and key secondary endpoints of overall survival and objective response rate (ORR) in Keynote-581/Clear trial with statistically significant improvement vs. sunitinib in intent-to-treat (ITT) population; Lenvima + everolimus also met trial’s primary endpoint of PFS and key secondary endpoint of ORR with statistically significant improvement vs. sunitinib in ITT population
Mitsubishi Tanabe Pharma America Inc., of Jersey City, N.J. Edaravone (oral, MT-1186) Antioxidant free radical scavenger Amyotrophic lateral sclerosis  MT-1186-A01 study fully enrolled with about 185 participants
Nicox SA, of Sophia Antipolis, France NCX-470 Nitric oxide-donating bimatoprost analogue Glaucoma First of about 650 participants enrolled in 3-month Denali trial assessing study drug vs. standard of care latanoprost ophthalmic solution 0.005% to lower intraocular pressure in open-angle glaucoma or ocular hypertension
Quest Pharmatech Inc., of Edmonton, Alberta Oregovomab Mucin 16 inhibitor Ovarian cancer Reported that Oncoquest Pharmaceuticals Inc., of Seoul, dosed first of about 602 participants in Flora-5 trial of study drug vs. placebo co-administered with standard chemotherapy to treat newly diagnosed advanced epithelial ovarian, fallopian tube or peritoneal carcinoma in conjunction with optimal debulking resection; primary and secondary endpoints, for adjuvant and neoadjuvant cohorts, are progression-free and overall survival, respectively

Notes

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