Company Product Description Indication Status
Phase I
Ayala Pharmaceuticals Inc., of Rehovot, Israel, and Novartis AG, of Basel, Switzerland AL-102; WVT-078 Gamma secretase inhibitor; Anti-B-cell maturation antigen Relapsed and/or refractory multiple myeloma after 2 or more standard of care lines of therapy including an immunomodulatory imide drug Treated first patient in the dose-escalation study testing the safety, tolerability and recommended dose regimen(s) of WVT-078 alone and in combination with AL-102; study will also measure preliminary efficacy and characterize the pharmacokinetics and immunogenicity of WVT-078 alone and in combination with AL-102
Cohbar Inc., of Menlo Park, Calif. CB-4211   Analog of the mitochondrial derived peptide MOTS-c Nonalcoholic steatohepatitis and obesity Completed last patient visit for the phase Ib study; top-line data expected in early July 2021
Evelo Biosciences Inc., of Cambridge, Mass. EDP-1815 Non-live strain of Prevotella histicola Mild and moderate atopic dermatitis Compared to placebo at day 70, 31% more patients treated with EDP-1815 achieved an Investigator’s Global Assessment (IGA) score of 0 or 1; 19% more EDP1815-treated patients reached an IGA score of 0 or 1 with a 2-point improvement from baseline compared to placebo
Revolution Medicines Inc., of Redwood City, Calif. RMC-5552 Bi-steric mTORC1 inhibitor Advanced relapsed/refractory solid tumors Treated first patient in the phase I/Ib study testing the safety, tolerability, preliminary efficacy and pharmacokinetics of RMC-5552
Vaccinex Inc., of Rochester, N.Y. Pepinemab Anti-semaphorin 4D antibody Non-small-cell lung cancer Data from the phase Ib/II Classical-Lung study published in Clinical Cancer Research showed 4 of 21 evaluable  immunotherapy naïve patients treated with pepinemab plus Bavencio (avelumab, Pfizer Inc./Merck KGaA) had a partial response; disease control rate was 81%; 2 of 29 evaluable patients previously treated with an anti-PD-1/L1 immunotherapy had a partial response with a DCR of 59%
Phase II
Agenebio Inc., of Baltimore AGB-101 Low-dose version of atypical anticonvulsant levetiracetam Mild cognitive impairment due to Alzheimer's disease Completed enrollment in the 78-week, 164-patient Hope4MCI study; data expected at the end of 2022
Antios Therapeutics Inc., of Mendham, N.J. ATI-2173 Active site polymerase inhibitor nucleotide Chronic hepatitis B virus (HBV) infection Treated first of 30 patients in the SAVE study comparing 2 dose levels of ATI-2173 plus tenofovir to placebo; an additional cohort will test the high dose in patients co-infected with HBV and hepatitis D virus (HDV); efficacy endpoints include maximum HBV DNA level responses and off-treatment sustained virologic responses for the mono-infected patients and HDV RNA treatment responses in the HBV/HDV-coinfected patients
Brii Biosciences Ltd., of Beijing, Vir Biotechnology Inc., of San Francisco, and VBI Vaccines Inc., of Cambridge, Mass. BRII-835 (VIR-2218); BRII-179 (VBI-2601) Small interfering ribonucleic acid targeting hepatitis B virus (HBV); protein-based HBV immunotherapeutic Chronic HBV infection First patient treated in the study comparing BRII-835 (VIR-2218) to BRII-835 (VIR-2218) plus BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant; primary efficacy endpoint is the percent of patients meeting the nucleoside reverse transcriptase inhibitor withdrawal criteria up to week 44
Humacyte Inc., of Durham, N.C. Human acellular vessels Implantable bioengineered human tissue Arteriovenous access in hemodialysis Secondary patency was 58.2% at 5 years, excluding deaths and withdrawals; no infections or immunological rejection were observed
Kadmon Holdings Inc., of New York Belumosudil (KD-025) Rho-associated coiled-coil kinase 2 inhibitor Chronic graft-vs.-host disease Data form the phase IIa KD025-208 study published in the Journal of Clinical Oncology showed the overall response rate was 65% across the 3 patient cohorts; median duration of response was 35 weeks; 50% of responders experienced at least a 7-point decrease in the Lee cGVHD Symptom Scale score; 67% of all patients were able to reduce steroid doses and 19% of patients completely discontinued steroids
Kancera AB, of Solna, Sweden KAND-567  Fractalkine blocker  COVID-19 Study has dosed two thirds of the total of 40 patients; expects to complete enrollment in the second quarter of 2021
Khondrion BV, of Nijmegen, the Netherlands Sonlicromanol Redox modulator with anti-inflammatory properties  Genetically confirmed primary mitochondrial disease with motor symptoms First patient treated in the Khenergyc pediatric study; primary objective is to evaluate the effect of sonlicromanol on motor function using quantitative assessments, including the Gross Motor Function Measure-88 and the Nine Hole Peg Test
Retrotope Inc., of Los Altos, Calif. RT-001  Isotopically stabilized, synthetic linoleic acid Amyotrophic lateral sclerosis Completed enrollment of more than 40 patients in less than 6 weeks; data expected by the end of 2021
TG Therapeutics Inc., of New York Ukoniq (umbralisib) + ublituximab + Venclexta (venetoclax, Abbvie Inc./Genentech Inc.) Dual PI3K-delta/CK1-epsilon inhibitor + anti-CD20 monoclonal antibody + Bcl-2 protein inhibitor Chronic lymphocytic leukemia Phase II portion of Ultra-V trial fully enrolled with ~165 participants with front line and relapsed/refractory disease; primary endpoint is overall response rate and complete response
Trevena Inc., of Chesterbrook, Pa. TRV-027 AT1 receptor selective agonist COVID-19 Drug will be included in the adaptive REMAP-CAP COVID-19 ACE2 RAS Modulation Domain study testing TRV-027 and 3 other active treatments; primary outcome is a composite of in-hospital mortality and provision of organ failure support while admitted to an ICU in the 21 days following randomization
Phase III
Novo Nordisk A/S, of Bagsværd, Denmark Semaglutide GLP-1 receptor agonist Obesity Pivotal phase IIIa program expected to begin in second half of 2021 and enroll ~1,000 people with obesity or overweight with comorbidities in 68-week trial assessing oral semaglutide dosed weekly at 50 mg
Ocugen Inc., of Malvern, Pa. Coxavin Virion inactivated COVID-19 vaccine COVID-19 infection Co-development partner Bharat Biotech International Ltd., of Hyderabad, India, reported data from second interim analysis showing point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate and severe infection, based on 127 symptomatic cases; efficacy against asymptomatic COVID-19 infection was 70%
TG Therapeutics Inc., of New York Ukoniq (umbralisib) + ublituximab + Venclexta (venetoclax, Abbvie Inc./Genentech Inc.) Dual PI3K-delta/CK1-epsilon inhibitor + anti-CD20 monoclonal antibody + Bcl-2 protein inhibitor Chronic lymphocytic leukemia Phase III portion of Ultra-V trial initiated, evaluating triple combination vs. doublet of Ukoniq + ublituximab in people with front-line and relapsed/refractory disease; primary endpoint is progression-free survival
Phase IV
Oncotelic Therapeutics Inc., of Agoura Hills, Calif. Pulmoheal Broad-spectrum, lung therapy food supplement COVID-19 In the Arti-19 study, 91% of WHO-4 patients achieved a reduction to WHO-3 after the first few doses of Pulmoheal plus standard of care (SOC) (p=0.0037); number of patients with oxygen saturation of 95% or less was reduced by 91% after treatment with Pulmoheal plus SOC compared to a 31% reduction for SOC alone

Notes

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