Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Shots:

  • The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs.
  • The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response, including in older adults. If P-II results are positive, the P-III study is expected to be initiated in Q2’21 with vaccine anticipated to be available in Q4’21
  • In parallel to the P-II study, Sanofi has commenced development work against new variants, which will be used to inform the next stages of the Sanofi/GSK development program

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: BioSpace

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Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Shots:

  • Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021
  • Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant system
  • The CEPI will continues to support Clover’s COVID-19 vaccine candidate and will fund its development through licensure

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Siakap Keli

The post Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate first appeared on PharmaShots.

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Shots:

  • Gristone to receive $60M at closing, including $30M up front and a $30M as an equity investment at a premium and is eligible to receive up to ~$725M as option exercise payments and milestones along with royalties on sales of therapy
  • Gilead will be in charge of conducting a P- I study for the vaccine and will hold an exclusive option to obtain a license to develop & commercialize the HIV-specific therapeutic vaccine beyond P-I study
  • The collaboration will utilize Gritstone’s prime-boost vaccine platform which includes self-amplifying mRNA (SAM) and adenoviral vectors with antigens developed by Gilead

Click here ­to­ read full press release/ article | Ref: Gristone | Image: BioSpace

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GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots:

  • Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant
  • The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of age and in elderly subjects aged ≥65yrs.
  • P-II trials will be conducted in multiple locations across Canada and, upon FDA’s approval, in the US. The P-III studies will start before the end of 2020 and will evaluate CoVLP in ~30,000 volunteers globally

Click here­ to­ read full press release/ article | Ref: GSK | Image: BioPharma Reporter

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AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots:

  • AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region
  • The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries except Brazil
  • The clinical trial conducted in the US, South Africa, England, and Brazil is expected to be completed in Nov or Dec’2020, after which the company would seek approvals. If approved, AstraZeneca will transfer technology to Argentina’s INSUD Group and Mexico’s Laboratorios Liomont at the end of the year and begin manufacturing in Q1’21

Click here ­to­ read full press release/ article | Ref: Reuters | Image: Bloomberg

Related News: AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots:

  • The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO
  • The dose range was determined based on early data from clinical trials conducted in Germany and the US. The participants will be dosed in Taizhou clinical P-I center, Jiangsu province
  • BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in EU while Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong, and Macau Special Administration Regions and in Taiwan if received approval in China

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PharmaShots

Related News: Fosun Pharma Signs an Agreement with BioNTech to Develop and Commercialize BNT162 for COVID-19




Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19

Shots:

  • Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities)
  • The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection @4wks. as well as complications of COVID-19 @8wks.
  • LY-CoV555 is a potent, neutralizing IgG1 mAb, directed against the spike protein of SARS-CoV-2. The therapy emerges from the collaboration b/w Lilly and AbCellera to create Ab therapies for the prevention & treatment of COVID-19

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Fierce Pharma




Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots:

  • The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
  • The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
  • Assuming clinical success, companies expect to seek regulatory approval as early as Oct’2020. Following the approval, the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing Abs and has received the US BT designation

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: StraitTimes

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19




Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Shots:

  • Zydus has received the US FDA’s approval to initiate clinical trials of Desidustat in CIA. The company has initiated two P-III studies of desidustat
  • The P-III DREAM-ND (NCT04012957) study is being conducted in 588 CKD patients not-on-dialysis while the P-III DREAM-D is being conducted in 392 CKD patients on dialysis (NCT04215120)
  • The therapy met its 1EPs in P-II study and demonstrated a good safety profile while P-I trials were earlier completed in Australia. Desidustat (PO) is a novel hypoxia-inducible factor prolyl hydroxylase inhibitor, currently undergoing P-III development for anemia in CKD patients, and P-II(b) studies for management of COVID-19 patients

Click here to read full press release/ article | Ref: Zydus | Image: Twitter