On September 24, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported upcoming presentations highlighting data from multiple clinical programs – including Sci-B-Vac, the company’s 3-antigen hepatitis B vaccine; VBI-2900, the company’s coronavirus vaccine program; and VBI-1901, the company’s cancer vaccine immunotherapeutic – at the World Vaccine Congress Washington 2020 and ID Week 2020 (Press release, VBI Vaccines, SEP 24, 2020, View Source [SID1234565567]).

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Presentation Details

World Vaccine Congress Washington 2020: September 28 – October 1, 2020

COVID-19 Panel Discussion: What existing treatments and vaccine development platforms show promise to control the rate of infection and spread?

Session: Emerging and Infectious

Participant: David E. Anderson, Ph.D., VBI’s Chief Scientific Officer

Date: Monday, September 28, 2020

Time: 3:50 – 5:20 PM ET

Presentation: Sci-B-Vac: Results on Ph3 Hep B vaccine

Session: Emerging and Infectious

Presenter: Francisco Diaz-Mitoma, M.D., VBI’s Chief Medical Officer

Date: Tuesday, September 29, 2020

Time: 4:35 – 5:05 PM ET

Presentation: Targeting CMV for the development of effective GBM immunotherapy

Session: Cancer & Immunotherapy

Presenter: David E. Anderson, Ph.D., VBI’s Chief Scientific Officer

Date: Wednesday, September 30, 2020

Time: 1:40 – 2:10 PM ET

World Vaccine Congress Event Website: View Source

ID Week 2020: October 21-25, 2020

Poster #: 8

Title: Higher hepatitis B antibody titers induced in all adults vaccinated with a tri-antigenic hepatitis B (HBV) vaccine, compared to a mono-antigenic HBV vaccine: results from two pivotal phase 3 double-blind, randomized studies (PROTECT and CONSTANT)

Poster Session: Adult Vaccines

Presenter: Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study

Date: Available October 21-25, 2020

Title: Rapid onset of seroprotection rates in young adults immunized with a tri-antigenic hepatitis B virus (HBV) vaccine compared to a mono-antigenic HBV vaccine

Poster Session: Hepatitis

Presenter: Timo Vesikari M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies

Date: Available October 21-25, 2020

ID Week 2020 Event Website: View Source

About Sci-B-Vac

Sci-B-Vac is a licensed, third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 750,000 patients. Sci-B-Vac is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, will comprise the basis for the regulatory submissions in the U.S., Europe, and Canada, expected to begin in the fourth quarter 2020.

To learn more about Sci-B-Vac, visit: View Source

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.

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illness of varying severities, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).1,2

On September 24, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the U.S. Food and Drug Administration (FDA) has cleared a new Investigational New Drug (IND) application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504, the Company’s off-the-shelf neoantigen ADXS-HOT candidate for prostate cancer (Press release, Advaxis, SEP 24, 2020, View Source [SID1234565566]). This new IND is in addition to the Advaxis sponsored IND, previously announced in January 2020. Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.

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"We are excited to announce the transition of our ADXS-504 HOT prostate program to an investigator sponsored study at this time," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "By partnering with a prestigious academic medical center, we would be gaining access to world-class expertise and a high volume of patients that together, may expedite both enrollment and eventual study results. This strategic decision also conserves resources which can be leveraged to support our encouraging and expanding HOT program in NSCLC. Our data generated to date with ADXS-503 in NSCLC leave us increasingly confident that our off-the-shelf neoantigen program can provide well-tolerated treatments with robust innate and adaptive immune responses and potential clinical activity. We look forward to the initiation of this Phase 1 study with ADXS-504 monotherapy in patients with prostate cancer before year end."

On September 24, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, reported treatment of the first patient in a randomized Phase 2 non-small cell lung cancer (NSCLC) clinical trial of the glutaminase inhibitor telaglenastat (CB-839) in combination with pembrolizumab, carboplatin and pemetrexed (Press release, Calithera Biosciences, SEP 24, 2020, View Source [SID1234565565]). The KEAPSAKE study will evaluate the safety and anti-tumor activity of telaglenastat plus standard-of-care immunotherapy as front-line therapy among patients with stage IV non-squamous NSCLC whose tumors have a KEAP1 or NRF2 mutation determined by next-generation sequencing.

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Mutations in the KEAP1/NRF2 pathway, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth. Recently presented clinical data demonstrate that activation of this pathway, either through the loss of KEAP1 function or activation of NRF2, are associated with poor clinical outcomes among patients with NSCLC receiving front-line standard-of-care chemoimmunotherapy. Pre-clinical models have shown that activation of the KEAP1/NRF2 pathway results in dependence on glutaminase activity for growth and survival, making these tumors exquisitely sensitive to inhibition of glutaminase activity by telaglenastat.

"Therapies that inhibit glutaminase in tumors with KEAP1/NRF2 pathway activation could have a meaningful clinical impact for a substantial percentage of people with NSCLC," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We’re proud that KEAPSAKE is among the first clinical trials investigating a potential new therapy for these patients who have a poor prognosis. Based on both the clear mechanistic rationale for telaglenastat in this indication and strong preclinical data, we’re hopeful that the study will provide valuable insights."

The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Guardant360 liquid biopsy test will be provided by the study sponsor as an investigational use only (IUO) testing option for patient selection. Calithera anticipates sharing interim data from the KEAPSAKE trial in 2021.

About Telaglenastat

Telaglenastat (CB-839) is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block cancer cells from using glutamine for growth and survival. Tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic antitumor effects when used in combination with standard-of-care therapies. Calithera is evaluating telaglenastat in combination therapy approaches for multiple solid tumor types, including metastatic renal cell carcinoma and non-small cell lung cancer.

About Lung Cancer

Lung cancer is one of the most common cancers, with approximately 228,820 new cases and 135,720 deaths in the U.S. projected in 2020, according to the American Cancer Society. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 84 percent of all lung cancer diagnoses. A recently published observational study demonstrated that the survival of patients with KEAP1 genomic alterations treated with standard-of care first-line chemo-immunotherapy was statistically significantly shorter when compared with patients without the mutations (7.8 months vs. 20.4 months p=0.002).1

On September 24, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported that it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights (Press release, Ideaya Biosciences, SEP 24, 2020, View Source [SID1234565558]). The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations (GNAQ/11), including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal cancer.

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Evaluating MUM patient clinical samples, IDEAYA identified cMET expression or activation as a potentially valuable biomarker that may guide IDE196 clinical treatment in this indication. IDEAYA also demonstrated preclinical synergy in MUM with the combination of IDE196 and crizotinib, which further supports the potential biomarker on cMET expression.

"We are excited to expand our agreement with Pfizer to evaluate the clinical combination of IDE196 and crizotinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Mick O’Quigley, Vice President, Head of Development Operations, IDEAYA Biosciences. "Through our translational research we have identified cMET expression as a potential biomarker, and we are excited to explore this rational combination between IDE196 and crizotinib clinically," said Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences.

IDEAYA’s clinical development plan in MUM for IDE196 is based on combination therapies, including with binimetinib, a MEK inhibitor, and crizotinib, a cMET inhibitor, enabled through our clinical trial collaboration and drug supply agreement with Pfizer. The company announced First-Patient-In (FPI) for the IDE196 and binimetinib clinical combination in June 2020 and is targeting FPI for the crizotinib clinical trial combination in late 2020 to early 2021. IDEAYA is also evaluating IDE196 as monotherapy in an ongoing GNAQ/11 non-MUM basket trial in additional solid tumor types, including in skin melanoma, where the company announced Phase 2 expansion.

IDEAYA and Pfizer have established a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will provide the crizotinib drug supply. If there is clinical data from the collaboration studies that could be used to obtain regulatory approvals or label changes, IDEAYA and Pfizer will enter into good faith negotiations to determine a regulatory submission strategy.

On September 24, 2020 Taiho Pharmaceutical Co., Ltd. and The University of Texas MD Anderson Cancer Center reported a three-year strategic collaboration to accelerate the development of treatments for significant unmet medical needs in oncology, including patients with brain metastases and those with cancers refractory to available therapies (Press release, Taiho, SEP 24, 2020, View Source [SID1234565553]).

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This collaboration will bring Taiho’s unique portfolio of preclinical and clinical brain-penetrant therapies together with both the industry-scale translational research capabilities of MD Anderson’s Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platform as well as insights and clinical development infrastructure from MD Anderson’s Brain Metastasis Clinic.

"Our collaboration with MD Anderson exemplifies a direct line of sight from target development to therapies for patients with limited treatment options," said Teruhiro Utsugi, Ph.D., managing director at Taiho. "Investigating our novel portfolio of drug candidates in this innovative research structure will enable us to more rapidly identify and develop effective treatment strategies."

According to the American Brain Tumor Association, metastases to the brain and spine are diagnosed in more than 200,000 patients annually in the US. However, the development of effective treatment approaches for these patients has been hampered because they often are excluded from clinical trials. However, recent studies in melanoma, lung and breast cancers have demonstrated that patients with brain metastases can gain significant clinical benefit from immunotherapy and targeted therapies, leading to improvements in quality of life and survival.

MD Anderson’s Brain Metastasis Clinic is a patient-focused, multidisciplinary center designed to reduce the time from a diagnosis to treatment for patients with brain metastases while improving access to clinical trials. The TRACTION platform, an industry-scale translational research unit within MD Anderson’s Therapeutics Discovery division, has established a robust integrated research framework with the Brain Metastasis Clinic to identify innovative treatment approaches and execute novel clinical trials.

"MD Anderson’s commitment to delivering novel therapeutic strategies to patients with unmet clinical needs is exemplified in the development of the Brain Metastasis Clinic and its close collaboration with the TRACTION platform," said Timothy Heffernan, Ph.D., executive director of TRACTION at MD Anderson. "Our alliance with Taiho combines outstanding drug discovery with expertise in translational research and clinical development to advance new treatment options for patients diagnosed with brain metastases."