Company Product Description Indication Status
Phase I
Adocia SAS, of Lyon, France M1pram (ADO-09) Fixed-ratio co-formulation of pramlintide and A21G human insulin analogue  Type 1 diabetes Preliminary phase Ib results showed in standardized meal test at day 24 treatment with individualized doses resulted in 39% decrease of the glycemic excursion vs. Novolog over the first 4 hours after the meal (primary endpoint, DeltaAUC-PG0-4h, 24±139 mg.h/dL vs 49±145 mg.h/dL, LSMratio 0.61, p=0.5); pharmacological effect of M1pram further confirmed by statistically significant decrease of glycemic excursion by more than 100% vs. Novolog over the first 2 hours after the meal (DeltaAUC-PG0-2h, -11±48 mg.h/dL vs 71±69 mg.h/dL, LSMratio -0,14, p<0.0001)
Surface Oncology Inc., of Cambridge, Mass. SRF-388 Antibody targeting IL-27 Advanced solid tumors Started the dose-escalation study, which includes expansion cohorts in late-stage renal cell carcinoma and hepatocellular carcinoma; data from dose-escalation phase expected by the end of 2020
Theravance Biopharma Inc., of Dublin TD-0903 Nebulized JAK inhibitor Healthy volunteers (eventually acute lung injury caused by COVID-19) Dosed first volunteer in study testing single and multiple ascending doses in 54 volunteers
Phase II
Aivita Biomedical Inc., of Irvine, Calif. DCV Autologous dendritic cell vaccines  Melanoma Patient-specific autologous DCV induced a different immune response associated with longer survival than autologous tumor cell vaccines
Biomarck Pharmaceuticals Ltd., of Durham, N.C. BIO-11006 inhalation solution Peptide that inhibits pro-inflammatory effects of overactive MARCKS protein Acute respiratory distress syndrome 38-patient phase IIa study met primary endpoint of no significant increase in serious adverse events and reduced all-cause mortality from ARDS at 28 days
Leap Therapeutics Inc., of Cambridge, Mass. DKN-01 Antibody targeting Dickkopf-1 Advanced gynecological malignancies Of the 20 evaluable endometrial cancer patients with a Wnt signaling alteration treated with DN-01, 1 has an ongoing complete response, 1 had a partial response and 8 had stable disease; of the 6 endometrial cancer patients without a Wnt signaling alteration, 1 had stable disease; of 5 evaluable patients with carcinosarcoma treated with DN-01, 2 had stable disease; of 6 evaluable patients with carcinosarcoma treated with DKN-01 plus paclitaxel, 2 had a partial response and 1 had stable disease; of 22 endometrial cancer patients treated with DKN-01 plus paclitaxel, 12 had stable disease
Obseva SA, of Geneva Linzagolix   GnRH receptor antagonist Endometriosis Data published in Obstetrics and Gynecology showed at 52 weeks, 64.3% and 76.2% of patients treated with the 75- and 200/100-mg doses, respectively, reported much or very much improved endometriosis symptoms on the Patient Global Impression of Change; HDL-C and LDL-C increased by 10% or less after 12 weeks; patients treated with 200/100 mg had a 32% increase in serum triglycerides compared to 20% for patients treated with placebo
Sanofi SA, of Paris SAR-442168 Bruton's tyrosine kinase inhibitor Multiple sclerosis  The 60-mg dose produced an 85% relative reduction of new Gd-enhancing T1 hyperintense lesions (p=0.03) and an 89% relative reduction in new or enlarging T2 hyperintense lesions (p<0.0001)
Windmil Therapeutics Inc., of Baltimore MILs Marrow-infiltrating lymphocytes Non-small-cell lung cancer Begun enrollment in phase IIa study in patients with locally advanced unresectable or metastatic disease who are refractory to or have relapsed on anti-PD-1-containing regimen; in this part of study, MILs will be administered in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.)
Phase III
Amryt Pharma plc, of London AP-101  Keratinocyte modulator Epidermolysis bullosa Enrollment in study ended early due to COVID-19; data expected late in the third quarter or early in the fourth quarter of 2020
Astrazeneca plc, of Cambridge, U.K. Farxiga (dapagliflozin) SGLT2 inhibitor COVID-19 with cardiovascular, metabolic or kidney risk factors Started the 900-patient Dare-19 study; primary endpoint is time to death or first occurrence of new/worsened organ dysfunction through 30 days of follow-up
Baudax Bio Inc., of Malvern, Pa. Anjeso (meloxicam) COX-2 inhibitor Pain associated with unilateral total knee arthroplasty Patients treated with Anjeso used a mean of 19 mg of opioids during the first postsurgical day compared to 28 mg for placebo (p<0.0001); Summed Pain Intensity score on the first postsurgical day and throughout their inpatient course was lower for patients treated with Anjeso (p≤0.0001)
Cel-Sci Corp., of Vienna, Va. Multikine  Leukocyte interleukin Head and neck cancer Data monitoring committee reviewed data from all 928 patients and recommended the trial continue without change
Incyte Corp, of Wilmington, Del. Jakafi (ruxolitinib) JAK1/JAK2 inhibitor Steroid-refractory acute graft-vs.-host disease Data from the Reach2 study published in The New England Journal of Medicine showed the drug produced an overall response rate at day 28 of 62% compared to 39% for patients treated with best available therapy (BAT) (p<0.001); durable ORR at day 56 was 40% and 22% for Jakafi and BAT, respectively (p<0.001); median failure-free survival was 5 months for Jakafi and 1 month for BAT (HR=0.46)
United Therapeutics Corp., of Silver Spring, Md. Orenitram (treprostinil) Prostacyclin mimetic Pulmonary arterial hypertension In the Freedom-EV study, Orenitram reduced pulmonary vascular resistance by 20%, increased cardiac output by 19% and increased the cardiac index by 17%; drug significantly improved patient risk status assessed by REVEAL 2.0 and French noninvasive

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