Company Product Description Indication Status
Phase I
Axial Therapeutics Inc., of Waltham, Mass. AB-2004  Microbiome modulator Autism spectrum disorder  Phase Ib/IIa study met the primary endpoint demonstrating safety, tolerability and adherence with no drug-related adverse events; patients with high irritability or high anxiety improved; improvements in social withdrawal and gastrointestinal symptoms observed
F-star Therapeutics Inc., of Cambridge, U.K. FS-120  Dual-agonist tetravalent bispecific antibody targeting CD137 and OX40 Advanced cancer First patient treated in the study measuring the pharmacokinetic and pharmacodynamic profile of FS-120 monotherapy; the drug will also be tested in combination with a PD-1 monoclonal antibody
Gemoab GmbH, of Dresden, Germany UniCAR-T-PSMA Switchable universal CAR T targeting PSMA Late-stage, relapsed/refractory solid tumors expressing the PSMA antigen Apheresed the first of up to 16 patients in the phase Ia study designed to determine the maximum tolerated dose and to determine the phase II dose level for UniCAR-T-PSMA plus PSMA target module TmpPSMA
Qpex Biopharma Inc., of San Diego QPX-7728 Beta-lactamase inhibitor Healthy subjects Started study testing the safety and pharmacokinetics of single and multiple intravenous doses of QPX-7728 monotherapy, and in combination with a beta-lactam antibiotic
Remynd NV, of Leuven, Belgium RES19-T  Restores calcium dyshomeostasis Healthy subjects (eventually Alzheimer’s disease) Started the study with an adaptive dose design to evaluate the safety, tolerability and pharmacokinetics of RES19-T
Sirnaomics, of Gaithersburg, Md. STP-705 siRNA inhibiting expression of TGF-beta1 and COX-2  Primary and metastatic liver cancer Following feedback from the FDA, the company plans to start a phase I study in the first quarter of 2021
Phase II
Enlivex Therapeutics Ltd., of Nes Ziona, Israel Allocetra Autologous cell-based therapy Severe and critical COVID-19 Interim results from 8 patients (6 severe, 2 critical) showed 7 of 8 patients had complete recovery and were discharged from the hospital after an average of 4.7 days; 8th patient was treated on Nov. 27 and went from critical condition to moderate/severe condition
Evelo Biosciences Inc., of Cambridge, Mass. EDP-1815  Strain of Prevotella histicola Mild to moderate psoriasis Completed enrollment of 113 patients required for the interim data readout; recruiting is ahead of schedule
IMV Inc., of Dartmouth, Nova Scotia DPX-Survivac 5 unique HLA-restricted survivin peptides formulated in the DPX drug delivery platform Recurrent, advanced platinum-sensitive and platinum-resistant ovarian cancer In the Decide1 study, 78.9% of the 19 evaluable patients had a clinical benefit; 37% of patients had a clinical benefit for over 6 months; median progression-free survival was 4.47 months; 12-month survival rate of 66.1%
Puretech Health plc, of Boston LYT-100 (deupirfenidone) Deuterated form of anti-inflammatory and antifibrotic pirfenidone Post-acute COVID-19 respiratory complications Started the study with a primary endpoint of 6-minute walk test distance; secondary endpoints include pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes including dyspnea and the 36-Item Short Form Health Survey; data expected in the second half of 2021
Resolve Therapeutics Inc., of St. Petersburg, Fla. RSLV-132 Targeted biologic designed to remove pro-inflammatory nucleic acids from circulation Primary Sjogren's syndrome Data published in Arthritis and Rheumatology showed RSLV‐132 improved EULAR Sjögren’s Syndrome Patient Reported Index score (p=0.27), Functional Assessment of Chronic Illness Therapy-Fatigue score (p=0.05), Profile of Fatigue score (p=0.07) and Digit Symbol Substitution Test (p=0.02) from baseline to day 99
Senhwa Biosciences Inc., of Taipei Silmitasertib CK2 inhibitor Moderate COVID-19 First of 20 patients enrolled in the study measuring the safety and tolerability of the drug, patient recovery time and possible clinical benefits
Valneva SE, of Saint-Herblain, France, and Pfizer Inc., of New York VLA-15 Lyme disease vaccine Lyme disease prophylaxis Plans to start the VLA15-221 study in 600 participants 5-65 years of age in the first quarter of 2021; study will compare 3-dose schedule at 0, 2 and 6 months with a 2-dose schedule at 0 and 6 months; study will also evaluate a booster at 18 months
Phase III
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Lumasiran RNAi targeting hydroxyacid oxidase 1 Advanced primary hyperoxaluria type 1 Completed enrollment in the Illuminate-C study; data expected in mid-2021
Jazz Pharmaceuticals plc, of Dublin, and Pharmamar SA, of Madrid, Spain Zepzelca (lurbinectedin) Alkylating agent targeting guanine residues in DNA Small-cell lung cancer after progression following 1 prior platinum-containing line In the Atlantis study, Zepzelca plus doxorubicin didn't improve overall survival compared to physician's choice of topotecan or cyclophosphamide/doxorubicin/vincristine; data to be presented at a future medical meeting

Notes

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