Company Product Description Indication Status
Phase I
Affimed NV, of Heidelberg, Germany AFM-24 Bispecific EGFR/CD16A-binding innate cell engager Advanced solid tumors First participant dosed in phase I/IIa trial evaluating study drug as monotherapy in adults with EGFR-positive disease progression; dose-escalation phase designed to determine maximum tolerated dose and establish recommended phase IIa dose
Magenta Therapeutics Inc., of Cambridge, Mass. MGTA-145 
CXCR2 chemokine agonist
Bone marrow transplantation Trial in healthy volunteers met primary and secondary endpoints, showing study drug's ability, in combination with plerixafor, to mobilize large numbers of functional stem cells in single day; enrollment in renal pharmacokinetic study complete; initiation of multiple phase II trials may be staggered over remainder of 2020 due to COVID-19 pandemic but initial phase II data may be available by year-end 2020, as planned
Novavax Inc., of Gaithersburg, Md. NVX-CoV2373 SARS-CoV-2 recombinant spike protein nanoparticle vaccine COVID-19 infection CRO Nucleus Network Ltd., of Melbourne, selected to oversee testing at Melbourne and Brisbane clinics for trial, expected to begin in May 2020
Vir Biotechnology Inc., of San Francisco VIR-2218 (ALN-HBV-02) Enhanced stabilization chemistry-plus (ESC+) siRNA conjugate Hepatitis B virus infection Phase I data from phase I/II study of VIR-2218, compared to parent RNAi therapeutic ALN-HBV, showed decreased propensity to cause ALT elevations in healthy volunteers at dose levels expected to have clinical relevance; interim data from ongoing phase II portion showed dose-dependent and durable reduction in hepatitis B surface antigen through week 24 in those with chronic HBV who received 2 doses ranging from 20 mg to 200 mg
Phase II
Amag Pharmaceuticals Inc., of Waltham, Mass. AMAG-423 Ovine antidigoxin polyclonal antibody fragment Pre-eclampsia Site initiation and enrollment in phase IIb/IIIa trial expected to be delayed by COVID-19 pandemic
Amag Pharmaceuticals Inc., of Waltham, Mass. Ciraparantag Factor IIa/Xa modulator Anticoagulant overdose Site initiation and enrollment in phase IIb trial in healthy volunteers expected to be delayed by COVID-19 pandemic
Biosig Technologies Inc., of Westport, Conn., and subsidiary Viralclear Pharmaceuticals Inc. Vicromax (merimepodib) Antiviral candidate targeting RNA-dependent polymerases COVID-19 Randomized, placebo-controlled trial to be conducted at Mayo Clinic; data expected within 3 months
Magenta Therapeutics Inc., of Cambridge, Mass. MGTA-456 (spanlecortemlocel) AHR gene inhibitor Hematopoietic stem cell transplantation Enrollment timelines for trial in inherited metabolic disorders shifted into 2021 due to COVID 19 pandemic; 16 of 18 participants enrolled in separate blood cancer trial, expected to complete enrollment in 2020
PDS Biotechnology Corp., of Princeton, N.J. PDS-0101  Cationic lipid nanoparticle formulated vaccine Head and neck cancer Initiation of Versatile-0022 trial in individuals with advanced/metastatic disease delayed due to COVID-19 pandemic
Sunovion Pharmaceuticals Inc., unit of Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan SEP-363856 Trace amine associated receptor 1 agonist; 5-HT 1a receptor agonist Schizophrenia In 4-week pivotal study, published online in The New England Journal of Medicine, once-daily, flexible-dose (50 mg-75 mg) treatment showed statistically significant improvement vs. placebo in Positive and Negative Syndrome Scale total score (-17.2 vs. -9.7, respectively; p=0.001); those dosed with study drug also showed improvement in overall severity of illness assessed by CGI-S (p<0.001); continued improvement in efficacy measures seen during 6-month open-label extension study
Phase III
Actinium Pharmaceuticals Inc., of New York Iomab-B (Iodine [131I] apamistamab) CD45 antagonist Acute myeloid leukemia Single ad hoc interim analysis for pivotal Sierra trial in older adults with relapsed/refractory disease will be exercised at company's discretion in second quarter of 2020, making top-line data available in fourth quarter of 2020; enrollment continuing at most sites despite COVID-19 pandemic
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 (repurposed ondansetron) 5-HT 3 receptor antagonist Alcohol use disorder Companion diagnostic genetic test verified as clinically effective through use in pivotal Onward trial
Indivior plc, of Slough, U.K. Sublocade (buprenorphine extended-release) ORL1 receptor agonist; opioid receptor mu partial agonist Opiate dependence Long-term data, published online in Journal of Clinical Psychopharmacology, showed safety profile of treatment up to 12 months was consistent with transmucosal buprenorphine with exception of injection-site reactions; 66.8% of participants reported >1 treatment-emergent adverse event (TEAE), with injection-site TEAEs (13.2% of participants) mostly mild or moderate in severity and no TEAEs potentially related to respiratory depression; after 12 months of treatment, 61.5% of phase III rollover and 75.8% of de novo participants were free of illicit opioid use
Roivant Sciences Inc., of New York and Basel, Switzerland Gimsilumab Fully human monoclonal antibody targeting GM-CSF COVID-19 First patient dosed at Temple University Hospital in Philadelphia in adaptive pivotal Breathe trial testing impact of treatment on mortality in patients with lung injury or acute respiratory distress syndrome; study to enroll up to 270 patients, randomized to gimsilumab or placebo; primary endpoint is incidence of mortality by day 43

Notes

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