Company Product Description Indication Status
Phase I
Biolinerx Ltd., of Tel Aviv, Israel, and Genentech Inc., of South San Francisco BL-8040 Functions as CXCR4 antagonist Acute myeloid leukemia Phase Ib/II Battle study testing combination with atezolizumab as maintenance treatment in subjects 60 and older terminated due to lack of enrollment
Heron Therapeutics Inc., of San Diego HTX-034 Extended-release bupivacaine Pain Initiated a phase Ib/II study in patients undergoing bunionectomy
Janssen Research & Development LLC, of Raritan, N.J. Amivantamab (JNJ-6372) EGFR-MET bispecific antibody Non-small-cell lung cancer Results of Chrysalis study evaluating drug in the treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations found objective response rate of 36% in all patients and 41% in patients previously treated with platinum-based chemotherapy
Janssen Research & Development LLC, of Raritan, N.J. Teclistamab (JNJ-7957) Bispecific antibody targeting BCMA and CD3 Relapsed/refractory multiple myeloma Initial results suggested manageable safety profile across all doses evaluated; patients achieved deep responses which persisted, including some MRD-negative complete responses, with 1 durable beyond 12 months
JHL Biotech Inc., of Hsinchu, China JHL-1266 Osteoclast differentiation factor antagonist  Bone tumor; hypercalcemia; osteoporosis; ostealgia; giant cell bone tumor; spinal cord compression; bone resorption First group of healthy volunteers randomized and dosed in study evaluating pharmacokinetic similarity of JHL's denosumab biosimilar vs. Prolia (denosumab)
Lipac Oncology LLC, of Menlo Park, Calif. Lipax  Paclitaxel for intravesical instillation Low-grade highly recurrent non-muscle invasive bladder cancer Interim phase I/II data showed 100% (6/6) of patients treated with TURBT (transurethral resection of bladder tumor) and Lipax achieved complete response 3, 6 and 9 months after start of therapy; 12-month recurrence-free survival rate was 85% (5/6) and 100% (3/3) for all patients that reached the 18-month mark; follow-up will continue until all patients have reached the 24-month mark
Moderna Inc., of Cambridge, Mass. MRNA-1273 COVID-19 spike glycoprotein modulator  COVID-19 Elicited neutralizing antibody titer levels in all 8 initial participants across the 25-µg and 100-µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera
Rapt Therapeutics Inc., of South San Francisco RPT-193 CCR4 chemokine antagonist  Atopic dermatitis Once-daily oral dosing for 7 days achieved target drug levels and target coverage with an excellent safety profile in healthy volunteers
Recardio Inc., of San Francisco Dutogliptin Dipeptidyl peptidase IV inhibitor Acute myocardial infarction or ischemia Trial in healthy volunteers found dutogliptin effectively inhibited DPP-IV to more than 86% over 24 hours after multiple doses of 120 mg; results published in British Journal of Pharmacology
Spark Therapeutics Inc., of Philadelphia, a member of the Roche Group SPK-3006 Gene therapy Late-onset Pompe disease Phase I/II study suspended until further notice due to COVID-19
Phase II
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Namodenoson  Selective agonist of the A3 adenosine receptor Nonalcoholic fatty liver disease with or without nonalcoholic steatohepatitis In-depth review of data reveal 25-mg dose was found to resolve significantly all cases of NASH, representing 25% of the 25-mg treated group, as compared to an increase in new NASH cases in the placebo group from a baseline of 0 to 5.9%
Chemocentryx Inc., of Mountain View, Calif. CCX-140 Oral selective inhibitor of chemokine receptor CCR2 Primary focal segmental glomerulosclerosis Top-line data from Lumina-1 trial showed drug did not demonstrate meaningful reduction in proteinuria relative to control group after 12 weeks of blinded treatment
Cindome Pharma LLC, a subsidiary of Cincinnati-based Cinrx Pharma LLC CIN-102 Peripherally selective dopamine (D2/D3) receptor antagonist  Diabetic gastroparesis Terminated due to impact of COVID-19 on trial activities
Janssen Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson JNJ-54175446 P2X7 antagonist Major depressive disorder Suspended due to COVID-19
Oculis SA, of Lausanne, Switzerland OCS-01 High-concentration, preservative-free SNP formulation of dexamethasone Inflammation and pain following cataract surgery Results showed Skyggn study met both primary endpoints; percentage of eyes with zero inflammation was statistically significantly greater vs. vehicle at day 15 (OCS-01 QD, 51% vs. vehicle, 19.6%, p=0.0009); percentage of eyes with zero pain was statistically significantly greater with OCS-01 QD vs. vehicle at day 4 (72.5% vs. 54.9%, p=0.005)
Oryzon Genomics SA, of Madrid, Spain Vafidemstat (ORY-2001) Oral, CNS-optimized LSD1 inhibitor COVID-19 Enrolled first patient in Escape study testing drug plus standard of care in preventing progression to acute respiratory distress syndrome in seriously ill patients; initial data are expected before the end of the year
Rezolute Inc., of Redwood City, Calif. RZ-358 Fully human negative IgG2 allosteric modulating monoclonal antibody  Congenital hyperinsulinism Enrollment in recently initiated phase IIb study paused due to COVID-19; company no longer expects to report mid-study data by fourth quarter 2020
Taiwan Liposome Co., of Taipei, Taiwan TLC-599 Bioseizer sustained-release formulation of dexamethasone sodium phosphate Osteoarthritis knee pain Subgroup analyses showed pattern of efficacy seen in overall population, with greater reductions in pain vs. placebo sustained from week 1 through week 24, consistent between various subgroups
Viiv Healthcare Ltd., of London Cabotegravir  HIV-1 integrase strand transfer inhibitor Prevention of HIV infection HIV Prevention Trials Network 083 showed drug was 69% more effective in preventing HIV acquisition in men who have sex with men and transgender women who have sex with men vs. current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg tablets; study achieved primary objective of noninferiority with the difference approaching superiority in favor of cabotegravir, pending final analysis
Phase III
Bayer AG, of Leverkusen, Germany Azelastine hydrochloride (BAYR-9258) Phthalazinone derivative Allergic rhinitis Suspended due to COVID-19
Bone Therapeutics SA, of Gosselies, Belgium JTA-004 Consists of mix of plasma proteins, hyaluronic acid and fast-acting analgesic Osteoarthritis knee pain Started treating first patients in pivotal study in Hong Kong SAR; several sites in Europe expected to resume enrollment activities as COVID-19 lockdown measures are lifted
Octapharma AG, of Lachen, Switzerland Panzyga  Intravenous immunoglobulin Chronic inflammatory demyelinating polyneuropathy Results from Procid study confirmed efficacy in adults at standard dose of 1 g/kg every 3 weeks; almost 80% (55/69) of patients responded to treatment with a decrease of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (INCAT) disability score by the end of the 24-week treatment period; results also suggested a dose response, with a greater proportion of patients responding with increasing doses: 64.7%, 79.7% and 91.7% of patients were considered responders on the adjusted INCAT score in the 0.5 g/kg, 1 g/kg and 2 g/kg groups, respectively
Progenics Pharmaceuticals Inc., of New York Pyl PSMA-targeted small-molecule PET imaging agent Prostate cancer Results showed Condor study in men with biochemical recurrence of disease achieved its primary endpoint, with correct localization rate (CLR) of 84.8% to 87% among 3 blinded independent readers; median CLR in patients with baseline PSA <0.5 ng/mL, 0.5 to <1 ng/mL, and 1 to <2 ng/mL were 73.3%, 75% and 83.3%, respectively; 63.9% of patients had a change in intended disease management plans due to imaging results, a key secondary endpoint
Samsung Bioepis Co. Ltd., of Incheon, Korea SB-11 Biosimilar of ranibizumab Neovascular age-related macular degeneration Study achieved primary endpoints of change from baseline in best corrected visual activity (BCVA) at week 8 and central subfield thickness (CST) at week 4; least squares (LS) mean change in BCVA was 6.2 letters for SB-11 vs. 7 letters for reference ranibizumab; LS mean change in CST was −108.4 μm for SB-11 vs. −100.1 μm for reference drug
Zai Lab Ltd., of Shanghai SUL-DUR (sulbactam and durlobactam) Broad-spectrum intravenous inhibitor of class A, C and D beta-lactamases Carbapenem-resistant Acinetobacter baumannii infections Dosed first Chinese patient in global Attack registrational trial 
Phase IV
Biogen Inc., of Cambridge, Mass. Spinraza (nusinersen) Antisense oligonucleotide Spinal muscular atrophy Additional data from Shine open-label extension study showed sustained efficacy and longer-term safety in a broad range of patients; findings showed treatment resulted in motor function improvement or disease stabilization in toddlers, children and young adults who were treated continuously, some for up to 6.5 years
Eyepoint Pharmaceuticals Inc., of Watertown, Mass. Dexycu Dexamethasone intraocular suspension Postoperative inflammation following ocular surgery Interim data from retrospective case study from 31 patients showed proportion with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 45.2%, 90% 90% and 100% at postoperative day 1, 8, 14 and 30, respectively; proportion of patients with no anterior chamber flares (flare score=0) was 87.1%, 100%, 100% and 100% at postoperative day 1, 8, 14 and 30, respectively; mean intraocular pressure at postoperative day 1 was 17.4 mmHg, with levels decreasing through to postoperative day 30


For more information about individual companies and/or products, see Cortellis.

No Comments