Company Product Description Indication Status
Phase I
Cellectar Biosciences Inc., of Florham Park, N.J. CLR-131 Phospholipid-drug conjugate delivering iodine-131 Children and adolescents with relapsed or refractory cancers All doses to date deemed safe and tolerated by the independent data monitoring committee, including the 60-mCi/m2 dose level
Karuna Therapeutics Inc., of Boston Karxt  Analgesic  Healthy volunteers No evidence of analgesic benefit of Karxt compared to placebo in phase Ib trial; company won't move forward to develop drug as a pain medication
Keros Therapeutics Inc., of Lexington, Mass. KER-047 Inhibits activin receptor-like kinase-2 Healthy volunteers (eventually anemias due to elevated levels of hepcidin and in fibrodysplasia ossificans progressiva) Completed single ascending and multiple ascending-dose cohorts; plans to add 2 additional cohorts of healthy volunteers to define dosing regimens for phase II studies scheduled to start in 2021
GT Biopharma Inc., of Beverly Hills, Calif GTB-3550 Trispecific fusion protein composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15 Acute myeloid leukemia Completed dose levels 1 and 2 in phase I/II trial; started treating patients at dose level 3 of 25 µg/kg/day
Regenxbio Inc., of Rockville, Md. RGX-314 NAV AAV8 vector encoding an antibody fragment targeting VEGF Wet age-related macular degeneration Cohorts 4 and 5 of study had 61% and 85% reduction of anti-VEGF injections, respectively; 73% of the 11 patients in cohort 5 remain anti-VEGF injection-free; plans to enroll patients in phase II study in third quarter of 2020
Phase II
Angion Biomedica Corp., of San Francisco ANG-3777 Hepatocyte growth factor mimic Acute lung injury associated with COVID-19 pneumonia Enrolled first of about 100 patients in Brazil; primary endpoint is the proportion of patients alive, without the need for mechanical ventilation and free of the need for renal replacement therapy on an ongoing basis at day 28
Arch Biopartners Inc., of Toronto Metablok DPEP-1 inhibitor Acute lung injury and acute kidney injury in severe COVID-19 Received independent institutional review board approval for study
Avelas Biosciences Inc., of San Diego Pegloprastide (AVB-620) Fluorescent marker Primary, nonrecurrent breast cancer undergoing surgery Phase II/III study met its primary endpoint of detecting cancer in margin specimens in real time (p<0.001); re-excision rate was 6%
Clene Nanomedicine Inc., of Salt Lake City CNM-Au8  Nanocrystalline gold Amyotrophic lateral sclerosis First patient enrolled in the phase II/III Healey ALS platform trial
Novartis AG, of Basel, Switzerland Kymriah (tisagenlecleucel) CD19-targeting CAR T  Relapsed or refractory follicular lymphoma Elara study met its primary endpoint of complete response rate; data to be presented at an upcoming medical meeting
Oncopeptides AB, of Stockholm Melflufen  Peptide-drug conjugate targeting aminopeptidases Relapsed refractory multiple myeloma Enrolled first of up to 25 patients in the Port study


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

No Comments