Company Product Description Indication Status
Phase I
Apellis Pharmaceuticals Inc., of Waltham, Mass. APL-9 C3 inhibitor COVID-19 patients with respiratory failure Started the 66-patient study measuring length of stay in the hospital, overall survival, time on oxygen therapy or mechanical ventilation and markers of complement activation, organ failure and coagulation
Enlivex Therapeutics Ltd., of Nes Ziona, Israel Allocetra Immunotherapy  Sepsis  Patients treated with Allocetra in phase Ib trial had reductions in pro- and anti-inflammatory cytokines, chemokines and additional immune modulators; mortality was 0% for 10 patients treated with Allocetra compared to 27% for 37 matched historical control patients; resolution of organ function and intensive care unit stays were shorter for patients treated with Allocetra compared to historical controls
I-Mab Biopharma Co. Ltd., of Shanghai TJM-2 Neutralizing antibody targeting human granulocyte-macrophage colony stimulating factor Cytokine release syndrome associated with severe COVID-19 Data monitoring committee recommended moving to part 2 of the phase I/II study testing a single dose of 6 mg/kg TJM-2 or placebo in 120 patients
Phase II
Akcea Therapeutics Inc., of Boston, and Ionis Pharmaceuticals Inc., of Carlsbad, Calif. Tegsedi (inotersen) Antisense targeting transthyretin Hereditary transthyretin amyloidosis with polyneuropathy Data from the open-label extension (OLE) of the phase II/III Neuro-TTR study published in the European Journal of Neurology, showed patients treated for 39 months had sustained benefits; patients taking Tegsedi for the entire study had a greater benefit in modified Neuropathy Impairment Score +7 (17.06 points) and Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (11.89 points) compared to patients who switched from placebo to Tegsedi in the OLE
Atriva Therapeutics GmbH, of Tubingen, Germany ATR-002 MEK inhibitor Moderate COVID-19 in the hospital Plans to start study in July 2020
Calcimedica Inc., of La Jolla, Calif. Auxora (CM-4620-IE) Inhibitor of CRAC channels Severe COVID-19 pneumonia on low-flow oxygen therapy Auxora plus standard of care (SOC) produced a greater than 50% reduction in the proportion of patients put on ventilators in the course of therapy compared to SOC; length of hospital stay was more than 50% shorter for patients treated with Auxora compared to SOC; shifting to a blinded study for severe COVID-19 pneumonia on low-flow oxygen therapy
Iovance Biotherapeutics Inc., of San Carlos, Calif. Lifileucel Autologous tumor infiltrating lymphocyte therapy Advanced melanoma In the first 68 patients of cohort 4 of the C-144-01 study, overall response rate was 32.4% after a median follow-up of 5.3 months; updated data from cohort 2 showed ORR of 36.4% with a duration of response not reached at 18.7 months of median follow-up
Neurotrope Inc., of New York Bryostatin-1 Protein kinase C agonist Moderate or moderately severe Alzheimer's disease Started the 100-patient study testing cognitive benefits as measured by the Severe Impairment Battery score
Oncopeptides AB, of Stockholm Melflufen Peptide-drug conjugate  Relapsed or refractory multiple myeloma Restarting enrollment in the Anchor, Bridge and AL Amyloidosis studies after an enrollment pause due to COVID-19
Partner Therapeutics Inc., of Lexington, Mass. Leukine (sargramostim) Recombinant human granulocyte-macrophage growth factor COVID-19 Investigator-initiated randomized, double-blind, placebo-control trial started in patients with acute respiratory failure associated with COVID-19, at Singapore General Hospital
Windmil Therapeutics Inc., of Baltimore MILs Marrow-infiltrating lymphocytes  Locally advanced unresectable or metastatic non-small-cell lung cancer  Dosed first patient in study testing MILs plus Opdivo (nivolumab, Bristol Myers Squibb Co.) in patients whose disease is refractory to, or who relapsed on, an anti-PD-1-containing regimen; trial measuring safety and overall response rate as the primary endpoints
Phase III
Genentech Inc., a unit of Roche Holding AG, of Basel, Switzerland Actemra (tocilizumab)  Monoclonal antibodies targeting interleukin-6 Hospitalized patients with severe COVID-19 pneumonia In June, plans to start the 450-patient Remdacta study testing Actemra plus remdesivir (Gilead Sciences Inc.); primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care variables
Genmab A/S, of Copenhagen, Denmark, and Janssen Biotech, a unit of Johnson & Johnson, of New Brunswick, N.J. Daratumumab CD38-targeting monoclonal antibody Light-chain amyloidosis Top-line results showed Andromeda study in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) in newly diagnosed patients met primary endpoint of hematologic complete response; patients treated with subcutaneous daratumumab plus CyBorD had a 53.3% hematologic complete response vs. 18.1% of patients on CyBorD alone (p<0.0001)
Zai Lab Ltd., of Shanghai Zejula (niraparib) PARP inhibitor Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after complete or partial response to platinum-based chemotherapy The 265-patient Nora study met its primary endpoint of improvement in progression-free survival and met all secondary endpoints; data to be presented at an upcoming medical meeting

Notes

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

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