On September 17, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported the first reported data from RATIONALE 304, the Phase 3 trial of its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a potential first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), and the first reported data from the pivotal Phase 2 trial of its investigational PARP inhibitor pamiparib in advanced ovarian cancer (OC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, which takes place on September 19-21 (Press release, BeiGene, SEP 17, 2020, View Source [SID1234565315]).

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"We are pleased to share the promising RATIONALE 304 results, which were used to support our recently accepted supplemental new drug application in first-line non-squamous NSCLC in China," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "BeiGene is evaluating tislelizumab in multiple Phase 3 trials for the treatment of lung cancer, including RATIONALE 307 in first-line squamous NSCLC, which was reported at ASCO (Free ASCO Whitepaper) 2020 and filed in China, RATIONALE 303 in second-line NSCLC, RATIONALE 315 in stage II/IIIA NSCLC, and RATIONALE 312 in first-line extensive-stage small cell lung cancer. Our hope is to advance our broad tislelizumab development program in lung cancer to potentially improve treatment outcomes for the most prevalent cancer, both globally and in China."

"In addition to our Phase 3 data on tislelizumab, we are glad to report that the pivotal Phase 2 data of pamiparib in advanced ovarian cancer patients with BRCA1/2 mutations demonstrated high objective response rates in both platinum-sensitive and platinum-resistant subtypes, and we look forward to advancing pamiparib, which is currently under regulatory review in China," added Dr. Ben.

RATIONALE 304, Phase 3 Trial of Tislelizumab in Combination with Chemotherapy in First-Line Locally Advanced or Metastatic Non-Squamous NSCLC

Poster #1263P

"Tislelizumab in combination with pemetrexed and platinum chemotherapy has demonstrated encouraging results among advanced NSCLC patients with non-squamous histology, including a median progression-free survival of 9.7 months and an overall response rate of 57.4 percent. We are hopeful that tislelizumab can bring a new treatment option to patients with lung cancers in China," commented Shun Lu, M.D., Ph.D., Professor of Shanghai Chest Hospital at Jiao Tong University and lead investigator for the trial.

RATIONALE 304 is a randomized, open-label, multi-center Phase 3 clinical trial of tislelizumab in combination with pemetrexed and platinum chemotherapy (either carboplatin or cisplatin) as a first-line treatment for patients with stage IIIB or stage IV non-squamous NSCLC, compared to pemetrexed and platinum alone (NCT03663205). A total of 334 patients in China were enrolled in the trial, randomized at 2:1 to receive tislelizumab (200 mg every three weeks) in combination with chemotherapy (Arm A) or chemotherapy alone (Arm B). As of the data cutoff on January 23, 2020, with a median follow-up time of 9.8 months, 97 patients (43.5%) remained on treatment in Arm A and 20 patients (18.0%) in Arm B. Results included:

The trial achieved the primary endpoint of progression-free survival (PFS) as assessed by independent review committee (IRC), with a median of 9.7 months in Arm A, a significant improvement compared to 7.6 months in the chemotherapy alone Arm B (p=0.0044; stratified hazard ratio [HR]=0.645 [95% CI: 0.462, 0.902]);
Higher objective response rate (ORR) and disease control rate (DCR) were achieved in patients who received tislelizumab in combination with chemotherapy as assessed by IRC per RECIST v1.1 – 57.4% (95% CI: 50.6, 64.0) and 89.2% (95% CI: 84.4, 93.0) in Arm A, compared to 36.9% (95% CI: 28.0, 46.6) and 81.1% (95% CI: 72.5, 87.9) in Arm B;
Longer duration of response (DoR) was observed in patients who received tislelizumab in combination with chemotherapy, with a median of 8.5 months (95% CI: 6.80, 10.58) in Arm A, compared to 6.0 months (95% CI: 4.99, not evaluable) in Arm B;
Treatment of tislelizumab in combination with platinum and pemetrexed was generally well-tolerated, with no new safety signals identified;
All patients in Arm A and 99.1% of patients in Arm B experienced at least one treatment-emergent adverse event (TEAE); TEAEs leading to permanent discontinuation of any component of treatment occurred in 25.7% and 9.1% of the patients in Arm A and Arm B, respectively;
Most treatment-related adverse events (TRAEs) were hematologic in nature and primarily mild-to-moderate in severity, as follows:
In Arm A, the most common (≥20.0%) Grade 1-2 TRAEs include anemia (68.0%), leukopenia (60.8%), thrombocytopenia (50.5%), nausea (42.3%), increased alanine aminotransferase (ALT; 41.4%), increased aspartate aminotransferase (AST; 38.7%), neutropenia (37.4%), fatigue (33.3%), decreased appetite (28.4%), and vomiting (24.8%);
In Arm B, the most common (≥20.0%) Grade 1-2 TRAEs include anemia (64.5%), leukopenia (59.1%), thrombocytopenia (50.0%), increased AST (44.5%), increased ALT (40.9%), nausea (39.1%), neutropenia (38.2%), fatigue (31.8%), decreased appetite (25.5%), and vomiting (20.9%);
Grade ≥3 TRAEs occurred in 67.6% of patients in Arm A and 53.6% in Arm B, with the most common (≥10.0%) in Arm A being neutropenia (44.6%), leukopenia (21.6%), thrombocytopenia (19.4%), and anemia (13.5%), and the most common (≥10.0%) in Arm B being neutropenia (35.5%), leukopenia (14.5%), thrombocytopenia (13.6%), and anemia (10.0%);
Immune-mediated AEs were reported in 57 patients in Arm A (25.7%), and most of them were mild-to-moderate in severity, with the most common ones being pneumonitis (9%), hypothyroidism (8.6%), and hyperthyroidism (2.7%); and
Across the trial, nine patients experienced a fatal TEAE, including seven in Arm A caused by pneumonitis (n=3), asphyxia, atrial fibrillation, cerebellar hemorrhage, and unspecified death (n=1, each), and two in Arm B caused by pneumonitis and embolism (n=1, each).
Pivotal Phase 2 Trial of Pamiparib in Advanced OC

Poster #820P

"Pamiparib demonstrated strong antitumor activity in patients with advanced ovarian cancer, having achieved clinically meaningful and durable responses in both platinum-sensitive and platinum-resistant patients with BRCA1/2 mutation. This is encouraging news for patients with relapsed disease or patients who discontinued standard treatment due to unacceptable toxicity, and we are excited about pamiparib’s potential to improve treatment outcomes for them," said Xiaohua Wu, M.D., Ph.D., Professor and Chair of Gynecologic Oncology Department at Fudan University Shanghai Cancer Center and lead investigator for the trial.

The preliminary results presented at ESMO (Free ESMO Whitepaper) 2020 were from a Phase 2 dose-expansion portion of a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915). A total of 113 patients in China with high-grade, non-mucinous, epithelial OC (including fallopian or primary peritoneal cancer), harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy were enrolled in the pivotal Phase 2 portion of the trial, including 90 patients with advanced platinum-sensitive OC (PSOC) in Cohort 1, and 23 patients with advanced platinum-resistant OC (PROC) in Cohort 2. Patients received pamiparib 60 mg orally twice daily in 21-day cycles. The primary endpoint of the study is ORR as assessed by IRC per RECIST v1.1. As of the data cutoff on February 2, 2020, with a median follow-up time of 12.2 months (0.2, 21.5), results included:

In Cohort 1 of patients with PSOC:
ORR was 64.6% (95% CI: 53.3, 74.9), including eight complete responses (CRs) and 45 partial responses (PRs);
DCR was 95.1% (95% CI: 88.0, 98.7);
Cancer antigen (CA)-125 response rate was 79.7% (95% CI: 68.8, 88.2);
The median DoR was 14.5 months (95% CI: 11.1, not evaluable) and the median PFS was 15.2 months (95% CI: 10.35, not evaluable);
In Cohort 2 of patients with PROC:
ORR was 31.6% (95% CI: 12.6, 56.6), including six PRs;
DCR was 94.7% (95% CI: 74.0, 99.9);
CA-125 response rate was 38.1% (95% CI: 18.1, 61.6);
Pamiparib was generally tolerated, consistent in patients with PSOC and PROC, and similar to other PARP inhibitors;
Across the trial, the most common (≥20.0%) TEAEs of any grade included anemia (89.4%), nausea (68.1%), decreased neutrophil count (61.1%), decreased white blood cell count (60.2%), vomiting (50.4%), decreased platelet count (31.0%), decreased appetite (30.1%), asthenia (28.3%), diarrhea (22.1%), increased AST (21.2%), decreased lymphocyte count (21.2%), increased ALT (20.4%), and leukopenia (20.4%);
Across the trial, the most common (≥10.0%) Grade ≥3 TEAEs included anemia (41.6%), decreased neutrophil count (33.6%), decreased white blood cell count (19.5%), and leukopenia (10.6%); and
No myelodysplastic syndrome or significant complications potentially related to hematologic AEs, such as Grade ≥3 hemorrhage, fever, or infection, were reported in the trial.
To learn more about the data presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 and BeiGene’s clinical pipeline, visit our virtual booth at View Source

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review, for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies. To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

A New Drug Application (NDA) for pamiparib for patients with ovarian cancer has been accepted and granted priority review by CDE of the NMPA.

On September 17, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the first quarter of fiscal year 2021 before the market open on Tuesday, September 29, 2020 (Press release, AngioDynamics, SEP 17, 2020, View Source [SID1234565314]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13710506.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, September 29, 2020, until 11:59 p.m. ET on Tuesday, October 6, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13710506.

On September 17, 2020 Brii Biosciences ("Brii Bio"), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burden,reported the appointments of Rogers Yongqing Luo, B.M., MBA, as President of the company and General Manager for greater China, and Ankang Li, Ph.D., J.D., CFA, as Chief Financial Officer of the company. Both executives are based in Shanghai (Press release, Brii Biosciences, SEP 17, 2020, View Source [SID1234565313]).

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Dr. Luo will play a central role in running Brii Bio’s business in China while supporting company’s growth in the United States. He will also lead the partnership with Tsinghua University and Shenzhen 3rd People’s Hospital to develop, manufacture and commercialize COVID-19 antibody therapies in China. Dr. Li is responsible for corporate finance & transactions, financial reporting and accounting, and internal control & audit.

"The appointments of Dr. Luo and Dr. Li mark a pivotal step for Brii Biosciences, as we advance clinical research, accelerate growth and prepare for the new and evolving healthcare marketplace in China and around the globe," said Zhi Hong, Ph.D., CEO of Brii Bio. "Dr. Luo has extraordinary knowledge of the science, proven leadership track record, and commercial expertise in patient access. Dr. Li’s broad financial credentials, supported by scientific and legal qualifications, also are a significant addition to our already strong capabilities. I am delighted that they have brought their expertise and energy to Brii Bio at this critical time of growth."

"I am excited to join a company with Brii Bio’s deep commitment to meeting the most urgent healthcare needs in China and to supporting global public health," said Dr. Luo. "The environment is changing rapidly in China, with a need for companies to anticipate and respond with deep insight, disruptive access technologies, novel purchasing and healthcare delivery strategies – at the national, regional and local level. Doing well as a business while doing good for the health and well-being of people and society is core to my decision to join Brii Bio."

Dr. Luo has more than 25 years of experience in healthcare industry. He joined Brii Bio from Gilead Sciences, where he was a global vice president and general manager of China. In four years with Gilead, as an early employee in China, he has built Gilead’s presence in China from beginning. Dr. Luo led the development, regulatory review and launch of eight innovative products, gaining rapid access across China. He led the team and established a unique business model encompassing science, commercialization and patient access. Prior to Gilead, he was Vice President of Roche China, pioneering novel strategies for patient access to oncology therapies. Before joining Roche, he was the General Manager of Novartis North China and Associate Marketing Director in Novartis global headquarter in Switzerland. Dr. Luo received his medical education from Xiangya School of Medicine, Central-South University, and served for three years as a surgeon at St. Luke’s Hospital, Shanghai. He also holds an EMBA from China Europe International Business School.

Dr. Li commented: "I am impressed by Brii Bio’s infectious disease pipeline and commitment to addressing the tremendous health challenges worldwide. Having worked with many multi-national research-based companies, I am inspired by Brii Bio’s focus on breakthrough innovation and insight with an entrepreneurial esprit de corps. I am honored to be a member of this remarkable team and looking forward to leading the company’s finance organization to accelerate the growth of Brii Bio."

Dr. Li brings more than 10 years of experience in investment banking, business development, legal transaction and biomedical research. He joined Brii from Terns Biopharmaceuticals, where he was CFO, developing and deploying financial and corporate strategies and budget. Prior to Terns, Dr. Li was the Executive Director of the Corporate Finance department division at Goldman Sachs, where he was responsible for investment banking in Asia outside Japan. Dr. Li also worked in Merck Asia Pacific Innovation Hub, overseeing business development and licensing transactions in the region. Before that Dr. Li worked at two prominent law firms, Davis Polk & Wardwell LLP and Ropes & Gray LLP as attorney, advising clients on capital markets and M&A transactions. His working career started in the Salk Institute as a biomedical researcher. Dr. Li received a Juris Doctor degree from The University of Chicago Law School, a Ph.D. in Biomedical Sciences from The Baylor College of Medicine, a Master of Science degree from The National University of Singapore, and a Bachelor of Science degree in Biochemistry from The Fudan University. He is also a Chartered Financial Analyst (CFA).

On September 17, 2020 Cullinan Pearl, a Cullinan Oncology company, reported that an abstract detailing the ongoing Phase 1/2a clinical trial evaluating CLN-081 for the treatment of EGFR exon 20 insertion mutant non-small cell lung cancer (NSCLC) will be presented as a poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cullinan Oncology, SEP 17, 2020, View Source [SID1234565312]).

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Poster Title: Preliminary Safety and Activity of CLN-081 in NSCLC with EGFR Exon 20 Insertion Mutations (Ins20)
Abstract Number: 2133
Poster Number: 1345P
Session Date & Time: From 09:00 Thursday, 17 September 2020 until 20:00 Monday, 21 September 2020.

The poster presentation will summarize the initial Phase 1 experience with CLN-081 up to the data cutoff of September 1, 2020, including data on 22 patients treated at dose levels ranging from 30-150 mg administered orally twice daily. CLN-081 demonstrated acceptable safety, with no dose-limiting toxicities (DLT) and no Grade 3 or greater drug-related adverse events. The most common drug-related adverse events included rash and dry skin, with only one case of Grade 1 drug-related diarrhea being observed.

In this group of heavily pretreated patients with EGFR exon-20 mutant NSCLC (over 80% with 2 or more prior lines of systemic therapy), encouraging preliminary antitumor activity was observed across multiple dose levels, including the initial dose level of 30 mg twice daily. Of the initial 22 patients, 17 were evaluable for objective response at the time of data cutoff, and 5 had not yet reached their initial scan. Of the 17 response evaluable patients, 6 experienced an objective response, including 2 patients with a confirmed partial response, 3 patients with ongoing partial responses not yet reaching a confirmatory scan, and 1 with an unconfirmed partial response. Among the 11 remaining response evaluable patients with a best response of stable disease, the change in target lesions ranged from +3% to -21%. Of these 11 patients, 9 patients remained on treatment with stable disease at the data cutoff.

Commenting on the preliminary data, Jon Wigginton, Cullinan Oncology’s Chief Medical Officer (CMO) stated, "We are encouraged with CLN-081’s initial safety and efficacy data in this very difficult to treat patient population, with antitumor activity across a broad range of doses tested to date and an acceptable safety profile. Guided by this data, we look forward to defining the recommended phase 2 dose of CLN-081, and initiating discussions with regulators regarding the future clinical development path for the program."

The accepted abstract is now available on the ESMO (Free ESMO Whitepaper) conference website HERE. The poster can be viewed on the Cullinan Oncology website HERE.

On September 17, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, VBI Vaccines, SEP 17, 2020, View Source [SID1234565310]).

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Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires were evaluated.

"We continue to broaden the analysis around tumor responders in our ongoing Phase 1/2a study of VBI-1901 to enable us to identify GBM patients most likely to benefit from the vaccine immunotherapeutic in the next phase of clinical development," said Dr. David E. Anderson, VBI’s Chief Scientific Officer. "This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. As with the previously announced CD4+/CD8+ ratio, a biomarker which may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients, these biomarkers will continue to be evaluated throughout the study."

In parallel to the ongoing biomarker analysis, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant system continues, with initial immunologic and tumor data expected in Q4 2020.

The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Phase 1 (Part A)
Dose escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018.
Phase 2a (Part B)
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.