Company Product Description Indication Status
Phase I
Agenus Inc., of Lexington, Mass. Agen-T797 Allogeneic cell therapy COVID-19 Dosed first patient
Aligos Therapeutics Inc., of South San Francisco ALG-000184 Small-molecule class II capsid assembly modulator  Hepatitis B virus Dosed first subject in phase Ia/b trial; top-line results expected in second half of 2021
Curevac NV, of Tubingen, Germany CVnCoV mRNA vaccine COVID-19 Interim data showed candidate was generally well-tolerated across all tested doses (2-12 µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T-cell activation
Mindmed Inc., of New York LSD Psychedelic drug Anxiety disorders  Completed study on acute dose-dependent effects; maximal good drug effects were reached at a 100-ug dose, though an experiential dose of 200 ug was shown to induce greater ego-dissolution, which is thought to be 1 of the key therapeutic potentials of the psychedelic experience and psychedelic assisted therapy process
Symvivo Corp., of Burnaby, Canada BacTRL-Spike  Oral vaccine candidate COVID-19 Enrolled and dosed first healthy volunteer in Australian trial for the prevention of COVID-19; preliminary data expected in early 2021
Ultimovacs ASA, of Oslo, Norway UV-1 Universal cancer vaccine Non-small-cell lung cancer Data accepted for publication in Frontiers in Immunology showed majority of 18 patients treated with maintenance therapy had specific T-cell responses; highest dose of 700 µg resulted in highest proportion of immune responses; in addition, immune responses in high-dose cohort were stronger, occurred at an earlier timeframe and were associated with long survival; 4-year overall survival for the highest cohort was 83%, as compared to 39% for the total patient group
Phase II
Aivita Biomedical Inc., of Irvine, Calif. AV-GBM-1 Autologous dendritic cell-based vaccine Glioblastoma Completed treatment of 57 patients; manufacturing had a 94% success rate; interim findings to be presented at an undisclosed medical meeting in November
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-151 Phosphodiesterase-4 inhibitor Chronic plaque psoriasis  In the 331-patient study, 0.3% dose produced significant itch reduction by week 2 as compared with vehicle and continued through week 12 with 63% of patients achieving a clinically meaningful itch reduction; Patient Symptom Diary Score at week 12 was 42 and 44 for the 0.3% and 0.15% doses, respectively
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-151 Phosphodiesterase-4 inhibitor Atopic dermatitis In the 136-patient phase IIb study, absolute change from baseline in EASI score at week 4 trended toward drug but wasn't statistically significant; 0.15% dose produced a 72.3% EASI improvement and >50% of patients achieved clear or almost clear skin on vIGA-AD
Gritstone Oncology Inc., of Emeryville, Calif. Granite Personalized immunotherapy of 20 tumor-specific neoantigens Microsatellite stable colorectal cancer after progression on FOLFOX/FOLFIRI and gastroesophageal cancer after progression on chemotherapy  Started treating expansion cohorts for both indications
Gritstone Oncology Inc., of Emeryville, Calif. Slate Off-the-shelf immunotherapy of 20 tumor-specific neoantigens Non-small-cell lung cancer patients with relevant KRAS mutations after immunotherapy or relevant TP53 mutations Started treating patients in the expansion cohort
Immunic Inc., of New York IMU-838 DHODH inhibitor Hospitalized moderate COVID-19 Enrolled 200 patients in the study; top-line data expected in first quarter of 2021
Jounce Therapeutics Inc., of Cambridge, Mass. Vopratelimab  Monoclonal antibody targeting inducible T-cell co-stimulator PD-(L)1 inhibitor-experienced non-small-cell lung cancer In the Emerge study, 22 evaluable patients treated with 0.1-mg/kg dose plus ipilimumab had a confirmed overall response rate of 4.5%; stopping enrollment in study
Jounce Therapeutics Inc., of Cambridge, Mass. Vopratelimab and JTX-4014 Monoclonal antibody targeting inducible T-cell co-stimulator and PD-1 inhibitor Immunotherapy-naïve non-small-cell lung cancer with TIS-vopra biomarker First patient dosed in the Select study comparing vopratelimab plus JTX-4014 to JTX-4014 alone; preliminary efficacy data expected in 2021
Novus Therapeutics Inc., of Irvine, Calif. AT-1501 Monoclonal antibody targeting CD40L Amyotrophic lateral sclerosis First patient enrolled in the 12-week, dose-escalating study; endpoints are safety and tolerability, and changes in pro-inflammatory biomarkers as well as neurofilament light chain
Revimmune Inc., of Bethesda, Md. CYT-107  Recombinant human interleukin-7 Critically ill COVID-19 Opened enrollment in phase IIa Iliad-7 study at 5 sites in the U.S.; study continues in U.K. and France; preparing to start enrollment in Brazil
Tetra Therapeutics, of Grand Rapids, Mich., a unit of Osaka, Japan-based Shionogi & Co. Ltd. BPN-14770 Phosphodiesterase‐4D allosteric inhibitor Fragile X syndrome Drug produced significant benefit in Oral Reading Recognition (LSMean Difference +2.80, p=0.0157), Picture Vocabulary (+5.79, p=0.0342) and Cognition Crystallized Composite Score (+5.29, p=0.0018); parent/caregiver ratings showed improvement in Language (LSMean Difference +14.04, p=0.0051) and Daily Functioning (+14.53, p=0.0017)
Tiziana Life Sciences plc, of New York Foralumab  Monoclonal antibody targeting CD3 COVID-19 Started study in Brazil testing foralumab alone or in combination with dexamethasone; data expected by the end of 2020
Phase III
Aim Immunotech Inc., of Ocala, Fla. Ampligen  TLR3 agonist Myalgic encephalomyelitis/chronic fatigue syndrome Data published in PLOS ONE showed 51.2% patients who had symptom duration for 2-8 years improved their exercise duration by at least 25% (p=0.003)
Daiichi Sankyo Co. Ltd., of Tokyo, and Astrazeneca plc, of Cambridge, U.K. Enhertu (fam-trastuzumab deruxtecan-nxki) Antibody-drug conjugate targeting HER2 Adjuvant therapy in HER2-positive early breast cancer with high risk of disease recurrence with residual invasive disease in the breast or axillary lymph nodes after neoadjuvant therapy Started the 1,600-patient Destiny-Breast05 study comparing Enhertu to Kadcyla (ado-trastuzumab emtansine, Roche Holding AG); primary efficacy endpoint is invasive disease-free survival; secondary efficacy endpoints include overall survival and disease-free survival
Eli Lilly and Co., of Indianapolis, and Incyte Corp., of Wilmington, Del. Baricitinib  JAK1/JAK2 inhibitor  Moderate to severe atopic dermatitis In the Breeze-AD3 extension study, 45.7% of responders and partial responders on 4 mg of baricitinib had a validated Investigator Global Assessment (vIGA-AD) score of 0 or 1 and 40% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy; 2-mg dose went from 46.4% of patients meeting goal to 50%
Humanigen Inc., of Burlingame, Calif. Lenzilumab  GM-CSF ligand inhibitor Hospitalized COVID-19 Treated first patient in the study testing recovery time
Resverlogix Corp., of Calgary, Alberta Apabetalone  Bromodomain and extra-terminal inhibitor Cardiovascular disease patients with type 2 diabetes mellitus Apabetalone plus SGLT2 inhibitors and standard-of-care medicines improved estimated glomerular filtration rate compared to SGLT2 inhibitors plus placebo (p=0.05); combination reduced plasma Hb1Ac compared to placebo (p<0.001)
Rhythm Pharmaceuticals Inc., of Boston Setmelanotide  Melanocortin-4 receptor agonist Proopiomelanocortin deficiency obesity and leptin receptor deficiency obesity Data published in The Lancet Diabetes & Endocrinology showed 8 of 10 patients with POMC and 5 of 11 patients with LEPR achieved at least 10% weight loss at approximately 1 year
Sun Pharmaceutical Industries Ltd., of Mumbai, India Ilumya (tildrakizumab-asmn) Monoclonal antibody targeting interleukin-23p19 Moderate to severe plaque psoriasis Data from the Resurface 1 and 2 studies showed 100-mg dose produced clear or almost clear skin (PASI 90) in 65.9% of patients, completely clear skin (PASI 100) in 32.8% of patients and PASI 75 in 88.7% of patients at week 244
UCB SA, of Brussels, Belgium Bimekizumab  IL-17A and IL-17F inhibitor Moderate to severe plaque psoriasis In the Be Sure study, 86.2% of patients treated with bimekizumab achieved at least a 90% improvement in the Psoriasis Area and Severity Index compared with 47.2% of patients treated with adalimumab at week 16 (p<0.001); 85.3% of patients treated with bimekizumab achieved Investigator Global Assessment of clear or almost clear compared to 57.2% of patients treated with adalimumab at week 16 (p<0.001)
Phase IV
Novartis AG, of Basel, Switzerland Aimovig (erenumab) CGRP receptor inhibitor Migraine prevention In the Her-Mes study, a greater proportion of patients taking Aimovig achieve at least a 50% reduction in their monthly migraine days compared to topiramate

Notes

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