Company Product Description Indication Status
Phase I
Bioinvent International AB, of Lund, Sweden BI-1808 Anti-TNFR2 antibody Solid tumors; cutaneous T-cell lymphoma First of about 120 participants enrolled in phase I/IIa trial assessing study drug as monotherapy and in combination with anti-PD-1 Keytruda (pembrolizumab, Merck & Co. Inc.)
Eucure Beijing Biopharma Co. Ltd., of Beijing, subsidiary of Biocytogen Boston Corp., of Boston YH-001 Anti-CTLA4 monoclonal antibody Advanced solid tumors First participant enrolled in trial in China assessing agent as monotherapy
I-Mab Biopharma Co. Ltd., of Shanghai, and Morphosys AG, of Planegg, Germany TJ-210/MOR-210 Complement factor C5a receptor 1 antagonist Advanced solid tumors First participant dosed in U.S. study assessing agent as monotherapy in relapsed/refractory disease
Imvax Inc., of Philadelphia IGV-001 IGF-1 receptor oligodeoxynucleotide-based immunotherapy Glioblastoma Phase Ib results in newly diagnosed disease, published in Clinical Cancer Research, showed 17.1-month progression-free survival for optimal dose cohort, with overall survival nearly 22 months; methylated subgroup showed increase in PFS, at 38.4 months
Qurient Co. Ltd., of Seongnam-Si, Korea Q-702 Axl/Mer/CSF1R triple TKI  Advanced solid tumors First of about 80 participants dosed in U.S. study assessing agent as monotherapy in relapsed/refractory disease
Vir Biotechnology Inc., of San Francisco VIR-3434 Hepatitis B large envelope protein modulator Hepatitis B virus infection Data from first blinded cohort (n=8) in ongoing trial in people with chronic infection, including 6 who received single 6-mg dose vs. 2 in placebo arm, showed 6 achieved mean reduction of 1.3 log10 IU/mL in serum HBV surface antigen by day 8
Phase II
Azurrx Biopharma Inc., of Delray Beach, Fla. VIR-3434 Lipase modulator Exocrine pancreatic insufficiency 2 additional sites activated in Poland for extension arm of phase IIb Option 2 study; top-line data expected in first quarter of 2021
Concentric Analgesics Inc., of San Francisco Vocacapsaicin (CA-008) Vanilloid VR1 agonist Pain Additional data from study in 187 people undergoing total knee arthroplasty showed 30% reduction in mean opioid consumption seen during hospitalization from 0-96 hours (p<0.0001) increased to 52% reduction after discharge from 96 hours to day 15 (p=0.0063); 17% reduction in mean pain at rest AUC 0-96h (p=0.0012) persisted at 15% from 0 to day 15 (p=0.03); 21% reduction in mean pain with ambulation AUC 0-96h (p=0.0006) persisted at 14% from 0 to day 15 (p=0.04)
Gesynta Pharma AB, of Solna, Sweden, and Orexo AB, of Uppsala, Sweden OX-MPI (GS-248)  Prostaglandin E synthase inhibitor Systemic sclerosis Started study testing the effect of the drug on Raynaud’s phenomenon and peripheral blood flow
Isa Pharmaceuticals BV, of Leiden, the Netherlands ISA-101b Immunotherapy targeting oncogenic E6 and E7 proteins of HPV16 Newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck cancer First patient treated in the study testing ISA-101b plus Keytruda (pembrolizumab, Merck & Co. Inc.), cisplatin and radiotherapy; primary endpoint is 2-year progression-free survival
Merck & Co. Inc., of Kenilworth, N.J. Islatravir  Nucleoside reverse transcriptase translocation inhibitor Pre-exposure prophylaxis of HIV-1 infection Trough concentrations for both doses remained above the prespecified pharmacokinetics threshold for HIV-1 prophylaxis of 0.05 pmol/106 PBMCs
Minoryx Therapeutics SL, of Barcelona, Spain Leriglitazone PPAR gamma agonist  Adrenomyeloneuropathy  The phase II/III Advance study didn't meet its primary endpoint of 6-minute walk test (6MWT) in the overall population; early symptomatic patients treated with leriglitazone had an improvement in 6MWT compared to placebo; 3 of 77 patients treated with leriglitazone and  8 of 39 patients treated with placebo arm showed new or progressing cerebral lesions (p=0.0066)
Orphomed, Inc., of San Francisco ORP-101 Opioid receptor kappa antagonist/mu partial agonist  Irritable bowel syndrome with diarrhea  Study cleared the first interim futility analysis triggered by enrollment of 200 patients; second interim analysis expected late in the first quarter of 2021; top-line results expected in the second half of 2021
Rhythm Pharmaceuticals Inc., of Boston Setmelanotide  Melanocortin-4 receptor agonist Severe obesity due to genetic variants in the melanocortin-4 receptor pathway In the basket study, 34.3% of the 35 patients responded, defined as losing at least 5% of their body weight over 3 months; mean body weight reduction was 3.7% for all patients and 10.1% for the responders; 50% of 8 patients with a pathogenic or likely pathogenic variant responded; 50% of patients with the N221D variant of  PCSK1 responded; 21.1% of patients with variant of unknown significance responded
Phase III
Eli Lilly and Co., of Indianapolis Bamlanivimab and etesevimab Monoclonal antibodies targeting SARS-CoV-2 COVID-19 In the Blaze-1 study, the antibodies reduced COVID-19-related hospitalizations and deaths by 70% (p=0.0004); in the Blaze-4 study, pharmacodynamic/pharmacokinetic data showed the bamlanivimab 700-mg and etesevimab 1,400-mg dose was similar to the bamlanivimab 2,800-mg and etesevimab 2,800-mg dose
Marinus Pharmaceuticals Inc., of Radnor, Pa. Ganaxolone  GABA A receptor modulator Refractory status epilepticus Enrolled first of approximately 125 patients in the Raise study; co-primary endpoints are the proportion of patients with SE cessation within 30 minutes of treatment initiation without other medications for the treatment of SE and the proportion of patients with no progression to I.V. anesthesia for 36 hours following treatment initiation
Myovant Sciences Ltd., of Basel, Switzerland, and Pfizer Inc., of New York Relugolix  Oral GnRH receptor antagonist Endometriosis  In the Spirit study, 84.8% of patients had clinically meaningful reductions in dysmenorrhea at 1 year; 73.3% of women had reductions in non-menstrual pelvic pain; drug produced an 82.8% average reduction from baseline on the Numerical Rating Scale for dysmenorrhea; plans to submit data in an NDA to the FDA in first half of 2021
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. REGEN-COV (casirivimab/imdevimab) Monoclonal antibodies targeting SARS-CoV-2 COVID-19 prophylaxis In patients with household exposure to a COVID-19 patient; 8 of 223 participants who received placebo developed symptomatic infection vs. 0 of 186 participants treated with REGEN-COV; infection rates (symptomatic and asymptomatic) were 23/223 for placebo vs. 10/186 for REGEN-COV

Notes

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