Company Product Description Indication Status
Phase I
Adicet Bio Inc., of Menlo Park, Calif. ADI-001 Allogeneic gamma delta T-cell therapy expressing a chimeric antigen receptor targeting CD20 B cell non-Hodgkin lymphoma relapsed or refractory to at least 2 prior regimens Started the 75-patient open-label study testing the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001; study may also test the combination of ADI-001 and interleukin 2; preliminary safety and tolerability data expected by the end of 2021
Alar Pharmaceuticals Inc., of Taichung, Taiwan Buprenorphine (ALA-1000) Opioid  Opioid use disorder Drug produced effective concentrations over 12 weeks in the single ascending-dose study; initial burst of drug was low
Aligos Therapeutics Inc., of South San Francisco LG-010133 Oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer Chronic hepatitis B virus infection Started dosing of the first cohort of patients in the ongoing ALG-010133-101 study; initial data from the patient cohorts are expected in the second half of 2021
Beigene Co. Ltd., of Beijing BGB-15025 Hematopoietic progenitor kinase 1 inhibitor Advanced solid tumors Treated first patient in the study testing the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-15025 alone and in combination with tislelizumab
Impact Therapeutics Inc. of Shanghai IMP-7068  Wee1 Inhibitor Advanced solid tumors Treated first patient in the study testing the safety, tolerability, pharmacokinetics and preliminary antitumor activity of IMP-7068
VBI Vaccines Inc., of Ottawa, Ontario VBI-2902 Monovalent enveloped virus-like particle COVID-19 vaccine COVID-19 prophylaxis Started enrollment of the phase I/II study; phase I portion will evaluate a 1- and 2-dose regimen of a 5-µg dose in up to 60 healthy adults ages 18-54; data from phase I expected by the end of the second quarter of 2021; phase II portion will assess escalating 1- and 2-dose regimens across 3 age cohorts: 18-54, 55-65 and 65+
Vertex Pharmaceuticals Inc., of Boston VX-880 Allogeneic human stem cell-derived islet cells  Type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness Started the open-label phase I/II study testing the safety and efficacy of different doses of VX-880; study will enroll approximately 17 patients
Phase II
Affimed NV, of Heidelberg, Germany AFM-13 Anti-CD30 and CD16 bivalent antibody Relapsed or refractory CD30-positive peripheral T-cell lymphoma Decided to continue enrollment in Redirect trial following preplanned interim futility analysis, demonstrating that response rate in cohort A achieved predefined threshold for continuation; response rate in cohort B was sufficiently comparable to allow merging of both cohorts into single cohort of all with CD30 >1%, per the study protocol; evidence of antitumor response observed in both cohorts, with complete and partial responses
Gilead Sciences Inc., of Foster City, Calif. Lenacapavir HIV p24 capsid protein inhibitor Multidrug-resistant HIV-1 infection Additional results from phase II/III Capella trial show drug, subcutaneously administered every 6 months, maintained high rates of virologic suppression through 26 weeks; 73% (n=19/26) of participants who reached week 26 since first dose achieved undetectable viral load (<50 copies/mL)
Viiv Healthcare Ltd., of London GSK-3640254 Maturation inhibitor HIV Phase IIa data established relationship between dose and antiviral response, with 140-mg and 200-mg doses showing greatest reduction in plasma HIV-1 RNA
Phase III
Eli Lilly and Co., of Indianapolis Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV-16) Therapeutic antibody; COVID-19 spike glycoprotein modulator; COVID-19 spike glycoprotein inhibitor COVID-19 New data from Blaze-1 study showed combination significantly reduced COVID-19-related hospitalizations and death in high-risk patients recently diagnosed; there were 4 events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87% risk reduction (p<0.0001)
Natera Inc., of Austin, Texas, and Genentech, of South San Francisco, a unit of Roche Holding AG Signatura Companion diagnostic Muscle-invasive urothelial carcinoma First patient screened in trial to use personalized molecule residual disease test to identify patients eligible for treatment with Tecentriq (atezolizumab)
Phase IV
Viriom Inc., of San Diego, and Chromis, a joint venture of Chemrar Group and the Russian Direct Investment Fund Avifavir (favipiravir) RNA polymerase inhibitor COVID-19 Data from post-registration study showed median time to virus elimination in Avifavir and standard-of-care (SOC) groups was 8 and 12 days, respectively (p<0.001); median time to clinical improvement was 12 and 15 days, respectively (p<0.001), with statistically significantly greater number of patients with clinical improvement for Avifavir group vs. SOC at 7 days (p=0.0248) and 14 days (p<0.001) of treatment initiation 

Notes

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