Company Product Description Indication Status
Phase I
Arcturus Therapeutics Holdings Inc., of San Diego ARCT-021 Self-replicating mRNA-based vaccine COVID-19 prophylaxis All 44 participants treated at the 2 higher doses had binding and/or neutralizing antibodies to SARS-CoV-2; peak geometric mean binding antibody titers were 4,959 for 5 µg single shot, 6,749 for 7.5 µg single shot, 16,642 for 5 µg prime-boosted and less than 400 for placebo; responder peak geometric mean neutralizing antibody titers were 32 for 5 µg single dose, 33 for 7.5 µg single dose and 46 for 5 µg prime-boost
Intra-Cellular Therapies Inc., of New York ITI-LLAI Long-acting injectable formulation of the antipsychotic  lumateperone  Schizophrenia Started the ITI-007-025 study testing the pharmacokinetics, safety and tolerability of single ascending doses of ITI-LLAI  in patients with stable symptoms of schizophrenia
Intra-Cellular Therapies Inc., of New York ITI-333 Antagonist of serotonin 5-HT2A receptors and a partial agonist at mu-opioid receptors Healthy volunteers (eventually opioid use disorder) Started the ITI-333-001 testing the safety, tolerability and pharmacokinetics of ascending doses of ITI-333
Nanology LLC, of Ft. Worth, Texas SOR-007  Topical submicron particle formulation of the chemotherapy paclitaxel Cutaneous metastases Overall response rate was 27% for the 11 patients in 28-day treatment group and 54% for the 11 patients in the 56-day treatment group
Phase III
Actinium Pharmaceuticals Inc., of New York Iomab-B I-131-labeled monoclonal antibody targeting CD45 Bone marrow transplant conditioning in active relapsed or refractory acute myeloid leukemia Interim results from the Sierra study showed all of the 49 patients treated with Iomab-B successfully proceeded to bone marrow transplant (BMT) and achieved engraftment compared to 16% of the 56 patients who received physician's choice of salvage therapies; all 30 patients who crossed over from physician's choice to Iomab-B had successful engrafting after BMT
VBL Therapeutics Ltd., of Tel Aviv, Israel Ofranergene obadenovec (VB-111) CD95/TNF receptor modulator  Platinum-resistant ovarian cancer Enrolled first patient in Europe into the ongoing Oval study; over 200 patients enrolled to date; next data safety monitoring committee review expected in the first quarter of 2021

Notes

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