VBI-1901 / VBI Vaccines, Brii Biosci - LARVOL DELTA

Tumor Responses in a Randomized Phase IIb Trial of a CMV Vaccine Immunotherapeutic Candidate (VBI-1901) in Recurrent Glioblastomas (SNO 2024) - P1/2 | "Approximately 60 adult subjects (18 years or older) with first recurrence of WHO 2016 grade IV Glioblastoma, IDH-wildtype will be randomized at a 1:1 ratio to two open-label cohorts to receive: VBI-1901 or standard of care (SOC) treatment with lomustine or carmustine. Among evaluable patients (n=13), disease control rates of 43% and 0% have been observed in the VBI-1901 and SOC arms, respectively, including 1 partial response in the VBI-1901 arm. Full enrollment (n=60) is anticipated by the end of the year across 11 sites, and updated tumor response data and select biomarkers associated previously with tumor responses will be presented."

Clinical • IO biomarker • P2b data • Brain Cancer • CNS Tumor • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • CSF2

Randomized phase IIb trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas. (ASCO 2024) - P1/2 | " Approximately 60 adult subjects (18 years or older) with first recurrence of WHO 2016 grade IV Glioblastoma, IDH-wildtype will be randomized at a 1:1 ratio to two open-label cohorts to receive: VBI-1901 or standard of care (SOC) treatment with lomustine or carmustine...Subjects must have a KPS ≥70, corticosteroid (dexamethasone or equivalent) dosage must be ≤ 2 mg daily that has been stable for at least 5 days before randomization into the study, and only subjects with a CD4/CD8 ratio ≥1 OR a CD4 count of ≥ 400/uL at screening are eligible, as people with a preserved immune system are more likely to respond to immunization with VBI-1901 based on the initial phase study...This hazard ratio corresponds to a difference in the mOS observed previously with VBI-1901 and a historical mOS of 8 months in the SOC group. As of January 31 st 2024 , 12 of 60 patients have been randomized and dosed across 8 US sites."

Clinical • P2b data • Brain Cancer • CNS Tumor • Cytomegalovirus Infection • Dermatology • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • CSF2

VBI Vaccines Announces New Tumor Response Data from Ongoing Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma Patients (Businesswire) - P1/2 | N=98 | NCT03382977 | Sponsor: VBI Vaccines Inc. | "Among the 7 patients on VBI-1901 treatment long enough to have 1+ MRI scan at the time of analysis, one partial tumor response (PR) and two stable disease (SD) observations have occurred as of May 15, 2024; The partial response, which demonstrated a 67% reduction in tumor size vs. baseline, was observed at week 6, after 2 doses of VBI-1901; The disease control rate (DCR) in the VBI-1901 study arm was 43% (n=3/7) compared to 0% in the control arm (n=0/6) – n=5/6 patients in the control arm have experienced a 2-8x increase in tumor size vs. baseline and have been taken off study protocol; Additional interim data expected Q4 2024, including additional tumor response data and initial survival data from early-enrolled participants, subject to speed of enrollment."

P2b data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

VBI Vaccines Announces Poster Presentation at 2024 ASCO Annual Meeting Highlighting New Interim Phase 2b Data from VBI-1901 in Recurrent Glioblastoma Patients (Businesswire) - "VBI Vaccines Inc...announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting."

P2b data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

VBI Vaccines Reports First Quarter 2024 Financial Results (Businesswire) - "VBI-1901: Cancer Vaccine Immunotherapeutic Candidate:...Additional tumor response data from ongoing Phase 2b study expected mid-year 2024, with initial survival data from early-enrolled participants expected by year-end 2024, subject to speed of enrollment."

P2b data • Glioblastoma

VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma (Businesswire) - P1/2b | N=98 | NCT03382977 | Sponsor: VBI Vaccines Inc. | "Phase 2b Patient Enrollment Update:...2 new clinical sites were activated in March 2024, with a third site expected to come online in April....44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR). 2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline....Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care....Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024....Additional interim data expected mid-year and year-end 2024."

P1/2 data • Trial status • Glioblastoma

VBI Announces Agreement to Sell Manufacturing Capabilities, Certain Related Assets, and Enter Into New License Agreement with Brii Biosciences (Businesswire) - "VBI Vaccines Inc...announced agreements whereby Brii Biosciences ('Brii Bio'), subject to certain activities, is expected to...enter into an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific region (APAC), excluding Japan....VBI received $2.5 million of consideration upon signing of definitive documents and is expected to receive up to an additional $30.5 million of consideration, subject to achievement of certain activities, with a target completion date of June 30, 2024."

Licensing / partnership • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

VBI Vaccines Presents Additional Biomarker Data from Phase 1/2a Study of VBI-1901 in Recurrent GBM at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting (Businesswire) - P1/2a | N=98 | NCT03382977 | Sponsor: VBI Vaccines Inc. | "New proof-of-mechanism data demonstrated that vaccination with VBI-1901 was associated with T-cell activation capable of trafficking across the blood-brain barrier to the tumor microenvironment, an area which is known to be highly immunosuppressive and difficult to infiltrate....After vaccination with VBI-1901 in the Phase 1/2a study in recurrent GBM patients, the data showed there were higher blood/plasma levels of C4G in patients who achieved partial tumor responses than in patients with stable or progressive disease. Additionally, higher levels of C4G after vaccination with VBI-1901 have been associated with longer progression-free survival."

Biomarker • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

Peripheral Biomarker Analysis of T cell-mediated Collagen Remodeling Correlates with Tumor Responses in a Phase IIa trial of vaccine immunotherapeutic candidate (VBI-1901) (SNO 2023) - P1/2 | "The peripheral C4G biomarker targets granzyme-B-cleaved type IV collagen, which is associated with T cell infiltration and has previously been shown to potentially identify recurrent GBM patients responding to nivolumab and bevacizumab. Evaluating the balance of immune infiltration vs. tumor cell growth in patients with brain tumors is challenging and these data suggest a means of assessing this dynamic using a peripheral biomarker. These data may be particularly useful in discerning pseudoprogression associated with T cell infiltration from tumor progression."

Biomarker • IO biomarker • P2a data • Brain Cancer • Cytomegalovirus Infection • Oncology • Solid Tumor • CD4 • CD8 • CSF2 • GZMB

VBI Vaccines Announces Dosing of First Patients in Phase 2b Study of VBI-1901 in Recurrent GBM (Businesswire) - "VBI Vaccines Inc...announced the first patients have been dosed in the randomized, controlled Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy, at 10 leading neuro-oncology centers across the United States....Patients will be randomized in a 1:1 ratio across two study arms: Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progressionl; Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity; Endpoints include: Safety and tolerability; Overall survival (OS) – median and overall; Tumor response rate (TRR); Progression-free survival (PFS)..."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

VBI Vaccines Reports Second Quarter 2023 Financial Results (Businesswire) - "VBI-1901: Cancer Vaccine Immunotherapeutic Candidate - Q3 2023: First patients expected to be dosed in Phase 2b study of VBI-1901, an FDA Fast Track and Orphan Drug Designated cancer vaccine candidate, in recurrent GBM patients; Q4 2023: Expected initiation of VBI-1901 study arm, as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus’ anti-PD-1, balstilimab, in primary GBM patients."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects (clinicaltrials.gov) - P1/2 | N=98 | Recruiting | Sponsor: VBI Vaccines Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

VBI Vaccines Announces Pricing of $18 Million Public Offering and $3 Million Concurrent Registered Direct Offering (Businesswire) - "VBI Vaccines Inc...today announced the pricing of its previously announced underwritten public offering of 10,909,091 common shares and accompanying common warrants to purchase up to 10,909,091 common shares, and its concurrent registered direct offering of 1,818,182 common shares and accompanying common warrants to purchase up to 1,818,182 common shares, at a combined public offering price of $1.65 per share and accompanying common warrant...The offerings are expected to close on or about July 10, 2023, subject to satisfaction of customary closing conditions...VBI intends to use the net proceeds from both offerings for the commercialization activities for PreHevbrio® [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses)."

Commercial • Pricing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hepatitis B • Novel Coronavirus Disease • Oncology • Solid Tumor

VBI Vaccines Announces Proposed Concurrent Public Offering and Registered Direct Offering of Common Shares and Warrants (Businesswire) - "VBI Vaccines...announced that it has commenced an underwritten public offering and a registered direct offering of its common shares and accompanying common warrants to purchase its common shares....VBI intends to use the net proceeds from both offerings for the commercialization activities for PreHevbrio® [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses)."

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hepatitis B • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor

VBI Vaccines Reports First Quarter 2023 Financial Results (Businesswire) - "VBI-1901: Cancer Vaccine Immunotherapeutic Candidate - Mid-year 2023: Expected initiation of next phase of development in recurrent GBM setting; Q3 2023: Expected initiation of VBI-1901 study arm, as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus’ anti-PD-1, balstilimab, in the primary GBM setting."

Commercial • New trial • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

VBI Vaccines Reports Full Year 2022 Financial Results (Businesswire) - "Based on the data seen to-date, we anticipate assessing VBI-1901 in randomized, controlled studies in both the primary and recurrent GBM settings; Q2 2023: Expected initiation of next phase of development in recurrent GBM setting, Mid-Year 2023: Expected initiation of VBI-1901 study arm, as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus’ anti-PD-1, balstilimab, in the primary GBM setting."

New trial • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Comprehensive biomarker analysis of responders and non-responders in a Phase IIa trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) (SNO 2022) - P1/2 | "Single cell, RNAseq is underway in an attempt to understand mechanistic differences in these immune cell populations in Tumor Responders vs. Non-Responders. The U.S. FDA granted Fast Track Designation to VBI-1901 adjuvanted with GM-CSF in first-recurrent GBM patients, and an expansion of the ongoing trial with this formulation in this patient population, with the addition of randomization with a contemporaneous control arm, is anticipated to begin in Q3 2022."

Biomarker • IO biomarker • P2a data • Cytomegalovirus Infection • Immunology • Oncology • CD4 • CD8 • CSF2 • IFNG

Interim results of the extension phase of a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM) (SNO 2019) - "Cytomegalovirus (CMV) antigens have been reported in over 90% of GBM tumors.  CD4+and CD8+T cells are most frequently directed against the gB and pp65 antigens, respectively, and are immunogenic targets in a CMV-based GBM vaccine.  We have initiated a phase I/IIa clinical trial for patients with recurrent GBM using gB/pp65 enveloped virus-like particles (eVLPs) formulated with GM-CSF and administered intradermally.  In phase I, eligible patients were age 18-70 with Karnofsky Performance Status at least 70, normal end-organ function, on stable or decreasing corticosteroids of at most 4mg dexamethasone (or equivalent), with recurrent GBM following any standard initial therapy and any number of recurrences of any size.  Patients were vaccinated monthly until tumor progression, with immune-monitoring performed 2 weeks after each vaccination and MRI exams every 6 weeks.  The primary endpoint was safety/tolerability and secondarily to assess..."

IO biomarker • P1/2 data • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor • CSF2 • IFNG

VBI Vaccines Presents Additional Phase 1/2a Data from VBI-1901 in Recurrent GBM at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting (Businesswire) - P1/2a | N=98 | NCT03382977 | Sponsor: VBI Vaccines Inc. | "VBI Vaccines...announced that additional biomarker data from the Phase 1/2a study of VBI-1901...were presented at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO)....Two (2) partial tumor responses (PR) were observed in patients...reaching survival of at least 32 months as of November 1, 2022. An additional five (5) patients demonstrated stable disease for a sustained period of time. All tumor responders (n=7) reached a minimum survival of 12 months. Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care....Six out of seven tumor responders (n=16) had normal baseline CD4+/CD8+ ratios, and all seven tumor responders saw boosting of gB antibodies after treatment with VBI-1901....'We look forward to initiating randomized, controlled evaluation of VBI-1901 in the recurrent setting in early 2023'."

Biomarker • New trial • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

VBI Vaccines Reports Third Quarter 2022 Financial Results and Provides Corporate Update (Businesswire) - "Recent Key Program Achievements and Projected Upcoming Milestones: VBI-1901: Cancer Vaccine Immunotherapeutic Candidate (i) Early 2023: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a randomized control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival. (ii) Early 2023: Evaluation of VBI-1901 in combination with Agenus’ anti-PD-1, balstilimab, in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial."

Clinical protocol • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

VBI Vaccines Announces Presentation of Data from Ongoing Phase 2a Study of VBI-1901 at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting (Businesswire) - "VBI Vaccines Inc...announced that its abstract highlighting data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), was accepted for poster presentation at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 16-20, 2022."

P2a data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Evaluation of tumor responses and overall survival in patients with recurrent glioblastoma (GBM) from a phase IIa trial of a CMV vaccine immunotherapeutic candidate (VBI-1901). (ASCO 2022) - P1/2 | "The U.S. FDA granted Fast Track Designation to VBI-1901 adjuvanted with GM-CSF in first-recurrent GBM patients, and an expansion of the ongoing trial with this formulation in this patient population, with the addition of randomization with a contemporaneous control arm, is anticipated to begin in H1 2022."

Clinical • P2a data • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Immunology • Oncology • Solid Tumor • CD4 • CSF2

VBI Vaccines and Agenus Announce Collaboration to Evaluate VBI-1901 in Combination with Anti-PD-1 Balstilimab in a Phase 2 Study in Primary Glioblastoma Patients (VBI Vaccines Press Release) - P2a | N=750 | INSIGhT (NCT02977780) |Sponsor: VBI Vaccines | "Steven O'Day...'This clinical collaboration with VBI is aligned with our priority of developing balstilimab as a component of novel combination therapies across a range of tumor types. Balstilimab is a promising anti-PD-1 therapy that has been studied in over 750 patients. Balstilimab has demonstrated clinically meaningful results alone and combined with anti-CTLA-4 therapy in advanced cervical cancer. Combining balstilimab with VBI's vaccine enhances innate and adaptive anti-tumor immunity and may offer promise to patients with GBM, an aggressive and difficult to treat cancer.'"

Media quote • P2a data

Phase 2 Study Will Evaluate VBI-1901 and Balstilimab Combination for the Treatment of Glioblastoma (Targeted Oncology) - "'This clinical collaboration with VBI Vaccines, Inc, is aligned with our priority of developing balstilimab as a component of novel combination therapies across a range of tumor types....Combining balstilimab with VBI's vaccine enhances innate and adaptive anti-tumor immunity and may offer promise to patients with glioblastoma, an aggressive and difficult to treat cancer,' added Steven O'Day, MD...in the press release."

Media quote

VBI Vaccines and Agenus Announce Collaboration to Evaluate VBI-1901 in Combination with Anti-PD-1 Balstilimab in a Phase 2 Study in Primary Glioblastoma Patients (GlobeNewswire) - "Randomized, controlled evaluation as part of INSIGhT adaptive platform trial expected to initiate around year-end 2022...Randomized, controlled extension study of VBI-1901 in recurrent GBM patients expected to initiate Q4 2022, subject to regulatory approvals...VBI Vaccines Inc...and Agenus...announced a collaboration to evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, and balstilimab, Agenus’ monoclonal antibody (mAb) targeting the programmed death receptor-1 (PD-1) protein, in primary glioblastoma (GBM) patients as part of the adaptive platform trial, INSIGhT. Under the agreement, VBI will be the study sponsor and will be responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support."

Licensing / partnership • New P2 trial • Glioblastoma • Oncology