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In the clinic for Oct. 29, 2020



October 29, 2020

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Company Product Description Indication Status
Phase I
Affyimmune Therapeutics Inc., of Natick, Mass. AIC-100 CAR T targeting ICAM-1 Thyroid tumor Enrolled first patient in the study measuring the safety, biological activity and real-time assessment of CAR T cell localization in patients
Anheart Therapeutics Co. Ltd., of Hangzhou, China Taletrectinib Next-generation ROS1/NTRK inhibitor Metastatic non small cell lung cancer Data from 18 evaluable patients with ROS1-positive NSCLC enrolled in 2 studies, confirmed ORR for ROS1 tyrosine kinase inhibitor-treatment-na？ve patients was 66.7%, with DCR of 100%; for those pretreated with 1 prior ROS1 TKI, ORR was 33.3% and DCR was 88.3%; confirmed ORR for patients pretreated with 2 prior ROS1 TKI was 33.3% with DCR of 66.7%; median PFS was 29.1 months for ROS1 TKI treatment-na？ve patients, 14.2 months for patients pretreated with 1 prior ROS1 TKI, and 4.1 months for patients pretreated with 2 prior ROS1 TKIs
Connect Biopharmaceuticals Ltd., of Taicang, China CBP-201 Antibody targeting IL-4Ralpha Atopic dermatitis At week 4, change from baseline in Eczema Area and Severity Index was 74% and 74.4% for the 150-mg and 300-mg doses, respectively, compared with 32.9% for placebo; reductions in Body Surface Area were 62.7% and 58.7% for the 150-mg and 300-mg doses, respectively, compared with 28.7% for placebo
Frequency Therapeutics Inc., of Woburn, Mass. FX-322 Activates progenitor cells and regenerates auditory hair cells in the inner ear Age related hearing loss First patient dosed; safety, otologic and audiologic will be measured on day 30 and 90 following administration of FX-322 or placebo; data readout expected in second quarter of 2021
Frequency Therapeutics Inc., of Woburn, Mass. FX-322 Activates progenitor cells and regenerates auditory hair cells in the inner ear Severe sensorineural hearing loss Plans to start study this quarter; safety, otologic and audiologic will be measured on day 30 and 90 following administration of FX-322 or placebo; data readout expected in Q3 2021
Hookipa Pharma Inc., of New York HB-202/HB-201 Replicating arenavirus therapy based on the pichinde (202) and lymphocytic choriomeningitis (201) viruses Human papillomavirus 16-positive cancers First patient dosed in the study testing alternating sequential treatment with HB-202 and HB-201; primary endpoint of phase I portion is determining the phase II dose; secondary endpoints include antitumor activity and immunogenicity
Immunomolecular Therapeutics Inc., of Woburn, Mass. IMT-002 HLA-DQ8 blocker Type 1 diabetes Completed phase Ia study in healthy subjects with no adverse events; launched the 30-patient phase Ib study testing multiple ascending doses of the drug; study will measure safety, tolerability and pharmacokinetic profiles of the drug
Leap Therapeutics Inc., of Cambridge, Mass. TRX-518 Anti-GITR product Advanced solid tumors Phase Ib/IIa study testing combination with cyclophosphamide and Bavencio (avelumab, EMD Serono/Pfizer Inc.) terminated; product development discontinued unrelated to safety
Plus Therapeutics Inc., of Austin, Texas Rhenium Nanoliposomes Nanoliposome-encapsulated radionuclide Recurrent glioblastoma First patient treated in the sixth and final cohort of the Respect study; expects to complete enrollment by the end of 2020
Spark Global, of Stanford, Calif. Temporary Immunity Agent for COVID-19 Antibodies against SARS-CoV-2 in a nasal drop COVID-19 prophylaxis First participant dosed in the study which will enroll 24 patients who will receive a single dose followed by multiple doses in an additional 24 participants
Phase II
Aerie Pharmaceuticals Inc., of Durham, N.C. AR-15512 TRPM8 agonist Dry eye disease First patient treated in the Comet-1 study comparing 2 dose levels of the drug to vehicle; primary efficacy endpoints are ocular discomfort and tear production; top-line results expected in the third quarter of 2021
Annovis Bio Inc., Berwyn, Pa. ANVS-401 Inhibits neurotoxic proteins Early Alzheimer’s disease Resumed treatment of patients in the study after it was paused in March 2020 due to COVID-19 pandemic; 15 patients enrolled in the 24-patient study; data expected in 2021
Avillion LLP, of London Sonelokinab (M-1095) Anti-IL-17 A/F Nanobody Chronic psoriasis Study met primary endpoint based on IGA at week 12 with clinically meaningful and statistically significant results for all tested doses (p<0.001); all secondary endpoints; PASI 75, PASI 90 and PASI 100 at week 12 endpoints were also met with high statistical significance (p≤0.002); at highest dose, PASI 90 responses seen in about 1/3 patients at week 4; 4/5 of patients at week 12 and half of patients at week 24
Biolinerx Ltd., of Tel Aviv, Israel Motixafortide CXCR4 inhibitor First-line metastatic pancreatic ductal adenocarcinoma Started investigator-initiated study which will test the drug in combination with cemiplimab, gemcitabine and nab-paclitaxel; study will initially enroll 10-12 patients and expand to 40 patients based on data from first set of patients; primary endpoint is ORR; secondary endpoints include safety and tolerability, PFS, duration of clinical benefit and OS; data expected in mid-2022
Chemocentryx Inc., of Mountain View, Calif. Avacopan Blocks the C5a receptor Hidradenitis suppurativa In the overall population, 35.1% of patients taking the 30-mg dose had a clinical response compared to 30.8% of patients taking placebo; in Hurley stage III patients, 42.6% of patients taking the 30-mg dose had a clinical response compared to 22.3% of patients taking placebo (p=0.0349)
Eli Lilly and Co., of Indianapolis Bamlanivimab (LY-CoV555) Neutralizing antibody COVID-19 Data from monotherapy arms of Blaze-1 study testing drug in outpatient setting, published in The New England Journal of Medicine, show it may be effective in treating COVID-19 by reducing viral load, symptoms and risk of hospitalization in patients recently diagnosed with mild to moderate illness
Frequency Therapeutics Inc., of Woburn, Mass. FX-322 Activates progenitor cells and regenerates auditory hair cells in the inner ear Acquired sensorineural hearing loss Plans to provide a complete analysis of day 90 data in the first quarter of 2021; end of study readout after 7 months is expected in the second quarter of 2021
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Vixarelimab Fully human monoclonal antibody targeting OSMRβ Prurigo nodularis Phase IIa study met primary efficacy endpoint with statistically significant reduction in weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) from baseline at week 8 vs. placebo; statistically significant percentage of vixarelimab recipients achieved a prurigo nodularis-investigator’s global assessment score of 0/1 at week 8 vs. placebo, and majority of treated subjects showed clinically meaningful greater-than-or-equal-to 4-point weekly-average WI-NRS reduction at week 8
Kintor Pharmaceutical Ltd., of Suzhou, China Proxalutamide (GT-0918) Anti-androgen treatment COVID-19 Study reached target enrollment of 381 patients; preliminary data expected before the end of the year
Leo Pharma A/S, of Ballerup, Denmark Delgocitinib Topical pan-JAK inhibitor Eczema Phase IIb dose-finding study demonstrated a statistically significant dose-response relationship, showing it may have the potential to become a new treatment option for adults with mild-to-severe chronic hand eczema
Leo Pharma A/S, of Ballerup, Denmark Tralokinumab IL-13 receptor antagonist Atopic dermatitis Results from a pooled safety analysis of the phase III trials ECZTRA 1, 2, and ECZTRA 3, the phase II ECZTRA 5 and phase IIb trials demonstrate overall frequency of AEs with tralokinumab was comparable to placebo in the initial 16-week period in adults with moderate to severe atopic dermatitis
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. REGN-COV2 Antibody cocktail targeting SARS-CoV-2 Mild to moderate COVID-19 In patients with high viral load, there was a 0.68 log10 copies/mL greater reduction in viral load with REGN-COV2 compared to placebo (combined dose groups; p<0.0001); in the overall population of 799 patients, REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% for combined dose groups vs. 6.5% for placebo; p=0.024)
Phase III
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) Oral JAK inhibitor Atopic dermatitis Data from Measure Up 1 and Measure Up 2 studies showed significantly more patients treated with either dose achieved at least 90% improvement in EASI vs. placebo at week 16 (53%/66% 15/30 mg vs. 8% in Measure Up 1; 42%/58% 15/30 mg vs. 5% in Measure Up 2 [p<0.001]); both doses also showed higher proportion of patients achieving clinically meaningful itch reduction vs. placebo at week 4 and maintained through week 16
Eli Lilly and Co., of Indianapolis Taltz (ixekizumab) IL-17 antagonist Psoriasis In UNCOVER-3 study, 83%, 73% and 89% of patients reported complete clearance in scalp, nail and palmoplantar psoriasis, respectively; safety profile over five years remained consistent with previous reports
Humanigen Inc., of Burlingame, Calif. and Gilead Sciences Inc., of Foster City, Calif. Lenzilumab and Veklury (remdesivir) GM-CSF ligand inhibitor and antiviral COVID-19 First patient dosed in Activ-5 Big Effect Trial, evaluating lenzilumab with remdesivir vs. placebo and remdesivir in patients hospitalized with COVID-19
Mallinckrodt plc, of Dublin Terlipressin Vasopressin analogue sel ective for V1 receptors Hepatorenal syndrome type 1 Results from 2 post-hoc studies based on pooled analyses from 3 trials found treated patients required renal replacement therapy (RRT) less often and had improved RRT-free survival up to day 90 vs. placebo; at day 30, 26% in terlipressin group needed RRT vs. 42% on placebo; at day 60, 27% in terlipresson group needed RRT vs. 45% on placebo; at day 90, the difference was 29% vs. 45%
Moderna Inc., of Cambridge, Mass. mRNA-1273 COVID-19 Spike glycoprotein modulator COVID-19 Phase III COVE study conducted in collaboration with NIH and BARDA fully enrolled with 30,000 participants, including 37% from diverse communities

3단계

캘리포니아주 벌링가메에 사는 휴머니겐사와 캘리포니아주 포스터시티에 있는 길리어드사이언스 사가 각각 소재하고 있다. Lenzilumab and Veklury (remdivir) GM-CSF 리간드 억제제 및 항바이러스 COVID-19 첫 번째 환자 CoVID-19로 입원한 환자들의 Lenzilumab을 렘디비르 대 위약과 렘디비르로 평가하면서 Activ-5 Big Effect Trial에 투여되었다

https://www.bioworld.com/articles/499570-in-the-clinic-for-oct-29-2020




Notes

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


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