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Tocagen Highlights Toca 6 Phase 1b Data at Society for Immunotherapy of Cancer Annual Meeting

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.

prismCDX Implements Ultivue’s UltiMapper™ Platform for Standardized, Comprehensive Cancer Tissue Phenotypic Characterization

On November 8, 2019 prismCDX, a highly specialized contract research organization reported the selection and adoption of the UltiMapper platform to broaden its offering of translational biomedical research services (Press release, PrismCDX, NOV 8, 2019, View Source [SID1234550829]). The addition of Ultivue’s highly standardized multiplex tissue marker assays enables the identification of critical cellular phenotypes and tissue marker signatures in support of translational and clinical research programs.

"The combination of Ultivue’s next generation tissue marker assays with our platforms for genomic and proteomic analysis provides novel biological insights into the characterization of individual tumor microenvironments," commented Dong-Jun Bae, CEO with prismCDX. "Such complete tumor profiling and characterization data support our mission at prismCDX to partner with biopharma organizations developing targeted, precision medicine therapies and associated companion diagnostic tests."

Prior to the launch of those expanded capabilities, prismCDX has received scientific personnel training and certification at both Ultivue’s lab in Cambridge, MA and at its company facilities in Seoul, South Korea.

Biodesix Named Company of the Year by Colorado BioScience Association

On November 8, 2019 Biodesix, Inc. reported that it has been named Company of the Year by the Colorado BioScience Association (CBSA) (Press release, Biodesix, NOV 8, 2019, View Source [SID1234550828]). The company was honored at the 16th Annual CBSA Awards Dinner on November 7, 2019. The CBSA serves as the hub for Colorado’s life science industry with member organizations spanning biotechnology, pharmaceutical, medical device, diagnostic, ag bio, mobile digital health, research, academic, and service providers. Biodesix was selected as Company of the Year in recognition of the significant milestones the company reached in advancing patient access to novel diagnostic testing in the clinic, and in ongoing development of new tests that address areas of high unmet clinical needs across the continuum of care in lung cancer. Lung cancer is still the leading cause of cancer death among men and women. In 2018, approximately 234,000 patients were diagnosed and 154,000 died due to lung cancer, which represents over 25 percent of all cancer deaths in the United States.

"CBSA’s Annual Awards Dinner highlighted how health innovations from Colorado make a global impact. We are proud to honor Biodesix for its innovation and bringing top minds together to strengthen the future of healthcare. As the first company to provide four best-in-class diagnostic tests for patients in lung cancer, Biodesix has demonstrated its commitment to helping physicians and their patients navigate lung cancer therapy decisions. The timing of this award is an additional honor, as it is lung cancer awareness month," said Jennifer Jones Paton, President and CEO of CBSA. "CBSA is proud to honor Biodesix for its breakthroughs for patients, leadership in Colorado’s life sciences community and track record of success."

Key milestones for Biodesix in 2019:

Acquisition of Oncimmune in the U.S. to expand minimally invasive diagnostics to patients in North America with the EarlyCDT Lung test for lung nodule management, adding a 4th blood-based test to the portfolio
Expanded reach of Nodify XL2 testing for lung nodule management
Partnership with Thermo Fisher Scientific to develop a next-generation sequencing blood assay
Patenting of the Biodesix Collection Device (BCD) to improve on ease of blood collection, reduce cost and environmental impact
"Our greatest reward is the positive impact we can have on the lives of patients and their loved ones as they navigate lung cancer treatment decisions," said Scott Hutton, COO and incoming CEO for Biodesix.

"There is no higher honor than knowing that we played a part in improving the quality of life for a person facing the dreadful disease of lung cancer," said David Brunel, CEO for Biodesix. "We are proud to be building a Colorado-based bioscience company with 150 employees. We began as a Colorado start-up and this year we celebrated several important milestones. We greatly appreciate the recognition of the Colorado BioScience Association."

In addition to being headquartered in Colorado, Biodesix operates facilities in Boulder and Steamboat Springs, Colorado.

Akoya Expands Spatial Biology Portfolio with Optimized PD-1/PD-L1 Panels for Melanoma and Lung Cancer

On November 8, 2019 Akoya Biosciences, Inc., The Spatial Biology Company, reported that it has launched two new multiplex immunofluorescence kits, expanding its portfolio of solutions for profiling immuno-oncology biomarkers in the tumor microenvironment (Press release, Akoya Biosciences, NOV 8, 2019, View Source [SID1234550827]). These kits focus on PD-1 immune checkpoint blockade in lung cancer and in melanoma. The MOTiF PD-1/PD-L1 panels were designed with guidance from key collaborators and were independently developed and analytically validated by Akoya. When coupled with Akoya’s automated workflow and industry leading software, these new panels provide basic and clinical researchers with a true end-to-end solution for multiplexed immunofluorescent tissue imaging.

Each kit includes six immunofluorescence markers, plus nuclear counterstain, to capture the critical cellular interactions associated with PD-1/PD-L1 immune suppression. These marker combinations represent the current standard of care for the growing number of biomarker-based clinical trials and translational research. Labeling samples with these kits, and imaging with the Vectra Polaris, provides a more complete view of the cellular interactions occurring in the tumor microenvironment associated with anti-PD-1 and anti-PD-L1 therapies.

The kits are optimized for high throughput staining on commonly used autostainers and rapid scanning on the Vectra Polaris multiplexed imaging system. The end-to-end workflow provides a simple, automated user experience for consistent and reliable results, including pre-configured image analysis algorithms for tumor segmentation and cellular phenotyping, with the inForm Software package.

"These kits are a great step forward for the field because they standardize the culmination of a lot of development work, and make it easier for researchers to explore the tumor micro-environment across cohorts of patients with a high throughput automated workflow," says Bernard Fox, PhD, Chief of Laboratory of Molecular and Tumor Immunology, Earle A. Chiles Research Institute, Providence Cancer Center. He continues "Multiplex immunofluorescence is proving invaluable to immuno-oncology research since it is the only effective and practical way to understand the biology occurring in the tumor microenvironment. These new panels from Akoya are a meaningful expansion of the power and utility of the Phenoptics platform and will make it easier for new researchers in this field to get results quickly."

"Due to the rapidly growing demand for multiplex immunofluorescence-based analysis, Akoya is delivering the most powerful, fully automated and complete workflow for high-throughput studies," said Terry Lo, President of Akoya. "These new panels are part of the complete Phenoptics platform providing the only validated end-to-end solution for quantitative multispectral imaging, while removing the researcher’s burden of developing validated biomarker panels."

Details of the new products will be showcased at Akoya’s Symposium and exhibit hall booth (#330) at this week’s annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place in National Harbor, MD. Registration for the Symposium can be found here. Further details on the new Opal MOTiF PD-1/PD-L1 Melanoma and Lung Cancer panels are available on Akoya’s website.

Ningbo Tai Kang Medical Technology Co., Ltd Announces Global Licensing Agreement With AstraZeneca

On November 8, 2019 Ningbo Tai Kang Medical Technology Co. Ltd. reported that it has entered into a licensing agreement with AstraZeneca (Press release, Ningbo Tai Kang Medical, NOV 8, 2019, View Source [SID1234550826]). Tai Kang has been granted the exclusive global rights to further develop and commercialize AZD3229, a small molecule KIT inhibitor that is active against primary, secondary and resistant KIT and PDGFRα mutations observed in gastrointestinal stromal tumor (GIST). The broad inhibitory activity over a spectrum of KIT and PDGFRα mutations and biochemical selectivity differentiate AZD3229 from other agents used in GIST treatment.

Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca, said: "GIST represents a significant unmet medical need. Through this agreement, the development of AZD3229, a small molecule that inhibits KIT, can be accelerated with the aim of bringing a new treatment to patients faster."

"We are very pleased to enter this global exclusive license agreement with AstraZeneca and look forward to working with medical experts and global regulatory agents to advance this promising investigational medicine," commented Dr. Zhenhai Shen, Tai Kang’s authorized representative.

Under the agreement, AstraZeneca will receive an upfront payment and milestone-based payments linked to clinical, regulatory and commercial successes, as well as royalty payments.

About AZD3229

AZD3229 is small molecule inhibitor of KIT and PDGFRα discovered and developed by AstraZeneca. It has the potential to be best-in-class based on preclinical data showing efficacy and a favorable safety profile.