On January 27, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported data from initial feasibility studies of its novel visceral lesion applicator (VLA) have been accepted to be presented at the Annual Meeting of the Society of Interventional Oncology in New Orleans from January 30 – February 3, 2020 (Press release, OncoSec Medical, JAN 27, 2020, View Source [SID1234553575]).

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The Company’s visceral lesion applicator (VLA) technology is designed to treat non-cutaneous, internal tumors through the direct delivery of OncoSec’s lead product candidate, TAVO (plasmid-based interleukin-12), or other immunologically relevant genes. Visceral lesions are typically difficult to treat, and include gastrointestinal tumors, pancreatic tumors, and hepatocellular carcinomas.

The study, titled, "Novel Controlled Delivery of Potent Anti-Cancer Immunotherapy Directly to Deep Visceral Lesions," will be featured in a poster displayed throughout the Society of Interventional Oncology’s annual meeting from January 30 – February 3, 2020 at the New Orleans Marriott.

About the Society of Interventional Oncology
The SIO Annual Scientific Meeting offers sessions on medical technology and how to implement new technology in oncologic practice. The conference provides a multi-disciplinary approach to cancer care. The annual meeting brings together international health care providers for international sharing of ideas. The conference leverages a combination of state-of-the-art lectures, panel discussions, invited papers, and selected abstracts of basic, translational, and clinical research to promote meaningful dialogue.

On January 27, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer (Press release, Oncolytics Biotech, JAN 27, 2020, View Source [SID1234553574]). The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) in San Francisco.

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"We have identified another biomarker candidate for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results correlate CEACAM6 levels with long term benefit in patients with pancreatic cancer. We are working with industry and academic colleagues to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes"

The poster, CEACAM6 is a candidate biomarker for Reolysin (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), highlights data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer. PFS increased over 80%, from 5.72 months to 10.32 months (p=0.05).

"I am very encouraged to see additional data come from this important study by the Ohio State University Comprehensive Cancer Center," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This statistically significant result highlights the potential for CEACAM6 to become an additional prognostic biomarker for pelareorep and could provide considerable clinical value as we investigate its potential in pancreatic and other GI cancers."

CEACAM6 is differentially expressed in pancreatic adenocarcinoma cells. High levels of CEACAM6 are known to block viral trafficking in virally infected cells, thereby decreasing viral replication. Study investigators speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity and may serve as a biomarker.

Key data and conclusions:

CEACAM6 was the most differentially expressed gene, with an eight-fold decrease in levels of mRNA, in long-term responders compared to early progressors in patients receiving pelareorep.

Low levels of CEACAM6 mRNA expression were associated with prolonged PFS in pelareorep-treated patients (p=0.05). This treatment effect was not seen in patients that were not treated with pelareorep (p=0.35).

In pelareorep treated patients, CEACAM6 mRNA expression level was very influential with a hazard ratio of 1.54 (p=0.01), suggesting that one unit increase in CEACAM6, corresponds to an increase in the risk of progression and/or death by 54% in this arm. There was no significant relationship seen in patients that were not treated with pelareorep

CEACAM6 may be included as a candidate biomarker of resistance to pelareorep and, in theory, could inhibit viral trafficking in tumor cells

The poster presentation was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona. It can be found on the Posters & Publications page of the company’s website: View Source

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 January 27, 2020 NuCana plc (NASDAQ: NCNA) reported that the first patients have been dosed in its Phase III study of Acelarin (NUC-1031) plus cisplatin for the first-line treatment of patients with biliary tract cancer and that the study design is being presented at the ASCO (Free ASCO Whitepaper)-GI Conference in San Francisco (Press release, Nucana BioPharmaceuticals, JAN 27, 2020, View Source [SID1234553573]). The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug application (IND) for Acelarin.

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"We are pleased to have commenced dosing the first patients in our Phase III NuTide:121 study," said Hugh Griffith, NuCana’s Chief Executive Officer. "Acelarin in combination with cisplatin has been shown in early clinical studies to achieve higher response rates compared to the current standard of care in patients with advanced biliary tract cancer, a devastating disease for which there is a significant need for more effective medicines."

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2).

NuCana also announced the presentation of a poster "NUC-1031 in combination with cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)" at the ASCO (Free ASCO Whitepaper)-GI Conference being held in San Francisco, CA. The poster details the study design of NuTide:121 and reviews the encouraging results previously reported in the Phase Ib ABC-08 Study. The poster may be found here.

The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

More information about this study may be found here.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in biliary tract cancer patients with locally advanced or metastatic disease is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

On January 27, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company and NantOmics, LLC, the leader in molecular analysis, reported a novel artificial intelligence platform for aiding pathologists in image-based lung cancer subtyping at the Society for Imaging Science and Technology’s International Symposium on Electronic Imaging 2020 (Press release, NantHealth, JAN 27, 2020, View Source [SID1234553572]). This novel machine vision software platform accurately subtypes lung cancer pathology and achieves high concordance with analysis performed by trained medical pathologists.

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An initial report of the AI technology was presented at the Sixth American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the International Association for the Study of Lung Cancer (IASLC) International Joint Conference. The study entitled, "Tumor-infiltrating lymphocytes (TILs) found elevated in lung adenocarcinomas (LUAD) using automated digital pathology masks derived from deep-learning models" concluded that despite lower overall TMB (tumor mutation burden) and lymphocyte levels, there exists a subset of lung cancers with very high infiltrating lymphocyte counts.

Derived from deep-learning models, together, the findings demonstrate a novel AI-based method for subtyping lung cancer pathologies which impacts treatment options for patients and improved methods of identifying tumor infiltrating white cells found elevated in lung cancer.

"Accurately identifying and quantifying tumor-infiltrating white cells is extremely important for prognosis and treatment decisions in this era of personalized medicine, yet it currently requires manual review of whole slide images by medically trained pathologists, and incurs significant delays and cost," explains Dr. Patrick Soon-Shiong, MD, Chairman and CEO of NantHealth. "Our goal was to develop a scalable remote cloud-based diagnostic imaging system, a NORAD of pathology diagnosis so to speak. To accomplish this, machine vision of digitally transmitted images of tumor tissue would facilitate a scalable cloud-based infrastructure, with an image patch-based, automated system to classify cancers by their immune status."

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, which is further classified as 40 percent adenocarcinoma (Adeno), 30 percent squamous cell carcinoma (Squamous) and the remainder, large cell carcinoma1. As analyses show that lung adenocarcinomas (LUAD) receive slightly more survival benefit from anti-PD1 therapy than squamous-cell lung carcinomas (LUSC), which have a higher TMB, a team of researchers explored whether lymphocyte distribution in the tumor microenvironment may give a rational explanation for the different responses to immuno-oncology agents independent of TMB.

"By focusing on classifying regions detected as tumorous, we achieved identification of adenocarcinomas versus squamous cell carcinomas in non-small-cell lung cancers with an approximate accuracy rate of 86 percent," explained Soon-Shiong. "With highly accurate tumor-region and lymphocyte detection, oncologists may better treat their patients with adeno versus squamous-based therapies and the use of immunotherapies may result in better outcomes."

Study Design:

The system was trained and tested on 876 subtyped NSCLC gigapixel-resolution diagnostic whole slide images (WSI) from 805 patients obtained from The Cancer Genome Atlas (TCGA) sources. Samples were randomly split into training (711 WSIs from 664 patients) and testing (165 WSIs from 141 patients) sets.

Findings show that NantOmics and NantHealth’s fully-automated histopathology subtyping AI method outperforms other algorithms reported in literature for diagnostic WSIs. The system also generated maps of (tumor) regions-of-interest within WSIs, providing novel spatial information on tumor organization.

Details of the oral presentation at the IS&T International Symposium on Electronic Imaging 2020 outlined below:

Title: "Pathology image-based lung cancer subtyping using deep-learning features and cell-density maps"

Authors: Mustafa I. Jaber, Christopher W. Szeto, Bing Song, Liudmila Beziaeva, Stephen Benz, Patrick Soon-Shiong, and Shahrooz Rabizadeh

Session and Number: Image Processing: Algorithms and Systems XVIII (IPAS-064)

Location: Hyatt Regency San Francisco Airport, Burlingame, CA

Date and Time: January 27, 2020 at 4:10 PM

On January 27, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported the pricing of an agency offering (the "Offering") of up to 20,000,000 units, subject to a minimum offering of 10,000,000 units (the "Units"), for gross proceeds of between $5,000,000 and $10,000,000, assuming no exercise of the over-allotment option granted to the Agent (as defined below), at a price of $0.50 per Unit (Press release, IntelGenx, JAN 27, 2020, View Source [SID1234553570]). Each Unit will consist of one share (each, an "Offered Share") of common stock of the Company ("Common Stock") and one warrant (each, a "Warrant") to purchase one share of Common Stock at an exercise price of $0.75 per share (a "Warrant Share"). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.

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The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the "Agent") in the provinces of British Columbia, Alberta, Manitoba and Ontario. Closing of the Offering is expected to occur on or about February 11, 2020.

The Company has granted to the Agent an option to increase the size of the Offering by up to 15%, exercisable in whole or in part at any time for a period of 30 days after and including the closing date of the Offering.

The net proceeds from the Offering will be used for the Company’s Phase 2A Montelukast Study and general working capital requirements.

The Company has applied to list the Offered Shares, the Warrants and the Warrant Shares underlying the Units on the TSX Venture Exchange (the "TSXV"). The approval is subject to fulfillment by the Company of customary closing conditions of the TSXV.

The Company intends to file a final short form prospectus (the "Prospectus") in the provinces of British Columbia, Alberta, Manitoba, Ontario and Quebec, as well as an amended registration statement on Form S-1 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") with respect to the Offering today. The Offering is subject to certain customary conditions including, but not limited to, the receipt of all necessary approvals, including the SEC declaring the Registration Statement effective.

Before investing, you should read the Prospectus and the Registration Statement, as well as other documents the Company has filed or will file late today with the SEC and the Canadian securities regulators for more complete information about the Company and this Offering. A copy of the Prospectus is available under the Corporation’s profile at www.sedar.com and a copy of the Registration Statement can be obtained from the SEC’s website at www.sec.gov or by request to Echelon Wealth Partners Inc. at [email protected].

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date.