Company Product Description Indication Status
Phase I
Agenus Inc., of Lexington, Mass.   Agent-797 Allogeneic iNKT cell therapy Moderate to severe COVID-19  Of 4 patients dosed, 3 were extubated and released after treatment; 2 patients were extubated within 24 hours of dosing
Aligos Therapeutics Inc., of South San Francisco   ALG-010133 Oligonucleotide  Chronic hepatitis B At single oral doses of up to 500 mg, ALG-000184 was safe, well-tolerated and demonstrated a linear pharmacokinetic profile supporting once-daily oral dosing; doses of 100 mg or higher resulted in plasma concentrations of active compound that are projected to result in antiviral activity in CHB patients
Codiak Biosciences Inc., of Cambridge, Mass.   Exoil-12 Exosomal protein Early stage cutaneous T-cell lymphoma Analyses of skin punch biopsies bordering the subcutaneous injection site of exoIL-12 revealed local retention of immunologically detectable IL-12 at the injection site, and localized pharmacological activity as measured by levels of the T-cell attractant chemokine, IP-10, in the skin
Crinetics Pharmaceuticals Inc., of San Diego CRN0-4894 Adrenocorticotropic hormone antagonist  Congenital adrenal hyperplasia and Cushing’s disease Initiated double-blind, randomized, placebo-controlled study of in healthy volunteers to assess safety and tolerability of single and multiple doses; will also measure effect of CRN0-4894 on suppression of cortisol, cortisol precursors and adrenal androgens following exogenous adrenocorticotropic hormone antagonist stimulation
Curevac NV, of Tübingen, Germany, and Boston CV-8102 Noncoding, single-stranded RNA complexed with a cationic peptide Advanced melanoma  Evidence of efficacy after intratumoral application as a single agent, and in combination with systemic anti-PD-1 antibody treatment
Dynavax Technologies Corp., of Emeryville, Calif., and Pune, India  CpG-1018 Adjuvant used in HEPLISAV-B Tetanus, diphtheria and acellular pertussis First participant dosed with the booster vaccine
Eucure Biopharma Co. Ltd., of Boston and Beijing, and Junshi Biosciences Co. Ltd., of Shanghai YH-003 and toripalimab Anti-CD40 antibody combined with anti-PD-1 antibody Advanced solid tumors Partial response at week 10 post-treatment, with a 38.5% reduction in total diameter of all target lesions; no dose-limiting toxicity observed
Phase II
ADC Therapeutics SA, of Lausanne, Switzerland Camidanlumab tesirine  Antibody-drug conjugate Relapsed or refractory non-Hodgkin lymphoma Enrollment completed
Atea Pharmaceuticals Inc., of Boston  AT-527 Antiviral agent derived from Atea’s nucleotide prodrug platform Mild to moderate COVID-19 infection First patient dosed
Biogen Inc., of Cambridge, Mass. BIIB-054 (cinpanemab) Alpha-synuclein inhibitor Parkinson's disease Disclosed in fourth-quarter 2020 earnings that Spark trial missed primary and secondary endpoints; program discontinued
Botanix Pharmaceuticals Ltd., of Sydney BTX-1801 Anti-microbial agent Staphylococcus aureus infection Two formulations proven safe, well-tolerated and successful at eradication
Golden Biotechnology Corp., of Taipei Hocena (antroquinonol) Small-molecule therapy Mild to moderate COVID-19 infection Positive response from data monitoring committee to continue study
I-Mab Biopharma Co. Ltd., of Shanghai TJ-107 (efineptakin alpha) Recombinant interleukin-7 Glioblastoma multiforme First patient dosed
Innocare Pharma Ltd., of Beijing ICP-192 Small-molecule pan-FGFR inhibitor Advanced cholangiocarcinoma and urothelial cancer Dosed first subject in U.S.
Neurorx Inc., of Radnor, Pa. Zyesami (aviptadil) Synthetic form of human vasoactive intestinal peptide Severe COVID-19 Started a phase II/III trial testing the inhaled treatment; objective is to determine if drug can reduce likelihood of progression to critical COVID-19 with respiratory failure 
Reistone Biopharma Co. Ltd., of Shanghai SHR-0302 JAK1 inhibitor Moderate to severe ulcerative colitis Met primary and key secondary endpoints in Amber2 study; data showed percentage of patients who achieved Clinical Response per 9-point Mayo Score in all active arms, 8 mg QD (46.3%), 4 mg BID (46.3%) and 4 mg QD (43.9%) compared to placebo (26.8%) with statistically significant differences at week 8; all treatment arms demonstrated statistically significant improvement in percentage who achieved Clinical Remission when measured by 9-point Mayo Score; phase III program set to start in 2021
Surface Ophthalmics Inc., of Pleasanton, Calif. SURF-200 (betamethasone in Klarity vehicle) Corticosteroid Acute dry eye  Dosed first patient; primary endpoint is Symptom Improvement of 1 unit based on the University of North Carolina Dry Eye Management Scale by day 8
Phase III
Aldeyra Therapeutics Inc., of Lexington, Mass. Reproxalap ophthalmic solution Small-molecule immune-modulating covalent inhibitor of RASP Dry eye disease Finalized design of Tranquility trial; ocular redness over 90 minutes in dry eye chamber will be primary endpoint; study to enroll about 150 patients per arm
Calliditas Therapeutics AB, of Stockholm Nefecon Oral formulation of budesonide IgA nephropathy First patient dosed in global open-label extension study, designed to offer 9-month treatment to all qualifying patients who completed Nefigard study
Corvus Pharmaceuticals Inc., of Burlingame, Calif. CPI-006 Humanized monoclonal antibody designed to bind to and activate B cells COVID-19 Initiated trial in hospitalized patients; study expected to enroll about 1,000 patients at sites in North America, Europe, South Africa and Latin America
Gilead Sciences Inc., of Foster City, Calif. Vemlidy (tenofovir alafenamide 25 mg) Nucleoside reverse transcriptase inhibitor Chronic hepatitis B virus Findings from 2 subanalyses demonstrated continued efficacy and improved safety vs. tenofovir disoproxil fumarate (TDF) in Asian patients; first study showed, over 240 weeks, patients in Vemlidy group had lower median declines in kidney function, and increases in bone mineral density were observed after switching from TDF to Vemlidy; results from second substudy showed that in virologically suppressed patients of Asian ethnicity with CHB on long-term TDF, switching to Vemlidy demonstrated maintenance of a high rate of viral suppression in 94% (n=376), along with continued high rates of normal ALT and improved markers of renal and bone health

Notes

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