BerGenBio Presents Key Results from PhII Programme with Selective AXL Inhibitor Bemcentinib at DNB’s 9th Annual Nordic Healthcare Conference

On December 12, 2018 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, reported that the Company will be presenting key results from its Phase II clinical programme with selective AXL inhibitor bemcentinib at the DNB’s 9th Annual Nordic Healthcare Conference in Oslo, Norway, today at 10:15-10:40 CET (Press release, BerGenBio, DEC 12, 2018, View Source [SID1234532017]).

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The slides are available for download at the Company’s website: www.bergenbio.com/investors/presentations/

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We have made significant progress during 2018 establishing clinical proof of concept for the remarkable utility of bemcentinib in cancers with high unmet clinical need and large market potential. We have shown that our once-a-day, oral selective AXL inhibitor is well tolerated as a monotherapy and in combination with immune-, targeted and chemotherapies. What is more, consistently we have seen that efficacy scales with AXL biomarker expression leading to superior response rates in AXL biomarker positive relapsed/refractory AML and MDS as a monotherapy as well as non-small cell lung cancer where we are combining with the immunotherapy blockbuster Keytruda. We have met all our operational milestones this year and are looking forward to starting a randomised phase II programme towards the end of H1 2019 based on key results obtained this year".

Aduro Biotech Data Published in Cell Reports Highlights the Significant Role of the Magnitude of Intratumoral STING Activation by ADU-S100 in Anti-Tumor Immunity

On December 12, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported the publication of a peer-reviewed paper in Cell Reports authored by Aduro scientists and Novartis collaborators as part of their ongoing research to study intratumoral stimulator of interferon genes (STING) pathway activation as a potential therapeutic approach for the treatment of cancer (Press release, Aduro Biotech, DEC 12, 2018, View Source;p=RssLanding&cat=news&id=2380389 [SID1234532015]). In this study, researchers determined an intratumoral dosing regimen of STING pathway activator, ADU-S100, optimized for adaptive immunity in mouse models. While high doses of ADU-S100 were effective at clearing injected tumors, researchers found that higher tumor ablative dosing regimens could compromise durable anti-tumor immunity. Lower immunogenic doses of ADU-S100 were shown to optimally elicit CD8+ T cell responses required for systemic and durable anti-tumor immunity, and were also found to be efficacious in combination with checkpoint inhibitor therapy.

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"We previously established that intratumoral STING pathway activation by ADU-S100 results in tumor regression in preclinical models. Our publication in Cell Reports now highlights the importance of optimizing the therapeutic dose regimen for STING agonists with the aim to balance innate and adaptive immune responses triggered by STING activation in the tumor microenvironment," stated Andrea van Elsas, Ph.D. chief scientific officer of Aduro. "Our findings support the use of immunogenic doses of ADU-S100 with checkpoint inhibitors to drive efficacious anti-tumor CD8+ T cell responses. We are encouraged by the potential of ADU-S100 as a novel treatment for cancer as we continue clinical evaluation of our lead compound in combination with checkpoint inhibitors."

The paper titled "Magnitude of Therapeutic STING Activation Determines CD8+ T-Cell Mediated Anti-Tumor Immunity," can be accessed online ahead of the print version in the peer-reviewed Journal Cell Reports.

ADU-S100 is the first STING pathway activator compound to enter the clinic and is currently being evaluated in a Phase 1 clinical trial as a single agent and in combination with ipilimumab (see www.clinicaltrials.gov, identifier NCT02675439) and in a Phase 1b combination trial with spartalizumab (PDR001), Novartis’ investigational anti-PD-1 monoclonal antibody (see www.clinicaltrials.gov, identifier NCT03172936).

About STING Pathway Activator Technology
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 monoclonal antibody. 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.

NexImmune Granted Key US Patent for Core E+E Technology

On December 11, 2018 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported that the United States Patent and Trademark Office has issued a new method of use patent to Johns Hopkins University related to the Company’s E+E (T cell Enrichment and Enhancement) technology for which NexImmune holds an exclusive license from Johns Hopkins (Press release, NexImmune, DEC 11, 2018, View Source [SID1234554955]). This further enhances the company’s AIM technology intellectual property portfolio and provides broad intellectual property rights protecting key aspects of the company’s lead product AIM ACT, an adoptive T cellular therapy for the treatment of cancer.

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"Using our proprietary E+E technology to generate antigen-specific T cells represents a uniquely differentiated approach to expanding polyclonal T cells that are highly antigen-specific, highly polyfunctional and with a phenotypic composition optimized for anti-tumor cytotoxicity, proliferative capacity and long-term immunologic memory. We believe our AIM E+E generated T cell products have the potential to address some of the clinical limitations observed with currently available genetically modified T cell therapies. Our hope is that these differences translate into meaningful benefit for patients suffering from a variety of hematological malignancies," commented Scott Carmer, Chief Executive Officer of NexImmune. "Ensuring a robust intellectual property position around E+E is inherent to advancing the program and the claims granted in this patent exemplify the novel science behind this exciting technology."

U.S. patent 10,098,939 adds to previously issued U.S. and international counterpart patents and patent applications that form NexImmune’s AIM patent portfolio. Claims were granted on the ability of E+E to expand large numbers of antigen-specific T cells from the body’s endogenous T cell repertoire. Preclinical studies have demonstrated that cells generated using E+E have a large proportion of highly functional central and effector memory T cells which the company believes will provide both a potent immediate therapeutic benefit for cancer patients and an enhanced durability of response compared to currently approved adoptive T cell therapies. NexImmune plans to advance its AIM ACT platform into early phase clinical trials in 2019.

Alligator Bioscience starts clinical phase I study with ATOR-1015

On December 11, 2018 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) reported that regulatory approvals have been obtained for the first clinical study of ATOR-1015 and patient recruitment can now be initiated. ATOR-1015 is a wholly-owned drug candidate developed for tumor-directed immunotherapy (Press release, Alligator Bioscience, DEC 11, 2018, View Source [SID1234538673]).

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The phase I study is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease at five different clinics across Sweden and Denmark. The primary aim of the study will be to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent Phase II studies.

"The start of clinical phase I study with ATOR-1015 represents a significant milestone for Alligator. We are first in the world with a new concept, a tumor-localizing bispecific CTLA-4 antibody. While the target is clinically validated, the clinical use of CTLA-4 blocking agents is restricted by severe toxicity. ATOR-1015 may provide a solution through its potential for selective activation of the immune system in the tumor area but not elsewhere in the body. The drug’s preclinical results are very promising, clearly supporting this concept", said Per Norlén, CEO of Alligator Bioscience.

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on December 11, 2018.

About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

Aro Biotherapeutics Raises $13 Million and Establishes Leadership Team to Develop Next Generation of Protein Therapeutics

On December 11, 2018 Aro Biotherapeutics, a newly established biotechnology company, reported that it has raised $13 million in start-up investment to develop and commercialize Centyrins, an innovative next generation protein drug platform (Press release, Aro Biotherapeutics, DEC 11, 2018, View Source [SID1234533213]). Co-founded by Sue Dillon, PhD, and Karyn O’Neil, PhD, both former R&D leaders at the Janssen Pharmaceutical Companies of Johnson & Johnson, Aro has recruited a highly accomplished scientific and executive management team headquartered in the Pennovation Center in Philadelphia. Aro holds an exclusive worldwide license for Centyrin protein therapeutics, which were discovered by Dr. O’Neil and her team at Janssen. Centyrins are designed to achieve improved efficacy and safety profiles for patients diagnosed with cancer and other serious diseases. Aro was established through an initial start-up investment from Johnson & Johnson Innovation – JJDC, Inc. (JJDC) and BioMotiv, LLC.

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"Centyrins were conceived with the aim of simplifying the complexities of antibodies," said Dr. Dillon, Co-founder and Chief Executive Officer of Aro. "This has enabled Aro scientists to rapidly create bi- and multi-specific Centyrins that are simultaneously optimized for potent anti-tumor activity and for efficient manufacture in E. coli. In addition, Aro is progressing Centyrin-nucleic acid drug conjugates to enable delivery to tumor cells, immune cells and other tissues with the aim of addressing disease targets that have been considered ‘undruggable.’"

Building a Pipeline of Life Changing Therapies

Centyrins are small, structurally simple, ultra-stable, highly soluble proteins. These characteristics enable the discovery of medicines with new mechanisms of action for cancer and other devastating diseases. Aro’s lead program, which is a bi-specific Centyrin, is in late-stage lead optimization for advanced non-small cell lung cancer. Aro’s second therapeutic program is focused on creating a Centyrin-siRNA conjugate for other forms of cancer. This first-of-its-kind combination is designed to address unmet medical needs by targeting drug payloads in high concentration to the site of disease, while lowering the toxicity to non-target organs. The company holds an exclusive worldwide license for research, development, manufacturing and commercialization of Centyrin protein therapeutics.

Aro Leaders Bring a Track Record of Success in the Discovery, Development and Commercialization of Blockbuster Biologics for Cancer and Immune Diseases

Co-founder Sue Dillon, PhD is Aro’s Chief Executive Officer. "Our executive management team has the breadth of experience to deliver on our promise to patients," added Dr. Dillon, who previously served as the Global Therapeutic Area Head, Immunology at Janssen, where her team achieved numerous regulatory approvals for innovative antibody products, which included REMICADE, SIMPONI, STELARA and TREMFYA. Dr. Dillon was named one of the Top Women in Biotech by FierceBiotech in 2013. She received her PhD in Immunology from Thomas Jefferson University in Philadelphia and completed a postdoctoral fellowship in Immunology at Duke University.

Co-founder Karyn O’Neil, PhD, is Aro’s Chief Scientific Officer. She previously served as the Director of Antibody Discovery and as the Venture Leader for Centyrex, an internal venture within Janssen. She is co-inventor on the Centyrin patents and led the team focused on advancing the Centyrin platform and establishing its potential for drug delivery. Dr. O’Neil received her PhD from the University of Pennsylvania where she focused on protein engineering and protein biophysics. She has authored more than 55 publications, is inventor on over 30 patents, and serves as an editor for Protein Engineering, Design and Selection.

Steve Nadler, PhD, is Vice President of Discovery and Translational Research. Dr. Nadler has over 25 years of extensive R&D experience, most recently serving as the Executive Director and Head Immunoscience, Immuno-oncology and Oncology Discovery Translational Research at Bristol-Myers Squibb. Dr. Nadler played a major role in discovery and development of ORENCIA and NULOJIX through global approvals. He received his PhD from the University of Texas at Houston followed by postdoctoral studies at Yale Medical School. Dr. Nadler has authored more than 80 publications and is co-inventor on over 10 patents. He is also an adjunct full professor at Rutgers Medical School.

Derek Miller is Chief Business Officer and Head of Corporate Strategy at Aro. Mr. Miller most recently served as Chief Business Officer for Celator Pharmaceuticals, where he was responsible for developing and executing against the company’s corporate development, pipeline and commercial strategies. Prior to Celator, he had successful track records in Global Launches and Commercialization, Business Development, and Portfolio Strategy at Genentech, Centocor and GlaxoSmithKline. Mr. Miller received an MBA from Villanova University and a BA in Biology from the University of Delaware.

Mark Laurenzi joined Aro as Vice President of Finance and Operations. He has held a number of roles at Johnson & Johnson Innovation, including Venture Leader. Previously, Mr. Laurenzi has consulted with private equity and venture capital firms, serving as an operating partner and interim executive for selected portfolio companies. Mr. Laurenzi received an AB in Economics from Princeton University, and is a graduate of New York University School of Law. He began his career practicing corporate and securities law in New York City.