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.

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: cecilia.hofvander@alligatorbioscience.com

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.

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.

On December 11, 2018 Black Diamond Therapeutics, a biotechnology company developing a new type of precision medicine for cancer, reported that $20 million Series A financing exclusively from founding investor Versant Ventures (Press release, Black Diamond Therapeutics, DEC 11, 2018, View Source [SID1234532909]). Black Diamond is the first company launched out of Ridgeline, Versant’s Discovery Engine based in Basel, Switzerland, and has a unique platform capable of prosecuting allosteric mutant oncogenes.

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Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

During its stealth stage, Black Diamond built and established proof of concept for its MAP (mutation, allostery and pharmacology) platform to uncover, discover and target allosteric mutant oncogenes. While Black Diamond founders David Epstein, Ph.D., and Elizabeth Buck, Ph.D., constructed and optimized the platform, parallel efforts by the Ridgeline team involved translational work to create leads, validate the resulting targets and bring forward drug candidates.

"The fundamental discovery underlying Black Diamond is there are whole sets of oncogenic lesions outside the ATP binding site that are activated by common mechanisms and are inhibited by a single class of our drugs," said Black Diamond CEO Dr. Epstein. "Our platform generates single molecules able to treat entire baskets of mutations that otherwise would have been deemed unactionable."

Dr. Epstein has extensive experience developing precision medicine cancer therapies. He previously was CSO of OSI Pharmaceuticals (acquired by Astellas Pharma), where he and Dr. Buck led research and translational science on a variety of novel agents including erlotinib, a small molecule inhibitor of epidermal growth factor receptor approved to treat non-small cell lung cancer and pancreatic cancer.

"As a new company in an important field of novel cancer medicines, Black Diamond is a premier example of Versant’s three key differentiating features – a focus on breakthrough innovation, geographic reach and company creation capabilities," said Alex Mayweg, Ph.D., a partner at Versant and a member of Black Diamond’s board. "We are very pleased to support a company that has an exceptionally powerful platform able to fuel its growth and pipeline for the foreseeable future."

To further progress and build out its breakthrough precision medicine platform, Black Diamond is finalizing a financing with additional investors that is expected to be announced in 2019. Proceeds will allow Black Diamond to advance two to three existing development candidates into the clinic in the next 24 months, and to bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. MAP involves mining a proprietary algorithm for allosteric oncogenes, validating their oncogenicity, elucidating the precise mechanism by which a given oncogene is allosterically activated, and designing drugs specific for these groups of allosteric mutations.

As genomic profiling and sequencing of cancer patients is becoming standard, MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent 2-15% of patients in a given tumor tissue or across tumor sites.

MAP has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification.

Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

The company also will use a portion of its Series A round to establish operations in Toronto, thus gaining access to the city’s deep pool of computing talent. Black Diamond expects this computational center of excellence will enable machine learning-based target discovery of new allosteric mutants that complements the existing MAP platform.

On December 11, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2018 fourth quarter and year ended September 30, 2018 (Press release, Arrowhead Research Corporation, DEC 11, 2018, View Source [SID1234532026]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6744427.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6744427.

Selected Fiscal 2018 and Recent Events

Hosted an Analyst R&D Day in September 2017 to highlight the following:

The Targeted RNAi Molecule platform, or TRiMTM, which utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting, while being structurally simple. The TRiMTM platform offers several potential competitive advantages including:

A more sophisticated RNAi trigger selection and screening process that identifies potent sequences rapidly in locations that RNAi competitors may miss

Multiple routes of administration including subcutaneous, intravenous, and inhaled

Faster time to clinical candidates

Optimal pharmacologic activity and long duration-of-effect

Potentially wide safety margins

Simplified manufacturing at reduced cost

And, the promise of taking RNAi to tissues beyond the liver

Presented new clinical data at HEP DART 2017 and EASL 2018 demonstrating up to 5.3 Log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following first generation RNAi therapy, ARC-520, in the 2001 open label extension study

One patient serocleared all viral markers, including HBsAg

Began a Phase 1 study of ARO-AAT, Arrowhead’s second generation subcutaneously administered RNAi therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency

Began a Phase 1/2 study of ARO-HBV, a third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential treatment for patients with chronic hepatitis B virus infection

Announced that Amgen had administered the first dose of AMG 890, formerly ARO-LPA, in a Phase 1 clinical study, which earned Arrowhead a $10 million milestone payment

Presented clinical data on ARO-AAT at the Alpha-1 National Education Conference and at the AASLD Liver Meeting 2018 demonstrating:

Three monthly doses of 300 mg ARO-AAT led to reductions in serum alpha-1 antitrypsin to below the level of quantitation in 100% of subjects

Reductions were sustained for greater than 14 weeks indicating that quarterly or less frequent dosing appears feasible

Single and multiple doses of ARO-AAT appeared to be well-tolerated at all doses tested

Presented clinical data on ARO-HBV at the World Gastroenterologists Summit and at the AASLD Liver Meeting 2018 demonstrating:

Mean HBsAg reduction of -1.9 Log10 (-98.7%) with a range of -1.3 Log10 (-95.0%) to -3.8 Log10 (-99.98%)

ARO-HBV appeared to be well-tolerated at monthly doses up to 400 mg

Signed a license agreement with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceuticals Companies of Johnson & Johnson, for ARO-HBV and a collaboration agreement for up to three RNAi therapeutic candidates that use our proprietary TRiMTM platform against new targets to be selected by Janssen

The total potential deal value is approximately $3.7 billion plus royalties on commercial sales

Received $175 million as an upfront payment and received $75 million in the form of an equity investment by Johnson & Johnson Innovation – JJDC, Inc., at a price of $23.00 per share of Arrowhead common stock

Hosted an R&D Day in October 2018 to discuss in more detail our emerging pipeline of RNAi therapeutics that leverage the TRiMTM platform

Filed for regulatory clearance to begin a Phase 1 study of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias and metabolic diseases