DCVax-Direct / Northwest Biotherap - LARVOL DELTA

Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility (PRNewswire) - "Northwest Biotherapeutics...announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV ('Autologous Dendritic Cell Vaccine')."

Commercial • Oncology • Solid Tumor

"Well if you talk to them ask them to run the DCVax Direct trials in Canada!!!" (@Johnny70250027)

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: Northwest Biotherapeutics; Initiation date: Jun 2002 ->Dec 2006

Trial initiation date • Biosimilar • Oncology

"@ScottGottliebMD How are you doing reviewing DCVAXL #ASCO for #Glioblastoma patients deserve @US_FDA fast approval https://t.co/AqoUjO1A5h"

Clinical • Biosimilar • Oncology

"@ASCO keep eye on @NorthwestBio P3 trial history is about to be made #ASCO2017 #immunotherapy DCVAXL https://t.co/gBai8KHuR3"

Biosimilar

"@PhRMA @steveubl Truth prevailed @NorthwestBio bringing #Immunotherapy DCVAXL to market #AACR17 https://t.co/PNnGI1rotY" - chrislacoursier

Biosimilar • Twitter

"Dcvax works on 13 indications. Open label use when approved. why big pharma wants bankrupt" (@KaseyCundy)

Clinical • Biosimilar

Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical Outcome in Patients with Diverse Cancers. (PubMed, Clin Cancer Res) - "In preclinical studies, intratumorally injected activated DCs (aDCs; DCVax-Direct) were superior to immature DCs in rejecting tumors from mice.Experimental Design: This single-arm, open-label phase I clinical trial evaluated the safety and efficacy of aDCs, administered intratumorally, in patients with solid tumors...Clin Cancer Res; 1-12."

Clinical • Clinical data • Journal

NW Bio to present updates on DCVax clinical programs in Industry Theater Presentation at ASCO (PRNewswire) - "Dr Bosch's presentation will provide updates about the Company's DCVax-Direct and DCVax-L programs. The DCVax-Direct updates will include follow-up data from the Company's Phase I trial for all types of inoperable solid tumors, and plans for further trials....The DCVax-L updates will include a progress report on the Company's work on preparations necessary for unblinding of the Company's Phase III trial of DCVax-L for Glioblastoma brain cancer."

New trial • P1 data • P3 data

"Awesome $NWBO news before #ASCO19. Improve balance sheet (40 million less shares) and restart new DCVax-Direct manufacturing" (@tbinfo1)