MEDIGENE PARTICIPATES AT FOUR CONFERENCES IN OCTOBER

On October 2, 2018 Medigene AG (FSE: MDG1, Prime Standard, SDAX) reported its participation at the following upcoming investor and scientific conferences (Press release, MediGene, OCT 2, 2018, View Source [SID1234529709]):

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Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper)
Date: 30 September – 03 October 2018
Location: New York, USA

European Society of Gene and Cell Therapy (ESGCT) Annual Congress
Date: 16 – 19 October 2018
Location: Lausanne, Switzerland

ESMO – European Society for Medical Oncology Congress
Date: 19 – 23 October 2018
Location: Munich, Germany

BTIG Healthcare Conference
Date: 25 October 2018
Location: New York, USA

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

From Discovery to Market and Nobel Prize; James Allison and Tasuku Honjo Awarded the Nobel Prize for their CTLA-4/PD-1 Discoveries

The 2018 Nobel Prize in Physiology or Medicine has been awarded jointly to James P. Allison and Tasuku Honjo for their almost 30 year old discovery of cancer therapy by inhibition of negative immune regulation. It was in the 1990s, when Dr James P. Allison’s laboratory at the University of California, Berkeley studied the T-cell protein CTLA-4. He was one of several scientists who had made the observation that CTLA-4 functions as a brake on T cells. In 1992, a few years before Allison’s discovery, Tasuku Honjo discovered PD-1, another protein expressed on the surface of T-cells. His research showed that PD-1, similar to CTLA-4, functions as a T-cell brake, but operates by a different mechanism.

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Fast forwarding to today and cancer immunotherapy is the established 4th pillar of cancer therapy and encompasses a highly diverse portfolio of treatment strategies from the early interferon-α/interleukin-2 therapies to the current progress of immune-checkpoint inhibitors and CAR-T therapies to make the immune system fight cancer.

The first approved immune-checkpoint inhibitor was Bristol-Myers Squibb’s ipilimumab (Yervoy) back in 2011 for the treatment of adult patients with previously-treated advanced melanoma. Then followed the approval of Opdivo (nivolumab) and Keytruda (pembrolizumab) in rapid succession. Currently there are seven approved immune-checkpoint inhibitors for the treatment of sixteen different tumor types, see table below. Just last Friday Regeneron and Sanofi reported that the U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

These approved drugs are just the tip of the iceberg with more than 500 immune-checkpoint drugs being developed world-wide for the treatment of cancer. No less than twenty of these are in late stage development.

The event of immune-checkpoint drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) have dramatically changed the possibility to harness the power of the immune system in fighting cancer not only as a monotherapy but, maybe more importantly, also as a combination therapy.

Genprex to Present at Upcoming Investor and Industry Conferences

On October 1, 2018 Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that the management team will present at the following upcoming investor and industry conferences (Press release, Genprex, OCT 1, 2018, View Source [SID1234529691]):

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Event: The MicroCap Conference
Date: October 2, 2018
Time: 12:00 PM EDT
Location: New York, NY
Presenter: Rodney Varner, Chairman and CEO

Event: BIO Investor Forum
Date: October 18, 2018
Time: 9:30 AM PDT
Location: San Francisco, CA
Presenter: Dr. Julien Pham, President and COO

Infinity Pharmaceuticals Earns $22 Million Payment From Verastem Oncology For FDA Approval Of COPIKTRA™ (duvelisib) And Updates 2018 Financial Guidance

On October 1, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib) (Press release, Infinity Pharmaceuticals, OCT 1, 2018, View Source [SID1234529882]). The payment was earned upon the approval by the U.S. Food and Drug Administration (FDA) on September 24, 2018 of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, as well as accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

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"We are really pleased that duvelisib is now available for patients with CLL/SLL and follicular lymphoma and are proud of the role Infinity played in its development," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "This $22 millionFDA approval payment from Verastem supports Infinity’s continued expansion of the development of IPI-549, our first-in-class, oral, immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma), including in doublet and triplet combination trials to identify the best combination regimens to treat patients with specific types of cancer."

In 2016, Infinity entered into a license agreement granting Verastem an exclusive worldwide license for the research, development, commercialization, and manufacture of duvelisib and products containing duvelisib in oncology. Pursuant to the terms of the license agreement, Verastem has notified Infinity of its election to make the $22 million payment in cash, which Infinity expects to receive later this year. Infinity also is eligible for royalties on worldwide net sales of duvelisib ranging from the mid-to-high single digits, shared equally with Takeda.

Infinity’s updated 2018 financial guidance is:

Net Loss: Infinity expects net loss for 2018 to range from $10 million to $20 million.
Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $50 million to $60 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2020. Infinity’s financial guidance excludes additional funding or business development activities and does not include a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

Aduro Biotech Announces Four Abstracts Accepted for Presentation at the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting

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.