Tags : P-I/II

Sanofi And GSK Initiate P-I/II Study of COVID-19 Protein-Based Vaccine

Shots: The P-I/II will assess the safety, reactogenicity, and immunogenicity of the COVID-19 adjuvanted recombinant protein-based vaccine in 440 healthy adults across 11 sites in the US The companies are expecting the result of P-I/II study in Dec’2020, aiming to initiate P-III study by end of 2020. If clinical data is sufficient, the global companies […]Read More

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, […]Read More

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against

Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches […]Read More

Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in

Shots: The ongoing P-I/II study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1 (10µg & 30µg/ 100 µg) vs PBO in 45 adults aged 18-55yrs. Results: @28days (7days after dose 2), neutralizing GMTs (168 & 267) corresponding to 1.8- and 2.8-times GMT of the convalescent serum panel; elevated RBD-binding IgG […]Read More

Inovio to Initiate P-I/II Study of INO-4800 Against COVID-19 in

Shots: Inovio and IVI collaborate with Seoul National University Hospital to begin P-I/II clinical study of INO-4800 in South Korea The P-II study will assess the safety, tolerability, and immunogenicity of the INO-4800 vaccine in 40 adults aged 19-50 yrs. and will expand to enroll an additional 120 people aged 19-64 yrs. the companies expect […]Read More

Celltrion and MSD Report Results of First-Line Triplet Regimen P-I/II

Shots: The P-I/II study involve assessing of pembrolizumab (IV, 200mg), Herzuma (biosimilar trastuzumab) (6mg/kg (after 8mg/kg load) D1 and CT in 43 patients with median follow up of 18 mons. In patients with HER2-positive advanced gastric cancer (AGC) P-I/II study results: tumor shrinkage of 95.3%, ORR of 76.7%, CR 16.3%, PR 60.5%, disease control rate […]Read More

Novavax Initiates P-I/II Study of NVX‑CoV2373 Vaccine Against COVID-19

Shots: The company reported the enrollment of the first participants in a P-I/II clinical study of its vaccine candidate, NVX‑CoV2373, developed utilizing nanoparticle technology. The vaccine includes Novavax’ Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing Abs with its expected preliminary immunogenicity and safety results in Jul’2020 The P-I-part evaluates the […]Read More

Pfizer and BioNTech Report First Patient Dosing with BNT162 in

Shots:Shots: The Phase 1/2 study assesses the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. The dose level escalation portion of the P-I/II study will enroll ~360 healthy subjects aged 18-55 and 65-85 yrs. The first person immunized in stage 1 of the study will be […]Read More

BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort

Shots: The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US The dose-escalation portion of the P-I/II study will include […]Read More

Allergan and Editas Report First Patient Dosing in P-I/II BRILLIANCE

Shots: The P-I/II study will assess the safety & efficacy of AGN-151587 (subretinal injection) in ~18 patients with Leber congenital amaurosis 10. The patients enrolled are both adult & pediatric patients (aged 3-17yrs.) The first patients dosing in BRILLIANCE study marks a significant milestone toward delivering the CRISPR medicines, treating the devastating LCA10 AGN-151587 (EDIT-101) […]Read More