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Clinical Catch-Up- May 2021


Biophytiscompleted recruitment of 155 patients to its COVA Phase II/III trial of Sarconeos in COVID-19 patients. This will allow the independent Data Monitoring Committee to run its second interim analysis. Sarconeos is an oral, small molecule being developed for sarcopenia in a Phase II trial, but also for severe respiratory aspects of COVID-19.


Merck announced positive results from the pivotal neoadjuvant/adjuvant Phase III KEYNOTE-522 trial of Keytruda (pembrolizumab) in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery. It met the dual primary endpoint of event-free survival (EFS).

Amgen and AstraZeneca published detailed results from the NAVIGATOR Phase III trial of Tezepelumab in severe asthma. Tezepelumab is being jointly developed. It is a potential first-in-class human monoclonal antibody that focuses on the airway epithelium by targeting and blocking thymic stromal lymphopoietin (TSLP).

Mustang Bior eceived the go-ahead from the FDA for a Phase I/II trial of MB-106 for relapsed or refractory CD20+ B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. MB-106 is the company’s CD20-targeted CAR-T therapy.

Daiichi Sankyo Company and AstraZeneca presented preliminary response and disease control of datopotamab deruxtecan (Dato-DXd) in metastatic triple negative breast cancer (TNBC) with disease progression after standard treatment. Data-DXd is a TROP2 directed DXd antibody drug conjugate (ADC).

Axcella initiated its Phase IIb EMMPACT trial of AXA1125 in nonalcoholic steatohepatitis (NASH). AXA1125 is an oral drug that is a composition of six amino acids and derivatives that target multiple metabolic pathways linked to fatty liver disease.

G1 Therapeutics initiatedits PRESERVE 4 Phase II trial of Cosela (Trilaciclib) administered prior to docetaxel in metastatic non-small cell lung cancer (NSCLC) in the 2nd and 3rd-line setting who have previously received a checkpoint inhibitor and chemotherapy. Cosela appears to help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6.

BioSight completed enrollment in its ongoing Phase IIb trial of aspacytarabine (BST-236) as a single-agent first-line acute myeloid leukemia (AML) therapy for patients who cannot receive standard intensive chemotherapy. Aspacytarabine is a novel anti-metabolite composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine.

UNITY Biotechnology announced initial safety and tolerability data from its Phase I trial of UBX1325 for diabetic macular edema and age-related macular degeneration. The drug is a small molecule inhibitor of Bcl-xL.

Biogen reported that its gene therapy, cotoretigene toliparvovec, failed to hit the primary endpoint of the Phase II/III XIRIUS trial for X-linked retinitis pigmentosa (XLRP). XLRP is a rare, inherited disease of the retina associated with progressive loss of vision as the cells in the retina that sense light slowly deteriorate. The gene therapy is an AAV8 vector-based gene therapy administered by subretinal injection. It delivers a full-length functioning retinitis pigmentosa GTPase regulator (RPGR) protein in XLRP patients whose disease is caused by mutations in the RPGR gene.

Fate Therapeutics announced encouraging interim Phase I data from its ongoing Phase I dose-escalation study of FT516 as monotherapy in relapsed/refractory acute myeloid leukemia (AML). FT516 is the company’s off-the-shelf, iPSC-derived natural killer (NK) cell program.

Published: May 17, 2021 By Mark Terry