On December 3, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported results from its latest proof of concept study (Press release, VolitionRX, DEC 3, 2019, View Source [SID1234551897]). A single pre-clinical Nu.Q assay utilizing a basic microtiter plate platform detected 80% of newly diagnosed Non-Hodgkins Lymphoma ("NHL") and Leukemia cases (mixture of Acute Lymphocytic Leukemia ("ALL") and Acute Myeloid Leukemia ("AML") at 95% specificity among healthy subjects. The Area Under the Curve ("AUC") for this single assay was 91%. A number of other assays in development also demonstrated promising individual assay results with AUCs ranging from 79% to 91%.

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Commenting on these results Dr. Jake Micallef, Chief Scientific Officer at Volition said, "This is a very exciting outcome as we continue the development of our assays beyond colorectal, lung and prostate cancer. We have previously announced results from both single assay and panels of Nu.Q biomarkers but the results of this discovery study are the best single Nu.Q assay result in any cancer we have demonstrated to date. We are delighted to report such promising results for Nu.Q’s ability to detect a range of blood cancers in this small study.

The objective of this proof of concept study was to investigate a range of cancer conditions not previously studied for detection using Nu.Q assays and the results showed remarkable detection for all 3 blood cancers tested. The next steps are to evaluate these findings in independent larger clinical trials of symptomatic populations using Volition’s automated ELISA product platform whilst we also continue pre-analytics studies".

Dr. Jason Terrell, Chief Medical Officer at Volition said, "This is an important finding for us. These types of hematopoietic malignancies are difficult to diagnose. Symptoms are often vague and non-specific such as fatigue and recurrent infections and yet the definitive diagnostic tools of bone marrow or lymph node biopsy are invasive and can be expensive. There are over 700,000 new cases of NHL, ALL and AML diagnosed globally each year and approximately 415,000 deaths. Whilst clearly more studies need to be conducted, we hope that a routine blood test using our Nu.Q technology could lead to earlier diagnosis."

About the Study

Commercially obtained patient blood plasma samples were taken from 62 healthy volunteers (mean age 45 years) as well as approximately 300 patients previously diagnosed with bladder, bone, brain, esophageal, head and neck, melanoma, skin, uterine, or cervical cancers (mean age 56 years) and 54 subjects diagnosed with hematopoietic cancers (mean age 57 years).

On December 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551864]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551882]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 3, 2019 ArcherDX, Inc., a growth-stage molecular diagnostics company dedicated to developing breakthrough solutions that advance personalized genomic medicine, reported a non-exclusive partnership with Illumina, Inc. (NASDAQ: ILMN) to develop in-vitro diagnostic (IVD) tests for Archer’s planned portfolio of next-generation sequencing (NGS)-based companion diagnostics (Press release, ArcherDX, DEC 3, 2019, View Source [SID1234551898]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The scope of the agreement includes ArcherDX’s future portfolio of IVD tests used to facilitate targeted therapy selection and monitoring of Minimal Residual Disease for the management of patients with solid tumor and blood cancers. The planned IVD tests will empower commercial laboratories, hospitals and health systems to run these assays in their local laboratories worldwide.

Under the agreement, ArcherDX will develop IVD tests to run on Illumina’s NextSeq 550Dx System. ArcherDX will be responsible for obtaining necessary regulatory approvals for each IVD kit and for their subsequent commercialization. ArcherDX and Illumina entered into a similar agreement for the MiSeq Dx System in 2016.

"We are pleased to expand our development partnership with Illumina, whose large install base and highly accurate sequencing systems will accelerate our efforts to democratize access to high-quality genomic testing by developing distributable diagnostic assays that can be used to identify targeted therapy options, as well as monitor for the recurrence of disease across a wide variety of cancers," said Jason Myers, Chief Executive Officer and co-founder of ArcherDX. "These IVD tests will provide important new options for providers and patients around the world."

"Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics," said Dr. Phil Febbo, Chief Medical Officer of Illumina. "By enabling ArcherDX to develop IVD tests, we are ensuring health care providers and patients have access to a growing menu of important distributable diagnostic tests that will improve patient outcomes."

On December 3, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer (Press release, Advaxis, DEC 3, 2019, View Source [SID1234551866]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to announce continued clinical progress of our ADXS-HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Results from our ADXS-NEO program provided important proof-of-concept data demonstrating the generation of CD8+ T cells against hotspot mutations. Based on these encouraging results, and the convenient and broadly accessible off-the-shelf approach of our HOT therapies, we are focused on expanding the HOT program to additional cancer-specific trials through various, capital-efficient avenues. In addition, we look forward to reporting immune data from the monotherapy arm of our ongoing Phase 1/2 HOT clinical trial in non-small cell lung cancer (NSCLC) in early 2020."

ADXS-504 is part of the company’s ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten ‘HOT’ drug candidates that are in various stages of development, with the company’s Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers. Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofectal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment approach designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.