Tags : Initiates

Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the

Shots:   Sosei Heptares to receive $5M as milestones triggered by the dosing of the first subject in a clinical trial. In Jun’2019, Pfizer nominated the candidate for advancement and granted $3M as milestones   The companies collaborated in 2015 to develop therapies directed at up to ten GPCR targets across multiple therapeutic areas. The collaboration […]Read More

Novavax Initiates P-III Study of its COVID-19 Vaccine in the

Shots: Novavax has initiated a P-III study assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks. Half the participants will receive two IM injections of a vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 […]Read More

J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine

Shots: The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently The P-III ENSEMBLE study is designed to assess the safety & efficacy of a single vaccine dose […]Read More

Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara

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

Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

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

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

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

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against

Shots: J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected […]Read More