Company Product Description Indication Status
Phase I
Amgen Inc., of Thousand Oaks, Calif. AMG-592 Interleukin-2-mutein-Fc fusion protein Active rheumatoid arthritis Phase I/II study terminated after company decision not to proceed with phase II
Innovent Biologics Inc., of Suzhou, China IBI-310 Anti-CTLA4 drug Advanced malignant tumors Preliminary results of phase Ia/Ib trial testing combination with Tyvyt (sintilimab injection) showed no dose-limiting toxicities in either phase, and the dose expansion in phase Ib is ongoing
Janssen Research & Development LLC, of Raritan, N.J, a unit of Johnson & Johnson Macitentan and tadalafil Dual endothelin receptor A and B antagonist and PDE5 inhibitor Pulmonary arterial hypertension Study in healthy adults suspended due to COVID-19
Spring Bank Pharmaceuticals Inc., of Hopkinton, Mass. SB-11285 STING agonist Solid tumors Phase Ia/Ib dose-escalation trial continues to advance to an escalated monotherapy dosing level, and safety review committee recommended dose escalation to monotherapy dose level 3 and concurrent opening and dosing of combination dose level 1 with PD-L1 checkpoint inhibitor Tecentriq (atezolizumab, Roche Holding AG)
Valerion Therapeutics LLC, of Concord, Mass. VAL-1221 Fusion protein Late-onset Pompe disease Phase I/II study terminated after company closure due to lack of funding
Phase II
Complexa Inc., of Berwyn, Pa. CXA-10 Nitrated fatty acid Focal segmental glomerulosclerosis Completed patient enrollment in  Firstx study; results of the initial 90-day dosing treatment phase are expected in the second half of 2020, with an open-label extension continuing into 2021
Replimune Group Inc., of Woburn, Mass. RP-1 Immulytic product Cutaneous squamous cell carcinoma and anti-PD-1 refractory melanoma New interim data from the phase II part of phase I/II trial in combination with Opdivo (nivolumab) from fully accrued 30 patient melanoma cohort continue to strongly support company’s registrational approach
Phase III
Allakos Inc., of Redwood City, Calif.   AK-002 Antolimab Eosinophilic gastritis/duodenitis/esophagitis Recruiting patients for 2 registrational clinical studies: study in EG and/or EoD will enroll about 160 patients and a phase II/III study in EoE that will enroll about 300 patients; top-line safety and efficacy results from both studies are expected in the second half of 2021
Aprea Therapeutics Inc., of Boston APR-246 (eprenetapopt) Small molecule Myelodysplastic syndromes Patient enrollment completed; top-line results expected by year-end 2020
Astrazeneca plc, of Cambridge, U.K. Anifrolumab Antibody binding to type 1 interferon receptor Systemic lupus erythematosus Showed early and sustained reduction of SLE disease activity, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment in new pooled analysis of Tulip 1 and 2 trials; additional pooled analysis showed consistent clinical benefits across all measured patient subgroups, including age, sex, age at onset and race, compared to placebo; anifrolumab also showed reduced annualized flare rates and prolonged time to first flare across both trials vs. placebo, with both arms receiving standard of care
Beyondspring Inc., of New York Plinabulin Non-G-CSF small molecule Non-small-cell lung cancer Reached second interim analysis for Dublin-3 trial; data safety monitoring board advised to continue study without modifications
Eli Lilly and Co., of Indianapolis Taltz (ixekizumab) Monoclonal antibody targeting interleukin-17A Psoriatic arthritis Subgroup analysis of phase IIIb/IV Spirit study of Taltz vs. Humira (adalimumab, Abbvie Inc.) at 52 weeks showed improvements with Taltz across multiple endpoints, with or without the use of methotrexate (MTX) or other conventional synthetic disease-modifying antirheumatic drug (csDMARD); higher proportion of patients treated with Taltz achieved Minimal Disease Activity (MDA) vs. Humira in monotherapy subgroup (49% vs. 33%), while response rates were similar between Taltz and Humira in concomitant MTX subgroup (47% vs. 47%) and concomitant csDMARD subgroup (47% vs 44%); more Taltz patients achieved primary endpoint of simultaneous achievement of ACR50 and PASI 100 at week 52 in all 3 subgroups: monotherapy (38% vs. 19%), concomitant MTX (39% vs. 30%) and concomitant csDMARDs (40% vs. 29%)
Eli Lilly and Co., of Indianapolis Olumiant (baricitinib)  JAK inhibitor Rheumatoid arthritis  Long-term data found that among patients with inadequate response to methotrexate (MTX), 52% initially treated with Olumiant (+MTX) were in state of SDAI LDA at week 24 and that rate was maintained through week 148; updated integrated safety analysis using data from 3,770 patients treated for up to 8.4 years found safety profile remains consistent, with no increases in rates of safety topics of interest and no new safety signals identified
Janssen Pharmaceutical Cos., of Beerse, Belgium, part of Johnson & Johnson Tremfya (guselkumab) Monoclonal antibody targeting IL-23 Active psoriatic arthritis Data from Discover-1 study showed 73% of patients receiving 100 mg every 4 weeks (q4w) and 60% receiving 100 mg every 8 weeks (q8w) achieved ACR20; 54% of q4w patients and 39% of q8w patients achieved ACR50; among patients with clinically relevant psoriasis at baseline, 83% of q4w, 69% of q8w and 82% of those who crossed over from placebo to q4w achieved clear or almost clear skin, with at least 2-grade improvement from baseline as assessed by Investigator Global Assessment (IGA); Discover-2 studies; in Discover-2, 71% of q4w and 75% of q9w achieved ACR20; 46% of q4w and 48% of q8w achieved ACR50; among those with clinically relevant psoriasis at baseline, 84% of q4w, 74% of q8w and 84% of patients who crossed over from placebo to q4w achieved clear or almost clear skin with least 2-grade improvement from baseline as measured by the IGA score
Novartis AG, of Basel, Switzerland Fevipiprant (QAW-039) DP2 receptor antagonist Asthma Study testing add-on to standard-of-care therapy, in terms of avoidance of corticosteroid use over 52 weeks, terminated due to company decision
Phase IV
Bristol Myers Squibb Co., of New York Orencia (abatacept) Selective co-stimulation modulator of T-cell activation Moderate to severe early rheumatoid arthritis Results from open-label switch period of Early Ample exploratory biomarker study showed early seropositive patients treated with Orencia had substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab; in seropositive patients switching from adalimumab to Orencia, efficacy responses generally increased over open-label period to week 48
Horizon Therapeutics plc, of Dublin Krystexxa (pegloticase injection) Recombinant uricase Uncontrolled gout New data from open-label Mirror study showed when treated with oral methotrexate (15 mg/week) prior to and throughout Krystexxa treatment period, 78.6% of patients (11 of 14) achieved complete response, defined as the proportion of serum uric acid (sUA) responders (sUA < 6 mg/dL) during month 6

Notes

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