Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types The focus of the study is to determine the maximum tolerated dose and recommended dose of DS-1055 for further study and […]Read More
Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More
Shots: The Korean MFDS has approved Celltrion’s IND to initiate a P-I trial of CT-P59 in patients with COVID-19. The company has initiated the enrollment and is set to evaluate the safety, tolerability, efficacy, PK, and immunogenicity of CT-P59 and anticipates the completion of study in Q3’20 The company anticipates the results of P-II & […]Read More
Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA If AZD7442 proves to be tolerated and has a favorable safety profile in the […]Read More
Shots: The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19 The trial is expected to be completed in […]Read More
Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and […]Read More
Shots: The two companies collaborated to develop a COVID-19 vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. The partners are planning to initiate P-I study in mid-July followed by pre-clinical results that showed combining the two platforms demonstrated a high level of neutralizing Abs following a single dose The study […]Read More
Shots: Following the US FDA’s approval, Gilead will screen healthy volunteers for P-I study this week and plans to initiate the study in patients with COVID-19 in Aug’2020. The therapy could be given to patients via nebulizer, which would allow for easier dosing outside the hospital and in earlier stages of the disease The inhaled […]Read More
Shots: Lilly’s partner Junshi has dosed the first healthy volunteer in a study evaluating JS016 to combat COVID-19. The study is being conducted by Junshi in China while Lilly to imminently initiate its P-I study in the US Both P-I studies aim to evaluate the safety, tolerability, PK and immunogenicity of JS016 in healthy participants […]Read More
Shots The company has commenced P-I clinical study assessing its vaccine candidate vs PBO in 144 healthy adults, aged 18-59yrs, with two different dosages of the vaccine candidate, conducted in Jiangsu Province The study evaluates the safety, tolerance, and preliminary immunogenicity of Sinovac’s SARS-CoV-2 vaccine under which two-thirds of the volunteers will be vaccinated with […]Read More
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