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

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.

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 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.