On October 1, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that four separate abstracts from its research and development portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C. from November 7-11, 2018 (Press release, Aduro Biotech, OCT 1, 2018, View Source;p=RssLanding&cat=news&id=2369686 [SID1234530081]). Preliminary clinical data from the ongoing Phase 1 dose-finding study evaluating ADU-S100 (MIW815), an intratumoral STING agonist in patients with advanced solid tumors or lymphomas, were accepted for presentation on November 9, 2018.

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"We look forward to sharing preliminary clinical data from the dose escalation portion of the monotherapy trial which provides an initial understanding of the potential role of ADU-S100 in the treatment of cancer and which contribute to the broader scientific understanding of the STING pathway," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro Biotech. "In collaboration with our partner Novartis, our objective is to characterize the safety and mechanism of action of ADU-S100 across a wide array of solid tumors and lymphomas and provide a basis for continued development of ADU-S100 in combination with checkpoint inhibitors targeting PD-1 and CTLA-4."

Researchers will present additional preclinical data for ADU-S100 in combination with immune checkpoint inhibitors. They will also present the results of early research to identify and characterize an anti-SIRPa antibody ADU-1805.

Details of the poster and oral presentations are as follows:

Abstract 10763: Phase I dose-finding study of MIW815 (ADU-S100), an intratumoral STING agonist, in patients with advanced solid tumors or lymphomas
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10938: ADU-S100 (MIW815) Synergizes with Checkpoint Inhibition to Elicit an Anti-Tumor CD8+ T Cell Response to Control Distal Tumors
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10923: SIRPα blockade increases the activity of multiple myeloid lineage cells, enhances dendritic cell cross-presentation, and aids in remodeling the tumor microenvironment
Session: Rapid Oral Abstracts
Date/Time: November 9, 2018, 1:00 – 2:00 p.m. ET
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10960: Pan-allele anti-SIRPα antibodies that block the SIRPα–CD47 innate immune checkpoint
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center
About STING Pathway Activator Platform
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

Aduro’s lead molecule, ADU-S100, is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 compound. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.

On October 1, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the LEERINK Partners Roundtable Series: Rare Disease & Immuno-Oncology, Wednesday, October 3, at 3:30 p.m. ET at the Lotte New York Palace, New York City (Press release, bluebird bio, OCT 1, 2018, View Source [SID1234529692]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the conferences.

On October 1, 2018 Arix Bioscience plc (LSE: ARIX) ("Arix" or the "Company"), a global healthcare and life science company supporting medical innovation, reported that it has invested in new Group Business, VelosBio Inc. ("VelosBio"), a next-generation oncology company, developing novel antibody-drug conjugates ("ADCs") to treat haematological cancers and solid tumours (Press release, VelosBio, OCT 1, 2018, View Source [SID1234533166]).

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As part of the financing, Arix has committed to invest $11 million (£8.4 million) for an 11.2% stake on a fully diluted basis. Arix Investment Director, Mark Chin, will join the VelosBio board of directors.

The financing was co-led by new investors Arix and Sofinnova Ventures and included Pappas Ventures and Chiesi Ventures, as well as existing investors Takeda Ventures, Inc and Decheng Capital. Proceeds from the financing will be used to complete nonclinical development and advance the company’s lead programmes into clinical studies.

Arix has built a diverse oncology portfolio that covers a range of different therapeutic modalities including CAR-T, DNA damage response / synthetic lethality, bi-specific antibodies, and targeted viruses. Arix’s position in oncology is further strengthened by the investment into VelosBio, extending its oncology investments into ADCs.

ADCs are a new class of highly potent drugs designed as a targeted therapy for the treatment of people with cancer. In contrast to traditional chemotherapeutic drugs, ADCs only target cancer cells so that healthy cells are less affected.

VelosBio has a highly experienced leadership team, led by Chief Executive Officer, Dave Johnson, the former CEO of Acerta Pharma, which developed the approved blood cancer treatment, CALQUENCE (acalabrutinib), acquired by AstraZeneca for up to $7 billion in 2015. Prior to Acerta, Mr. Johnson contributed to the development and commercialisation of numerous approved global oncology agents holding roles of increasing responsibility in Clinical Development, Medical Affairs, Pipeline Development, and Commercial at Roche, Immunex (acquired by Amgen), Millennium (acquired by Takeda), Gloucester (acquired by Celgene), and Calistoga (acquired by Gilead Sciences).

VelosBio’s Executive Vice President of Development and Chief Medical Officer, Langdon Miller, MD, is an accomplished drug development expert with over 25 years of experience in the design and conduct of translational and clinical drug development programmes in oncology and orphan diseases. Trained as a medical oncologist at Stanford University, he has held senior leadership positions at the National Cancer Institute, Pharmacia Corporation, PTC Therapeutics, Calistoga Pharmaceuticals, and Gilead, and has played a major role in the regulatory approvals of multiple clinically and commercially successful cancer therapeutics.

Joe Anderson, Chief Investment Officer of Arix, commented: "Cancer emerges through multiple molecular and cellular pathways and accordingly needs to be tackled with multiple therapeutic tools. Our strategy in oncology is to support a diverse portfolio of companies using novel and differentiated approaches to treat cancer and improve patient outcomes. VelosBio is led by an exceptional team developing a novel, high potential approach to the targeted killing of cancer cells. It is great to see such a strong syndicate come together to support the Series A, including leading venture capital groups and our strategic partner Takeda. We look forward to working with the VelosBio leadership team and our co-investors to help accelerate the development of this exciting company."

David Johnson, CEO of VelosBio, commented: "We are delighted with the strong support for the Series A financing from Arix, as well as our existing and new investors. The proceeds from the Series A will enable us to drive VelosBio’s business forward ambitiously as we approach our next stage of growth and development. VelosBio will also be strengthened by Arix’s extensive global networks and deep industry knowledge, and we are pleased to welcome Mark Chin to the Board."

On October 1, 2018 Dragonfly Therapeutics reported a strategic collaboration with Merck, known as MSD outside the United States and Canada, through a subsidiary, to discover, develop and commercialize innovative immunotherapies for patients with solid tumor cancers (Press release, Dragonfly Therapeutics, OCT 1, 2018, https://www.prnewswire.com/news-releases/dragonfly-therapeutics-announces-new-multi-target-collaboration-with-merck-to-use-dragonflys-proprietary-trinket-platform-to-develop-novel-drug-candidates-for-patients-with-solid-tumors-300721744.html [SID1234533238]). The collaboration grants Merck the option to license exclusive worldwide intellectual property rights to products developed using Dragonfly’s TriNKET technology platform for a number of solid-tumor programs, with the potential to earn Dragonfly up to $695 million in up front and milestone payments per program as well as royalties on sales of approved products.

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"Merck is a world leader in solid-tumor cancer therapies and has a demonstrated history of delivering breakthrough treatment options for patients," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We’re excited to work with Merck to accelerate bringing drug candidates developed using our innovative TriNKET technology platform to patients with a number of solid tumor malignancies."

"Dragonfly’s technology platform offers an opportunity to harness the power of NK cell receptor engagement to develop novel therapeutics targeting solid tumor indications," said Dr. Joe Miletich, Senior Vice President Discovery and Preclinical Development, Merck Research Laboratories. "We look forward to working with the Dragonfly team."

On September 30, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today is presenting data describing the tumor microenvironment and immunogenicity of Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) in patients with solid tumor malignancies at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) hosted by The Cancer Research Institute (CRI), the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), the European Academy of Tumor Immunology (EATI), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New York City (Press release, Tocagen, SEP 30, 2018, View Source;p=RssLanding&cat=news&id=2369481 [SID1234529699]). The lead author is Jaime Merchan, M.D., director, Phase 1 clinical trials program at Sylvester Comprehensive Cancer Center; associate professor of medicine at the University of Miami Miller School of Medicine.

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The poster describes data available as of August 31st for 20 patients with advanced solid tumors, including colorectal, sarcoma, pancreas and non-small cell lung cancer, treated with intravenous Toca 511 followed by oral Toca FC in the Phase 1b Toca 6 clinical trial. Among these patients, 15 also received Toca 511 via intratumoral administration.

In this preliminary analysis of immune activation in patients with advanced solid tumors, analysis of peripheral blood shows immune cell modulation that is consistent with what has been observed in preclinical studies and in patients with recurrent high grade glioma treated with Toca 511 & Toca FC in previous clinical trials. In addition, available tumor samples from three patients show Toca 511 infected both "hot" (T cells present) and "cold" (T cells low or absent) areas of metastatic tumor, suggesting Toca 511 can penetrate multiple tumor microenvironments. Toca 511 & Toca FC treatment was well tolerated.

"The encouraging preliminary immune activity data from the Toca 6 trial continue to support the proposed mechanism of action for Toca 511 & Toca FC and its potentbiial in the treatment of multiple cancers," said Asha Das, M.D., chief medical officer of Tocagen. "We look forward to advancing expansion opportunities for our lead product in patients with solid tumors."

CRI-CIMT-EATI-AACR Abstract/Poster Number: A018
Abstract Title: Effects of Toca 511 & Toca FC on tumor microenvironment and peripheral blood populations in patients with advanced malignancies
Date: Sunday, September 30, 2018
Time: 11:45 a.m. – 2:15 p.m. ET
The poster is available on Tocagen’s website.

About Toca 6
Toca 6 is a multi-center, open-label Phase 1b study evaluating Toca 511 & Toca FC in patients with advanced solid tumors. The study will evaluate the safety and presence of Toca 511 genes in tumors of patients with widely disseminated disease, immunologic activity in blood and tumor, and clinical activity such as tumor response and clinical benefit. More information can be found at www.tocagen.com/toca6 or by searching clinicaltrials.gov using the clinical trial identifier NCT02576665.

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.