On November 8, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that the Company presented data from the Toca 6 Phase 1b study of Toca 511 and Toca FC in patients with non-CNS tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD and will have two presentations related to brain cancer at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO), to be held Nov. 20-24 in Phoenix (Press release, Tocagen, NOV 8, 2019, View Source [SID1234550838]).

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The SITC (Free SITC Whitepaper) poster titled, "Immunomodulation in peripheral blood and tumor following Toca 511 & Toca FC treatment in patients with solid tumors," was a summary of the results in the Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors. The objectives of the study were to assess changes in immune activity of peripheral blood mononuclear cells (PBMCs) relative to baseline following treatment and to evaluate immune cell modulation in the tumor microenvironment from tumor biopsies taken at baseline compared to biopsies collected following treatment.

Data Summary

The Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors demonstrated vector deposition, immune activity, a potential signal of clinical activity and a favorable safety profile.

Treatment was generally well tolerated, with predominantly Grade 1 and 2 treatment-related gastrointestinal adverse events. Most patients enrolled (81%) had metastatic colorectal cancer; the median lines of prior chemotherapies was four (1, 12).
Clinical activity was supported by observations of partial response and stable disease. The median overall survival was 9.6 months (95% CI 6.3, 16.4) in this heavily pre-treated population.
Toca 511 and Toca FC was associated with a T-cell mediated immune response in peripheral blood and metastatic tumor in some patients, consistent with the mechanism of action observed in preclinical models.
Peripheral blood T-cells shift from naïve to effector phenotypes indicating that T-cells are encountering their target antigens, potentially including proteins released by tumor cell killing.
Expansion of CD4+ memory T-cells after treatment is consistent with engagement of the adaptive immune system.
Increased post-treatment quantities of B-cells further suggests immune activation during the course of Toca 511 and Toca FC therapy.
Toca 511 and Toca FC led to a decrease of CD11b+ myeloid cells in five of six patients with evaluable colorectal metastasis. This immune fluorescence analysis suggests a decrease in the immunosuppressive myeloid cells, as seen in preclinical models, and potentially makes the tumor and the tumor microenvironment more conducive to immunologic modulation.
"Data from our poster at SITC (Free SITC Whitepaper) are encouraging and support the planned exploration of our Toca regimen in non-muscle invasive bladder cancer," said Marty Duvall, chief executive officer of Tocagen. "In addition, we look forward to presenting Toca 5 analyses at the upcoming SNO conference Toca 5 analyses including subgroups and molecular data in addition to details of the planned NRG Oncology trial in patients with newly diagnosed glioblastoma."

Details of the SNO presentations are as follows. Copies of the presentations will be available on Tocagen’s website following the presentations.

Presentation Type: Plenary Presentation (Abstract: LTBK-08)
Title: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
Presenter: Timothy Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program
Date and Time: Friday, Nov. 22, 11:50 a.m. – 12:00 p.m. MST

Presentation Type: Poster Presentation (Abstract: RBTT-11)
Title: NRG Oncology NRG-BN006: A phase II/III randomized, open-label study of Toca 511 and Toca FC with standard of care compared to standard of care in patients with newly diagnosed glioblastoma
Presenter: Manmeet Ahluwalia, M.D., head of operations, Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic.
Date and Time: Saturday, Nov. 23, 5:00 p.m. – 7:00 p.m. MST

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On November 8, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported updated data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD (Press release, Neon Therapeutics, NOV 8, 2019, View Source [SID1234550751]).

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"We are pleased to present these updates for both NEO-PV-01 and NEO-PTC-01, both of which demonstrate Neon’s continued leadership in advancing neoantigen-based science and drug development. We continue to believe that these personalized approaches to treating cancer represent significant potential to reshape the treatment landscape for solid tumors," said Richard Gaynor, M.D., Neon’s President of Research and Development.

NEO-PV-01: Updated Results from the NT-001 Clinical Trial

Neon reported updated results (August 2019 data cut) from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO (nivolumab) in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer. Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) and overall survival (OS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data. Further, neoantigen-specific immune responses and epitope spread to RECON-predicted targets were associated with longer PFS and major pathological responses post-administration of NEO-PV-01 in melanoma patients were also associated with longer PFS. The safety data for NT-001 were consistent with the safety profile for OPDIVO monotherapy. These updated results come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial. The NT-001 trial was initiated in November 2016 and completed enrollment in July 2018.

NT-001 Clinical Trial Results
August 2019 data cut; overall survival analysis includes previously censored patients from April 2019 data cut
Initiated OPDIVO: Patients that received at least one dose of OPDIVO (ITT set)
Initiated NEO-PV-01: Patients who received at least one dose of NEO-PV-01 (ITT subset)

1 Historical checkpoint inhibitor data for advanced or metastatic melanoma: Larkin, et al, JCO 2017; Schachter, et al, Lancet 2017; Wolchok, et al, NEJM 2017.
2 Historical checkpoint inhibitor data for advanced or metastatic non-small cell lung cancer: Borghaei, et al, Lancet 2015; Carbone, et al, NEJM 2017; Herbst, et al, Lancet 2016.
3 Historical checkpoint inhibitor data for advanced or metastatic bladder cancer: Balar, et al, Lancet 2017; Bellmunt, et al, NEJM 2017; Sharma, et al, Lancet 2016.

NEO-PTC-01: Advanced Process Development Supports Clinical Trial Application Filing in Europe by End of 2019

Neon continues to advance its preclinical and process development work for NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor. NEO-PTC-01 leverages Neon’s RECON bioinformatics platform to individually select a set of neoantigen targets for each patient, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo. Neon believes that this approach will allow NEO-PTC-01, a non-engineered T cell product that leverages peripheral blood mononuclear cells (PBMCs) as its starting material, to specifically target each patient’s individual tumor with T cells that can drive a robust and persistent anti-tumor response.

In the update presented today at SITC (Free SITC Whitepaper), Neon demonstrated that it can reproducibly generate a potent T cell product from PBMCs of melanoma patients, as well as at therapeutic scale using a healthy donor sample. This process development work showed that NEO-PTC-01 induced multiple CD8+ and CD4+ T cell responses from both the memory and naïve T cell compartments. The induced T cell responses were mutant-specific, showed a polyfunctional profile and had a central and effector memory phenotype. The induced T cell responses had cytotoxic capability, shown by the recognition of antigen-expressing tumor cell lines. Importantly, NEO-PTC-01 induced T cell cultures that directly recognized autologous tumor digest.

Neon is focusing the initial clinical development of NEO-PTC-01 in patients with solid tumors that are refractory to checkpoint inhibitors. Neon expects to file a clinical trial application, or CTA, in Europe by the end of 2019 to evaluate NEO-PTC-01 in the solid tumor setting.

Details for the NEO-PV-01 poster presentation are as follows:

Presentation Title: Disease-related Biomarkers are Associated with Extended Progression-Free Survival after Treatment with NEO-PV-01 in Combination with Anti-PD1 in Patients with Metastatic Cancers
Poster Hall Hours: Friday, November 8 from 7:00 a.m. – 8:00 P.M. ET
Poster Number: P437
Location: Gaylord National Convention Center

Details for the NEO-PTC-01 poster presentation are as follows:

Presentation Title: The Development of an Autologous Neoantigen-Specific T cell Product from Peripheral Blood, NEO-PTC-01, through the ex-vivo Induction Protocol, NEO-STIM
Poster Hall Hours: Friday, November 8 from 7:00 a.m. – 8:00 P.M. ET
Poster Number: P197
Location: Gaylord National Convention Center

The posters will also be made available at View Source

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

On November 8, 2019 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that its senior management will deliver presentations at the following upcoming investor conferences (Press release, eHealthInsurance, NOV 8, 2019, View Source [SID1234550768]):

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28th Annual Credit Suisse Healthcare Conference, on Tuesday, November 12, 2019 at 11:30 a.m. M.T. The conference is being held at The Phoenician Resort in Scottsdale, Arizona.
Stephens Nashville Investment Conference, on Thursday, November 14, 2019 at 1:00 p.m. C.T. The conference is being held at the Omni Nashville, Nashville, TN.
Interested investors can access the live audio webcast of the presentations at www.ehealthinsurance.com under Investor Relations. Please visit the website at least 15 minutes early to register, download, and install any necessary software. A replay of this event will be available on the company’s website shortly after the conclusion of the event and will remain available for 14 days.

eHealth will also hold one-on-one and small group meetings with institutional investors at the 10th Annual Craig-Hallum Alpha Select Conference, on Tuesday, November 12th, 2019. The conference is being held at Sheraton Times Square Hotel, New York, NY.

On November 8, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for the three and nine months ended September 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 8, 2019, View Source [SID1234550784]).

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"We are advancing four Breakthrough Therapy Designation programs into late stages, all with first-in-class therapies targeting rare diseases with no approved treatments," said David Cory, Eiger President and CEO. "We recently completed successful pre-NDA and pre-MAA meetings with both FDA and EMA for Progeria and Progeroid Laminopathies and plan to submit an NDA by year-end. We recently announced positive results from the HDV Lambda and Lonafarnib combination LIFT study, which will be presented as an oral late-breaker at AASLD. Our Phase 3 HDV global D-LIVR study continues to activate sites, enroll and dose patients. We look forward to updating on continued progress in the future."

Recent Highlights

Lonafarnib in Progeria and Progeroid Laminopathies

Positive pre-NDA meeting with FDA
Positive pre-MAA meeting with EMA
Peginterferon Lambda (Lambda) in Hepatitis Delta Virus (HDV)

Late-breaking oral presentation of positive Phase 2 LIFT (lambda + lonafarnib boosted with ritonavir) interim end-of-treatment results accepted for AASLD
95% of patients achieved primary endpoint of >2 log reduction in HDV RNA
>50% of patients were HDV RNA undetectable or BLOQ
Adverse events were mostly mild to moderate
Breakthrough Therapy Designation granted by FDA
Avexitide in Post-Bariatric Hypoglycemia (PBH)

Positive End of Phase 2 meeting with FDA for avexitide in PBH
Upcoming Milestones

Oral presentation of Phase 2 LIFT interim end-of-treatment results in HDV at AASLD
NDA submission for Progeria and Progeroid Laminopathies by year-end, followed by MAA submission in the first quarter of 2020
Phase 3 D-LIVR study in HDV (N=400) enrollment update after year-end
End of Phase 2 meeting for Lambda monotherapy in HDV in the first quarter of 2020
Third Quarter 2019 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2019 totaled $109.9 million compared to $125.3 million at June 30, 2019, a decrease of $15.4 million.

The Company reported a net loss of $18.6 million, or $0.76 per share for third quarter 2019, as compared to $17.1 million, or $1.20 per share, for the same period in 2018.

Research and Development expenses were $14.1 million for third quarter 2019, as compared to $13.2 million for the same period in 2018, an increase of $0.9 million. The increase was primarily due to employee-related costs, including stock-based compensation, and expenditures related to our clinical programs.

General and Administrative expenses were $4.2 million for third quarter 2019, as compared to $3.6 million for the same period in 2018, an increase of $0.6 million. The increase was primarily due to additional employee-related costs, including stock-based compensation.

Third quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.5 million for the same period in 2018.

As of September 30, 2019, Eiger had 24.5 million of common shares outstanding.

On November 8, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), highlighting data from the AWARE-1 study in early breast cancer (Press release, Oncolytics Biotech, NOV 8, 2019, View Source [SID1234550800]). The 34th Annual SITC (Free SITC Whitepaper) Meeting is being held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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"This is the first-time our biomarker data from AWARE-1 has been presented at a major academic conference," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The primary objective of this study is to evaluate changes in the immune environment of patients diagnosed with early stage breast cancer using our biomarker of T cell clonality measured by CelTIL score. This measures a change or expansion of infiltrating immune cells and importantly, an increase in CelTIL is known to correlate with a positive patient outcome. This initial data shows replication of pelareorep occurs exclusively in tumor tissue and there is an increase in CelTIL through the expansion of existing T cells, and most importantly, through the creation of new T cell clones. We continue to show that pelareorep changes the immunogenetic environment within the tumor, and the results of this early stage breast cancer study support our use of this biomarker and its value in predicting tumor response in our upcoming BRACELET-1 study in hormone receptor positive metastatic breast cancer."

The next patient cohort to report from AWARE-1 focuses on patients receiving pelareorep and the standard of care, without Tecentriq. This cohort will allow for the comparison of patients treated with standard of care plus pelareorep, to patients receiving the standard of care, plus pelareorep, plus Tecentriq. This will be the first data from AWARE-1 to confirm the impact pelareorep has on enhancing the anti-tumor T cell response both on its own, and in combination with a checkpoint inhibitor.

The poster, "A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)", was authored by AWARE-1 principal investigator, Aleix Prat, et al, and presented by Dr. Patricia Villagrasa, Scientific Director at SOLTI Innovative Breast Cancer Research. The AWARE-1 study continues to screen and enroll patients and we expect to provide interim data before the end of the year and final results in the first half of 2020.

SITC Presentation Details

Title: A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)
Abstract ID: P373
Poster Presentation – Friday, Nov. 8, 7:00 am – 8:00 pm
Location: Poster Hall (Prince George AB)
About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early stage breast cancer that will enroll 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines the standard of care by breast cancer subtype with pelareorep and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

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.