Company Product Description Indication Status
Phase I
Caladrius Biosciences Inc., of Basking Ridge, N.J. CLBS-119 Autologous CD34+ cell therapy product COVID-19-induced lung damage Study withdrawn; acute treatments have led to decreased use of ventilatory support and, coupled with vaccine approval, has changed profile/prognosis of patients and led to lack of patients with long-term hypoxia
Clearside Biomedical Inc., of Alpharetta, Ga. CLS-AX (axitinib) Tyrosine kinase inhibitor Neovascular age-related macular degeneration First patients enrolled in the phase I/IIa Oasis study; primary endpoint is safety and tolerability of CLS-AX; secondary endpoints will evaluate the pharmacokinetics, visual function, ocular anatomy and the need for additional treatment; data from first cohort expected in mid-2021
Gannex, of Shanghai, a unit of Ascletis Pharma Inc. ASC-41  Thyroid hormone receptor beta agonist Elevated low-density lipoprotein cholesterol The 5-mg dose produced a 19.99% placebo-adjusted reduction in low-density lipoprotein cholesterol (p=0.002) and a 34.49% placebo-adjusted reduction in triglycerides (p=0.015) after 14 days of treatment
GT Biopharma Inc., of Beverly Hills, Calif. GTB-3550 Trispecific scFv recombinant fusion protein conjugate containing the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15 CD33+ malignancies Restarted enrollment in phase I/II study after a 30-day pause due to the COVID-19 pandemic
Helsinn Healthcare SA, of Lugano, Switzerland, and Taiho Pharmaceutical Co. Ltd., of Tokyo TAS-0953/HM-06 RET inhibitor Advanced solid tumors with RET gene abnormalities First patient treated in the phase I/II study; primary purpose of the phase I portion is to determine the maximum tolerated dose and the recommended phase II dose; primary endpoint of the phase II portion is objective response rate
Merus NV, of Utrecht, the Netherlands MCLA-158 Bispecific antibody targeting EGFR and LGR5 Metastatic colorectal cancer Drug was well-tolerated; enrolling patients with gastric and other non-colorectal cancers in the expansion phase
Ox2 Therapeutics Inc., of Minneapolis CD200AR-L Peptide checkpoint ligand Recurrent high-grade glioblastoma Treated first patient in the dose-escalation study
Rezolute Inc., of Redwood City, Calif RZ-402 Plasma kallikrein inhibitor Healthy volunteers (eventually diabetic macular edema) Started dosing of patients in the RZ402-101 study testing the safety, tolerability and pharmacokinetics of RZ-402; data expected in the first half of 2021
Vir Biotechnology Inc., of San Francisco, and Glaxosmithkline plc, of London VIR-7832 SARS-CoV-2 neutralizing antibody Mild to moderate COVID-19 VIR-7832 will be tested in the phase Ib/IIa Agile trial platform study scheduled to start in the first quarter of 2021; phase Ib will enroll 24 patients randomized 3-to-1 to VIR-7832 or placebo to determine the optimal dose; 125-patient phase IIa will compare VIR-7832 to VIR-7831 and to placebo; primary endpoints are safety and change in SARS-CoV-2 viral load from baseline to day 8
Vitalis LLC, of New York VTS-K VTS-aspirin and ketamine Acute musculoskeletal pain Treated first of 25 patients in the pilot study; primary endpoint is reduction of pain scores on numeric rating pain scale at 60 minutes post-administration; secondary endpoints include a need for rescue analgesia and rates of adverse events up to 90 minutes post-administration; top-line data expected in the first quarter of 2021
Phase II
Bone Therapeutics SA, of Gosselies, Belgium Allob  Allogeneic cell therapy Difficult-to-heal tibial fractures Treated first patient in phase IIb trial; top-line data expected in second half of 2022
Clovis Oncology Inc., of Boulder, Colo. Rucaparib  PARP inhibitor Select solid tumors, including high-grade serous or endometroid ovarian cancer Study testing combination with Opdivo (nivolumab, Bristol Myers Squibb Co.) terminated due to low accrual
Lipocine Inc., of Salt Lake City LPCN-1144 Oral prodrug of endogenous testosterone Noncirrhotic nonalcoholic steatohepatitis Top-line results from study enrolling biopsy-confirmed male subjects showed post 12 weeks of treatment resulted in robust liver fat reduction, assessed by Magnetic Resonance Imaging Proton Density Fat Fraction, and showed improvement of liver injury markers with no observed tolerability issues; inclusion of d-alpha tocopherol formulated with testosterone prodrug resulted in additional liver benefits, notably improved key liver markers without compromising tolerability
Terns Pharmaceuticals Inc., of Foster City, Calif. TERN-101 Liver-distributed nonbile acid FXR agonist Nonalcoholic steatohepatitis Completed enrollment in phase IIa Lift study; data expected in third quarter of 2021
Phase III
Blue Earth Diagnostics Inc., of Burlington, Mass. 18F-fluciclovine PET imaging radiopharmaceutical Recurrent brain metastases First patient dose in Revelate trial assessing diagnostic performance in detecting recurrent brain metastases in patients previously treated with radiation therapy
Cellectar Biosciences Inc., of Florham Park, N.J. CLR-131 Phospholipid Drug Conjugate designed to provide targeted delivery of radioisotope iodine-131 Waldenström's macroglobulinemia Initiated pivotal trial, designed as global, noncomparator, single-arm, expansion cohort of ongoing phase II Clover-1 trial
Mesoblast Ltd., of New York Rexlemestrocel-L Cardioprotectant Chronic heart failure Additional data from Dream-HF trial showed 60% reduction in incidence of Major Adverse Cardiac Events (MACE) due to heart attacks or strokes across entire 537-patient study population, irrespective of NYHA class II or III, ischemic or non-ischemic etiology (p=0.002); 68% reduction in rate of recurrent hospitalizations from nonfatal heart attacks or strokes, with a hospitalization rate of 1.90 per 100 patient-years of follow-up vs. 5.95 per 100 patient-years of follow-up in control arm (p=0.0002); 60% reduction in cardiac death in NYHA class II patients (p=0.037) and prevention of progression to NYHA class III rate of cardiac death (p=0.004); 30% reduction in incidence of 3-point MACE (cardiac death, heart attack or stroke) across entire population (p=0.027)
Resverlogix Corp., of Calgary, Alberta Apabetalone Small-molecule BET inhibitor Heart failure Prespecified analysis from Betonmace study published in Cardiovascular Diabetology showed significantly fewer hospitalizations for heart failure (HHF) patients with type 2 diabetes and recent history or acute coronary syndrome vs. placebo; company plans to include HHF in composite primary endpoint for upcoming registration-enabling study, Betonmace2
Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) Anti-PD-L1 inhibitor Hepatocellular carcinoma Updated data from Imbrave150 study in combination with Avastin (bevacizumab) vs. sorafenib in patients with unresectable disease who have not received prior systemic therapy showed, at median follow-up of 15.6 months, reduction in risk of death by 34%; median overall survival of 19.2 months vs. 13.4 months for sorafenib

Notes

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