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First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation
By: News Feed | Last updated: 22nd August 2018 | In: Breast Cancer, Genitourinary Cancer, ImmunoOncology, Immunotherapy, Lung Cancer, Medical News Asia, Melanoma & Skin Cancer, Oncology, Translational Research
BIL06v, Biosceptre, cancer vaccines, nfP2X7, NSCLC, P2X7, prostate cancer, TME
CAMBRIDGE, England, Aug. 21, 2018 /PRNewswire/ — Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v in patients with several types of cancer refractory to, or rejecting, standard of care treatment. Although the study is in broad cancer indication, there will be a focus on lung cancer and prostate cancer.
Biosceptre’s BIL06v vaccine is a peptide-protein conjugate and recruits the patient’s immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells, resulting in tumour cell death.
The nfP2X7 is the ‘non-functional’ P2X7 receptor. The nfP2X7 receptor has lost the pore functionality (cell death signalling) but remains the ability of ion channel-driven proliferation signalling. Expression of nfP2X7 plays an important role in the cancer cell’s avoidance of programmed cell death signals in the tumour microenvironment (TME), thus providing prolific and metastatic advantages to cancer cells.
“The relationship between P2X7 and cancer is a field of increasing research focus at the moment, and Biosceptres’ data supports the therapeutic potential of targeting nfP2X7 in human cancer in the clinic.”
~Sir Gregory Winter – Chairman Biosceptre
The Phase I study was designed by Dr Bob Li, attending oncologist at the Memorial Sloan Kettering Cancer Center in New York, and will evaluate the primary endpoints of safety and immunogenicity. The secondary endpoints include the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Besides the tolerability and safety, the study will investigate efficacy endpoints such as the disease control rate (DCR) at 12 weeks and the progression-free survival (PFS) and the exploratory endpoints quality-of-life (QoL), overall survival (OS), serum tumour biomarkers, and cellular immunogenicity. Archived tissue samples will be collected for screening of nfP2X7 expression.
“I am delighted that the first patient has been treated on our Phase 1 trial. I look forward to reviewing the data and to taking BIL06v into further clinical studies.”
~Paul de Souza – Chief Medical Officer Biosceptre
The first patient was recruited by Principal Investigator Associate Professor Gavin Marx on August 16th at the Sydney Adventist Hospital in Sydney, Australia. Other clinical sites are gradually added to the trial over the coming months. Recruitment in the study is competitive and the accrual of the full cohort (20-30 subjects) is expected to take 12 months.
Professor Paul De Souza, Biosceptre’s Chief Medical Officer, Honorary Professor of the NHMRC Clinical Trials Centre, University of Sydney, and Foundation Chair of Medical Oncology, School of Medicine, at Western Sydney University, will oversee the study.
Biosceptre is a biotechnology company headquartered in Cambridge, United Kingdom. Biosceptre is focused on developing next-generation oncology therapeutics targeting nfP2X7. Its pipeline includes a range of biologic therapeutics aimed at treating a range of cancer types.
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This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd. – First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation
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Olaparib plus Bevacizumab as Maintenance Therapy in Ovarian Cancer
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Ribociclib plus Fulvestrant Improves Survival in Advanced Breast Cancer
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ASCO 2019 Lung Cancer: 36 Oral Presentations of the ASCO19 lung cancer track summarised
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ASCO 2019 Breast Cancer: The ASCO19 breast cancer track summarised
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Venetoclax FDA approved for CLL and SLL
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FDA approves avelumab plus axitinib for renal cell carcinoma
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Ramucirumab FDA approved for hepatocellular carcinoma
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T-DM1 FDA approved for early breast cancer
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Ivosidenib FDA-approved as first-line treatment for AML patients with IDH1 mutation
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Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?
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Pembrolizumab plus axitinib FDA approved for the first-line treatment of advanced renal cell carcinoma patients
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KEYNOTE-158: pembrolizumab in previously treated advanced cervical cancer
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Atezolizumab +/- cobimetinib vs regorafenib for previously treated metastatic colorectal cancer (IMblaze370)
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Palbociclib approved for the treatment of male breast cancer
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Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma
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Atezolizumab FDA approved for extensive-stage small cell lung cancer (SCLC)
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Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer
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Combinations: upcoming treatment strategies in metastatic renal cell carcinoma
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Trifluridine/tipiracil combination FDA approved for metastatic gastric or GEJ adenocarcinoma
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Pembrolizumab FDA approved for adjuvant treatment of melanoma
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Trastuzumab-biosimilar Ontruzant® FDA approved in several indications
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Cabozantinib FDA approved in HCC patients failing sorafenib
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Erasmus University MC investigating a new surgical matrix to reduce post-operative complications
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Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma
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Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients
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Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
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Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer
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Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer
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Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC
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MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab
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TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
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Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations
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TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion
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FDA Approves Truxima as Biosimilar to Rituxan
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Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients
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Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients
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The Emerging Role of Yttrium-90 in Primary and Metastatic Liver Cancer
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Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis
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Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas
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Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction
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Pembrolizumab FDA approved in hepatocellular carcinoma patients pretreated with sorafenib
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Lorlatinib FDA approved for metastatic ALK-positive NSCLC
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ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised
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Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC
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Management of Immune-Mediated Hepatitis: a Case Report
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PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer
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Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA
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IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer
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Pembrolizumab plus chemotherapy effective in squamous NSCLC
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Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
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Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC
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CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW
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PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC)
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JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC
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Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC
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Duvelisib FDA approved for adult patients with R/R CLL or SLL
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Duvelisib FDA approved for adult patients with R/R follicular lymphoma
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Frontline atezolizumab plus chemotherapy improves PFS in NSCLC
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First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC
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Early breast cancer treatment in China remains conservative
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ImmunoOncology: Dr Oscar Chan on the treatment of irAE rash
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Prof Stefan Kasper on I-O in EXTREME-ineligible SCCHN
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Camrelizumab anti-PD-1 with or without chemotherapy for NPC
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Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia
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I-O in Special Populations: the Treatment of Immunotherapy-Induced Pneumonitis
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Venetoclax FDA label updated to include Minimal Residual Disease negativity data
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Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan
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Capmatinib plus gefitinib promising in MET-dysregulated NSCLC
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CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer
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DRIVER connects cancer patients in China and the United States to the best care
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Plasma TMB predicts response to atezolizumab in NSCLC patients
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Pembrolizumab and atezolizumab USPIs updated by FDA
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Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)
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Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous NSCLC
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Talazoparib in advanced breast cancer patients with a germline BRCA1/2 mutation
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CheckMate 032: Nivolumab +/- ipilimumab for metastatic esophagogastric cancer
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Lenvatinib FDA approved for 1st-line treatment of HCC
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PolyU Researchers Develop Novel Self-fitting Scaffold for Bone-Regeneration
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Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China
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FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL
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Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients
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Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours
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Osimertinib in patients with T790M-positive advanced non-small cell lung cancer and brain metastases (AURA3)
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Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma
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Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia
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Filgrastim-aafi FDA approved as Filgrastim Biosimilar
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Ribociclib FDA label updated to include pre- and perimenopausal women
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Enzalutamide FDA approved for castration-resistant prostate cancer (CRPC)
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EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer
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Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC
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Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved
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ASCO 2018 NSCLC: The ASCO18 Lung Cancer Track Summarised
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FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma
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https://medi-paper.com/wp-content/uploads/2018/06/ASCO-2018-breast-cancer-TNBC-MBC-ABC-ASCO18-PHEREXA-D-CARE-ABCSG-18-ASTRRA-TEXT-SOFT-MONARCH-2-MONALEESA-3-SANDPIPER-BOLERO-6-TOPACIO-KEYNOTE-162-TONIC-TOPACIO-GeparNeuvo.jpg 1000 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2018-06-19 09:02:512018-06-19 23:57:08ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised
Bevacizumab in combination with carboplatin and paclitaxel FDA approved for several types of gynaecological cancers
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FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients
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FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1
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ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised
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FDA approves venetoclax in 2nd-line for patients with CLL or SLL
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FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy
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AACR 2018: first-line atezolizumab, bevacizumab plus chemotherapy active in non-squamous NSCLC
https://medi-paper.com/wp-content/uploads/2018/05/IMPower150-Reck-Socinski-ELCC-AACR-2018-firstline-atezolizumab-bevacizumab-chemotherapy-non-squamous-nsclc.jpg 1000 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2018-05-10 16:19:462018-05-24 09:31:31AACR 2018: first-line atezolizumab, bevacizumab plus chemotherapy active in non-squamous NSCLC
US FDA approved CAR-T cell and BiTE immunotherapy – Updated 2-May-2018
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Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma
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Nivolumab-Ipilimumab Combination: A New Option for TMB-High NSCLC (CheckMate 227)
https://medi-paper.com/wp-content/uploads/2018/04/First-line-Nivolumab-Ipilimumab-in-TMB-high-NSCLC-front-line-immunotherapy-for-non-small-cell-lung-cancer-CheckMate-227-NCT02477826.jpg 1000 1500 Stijn van den Borne, MSc https://medi-paper.com/wp-content/uploads/2020/02/MediPR-MediPaper-Medical-Communications-Ltd-Healthcare-Writers-Medical-Writers-Medical-Writer-Agency-Hong-Kong-Medical-Writing-Services-Solutions-Quote-醫學寫作-香港-醫學作家香港-medical-PR-public-relations-1030x374.png Stijn van den Borne, MSc2018-04-21 10:30:432018-05-24 09:37:03Nivolumab-Ipilimumab Combination: A New Option for TMB-High NSCLC (CheckMate 227)
FDA approved osimertinib for the 1st-line treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutations positive metastatic non-small cell lung cancer (NSCLC)
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Frontline Combination of Pembrolizumab and Chemotherapy: A New Standard of Care for Non-squamous NSCLC