AbbVie and Tizona Therapeutics Announce Strategic Collaboration to Develop First-in-Class Immunotherapy for Cancer Targeting CD39

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Tizona Therapeutics, Inc. ("Tizona"), a privately held immunotherapy company, reported that they have entered into a global, strategic collaboration to develop and commercialize CD39-targeted therapeutics, including TTX-030, a first-in-class antibody for the treatment of cancer (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532450]).

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The ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment (TME) by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway.

"Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Mo Trikha, Ph.D., Vice President, Head of Oncology Early Development, AbbVie. "Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody."

"Tumors employ various strategies to create a tolerogenic microenvironment, which reduces the immune system’s ability to detect and fight cancer," said Courtney Beers, Ph.D., Vice President, Immunology, Tizona. "Preclinical research shows that inhibiting CD39 may hold the key to restoring and bolstering immune responses against tumors. In AbbVie, we have a partner who shares our passion for science and commitment to delivering breakthrough innovation to patients with cancer. We look forward to advancing this exciting program."

Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona will lead clinical development through completion of Phase 1b studies, after which AbbVie has an exclusive option to lead global development and commercial activities. Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

An investigational new drug application for TTX-030 has been accepted by the US Food and Drug Administration.

TTX-030, the Adenosine Axis, and the Tumor Microenvironment

TTX-030 is a monoclonal antibody that inhibits the activity of CD39, a cell surface enzyme upregulated on tumors, exhausted T cells, as well as many suppressive cell types as an immune evasion strategy. It catalyzes the conversion of ATP to AMP, the first step in the generation of adenosine. By blocking the action of CD39, TTX-030 prevents the formation of immune suppressive extracellular adenosine, which would otherwise inhibit effector cells in the tumor microenvironment (TME). In addition to preventing the formation of suppressive adenosine, TTX-030 prevents the degradation of ATP, preserving its ability to stimulate dendritic and myeloid-derived cells responsible for innate immunity and immune cell priming necessary for adaptive immunity.

Avalon GloboCare Establishes Joint Venture with Arbele Limited to Co-develop Next-Generation Multi-Targeted CAR-T Cellular Immunotherapy

On January 3, 2019 Avalon GloboCare Corp. (NASDAQ: AVCO), a leading global developer of cell-based technologies, reported that the Company and its wholly owned subsidiary, Avactis Biosciences, have entered into a joint venture and exclusive license agreement with Arbele Limited to co-develop next generation, transposon-based Chimeric Antigen Receptor (CAR)-T and CAR-Natural Killer (NK) cellular therapies (Press release, Avalon, JAN 3, 2019, View Source [SID1234609548]). These unique CAR vector constructs are non-virally engineered, possessing multiple therapeutic targets as well as unique "safety-switch" mechanisms. Based on Avalon’s extensive hospital network for cellular therapy, together with the Company’s established GMP bio-production facility in China (Epicon Biotech, Nanjing), this joint venture allows Avalon to accelerate the clinical development of more efficacious and safer CAR-T/CAR-NK therapies, such as those developed by Arbele.

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"We are very excited to establish this joint venture with Arbele Limited to accelerate our clinical programs in cellular therapy," stated David Jin, M.D., Ph.D., CEO and President of Avalon GloboCare Corp. "Arbele’s strong proprietary technology platform in designing and production of non-viral, transposon-engineered, multi-targeted CAR will allow us to generate next-generation, better and safer CAR-T and CAR-NK cellular therapeutics. This joint venture will strengthen our core technological capabilities, enrich our intellectual properties, as well as further establish our leadership in the field of cellular immunotherapy," added Dr. Jin.

Kashiv Pharma Acquires Adello Biologics and Becomes Kashiv BioSciences

On January 3, 2020 Kashiv Pharma, LLC, a pharmaceutical research and drug delivery company developing next-generation technologies, innovative medicines for patients with unmet medical needs and drug life-cycle management products, reported its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars of leading global brands in the fields of oncology and immunology (Press release, Kashiv BioSciences, JAN 3, 2019, View Source [SID1234563292]). Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey plus research and development and manufacturing facilities in Bridgewater and Piscataway, New Jersey, Chicago, Illinois and Ahmedabad, India.

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Established in 2010, Kashiv Pharma focuses on innovative drug delivery systems and specialty drug products for the treatment of various debilitating diseases. The company seeks to partner with established pharmaceutical firms to commercialize products at an appropriate stage of development by offering novel products based on the next generation of advanced drug delivery platforms. Kashiv has created several proprietary technology platforms under the leadership of Dr. Navnit Shah, a world-renowned pharmaceutical scientist, for extended and time-specific oral delivery of small molecules including a novel gastric retention system (GRANDE) and a chronobiological delivery system (KRONOTEC). These advanced drug delivery systems target the drug to its optimal absorption site and at a time when the body needs it the most for maximal therapeutic effect.

Currently based in Piscataway and Chicago, Adello Biologics has been working to develop high-quality, affordable biosimilars for patients worldwide. The company is advancing a pipeline of complex proteins and monoclonal antibodies with lead candidates in oncology and immunology.

As a result of the acquisition, Kashiv BioSciences’ broad business offering includes drug delivery platforms incorporating delayed release technology and gastric retention systems that improve the efficacy and safety of known drugs; a 505(b)(2) pipeline of seven development products targeting unmet clinical needs; biosimilars; prodrugs; and, as part of a development collaboration with Amneal Pharmaceuticals LLC, 10 approved generic products and an additional 13 generic products in advanced stages of development, including several complex generic products. Kashiv BioSciences’ medications will improve the lives of patients suffering from cancer as well as neuromuscular, movement and endocrine disorders, among other debilitating conditions, both in the U.S. and globally.

"The acquisition of Adello will create a fully integrated biosciences company with a strong platform for growth," said Chintu Patel, who will become CEO of Kashiv BioSciences. "The combined breadth of expertise in small and large molecules, peptides, proteins and monoclonal antibodies will enable us to develop products with meaningful clinical differentiation and a compelling value proposition for patients, physicians and payers."

Lilly to Participate in J.P. Morgan Healthcare Conference

On January 3, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 (Press release, Eli Lilly, JAN 3, 2019, View Source [SID1234532392]). David A. Ricks, Lilly’s chairman and chief executive officer, will participate in a fireside chat from 6:00 p.m. to 6:25 p.m. Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

AbbVie to Host Fourth-Quarter and Full-Year 2018 Earnings Conference Call

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its fourth-quarter and full-year 2018 financial results on Friday, January 25, 2019 before the market open (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532409]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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