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OncoSec To Present Data in Late-Stage Triple Negative Breast Cancer (TNBC) at the 2018 San Antonio Breast Cancer Symposium®

On November 13, 2018 OncoSec Medical Inc., (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that TAVO will be featured in two poster sessions during the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4-8 in San Antonio, Texas (Press release, OncoSec Medical, NOV 13, 2018, View Source [SID1234531329]). Posters include data on TAVO as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with Merck’s KEYTRUDA (pembrolizumab) for the treatment of late stage triple negative breast cancer (TNBC).

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"We are encouraged with the preliminary clinical observations we are seeing thus far, both in a monotherapy setting and in combination with checkpoint inhibitors," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "Based on this, we are excited to continue on the path toward developing novel treatment options for this large unmet medical need,"

Details on the poster presentations are as follows:

Presentation Title: Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Session Date & Time: Thursday, December 6, 7:00 – 9:00 a.m. CT (8:00 – 10:00 a.m. ET)
Session Title: Poster Session 2: Treatment: Immunotherapy (clinical)
Location: Hall 1, Henry B. Gonzalez Convention Center

Presentation Title: A phase 2 study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation with pembrolizumab in patients with inoperable locally advanced or metastatic triple negative breast cancer
Session Date & Time: Thursday, December 6, 5:00 – 7:00 p.m. CT (6:00 – 8:00 p.m. ET)
Session Title: Ongoing Clinical Trials: Immunotherapy
Location: Hall 1, Henry B. Gonzalez Convention Center

The abstracts for these presentations are now available online on the SABCS website at View Source

INTELGENX CLOSES PRIVATE PLACEMENT FINANCING

On November 13, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported the closing of Tilray, Inc.’s strategic investment in IntelGenx by way of private placement (the "Private Placement") (Press release, IntelGenx, NOV 13, 2018, View Source [SID1234531303]). Pursuant to the Private Placement, the Company issued 1,428,571 common shares ("Common Shares") at a subscription price of U.S.$0.70 per Common Share for gross proceeds of U.S.$1,000,000. The Corporation intends to use the proceeds of the Private Placement for cannabis-infused VersaFilm product development under its previously announced definitive license, development and supply agreement (the "Agreement") with Tilray Inc.

The Common Shares issued to Tilray, Inc. are subject to a four-month statutory hold period which expires March 14, 2019. Additionally, under the Private Placement purchase agreement, Tilray, Inc. agreed that until May 14, 2019 it would not cause or permit any transfer of any Common Shares.

OncoCyte Reports Third Quarter 2018 Financial Results and Progress in DetermaVu™ Development

On November 13, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Oncocyte, NOV 13, 2018, View Source [SID1234531301]).

"During the third quarter and subsequent period, we made significant progress on our DetermaVu development plan by completing the transition to a new diagnostic testing platform that is yielding very consistent and reliable data," said William Annett, President and Chief Executive Officer. "Using this equipment, we have now run over half of the 700-blood samples that are being used in our Algorithm Development Study. This study will establish a proprietary mathematical algorithm that will be used to interpret test results for DetermaVu. Once all samples have been run, development of the algorithm will begin, and we expect its completion next month."

"After the new algorithm is derived, we will move on to an R&D Validation Study that should determine the accuracy of DetermaVu to within approximately plus or minus eight percentage points. By about the end of 2018 or early 2019 we anticipate finishing this study and will then be able to confirm with a high degree of certainty whether we have a commercially-viable diagnostic test poised to address the multi-billion-dollar market for a liquid biopsy lung cancer diagnostic test. On successful completion of the R&D Validation study we will be on-track to complete all of the necessary pre-launch development work in the first half of 2019. If the test’s accuracy is maintained in the planned studies, we plan to make DetermaVu commercially available in the second half of 2019."

Highlights

Following rigorous testing, completed transition to a new Next Generation Sequencing diagnostic testing platform and quality control testing of new custom panel reagents
Initiated a 700–blood sample Algorithm Development Study to develop the proprietary mathematical algorithm that will be used to interpret the results of DetermaVu
On-track to initiate an R&D Validation Study of 250 blinded, prospectively-collected patient blood samples with results expected by the end of this year or early 2019
Remaining Validation Pathway for DetermaVu:

Approximately yearend 2018: R&D Validation study – to confirm algorithm performance on a blinded sample set in an R&D setting
1H 2019: Analytical Validation study – to establish the performance characteristics of the assay system to be validated in OncoCyte’s CLIA laboratory
1H 2019: CLIA Validation study – to confirm that the assay has been successfully transferred to the CLIA lab
1H 2019: Clinical Validation study – approximately 300 blood sample study to establish the DetermaVu performance in an independent, blinded data set
2H 2019: Commercial availability of DetermaVu
Post-launch (2019/2020): Clinical Utility study – follow-on real world tracking study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system
Third Quarter 2018 Financial Results

At September 30, 2018, OncoCyte had $10.8 million of cash and cash equivalents in addition to marketable equity securities valued at $0.8 million for a total of $11.6 million of liquid assets. This cash balance includes $3.3 million raised during the third quarter, net of financing expenses, from an at-market registered direct offering of common stock and warrants.

For the third quarter ended September 30, 2018, OncoCyte incurred a net loss of $3.0 million, or $0.07 per share, compared to a net loss of $6.9 million, or $0.22 per share, in the third quarter of 2017.

Operating expenses for the three months ended September 30, 2018 were $3.0 million, as reported, and were $2.6 million, on an as adjusted basis. The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the third quarter ended September 30, 2018 were $1.5 million compared to $1.8 million for the same period in 2017, a decrease of $0.3 million.

General and administrative expenses for the three months ended September 30, 2018 were $1.3 million compared to $4.3 million for the same period in 2017, a decrease of $3.0 million.

Cash used in operations was $2.5 million for the third quarter of 2018, which compares to cash used in operations of $3.5 million during the third quarter of 2017, the reduced cash used in operating activities in the current quarter mostly resulting from OncoCyte’s staff reductions and executive sabbatical programs implemented last quarter.

Conference Call

OncoCyte will host a conference call today, Tuesday, November 13, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is +1-201-493-6779. For all callers, please refer to Conference ID 13684100. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 844-512-2921 toll-free (from U.S./Canada); international callers dial +1-412-317-6671. Use the Conference ID 13684100. Additionally, the archived webcast will be available at View Source

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.

DetermaVu is a trademark of OncoCyte Corporation.

Oncolytics Biotech® Announces Attendance of Upcoming Conferences

On November 13, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the Company is scheduled to attend the following upcoming conferences (Press release, Oncolytics Biotech, NOV 13, 2018, View Source [SID1234531298]):

Jefferies 2018 London Healthcare Conference
November 14 & 15, 2018, Waldorf Hilton, London, UK

Dr. Matt Coffey, President & CEO and Mr. Kirk Look, CFO, to attend and host meetings

60th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 1 – 4, 2018, San Diego Convention Center, San Diego, CA

Dr. Matt Coffey, President & CEO, to attend and host meetings

Dr. Craig C. Hofmeister, Acting Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, will present data in a poster presentation from 6:00 to 8:00 p.m. PDT on Sunday, December 2, in Hall GH

American Society of Clinical Oncology sponsored, Gastrointestinal Cancers Symposium 2019
January 17 – 19, 2019, Moscone West Building, San Francisco, CA

Dr. Matt Coffey, President & CEO, to attend and host meetings

Immutep Presents Positive New Data from Ongoing TACTI-mel Study at Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting

On November 13, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported new positive interim data from its TACTI-mel Phase I clinical trial, presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Washington, D.C., U.S (Press release, Immutep, NOV 13, 2018, View Source [SID1234531297]).

The TACTI-mel study is evaluating the use of eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for unresectable or metastatic melanoma.

In an oral presentation, Prof. Adnan Khattak, Consultant Medical Oncologist at Fiona Stanley Hospital and a principal investigator of the on-going TACTI-mel study, showed efficacy and safety data from 18 patients in part A, the dose escalation part of the study, and first safety data from 6 patients in part B.

In part A, dose escalation, combination therapy started after four cycles of KEYTRUDA monotherapy. In part B, patients were treated with the combination from the first day of treatment i.e. receiving efti from day one, cycle one with KEYTRUDA.

The efficacy data from part A was encouraging and supportive of previously disclosed response rates with a 33% Overall Response Rate (ORR) when measured from start of the combination at cycle 5 of KEYTRUDA. The ORR was 61% when measured from the start of KEYTRUDA monotherapy treatment in an explorative analysis measuring from cycle 1, day 1. A disease control rate of 66% was reported from the combination treatment. The patient population was partly pre-treated before the start of KEYTRUDA, suboptimally responding to KEYTRUDA and the majority had increased risk factors.

In both parts (A and B), combination therapy has been well tolerated with no dose-limiting toxicities and local erythema and injection site reactions as the most common side effects. Importantly the safety data of part B supports the dose scheduling of the Company’s planned Phase II TACTI-002 clinical study in collaboration with MSD.

Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer, also commented "We were honored to have been selected for an oral presentation of the data which further supports our hypothesis that combining efti with a checkpoint inhibitor results in a combinatory therapeutic benefit to patients, pushing the accelerator and releasing the brake of the immune system. The data also highlights the excellent safety profile of efti, when combined with an anti-PD-1 therapy."

Prof. Adnan Khattak commented, "We are very pleased with the responses we have observed in this patient population. These patients had a sub-optimal response to pembrolizumab monotherapy. However, after participating in the TACTI-mel study, we have seen good responses in these patients, with a very encouraging overall response rate."

The data was also presented in a poster presentation titled "Results from a Phase I dose escalation trial (TACTI-mel) with the soluble LAG-3 protein (IMP321, eftilagimod alpha) together with pembrolizumab in unresectable or metastatic melanoma."

The trial design of the Company’s planned Phase II TACTI-002 clinical study in collaboration with MSD was presented at SITC (Free SITC Whitepaper) in a poster titled, "A Multicenter, Phase II Study in Patients With First Line NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent HNSCC Receiving Eftilagimod Alpha in Combination With Pembrolizumab (TACTI-002)".

Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer, commented, "We are looking forward to the initiation of TACTI-002 later this year and I believe the clinical trial collaboration and supply agreement that we entered into with MSD earlier this year, as well as the recently announced agreement with Merck KGaA and Pfizer Inc., further supports the development of efti in combination with PD-1 and PD-L1 therapeutics."

The TACTI-mel poster and presentation, along with the TACTI-002 poster are available on Immutep’s website under the "Investor & Media" tab at www.immutep.com/investors-media/presentations.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label, dosing escalating (1, 6 or 30 mg of eftilagimod alpha or "efti") study evaluating the combination of efti with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

In Part A of the study, the combination therapy starts at treatment cycle 5 (of pembrolizumab) for 6 months and consists of three cohorts of six patients. Part B is an expansion of the initial study by an additional cohort of 6 patients that receive 30 mg of efti in combination with pembrolizumab starting at cycle 1 and with a treatment duration of 12 months.