On December 1, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present updated 12-month and 18-month overall survival (OS) data from the Phase 2a study investigating VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate targeting recurrent glioblastoma (GBM), at the World Vaccine & Immunotherapy Congress at 3:10 PM PT / 6:10 PM ET on December 1, 2021 (Press release, VBI Vaccines, DEC 1, 2021, View Source [SID1234596359]).

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Building on the data announced in June 2021, which supported the U.S. Food and Drug Administration (FDA) granting VBI-1901 Fast Track Designation for the treatment of recurrent GBM patients with first tumor recurrence, the updated data highlighted in Dr. Anderson’s presentation include:

Study arm 1 : VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF)
18-month OS : 30% (n=3/10)
One patient remains on protocol past week 86, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study
Two additional patients achieved OS of at least 20 months, but are no longer on protocol
Study arm 2 : VBI-1901 + GSK’s AS01 adjuvant system2
12-month OS : 70% (n=7/10)
18-month OS not yet reached
With few options for recurrent GBM patients, historical control data have demonstrated OS to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy1.

"Data from the Phase 1/2a study have shown encouraging efficacy signals, including durable tumor responses and improvements in overall survival compared to historical controls, with a promising tolerability profile," said Patrick Y. Wen, M.D., Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, Professor of Neurology at Harvard Medical School, and principal investigator of the INSIGhT trial. "These results merit further investigation especially as GBM patients have very limited treatment options, signaling a critical need for innovative new therapies to be assessed in the clinic. We will continue to evaluate VBI-1901 in the INSIGhT trial, with the hope of providing primary GBM patients alternative treatment options."

"We are very excited to be sharing these results as part of the World Vaccine & Immunotherapy Congress, and are inspired, in particular, by and for the patient who has achieved a 93% tumor reduction," said Dr. Anderson. "If we are able to replicate the tumor responses and overall survival data seen to-date in the next phases of development, we believe VBI-1901 could become a meaningful addition to a treatment field with very few options. We look forward to evaluating VBI-1901 in both primary and recurrent GBM settings and strive to provide hope for patients battling either stage of this aggressive and devastating brain cancer."

Next Steps for VBI-1901

Based on the data seen to date in the Phase 1/2a study in recurrent GBM patients, VBI expects to assess VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients in the next phase of development.

Recurrent GBM :
Expected Q1 2022 initiation of enrollment of expanded number of patients in ongoing study in recurrent GBM, subject to discussions with the FDA, increasing study size and adding a control arm to support the potential for application for accelerated approval based upon tumor response data and improvements in overall survival
Primary GBM :
Beginning mid-year 2022, VBI expects to evaluate VBI-1901 in new investigational treatment arms of INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial
Patients will be randomized against a standard of care control arm, temozolomide in combination with radiotherapy, with a primary objective of improved overall survival in the frontline setting
To learn more about VBI’s ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).

World Vaccine & Immunotherapy Congress Presentation Details

Title: Development of eVLP platform for viral associated cancers
Presenter: David E. Anderson, Ph.D., VBI’s Chief Scientific Officer
Date: Wednesday, December 1, 2021
Time: 3:10 PM PT / 6:10 PM ET
About Fast Track Designation

The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.

Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM.

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 has a high mortality.

On December 1, 2021 SimBioSys, the technology company that predicts tumor responses to therapy, reported that new research on the accuracy and specificity of their simulation software, TumorScope, for breast cancer treatment planning during the 2021 San Antonio Breast Cancer Symposium (SABCS) (Press release, SimBioSys, DEC 1, 2021, View Source [SID1234596358]). The studies covering eight separate posters at SABCS are based on data from both internal and external validation studies of SimBioSys’ proprietary platform. The results include biophysical simulations of neoadjuvant therapy (a preliminary step to begin shrinking a tumor); biological drivers for different racial groups including African Americans vs Caucasians; prognostic responses to identify the patients who will, or will not, benefit from various chemotherapies; and characterization of the tumor’s microenvironment.

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TumorScope is a first-of-its-kind platform combining artificial intelligence with biophysical simulations to model the impact of phenomena such as drug delivery, metabolism, and spatial heterogeneity in a comprehensive model using standard-of-care data alone. The results are generated within minutes, enabling physicians to make a well-informed decision while improving patient experience and shared decision-making. In addition, the technology can support the drug development process across pre-clinical and clinical trial settings.

"Breast cancer continues to be at the forefront of the precision medicine movement, and yet clinicians have been unable to individualize care for patients. Beyond our clinical utility in treatment selection, we are excited to expand TumorScope for use in biopharma for clinical trial optimization and biomarker identification," said John Cole, Ph.D., Chief Scientific Officer at SimBioSys. "Having eight posters accepted at the SABCS speaks to the breadth of our platform. We are proud of the work and the results that our multidisciplinary R&D team has accomplished in breast cancer."

Key SimBioSys studies from the symposium include:

Virtual replication of the NeoSphere trial using SimBioSys TumorScope: Associating standard of care data with clinical outcomes in HER2 positive breast cancer patients to garnish novel insights in silico
Brief Summary: Matched analysis using SimBioSys virtual tumor bank (3000+ patient tumors) and the Neosphere trial created an in silico virtual clinical trial of 144 HER2+ breast cancer patients. TumorScope biophysical simulations were able to predict equivalent rates of pCR and disease progression to the Neosphere trial. In the near future, virtual clinical trials may curtail the need for real-world clinical trials, enabling more efficient drug discovery. (Date/time: Wednesday, 12/8, 5:00 pm – 6:30 pm CT.)
SimBioSys TumorScope: Biophysical modeling of patient-specific response to chemotherapy
Brief Summary: TumorScope constructed 3D in silico tumor models from patient’s pretreatment DCE-MRIs through the combination of a spatial model with vascular data, tumor metabolism, pharmacokinetic and pharmacodynamic models. Validation was performed across 780 breast cancer patients (n=480 with EFS data available). Tumor volumetric response predictions were calculated with an error rate 0.03% and a mean absolute deviation of 8.2% in patients that underwent neoadjuvant chemotherapy. (Date/time: Wednesday, 12/8, 7:00 am – 8:30 am CT.)
Evaluation of the prognostic accuracy of SimBioSys TumorScope in early breast cancer
Brief Summary: Blinded study conducted prospectively using retrospective data with the University of Chicago (n=141) for patients who received neoadjuvant chemotherapy for early stage breast cancer. TumorScope accurately predicted event free survival in patients, comparable to the predictive accuracy of pCR. TumorScope demonstrates utility in guiding escalation and de-escalation of treatment regimens. (Date/time: Thursday, 12/9, 5:00 pm – 6:30 pm CT.)
A transdisciplinary approach for characterizing racial differences in the biology of breast cancer by integrating imaging and -omics data
Brief Summary: Using imaging and transcriptomic data from over 500 patients, TumorScope biophysical modeling software demonstrates how multi-modal imaging and systems biology models of patient tumors shed light on metabolic features that drive differences in response between African American and Caucasian tumors. The data assists with understanding chemotherapeutic drug responses (high spatial heterogeneity of drug delivery and secretion) and improving clinical management. (Thursday, 12/9, 7:00 am – 8:30 am CT.)

On December 1, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its multi-year agreement with Janssen Research & Development, LLC (Janssen) (Press release, Tempus, DEC 1, 2021, View Source [SID1234596357]). The expanded scope is anchored in new AI-based work, in which Tempus will collaborate with a multidisciplinary team of data scientists at Janssen to enhance the discovery and development of therapies for oncology indications using AI/ML and real-world evidence (RWE). This agreement leverages Tempus’ platform, including its multimodal data library, genomic sequencing offerings, and TIME Trial Network of clinical sites to advance the recruitment of patients.

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Tempus’ platform is well positioned to solve many of the challenges clinical trial sponsors face, especially finding rare biomarker-driven patient populations. This work leverages Tempus’ AI capabilities to jointly create algorithms intended to further patient pre-screening efforts for specific cancer indications, including biomarker-selected cohorts. Tempus’ multidisciplinary team’s expertise spans clinical RWE, computational biology, software engineering, machine learning, and trial matching program management, and is a key factor in successfully leveraging an AI-enabled approach to trial recruitment.

"We’re excited to expand our collaboration to apply the Tempus AI platform," said Ryan Fukushima, Chief Operating Officer of Tempus. "We will explore leveraging our data to develop and co-develop novel AI applications to identify the best treatment options for patients in need, and ultimately accelerate the drug development process, bringing novel medicines to patients in a fraction of the time."

On December 1, 2021 RefleXion Medical, Inc., a therapeutic oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors (Press release, RefleXion Medical, DEC 1, 2021, View Source [SID1234596356]). The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery.

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"Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs," said Terence Williams, M.D., Ph.D., chair of radiation oncology at City of Hope Comprehensive Cancer Center. "The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies."

The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. Lung cancer is the most common cause of cancer- related death, accounting for 25% of all cancer deaths in the United States.1 The lungs are also among the most common location for metastatic tumors arising from cancers located in other parts of the body.

"The unmet need in lung cancer is staggering," said Todd Powell, president and CEO of RefleXion. "By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumor motion with unprecedented precision. Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S."

The vision for BgRT is to expand treatment options for patients with all stages of cancer. Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors. BgRT aims to overcome this limitation and eventually deliver radiotherapy to more sites of disease in hopes of improving outcomes for more patients with advanced disease.

On December 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day on Wednesday, December 8, 2021 from 1:00 PM to 4:00 PM ET in New York City (Press release, McKesson, DEC 1, 2021, View Source [SID1234596355]). The meeting will feature presentations by McKesson’s leadership team and a live Q&A session with chief executive officer Brian Tyler and chief financial officer Britt Vitalone . Management will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook.

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Webcast and Presentations

The video webcast will be available live and archived on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.