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.

On October 2, 2018 AskAt Inc. (AskAt) (Headquarters: Nagoya, Japan, CEO: Akihiro Furuta) reported that Arrys Therapeutics, Inc. (Headquarters: Cambridge, Massachusetts), which licensed AAT-007 in immuno-oncology from AskAt in December 2017, has initiated a clinical study with AAT-007 (grapiprant) (ARY-007) in combination with pembrolizumab (anti PD-1 antibody, KEYTRUDA) (Press release, AskAt, OCT 2, 2018, View Source [SID1234535044]).

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The study is an Open-label, Single-arm, Phase 1b clinical trial to evaluate the safety and efficacy of grapiprant in combination with pembrolizumab in patients with advanced or progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC).

Arrys is the sponsor of the study, in collaboration with Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

On October 2, 2018 PharmAbcine, Inc, a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications reported that the company received "Study May Proceed Letter " from the US Food and Drug Administration (FDA) for the Investigational New Drug ("IND") application of its flagship antibody, TTAC-0001 (Press release, PharmAbcine, OCT 2, 2018, View Source [SID1234529710]). This enables the Company to begin opening US clinical trial sites for phase II clinical trial with bevacizumab (Avastin) refractory recurrent GBM patients.

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Recurrence of GBM is inevitable and recurrent GBM (rGBM) is one of the most aggressive and has the worst prognosis. The treatment options are limited with modest activity for rGBM. Therefore, there is no universally held standard of care available till now.

Patients with rGBM are suffering under cerebral edema and partially responded to bevacizumab. However, patients responded to bevacizumab ultimately become non-responder during the treatment and once patients become bevacizumab non-responder, unfortunately, there are no more therapeutic options.

Cerebral edema comes from excessive secretion of VEGF-A, B, C and D from brain tumors. While bevacizumab traps VEGF-A only, TTAC-0001 binds to VEGFR2 specifically and interferes the activation of VEGFR2 by VEGF-A, C and D.

TTAC-0001 has completed its phase IIa in recurrent GBM in Australia last year with clear safety profile (all DAE maintain within grade 2) and 25% disease control rate. rGBM patients in the study responded to TTAC-0001 for cerebral edema (>40%). No hypertension, hemorrhage, gastric/lung perforation or proteinuria have been observed.

Jin-San Yoo, CEO of PharmAbcine, Inc., commented: "As part of the study design, it was always planned that US trial sites would become part of our Bevacizumab refractory recurrent GBM Phase II clinical trial. We are pleased with today’s IND approval from the FDA as it will accelerate patient enrolment into the global bevacizumab recurrent GBM phase II trial. Moreover, the FDA’s decision is positive news for eligible American sufferers under this devastating condition who can now participate in the study."

This research was supported by Korea Drug Development Fund (KDDF) funded by MSIT, MOTIE and MOHW (Grant No. KDDF201509-07, Republic of Korea)

On October 2, 2018 Quentis Therapeutics, Inc., a biotechnology company developing therapies that target endoplasmic reticulum (ER) stress pathways, reported that FierceBiotech has named the company to its "Fierce15" list for 2018, designating Quentis as one of the most promising private emerging biotechnology companies (Press release, Quentis Therapeutics, OCT 2, 2018, View Source [SID1234529833]). Quentis also announced the appointment of industry veteran, Mark Murcko, PhD, to its Board of Directors.

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"Quentis is thrilled to be recognized by FierceBiotech at this stage in the company’s growth and development. The science and understanding of the role of ER stress in disease has advanced significantly, providing a path to develop new therapies with the potential to treat cancer and other diseases in a meaningful way. Our lead program has the potential to overcome suppression and restore normal immune-cell function in the tumor micro-environment leading to increased tumor killing and improved patient outcome," said Michael Aberman, MD, President and CEO of Quentis Therapeutics.

The endoplasmic reticulum (ER) is a structure within cells that is responsible for multiple functions, including serving as a sensor of cellular stress. Many diseases, including cancer, neurodegenerative, and autoimmune diseases, can cause persistent ER stress, triggering aberrant responses that disrupt normal cellular functions. The company’s lead program is a first-in-class IRE1α inhibitor designed to boost anti-tumor immunity in cancer. Quentis plans to advance a pipeline of programs designed to address ER stress in multiple diseases.

Sponsored by FierceBiotech, an internally recognized provider of life science news and analysis, Fierce15 is an annual award bestowed upon 15 privately held-life science companies that embody the word "fierce" – championing innovation and creativity in the face of intense competition. Now in its 16th year, recipients are selected from hundreds of private companies from around the world based on the strength of their technology and science, partnerships, investors and competitive market position.

New Appointment to Board of Directors

Quentis also announced that Dr. Murcko has joined its Board of Directors providing deep experience in drug discovery and development. Dr. Murcko is a Founder, Board member, and served as interim chief scientific officer of Relay Therapeutics. He is a senior lecturer in the Department of Biological Engineering at MIT and has served on scientific advisory boards and corporate boards of directors for a diverse range of organizations. Prior to co-founding Relay Therapeutics, Dr. Murcko was chief technology officer and chair of the Scientific Advisory Board of Vertex Pharmaceuticals. He previously worked at Merck Sharpe & Dohme, where he helped discover multiple drug candidates. Dr. Murcko has directly contributed to the development of seven marketed drugs over his career, is a co-inventor on more than 50 issued and pending patents, and has co-authored more than 85 scientific articles. He holds a PhD in organic chemistry from Yale University.

"I am excited to join the Board of Directors at this important time and look forward to collaborating with the talented Quentis team to realize the promise of ER stress in cancer and beyond," said Dr. Murcko

On October 2, 2018 Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics, a biotechnology company focused on the discovery of therapeutic antibodies through single B cell screening and analysis, reported the companies have entered into a research collaboration and license agreement to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers, including solid tumors (Press release, Kite Pharma, OCT 2, 2018, View Source [SID1234537506]).

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Kite and HiFiBiO intend to adapt HiFiBiO’s proprietary single cell technology platform to create a high throughput approach that will potentially allow for the in-depth screening of TCR repertoires from patient samples to identify shared antigen and neoantigen TCRs for use in adoptive cellular therapies. Neoantigens arise from tumor-specific mutations that are unique to each patient’s cancer, offering the potential for more targeted antitumor activity.

Under the terms of the agreement, HiFiBiO will receive a $10 million upfront payment and will be eligible for additional payments based on the achievement of certain research milestones. Kite will have an exclusive option to license HiFiBiO’s platform to screen T cell repertoires and to identify TCRs for use in TCR engineered T cell therapies with a corresponding payment to HiFiBiO.

"Neoantigen-based cell therapy is a very exciting, yet complex, area of research that has the potential to transform the way we treat many solid tumors," said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. "We are excited about this collaboration with HiFiBiO, which will build upon our existing capabilities focused on discovering cell therapies which target patient-specific tumor neoantigens."

"Kite is a recognized leader in the cell therapy field," said Liang Schweizer, PhD, President and Chief Executive Officer, HiFiBiO Therapeutics. "We are proud that our proprietary single cell technology platform, which is utilized to support the rapid progression of our novel antibody therapeutics pipeline, will now also be implemented by Kite for the development of novel cell therapies targeting neoantigens."