On November 6, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported three presentations of updated clinical and preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting & Pre-Conference Programs, to be held Nov. 7-11 in Washington, D.C., the 3rd CNS Anticancer Drug Discovery and Development Conference (CADDDC), to be held Nov. 14-15 in New Orleans and the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), to be held Nov. 15-18 in New Orleans (Press release, Tocagen, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375540 [SID1234530869]).

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The clinical data includes details of immunologic trends seen in responding patients with recurrent high grade glioma (HGG) from a Phase 1 study of Toca 511 (vocimagene amiretrorepvec) & Toca FC (5-fluorocytosine, extended-release). Additionally, new preclinical data will be presented demonstrating the enhanced efficacy of Toca 511 & Toca FC regimen when combined with metronomic cyclophosphamide.

Summaries are provided below; full posters or presentations will be placed on Tocagen’s website following the presentation.

Details of the SITC (Free SITC Whitepaper) presentation are as follows:

Presentation Type: Poster (Abstract: P620)
Title: Enhanced Efficacy and Combinability of Low Dose Toca 511 and 5-FC with Metronomic Chemotherapy in Preclinical Models
Presenter: Sophie Viaud, Ph.D.
Date and Time: Saturday, Nov. 10, 7:00-8:30 p.m. ET
Summary:

This study aimed to determine if the addition of metronomic cyclophosphamide would provide therapeutic benefit when combined with Toca 511 and 5-FC (5- fluorocytosine) in a preclinical, subcutaneous glioma model.
The addition of metronomic cyclophosphamide improved tumor control and survival.
Regulatory T cells were significantly reduced in the peripheral blood with the combination with metronomic cyclophosphamide and CD8+ T cells were significantly increased.
Results support the further evaluation of Toca 511 & Toca FC with metronomic dosing of cyclophosphamide and potentially other chemotherapeutics.
Details of the CADDDC presentation are as follows:

Presentation Type: Oral Presentation (Abstract: 0023)
Title: PD-L1 Checkpoint Blockade Using a Single-Chain Variable Fragment Targeting PD-L1 Delivered by Retroviral Replicating Vector (Toca 521) Enhances Anti-Tumor Effect in Cancer Models
Presenter: Amy Lin, Ph.D.
Date and Time: Wednesday, Nov. 14, 1:35-1:45 p.m. CST
Summary:

Toca 521, a retroviral replicating vector (RRV) expressing a single-chain variable fragment (scFv) targeting PD-L1, was developed using Tocagen’s proprietary cancer-selective gene therapy platform technology.
Preclinical results demonstrated Toca 521 reversed PD-1/PD-L1 mediated immune suppression in a human in vitro cell culture system, and conferred robust, durable and highly selective anti-tumor activity compared to systemically administered anti-PD-1 or anti-PD-L1 monoclonal antibodies.
Plasma levels of scFv PD-L1 were equivalent to negative control levels and hence very low compared to reported levels in humans given systemic anti-PD1/PD-L1 therapy.
These results warrant further development of Toca 521 to investigate the potential for improved safety and efficacy profiles compared to systemic monoclonal antibodies against the same checkpoint target. Toca 521 could also be useful in combination with other agents, including immuno-oncology therapies.
Details of the SNO presentation are as follows:

Presentation Type: Poster (Abstract: ATIM-26)
Title: Immunologic trends associated with recurrent high grade glioma patient outcomes in a Phase 1 clinical trial of Toca 511 and Toca FC
Presenter: William Accomando, Ph.D.
Date and Time: Saturday, Nov. 17, 5:00-7:00 p.m. CST
Summary:

Human immune monitoring results from a Phase 1 clinical trial of Toca 511 & Toca FC support an immune-related mechanism of action for the regimen.
Preliminary analyses identified immunologic biomarkers that can potentially predict, with high sensitivity and selectivity, patient outcomes following treatment with Toca 511 & Toca FC.
These results indicate the value of evaluating potential biomarkers of patient outcomes in the ongoing randomized Toca 5 Phase 3 trial in patients with recurrent HGG.
About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. 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, only 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 6, 2018 Jnana Therapeutics reported that Joanne Kotz, Ph.D., a company co-founder, has been named Chief Executive Officer (Press release, Jnana Therapeutics, NOV 6, 2018, View Source [SID1234530929]). Dr. Kotz has served as Jnana’s president since December 2017.

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"Joanne has demonstrated exceptional leadership in guiding the company through its early stages of growth, and we believe she is the ideal person to bring Jnana through its next phase and execute on the company’s vision to unlock SLC transporters as a therapeutic class," said Dr. Amir Nashat, a member of Jnana’s Board of Directors and a managing partner at Polaris Partners. Dr. Nashat also served previously as the company’s interim Chief Executive Officer. "She has built a talented team and a collaborative, empowering culture, while also leading important work to validate Jnana’s proprietary drug discovery platform. Together these position Jnana for even greater success going forward."

Dr. Kotz has broad life sciences experience in research, business, and operations. She helped formulate the initial scientific strategy for Jnana and has led the business and operations of the company since its launch in January 2017. Prior to founding Jnana, she held a leadership position in the F-Prime Biomedical Research Initiative, whose mission is to advance the discovery of novel therapeutic agents for the treatment of neurodegenerative disease by funding early-stage research in academia and biotech companies. Prior to F-Prime, Dr. Kotz was a director at the Broad Institute, where she played a leadership role in creating and guiding partnerships to advance drug discovery efforts, including the Broad-Bayer collaboration in oncology that resulted in the identification of multiple drug candidates. She received a Ph.D. in chemistry from the University of California, Berkeley and conducted postdoctoral research at the Necker Children’s Hospital in Paris and at Genentech.

"I am very proud of what the Jnana team has accomplished to date," said Dr. Kotz. "We have made significant progress in advancing our technology platform, which is the first to explicitly target the SLC family of metabolite transporters, established a strategic collaboration with Neurocrine Biosciences to discover new medicines for central nervous system disorders, and recruited a strong team committed to making a positive impact on patients and their families. I am honored to have been chosen to serve as CEO, and look forward to guiding Jnana’s efforts to transform our knowledge of SLCs into new therapeutics for patients lacking viable treatment options."

On November 6, 2018 Nektar Therapeutics (NASDAQ:NKTR) reported that it has entered into an oncology clinical collaboration with Pfizer Inc. (NYSE:PFE) to evaluate several combination regimens in multiple cancer settings, including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN) (Press release, Nektar Therapeutics, NOV 6, 2018, View Source [SID1234534537]). The collaboration will evaluate Nektar’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214 with avelumab, a human anti-PD-L1 antibody in development by Merck KGaA, Darmstadt, Germany, and Pfizer; talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer; or enzalutamide, an androgen receptor inhibitor in development by Pfizer and Astellas Pharma Inc.

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"We are excited to partner with Pfizer to evaluate the potential benefit of the combination of NKTR-214 with agents targeting multiple mechanisms in the Company’s portfolio for patients with a diagnosis of prostate and head and neck cancer," said Mary Tagliaferri, M.D., Chief Medical Officer and Senior Vice President of Clinical Development at Nektar. "Importantly, this new clinical collaboration will allow us to understand how we might access multiple immuno-oncology and targeted modalities simultaneously to treat cancer in complementary and novel ways."

Under the new collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and NKTR-214 and separately avelumab, enzalutamide and NKTR-214. Nektar, Pfizer and their respective partners will each maintain global commercial rights to their respective medicines.

"We are looking forward to combining Nektar’s unique CD122-biased agonist with a number of agents with distinct mechanisms," said Chris Boshoff, M.D., Ph.D., Senior Vice President of Immuno-Oncology, Early Development and Translational Oncology at Pfizer. "We hope to achieve our goal of improving the care of patients with difficult-to-treat cancers with unique immunotherapy-based regimens."

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. NKTR-214 is being evaluated in multiple clinical trials in cancer patients. It has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

About Metastatic Castration-Resistant Prostate Cancer

Other than skin cancer, prostate cancer is the most common cancer in American men and is the second leading cause of death for American males. The American Cancer Society estimates over 164,000 new cases of prostate cancer are projected in 2018, with approximately 29,000 expected deaths. mCRPC is an incurable disease and is usually associated with poor prognosis. The five-year survival rate for mCRPC is approximately 29%.1

About Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinomas of the head and neck (SCCHN) are usually only diagnosed at an advanced stage and thus have a relatively poor prognosis. One cause may be human papillomavirus (HPV), but the main cause is tobacco smoking and excessive consumption of high-percentage alcohol.

On November 6, 2018 Personalis, Inc., a provider of advanced genomic sequencing and analytics for immuno-oncology, reported that the company, along with one of their collaborators, Dr. Sekwon Jang of the Inova Cancer Center, will present new data at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, taking place in Washington, D.C., November 9-11, 2018 (Press release, Personalis, NOV 6, 2018, View Source [SID1234530767]).

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Following is a list of abstracts that will be presented at the meeting.

Rapid Oral Abstracts

Session ID Title & Presenter Day & Time Location
Rapid Oral Abstracts Molecular profiling of anti-PD-1 treated melanoma patients reveals importance of assessing neoantigen burden and tumor escape mechanisms for clinical treatment
Presenter: Sekwon Jang, MD
Director, Melanoma and Cutaneous Oncology Therapeutics and Research
Inova Melanoma and Skin Cancer Center

November 9:
1:40 PM

Poster section
12
Scientific Poster Presentations

Poster Number Title & Presenter Day & Time Location
P13

Molecular profiling of anti-PD-1 treated melanoma patients reveals importance of assessing neoantigen burden and tumor escape mechanisms for clinical treatment
Presenter: Charles W. Abbott, PhD

November 9
12:45pm-2:15pm and 6:30pm-8:00pm

Hall E
P151 Improving neoantigen identification for therapeutic and diagnostic use in immuno-oncology using mass spectrometry and machine learning
Presenter: Sean M. Boyle, PhD

November 9
12:45pm-2:15pm and 6:30pm-8:00pm

Hall E
P78 More sensitive identification of T-cell receptor beta rearrangements with an augmented transcriptome method
Presenter: Eric Levy, PhD

November 10
12:20pm-1:50pm and 7:00pm-8:30pm

Hall E
Personalis will also be exhibiting during the conference (Booth #617). Representatives will be available to answer questions about the company’s cancer immunogenomics services.

On November 6, 2018 Daré Bioscience, Inc. (NASDAQ: DARE), a clinical-stage, women’s biopharmaceutical company, reported that it will host a conference call and live webcast at 8:30 a.m. Eastern Time on Tuesday, November 13, 2018, to provide a corporate update and to discuss the Company’s financial results for the quarter ended September 30, 2018 (Press release, Dara Biosciences, NOV 6, 2018, View Source [SID1234530790]).

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To access the conference call via phone, dial (844) 831-3031 (domestic) or (443) 637-1284 (International). The conference ID number for the call is 5463588. The live webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at www.darebioscience.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 5463588. The telephone and webcast replay will be available until November 20, 2018.