Company Product Description Indication Status
Phase I
F-star Therapeutics Inc., of Cambridge, U.K. FS-222 Bispecific antibody targeting CD137 and PD-L1 Advanced malignancies First patient treated in the study testing the safety, tolerability and clinical activity of FS-222
Harpoon Therapeutics Inc., of South San Francisco HPN-328 Trispecific T cell-activating construct targeting delta like ligand 3 Small-cell lung cancer and other tumors associated with DLL3 expression Treated first patient in the phase I/II study assessing safety, tolerability and pharmacokinetics of HPN-328
Mei Pharma Inc., of San Diego Zandelisib Phosphatidylinositol 3-kinase delta inhibitor B-cell malignancies Safety review committee completed safety evaluation of zandelisib plus Brukinsa (zanubrutinib, Beigene Ltd.); expanding into disease specific B-cell malignancy cohorts
Pandion Therapeutics Inc., of Watertown, Mass. PT-101 IL-2 mutein fused to a protein backbone Healthy volunteers (eventually ulcerative colitis, systemic lupus erythematosus and other autoimmune diseases) PT-101 expanded total regulatory T cells (Tregs) up to 3.6 times baseline; Tregs with high CD25 expression increased up to 72.5-fold over baseline; no evidence of expansion of natural killer T cells and pro-inflammatory conventional T
Phase II
Aptinyx Inc., of Evanston, Ill. NYX-2925 NMDA receptor modulator Diabetic peripheral neuropathy Restarted recruitment and screening following a suspension due to the COVID-19 pandemic
Calithera Biosciences  Inc., of South San Francisco Telaglenastat Glutamine inhibitor Advanced or metastatic renal cell carcinoma In the Cantata study, progression-free survival for telaglenastat plus Cabometyx (cabozantinib, Exelixis Inc.) was 9.2 months compared to 9.3 months for Cabometyx alone (HR=0.94, p=0.65)
Dicerna Pharmaceuticals Inc., of Lexington, Mass. Nedosiran RNAi targeting lactate dehydrogenase expression Primary hyperoxaluria type 1 and 2 Completed enrollment in the Phyox2 study; top-line results expected in the middle of 2021
Kaleido Biosciences Inc., of Lexington, Mass. KB-109 Glycan Mild to moderate COVID-19 Completed enrollment of the 350-patient study; top-line data expected in the first quarter of 2021
Landos Biopharma Inc., of Blacksburg, Va. BT-11 LANCL2 modulator Mild to moderate ulcerative colitis Remission rates, defined by the 3-component modified Mayo Score, were 31.8% for the 1,000-mg dose and 30.3% for the 500-mg dose compared to 22.7% for placebo (p=0.340 and 0.235, respectively)
Qu Biologics Inc., of Vancouver, British Columbia QBECO Gastrointestinal-targeted immunomodulator Moderate to severe Crohn’s disease Positive signs of clinical, endoscopic and histologic response observed in the Restore study; full data from stage 1 of the study expected in February 2021
Tiziana Life Sciences plc, of New York Foralumab Monoclonal antibody targeting CD3 COVID-19 Completed study; top-line data expected in January 2021
Phase III
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Troriluzole  Glutamate modulating agent Obsessive-compulsive disorder First patient enrolled in study testing the drug in approximately 600 patients not responding to standard of care treatment
Insmed Inc., of Bridgewater, N.J. Arikayce (amikacin) 30S ribosomal protein inhibitor   Nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex Treated first patient in the front-line clinical program, consisting of the Arise study to validate cross-sectional and longitudinal characteristics of patient-reported outcome tools and the Encore pivotal study in newly diagnosed patients
Kedrion Biopharma SpA, of Fort Lee, N.J. 10% intravenous immunoglobulin Antibodies Primary immunodeficiency disease Last patient treated in the Cares10 study

Notes

For more information about individual companies and/or products, see Cortellis.