On January 3, 2019 Takeda Pharmaceutical Company Limited ("Takeda") (TSE: 4502) reported new research collaborations in immuno-oncology (I-O), an area of key strategic focus for the company (Press release, Takeda, JAN 3, 2019, View Source [SID1234532414]). Through these collaborations, Takeda seeks to accelerate the discovery of next-generation cancer immunotherapies, including novel cell therapy approaches that may provide important opportunities for addressing the needs of patients with hard-to-treat cancers.

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"We are excited by the recent momentum in oncology R&D, especially around the curative potential of cell-based therapies through our growing partnership network," said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "We look forward to continuing to collaborate with some of the leading pioneers in the field to fuel research and discovery with the aim of targeting novel mechanisms of action in the cancer-immunity cycle to help us fulfill our aspiration to cure cancer."

Takeda will collaborate with Memorial Sloan Kettering Cancer Center (MSK) to discover and develop novel chimeric antigen receptor T-cell (CAR-T) products for the treatment of multiple myeloma, acute myeloid leukemia and additional solid tumor indications. The broad, multi-faceted collaboration will be co-led by CAR-T therapy pioneer Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering at MSK and scientific founder of Juno Therapeutics.
Takeda exercised an option under its existing research collaboration with Noile-Immune Biotech Inc. (Noile), which originated in September 2017. Due to the success of the collaboration, Takeda exclusively licensed NIB-102 and NIB-103 for the treatment of various solid tumor indications, and will co-develop these CAR-T cell therapies with Noile utilizing the company’s proprietary "Prime" (proliferation inducing and migration enhancing) CAR-T platform. The company plans to gain regulatory approval for human testing of NIB-102 by the end of this year.
Takeda’s exercised option for an exclusive oncology-targeted Humabody license from Crescendo Biologics will allow Takeda to additionally evaluate these Humabody VHs for the development of novel CAR-T therapeutics. The development will leverage the unique properties of single-domain tumor-targeted binders as an alternative to conventional single-chain variable fragment (scFv)-based approaches.
Takeda’s diversification into next-generation cell therapy builds directly on its three strategic pillars in oncology: hematologic malignancies, lung cancer and immuno-oncology. Through collaboration with external partners and its newly established translational cell therapy engine, Takeda plans to deliver a rich pipeline of early-stage assets in the coming years.

Takeda has established a new internal translational cell therapy engine with bioengineering, chemistry, manufacturing and control (CMC), clinical and translational expertise. The group aims to rapidly translate innovative and differentiated cell therapy concepts in to the clinic under the leadership of Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies.

"There’s an incredible opportunity to combine promising external innovation with the power of a fit-for-purpose translational cell therapy engine to accelerate the development of truly novel cell therapies," said Stefan Wildt. "We have assembled a very talented team with deep and relevant cell therapy development experience who will help us achieve this goal."

On January 3, 2019 Amgen (NASDAQ: AMGN) reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference at 8:30 a.m. PT on Tuesday, Jan. 8, 2019, in San Francisco (Press release, Amgen, JAN 3, 2019, View Source [SID1234532430]). Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On January 3, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported the identification of predictive biomarkers for AsiDNA, its first-in-class non-targeted DNA Damage Response (DDR) inhibitor, which enables personalized medicine approaches (Press release, Onxeo, JAN 3, 2019, View Source [SID1234532449]).

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Judith Greciet, Chief Executive Officer of Onxeo, said: "The development of AsiDNA is undergoing a strong momentum both in terms of preclinical and clinical activities. Identifying predictive biomarkers is an important step forward that will assist in the design of the next phases of the clinical development of AsiDNA. Indeed, these biomarkers will make possible an upstream selection of the patients with a better sensitivity to treatment with AsiDNA, which will maximize the likelihood of success for upcoming clinical studies as well as enable a personalized medicine approach for these patients over time. We now have a robust and state-of-the-art set of preclinical and clinical data for this particularly promising drug candidate in the field of DDR. The identified biomarkers are important components in the design of future studies and will be included as soon as the next phase 1b/2 combination study that we expect to initiate in the coming weeks, thanks to the favorable intermediate results of activity and tolerance in the ongoing DRIIV-1 study. Each of these advances in our developments significantly enhances the value of AsiDNA and our R&D assets."

Preclinical studies identified predictive biomarkers for patient selection in upcoming studies of AsiDNA

Extensive tests investigated AsiDNA sensitivity signature using bioinformatics analysis from transcriptomic experiments, validated this signature in vitro on multiple cell lines and then analyzed the genes presenting an expression profile highly correlated with sensitivity to AsiDNA.

These studies showed that sensitivity to AsiDNA is correlated with the level of DNA repair gene expression in the tumor and identified several tumor genes for which the level of expression is the most correlated to AsiDNA sensitivity. A low level of these genes expression in a patient’s tumor greatly increases the likelihood that the patient will respond to treatment with AsiDNA. As a result, analysis of these genes will be used to select the patients with the highest sensitivity to treatment and thus the greater probability of response in upcoming trials.

Use of such predictive biomarkers is part of the best practices in clinical trial design and in treatment (personalized medicine) today. During clinical development, their use greatly reduces risks and maximizes the chances of success. In clinical practice, prior assessment via predictive biomarkers allows for personalized care that optimizes the patient’s chances by selecting the most appropriate treatment for a given patient.

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.

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."