Company Product Description Indication Status
Phase I
Faron Pharma Oy, of Turku, Finland Bexmarilimab Stabilin 1 inhibitor Solid tumors Ongoing phase I/II Matins trial showed early signs of efficacy as monotherapy in 4 cohorts with participants who have metastatic or inoperable disease, enabling them to move to part III, according to study protocol; additional data from part II cohorts will determine which indications will move forward, including potential programs in newly diagnosed colorectal and kidney cancers, non-small-cell lung cancer combination study with anti-PD-(L)1 therapy and combination with standard of care in acute myeloid leukemia/myelodysplastic syndrome
India Globalization Capital Inc. (IGC), of Potomac, Md. IGC-AD1 Phytocannabinoid-based therapeutic Alzheimer's disease Subsidiary IGC Pharma LLC initiated trial and enrolled first of 12 participants with mild to severe AD dementia 
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa. INO-3107 DNA HPV-6/HPV-11 vaccine Recurrent respiratory papillomatosis First of up to 63 participants dosed in phase I/II trial; primary efficacy endpoint is doubling or more in time between surgical interventions following first dose relative to frequency before study therapy
Maplight Therapeutics Inc., of San Francisco ML-004  Serotonin receptor agonist Autism spectrum disorder Dosing completed in 40 healthy volunteers enrolled across 5 cohorts; initial results suggest study drug appears well-tolerated at all dose levels to treat  deficits in sociability and irritability in ASD
Molecular Partners AG, of Zurich-Schlieren, Switzerland MP-0420 (ensovibep) COVID-19 Spike glycoprotein inhibitor COVID-19 infection First cohort of 8 healthy volunteers dosed in first-in-human study of Darpin therapeutic candidate expected to enroll up to 24 volunteers across 3 dose cohorts
PMV Pharmaceuticals Inc., of Cranbury, N.J. PC-14586 p53 tumor suppressor protein stimulator Advanced solid tumors First of up to 130 people with p53 Y220C disease variant dosed in phase I/II study; phase II portion will assess overall response rate and duration of response at dose identified in phase I
Silicon Therapeutics LLC, of Boston SNX-281 STING agonist Advanced solid tumors; lymphoma First of up to 128 participants dosed; after optimal dose identified, expansion cohorts will assess efficacy against colorectal and ovarian carcinoma as monotherapy and in tumors refractory/relapsed to checkpoint inhibitors in combination arm with PD-1 inhibitor pembrolizumab (Keytruda, Merck & Co. Inc.)
Syndevrx Inc., of Cambridge, Mass. SDX-7320 MetAP2 inhibitor Advanced solid tumors Dose-escalation study that enrolled 32 people showed 28 had at least 1 tumor burden assessment performed, with 21 (75%) of these showing at least 1 stable disease determination before leaving study or experiencing progressive disease; of the 21 patients, period of measurable stable disease averaged 85 days, with no objective partial or complete responses
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (Ifenprodil) NMDA receptor antagonist COVID-19 infection Phase IIb/III study enrolled 154 participants; due to attrition, enrollment will be increased to 168
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-154 (topical roflumilast foam) PDE4 inhibitor Psoriasis In phase IIb study, daily 0.3% dose showed statistically significant improvement vs. vehicle on key efficacy endpoint in 304 adult and adolescent participants, achieving rate of 59.1% vs. 11.4%, respectively (p<0.0001), on primary endpoint of Scalp Investigator Global Assessment success at week 8; study drug achieved rate of 40.3% vs. 6.8% for vehicle (p<0.0001) on key secondary endpoint of Body Investigator Global Assessment success at week 8
Astrazeneca plc, of Cambridge, U.K. AZD-1222 COVID-19 Spike glycoprotein modulator COVID-19 infection Pooled analysis of phase II/III COV002 trial in U.K. and phase III COV003 trial in Brazil showed average efficacy of 70.4% across 2 dose regimens (n=11,636), increasing to 90% in prime-boost arm (n=2,741); results were statistically significant (p<=0.0001) and data safety monitoring board deemed analysis met primary endpoint showing protection from infection occurring 14 days or more after receiving 2 doses
Dnatrix Inc., of Houston DNX-2401 (tasadenoturev) Oncolytic adenovirus Glioblastoma Captive combination study with pembrolizumab (Keytruda, Merck & Co. Inc.) in people with recurrent disease showed median overall survival of 12.5 months (n=42); survival rate at 18 months was 20.2%
Eisai Inc., unit of Eisai Co. Ltd., of Tokyo Lenvima (lenvatinib)  Multiple receptor tyrosine kinase inhibitor Differentiated thyroid cancer  Study 211 in people with radioactive iodine-refractory disease showed lower starting dose (18 mg) did not meet threshold for noninferiority vs. FDA-approved starting dose (24 mg); in primary efficacy analysis, objective response rate at week 24 was 57.3% in 24-mg arm vs. 40.3% for 18 mg 
Gemvax & Kael Co. Ltd., of Seoul GV-1001  Telomerase modulator Alzheimer's disease Trial showed statistically significant improvement in neuropsychiatric inventory and improvement trend in AD Cooperative Study-Activities of Daily living 
Idorsia Ltd., of Allschwil, Switzerland Clazosentan Endothelin ET-A receptor antagonist Post-aneurysmal subarachnoid hemorrhage Top-line results from Japanese registration program demonstrated drug reduced occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p<0.01 for both studies); drug showed numerical reduction of all-cause morbidity and mortality in both studies, with effect significant (p<0.05) in preplanned pooled analysis
Imugene Ltd., of Sydney HER-Vaxx (IMU-131) ERBB2 tyrosine kinase receptor inhibitor Gastric cancer Interim data from ongoing study in HER2/Neu-overexpressing advanced/metastatic disease showed statistically significant overall survival (OS) with HR of 0.418 (80% 2-sided CI: 0.186, 0.942); study drug + chemotherapy showed 58.2% reduced risk of death vs. chemotherapy alone; median OS for those who received HER-Vaxx + chemo was 14.2 months vs. 8.8 months for chemotherapy alone
Neurana Pharmaceuticals Inc., of San Diego Tolperisone Analgesic Acute and painful muscle spasms of the lower back Results from Star study, published in the Journal of Pain Research, showed mean change from baseline in numeric rating scale score of pain "right now" on day 14 was -3.5 for placebo vs. -4.2, -4, -3.7 and -4.4 for tolperisone 50 mg, 100 mg, 150 mg and 200 mg TID, respectively
Saniona AB, of Copenhagen Tesomet (tesofensine + metoprolol) Triple monoamine reuptake inhibitor + beta-1 selective blocker Hypothalamic obesity Average weight reduction achieved in double-blind period was maintained through 24-week open-label extension (OLE), with participants showing statistically significant 5.96% average reduction in body weight at week 48 (p=0.008 vs. baseline); those who received placebo during double-blind period and switched to Tesomet at week 24 for OLE showed 4.95% average reduction in body weight from baseline to week 48
Phase III
3Sbio Inc., of Shenyang, China, and Selecta Biosciences Inc., of Watertown, Mass. SEL-212 Uricase stimulator Chronic refractory gout Selecta commenced program known as Dissolve on behalf of partner Swedish Orphan Biovitrum AB
Bellerophon Therapeutics Inc., of Warren, N.J. Inopulse Inhaled nitric oxide therapy COVID-19 Independent data monitoring committee completed prespecified interim analysis of first 100 patients in Covinox study and, based on recommendation of DMC, company put study on hold
Bioshin Ltd., of Shanghai Rimegepant CGRP receptor antagonist  Acute migraine Enrolled first patients in BHV3000-301 study
Cytodyn Inc., of Vancouver, Washington Vyrologix (leronlimab; PRO-140) CCR5 antagonist COVID-19 Reached enrollment of 293 patients with severe to critical symptoms, meeting requested criteria for second interim efficacy analysis by data safety monitoring committee
Immunocore Ltd., of Oxfordshire, U.K. Tebentafusp (IMCgp-100) HLA class I antigen A-2 alpha modulator; melanocyte protein Pmel 17 modulator; CD3 modulator Metastatic uveal melanoma IMCgp100-202 study met predefined boundaries for statistical significance of primary endpoint of overall survival in first preplanned interim analysis conducted by independent data monitoring committee; OS hazard ratio in intent-to-treat population favored tebentafusp (HR=0.51; p< 0.0001), over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine); though not yet mature, the Kaplan-Meier estimates suggest a 1-year OS rate of about 73% vs. 58%, respectively
Innovent Biologics Inc., of San Francisco and Suzhou, China Tyvyt (sintilimab injection) and Byvasda (bevacizumab biosimilar injection) Anti-PD-1 antibody and anti-VEGF antibody Hepatocellular carcinoma Interim analysis of data from Orient-32 study in patients with advanced unresectable disease showed combination significantly improved overall survival and independent radiographic review committee (IRRC) progression-free survival vs. sorafenib; combo showed 43.1% decreased risk of all-cause mortality (p<0.0001); median OS was not reached in combo arm vs. 10.4 months in sorafenib arm; Tyvyt/Byvasda also demonstrated 43.5% decreased risk of progression as assessed by IRRC (p<0.0001); median PFS was 4.6 months in combo arm vs. 2.8 months in sorafenib arm
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Exportin 1 inhibitor Liposarcoma Results from phase III portion of Seal study showed improvement in progression-free survival vs. placebo in patients with at least 2 prior therapies; median PFS was 2.83 months vs. 2.07 months (p=0.-23), indicating Xpovio reduced risk of disease progression or death by about 30%; estimated 6-month PFS survival probability was 23.9 months vs. 13.9 months; 7.5% of patients on selinexor had a 15% or greater reduction in disease burden as measured by target lesion size while none of the patients on placebo achieved that level of reduction
Pfizer Inc., of New York Marstacimab (PF-06741086) Anti-tissue factor pathway inhibitor Severe hemophilia A or B, with or without inhibitors First participant dosed in Basis study, intended to evaluate annualized bleed rate through 12 months on prophylaxis treatment

Notes

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