On August 28, 2018 GT Biopharma Inc. (GTBP) (Euronext Paris: GTBP.PA) reported the initiation of a combination trial of OXS-1550 and multi-billion dollar oncology drug, owned by a major Pharmaceutical Company (the Company) (Press release, GT Biopharma , AUG 28, 2018, View Source [SID1234539524]). This effort is headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics at the Masonic Cancer Center, University of Minnesota. Under this Material Transfer Agreement (MTA) announced on July 19, 2018 between GT Biopharma, Inc and the Company, Dr. Vallera has been supplied with a formulation of their this widely prescribed drug approved for use in several hematologic malignancies for preclinical studies.

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Dr. Daniel Vallera said: "Based on our exciting preliminary in vitro experiments, the initial preclinical work suggests a much greater effect when OXS-1550 is given with this drug. We are very excited about our progress with GT’s OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent. We believe combination therapies like these that kill cancer cells based on entirely different mechanisms are the future of cancer treatment."

Dr. Vallera is the lead researcher for GT Biopharma’s bispecific antibody drug conjugate (ADC) program, and the innovator of DT2219, also known as OXS-1550. OXS-1550 is a bispecific antibody drug conjugate which means it targets two antigens on cancer cells and contains a cytotoxic payload thereby increasing the probability it will kill the cancer cells. OXS-1550 targets cancer cells expressing the CD19 receptor and/or CD22 receptors which includes B-cell leukemias and lymphomas and has a modified form of diphtheria toxin (DT390) as its cytotoxic drug payload. After OXS-1550 binds to cancer cells, it is taken in by the cancer cells and subsequently deploy its cytotoxic diphtheria toxin payload which inhibits protein synthesis and kills the cancer cells.

On August 28, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that two peer-reviewed papers reporting clinical studies of SD-101 have been published by Cancer Discovery, a journal publication from American Association of Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Dynavax Technologies, AUG 28, 2018, View Source [SID1234530119]). The investigators report clinical activity and broad immune activation in the tumor microenvironment when SD-101 is administered in combination with either low dose radiation in patients with indolent lymphoma or in combination with PD-1 blockade in patients with unresectable or metastatic melanoma. Top-line results from these studies have previously been presented at major oncology conferences.

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"Promising data from multiple trials studying intratumoral administration of TLR9 agonists indicate that stimulating the innate immune system through the TLR9 pathway can enhance the adaptive immune response to both injected and non-injected tumors," said Antoni Ribas, M.D., Ph.D., Director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center. "TLR9 agonists are showing potential as an important component of combination immuno-therapy for the treatment of cancer. With further research we hope to realize the full value that this approach can create for immuno-oncology."

Dr. Ribas is the lead author for the paper titled SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase 1b, Multicenter Study. This trial evaluated 22 patients who received intratumoral SD-101, a synthetic CpG-oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with a PD-1 inhibitor in patients with unresectable or metastatic malignant melanoma. The combination was well tolerated and the most common adverse events related to SD-101 were injection site reactions and transient, mild-to-moderate "flu-like" symptoms. Durable tumor responses were seen in both peripheral and visceral lesions. Among the 9 patients naïve to anti-PD-1 therapy, the overall response rate (ORR) was 78%. The estimated 12 month progression free survival (PFS) rate was 88%, and overall survival (OS) rate was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR was 15%. These clinical responses were supported by biomarker data indicating the induction of broad immune activation in the tumor microenvironment, including increased NK cells, cytotoxic cells, dendritic cells, B cells and CD8+ T cells and T cell infiltration. Increases in CD4+ and CD8+ T cells generally correlated with tumor responses. The paper can be found online here.

Ronald Levy, M.D., Robert K. and Helen K. Summy Professor in the School of Medicine at Stanford University, is the lead author of the paper titled In situ vaccination with a TLR 9 agonist and local low dose radiation induces systemic responses in untreated indolent lymphoma. It reports on a phase 1/2 multicenter study in which 29 patients received 4 Gy of radiation followed by five weekly intratumoral injections of SD-101 at a single tumor site. The paper can be found online here.

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On August 28, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present a corporate overview at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC, in New York City on Thursday, September 6, 2018, at 12:05 PM ET (Press release, VBI Vaccines, AUG 28, 2018, View Source [SID1234529430]).

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A live webcast of the presentation and a subsequent replay may be accessed by visiting the Investors page of VBI’s website at: www.vbivaccines.com/investors/events-presentations/. A replay of the webcast will be archived on the company’s website for 90 days following the presentation.

Event: 20th Annual Rodman & Renshaw Global Investment Conference sponsored by H.C. Wainwright & Co., LLC
Date: Thursday, September 6, 2018
Time: 12:05 – 12:30 p.m. ET
Location: Louis XVI A, St. Regis New York Hotel in New York City
Webcast: View Source

On August 28, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the 13th Annual Wells Fargo Securities Healthcare Conference on Thursday, September 6, 2018, in Boston (Press release, Medtronic, AUG 28, 2018, View Source;p=RssLanding&cat=news&id=2365106 [SID1234529341]).

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Bob White, executive vice president and president of the Minimally Invasive Therapies Group (MITG) of Medtronic, will answer questions about the company beginning at 10:55 a.m. EDT (9:55 a.m. CDT).

A live audio webcast of the presentation will be available on September 6, 2018, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.

On August 28, 2018 INmune Bio Inc., an immunotherapy company developing treatments to reprogram the innate immune system to fight disease, reported that its co-founder and CEO, Raymond J. Tesi, M.D., will participate in a panel at the Immuno-Oncology Investing & Partnering Forum on Aug. 30. He will also chair a session and present at the 2nd Annual Emerging Immuno-Oncology Targets Conference on August 31 (Press release, INmune Bio, AUG 28, 2018, View Source [SID1234529238]). Both conferences will take place in Boston.

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"It is a privilege to present to many of the leading minds in immunotherapy from both academia and industry," said Dr. Tesi. "Understanding why some patients are resistant to immunotherapy is vital as immunotherapy becomes the backbone of cancer treatment. We believe reprogramming the innate system to allow for more effective immunotherapy is key to solving this problem."

During Dr. Tesi’s panel at the Immuno-Oncology Investing & Partnering Forum, titled "Novel Therapeutics in Cancer Immunotherapy," he will discuss new immunotherapy drugs and therapeutic strategies in an attempt to highlight new approaches in the field.

The inaugural Immuno-Oncology Investing & Partnering Forum will be hosted by Cambridge Healthtech Institute as part of the Immuno-Oncology Summit. The forum brings together early and late-stage investors, fundraising CEOs and research entrepreneurs to encourage partnering and investment and to boost the immunotherapy market.

At the Emerging Immuno-Oncology Targets Conference, Dr. Tesi will present "Targeting Soluble TNF in Tumor Microenvironment (TME) to Reverse Resistance to Immunotherapy." His talk will highlight the role of chronic inflammation as a cause for failed checkpoint inhibitor therapies and will discuss how neutralizing soluble tumor necrosis factor (TNF) in the TME can target MDSC, a major cause of resistance to checkpoint inhibitors and other immunotherapies.

The Emerging Immuno-Oncology Targets conference, also hosted by Cambridge Healthtech Institute, covers the emerging target space, including immunomodulatory inhibitor and agonist targets, stromal and immune cell targets, and strategies for rational combination immunotherapy.

Details of the presentations are as follows:
Immuno-Oncology Investing & Partnering Forum
Session Title: Novel Therapeutics in Cancer Immunotherapy
Date and Time: August 30, 2018, at 1:30 p.m.
Location: Seaport World Trade Center, Boston, Massachusetts

Emerging Immuno-Oncology Targets
Title: Emerging Cytokine Targets
Session Title: Targeting Soluble TNF in Tumor Microenvironment (TME) to Reverse Resistance to Immunotherapy
Date and Time: August 31, 2018, at 9:05 a.m.
Location: Seaport World Trade Center, Boston, Massachusetts