On October 3, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL) (Press release, Daiichi Sankyo, OCT 3, 2018, View Source [SID1234530246]).

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"Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "This designation represents the third Orphan Drug designation granted for an investigational therapy in our oncology pipeline, demonstrating our commitment to transforming innovative science into value for patients. We look forward to working closely with the Japan Health Authority to bring this important cell therapy to patients in Japan as soon as possible."

The Japan MHLW Orphan Drug designation system is designed to promote research activities and support the development of orphan drugs for serious, difficult-to-treat diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational therapy can qualify for Orphan Drug designation if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected. Therapies receiving Orphan Drug designation qualify for several measures intended to support development including, but not limited to, guidance and subsidies for research and development activities, priority consultation for clinical development and priority review of applications.

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight certain types of B-cell lymphoma. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite Pharma, Inc., a Gilead company. Based on the results of a Phase 1/2 study (ZUMA-1), axicabtagene ciloleucel has been approved in the U.S. and Europe. A Phase 2 study similar to the ZUMA-1 study is currently being planned in Japan.

On October 2, 2018 Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics, a biotechnology company focused on the discovery of therapeutic antibodies through single B cell screening and analysis, reported the companies have entered into a research collaboration and license agreement to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers, including solid tumors (Press release, Kite Pharma, OCT 2, 2018, View Source [SID1234537506]).

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Kite and HiFiBiO intend to adapt HiFiBiO’s proprietary single cell technology platform to create a high throughput approach that will potentially allow for the in-depth screening of TCR repertoires from patient samples to identify shared antigen and neoantigen TCRs for use in adoptive cellular therapies. Neoantigens arise from tumor-specific mutations that are unique to each patient’s cancer, offering the potential for more targeted antitumor activity.

Under the terms of the agreement, HiFiBiO will receive a $10 million upfront payment and will be eligible for additional payments based on the achievement of certain research milestones. Kite will have an exclusive option to license HiFiBiO’s platform to screen T cell repertoires and to identify TCRs for use in TCR engineered T cell therapies with a corresponding payment to HiFiBiO.

"Neoantigen-based cell therapy is a very exciting, yet complex, area of research that has the potential to transform the way we treat many solid tumors," said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. "We are excited about this collaboration with HiFiBiO, which will build upon our existing capabilities focused on discovering cell therapies which target patient-specific tumor neoantigens."

"Kite is a recognized leader in the cell therapy field," said Liang Schweizer, PhD, President and Chief Executive Officer, HiFiBiO Therapeutics. "We are proud that our proprietary single cell technology platform, which is utilized to support the rapid progression of our novel antibody therapeutics pipeline, will now also be implemented by Kite for the development of novel cell therapies targeting neoantigens."

On October 2, 2018 AskAt Inc. (AskAt) (Headquarters: Nagoya, Japan, CEO: Akihiro Furuta) reported that Arrys Therapeutics, Inc. (Headquarters: Cambridge, Massachusetts), which licensed AAT-007 in immuno-oncology from AskAt in December 2017, has initiated a clinical study with AAT-007 (grapiprant) (ARY-007) in combination with pembrolizumab (anti PD-1 antibody, KEYTRUDA) (Press release, AskAt, OCT 2, 2018, View Source [SID1234535044]).

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The study is an Open-label, Single-arm, Phase 1b clinical trial to evaluate the safety and efficacy of grapiprant in combination with pembrolizumab in patients with advanced or progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC).

Arrys is the sponsor of the study, in collaboration with Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

On October 2, 2018 Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotech companies in the industry (Press release, Compass Therapeutics, OCT 2, 2018, View Source [SID1234529744]).

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Compass, which completed its $132 million Series A financing this year, is forging a new approach to identifying antibody drug candidates that engage all targets in the biologically complex human immune synapse. The company’s antibody discovery platform enables the rapid identification of therapeutic candidates that engage with a broad range of epitopes and its StitchMabs bispecific screening platform enables the empirical, high-throughput identification of novel synergistic combinations and bispecifics. To date, the company’s integrated R&D approach has generated therapeutic candidates for more than 30 targets in cancer, inflammation and autoimmune disease. More than 15 of them are now advancing through preclinical development.

"We’re honored that the editors of FierceBiotech have recognized Compass for our pioneering approach to antibody-based therapeutics," said Thomas Schuetz, M.D., Ph.D., the company’s co-founder and chief executive officer. "We believe our empirical, unbiased approach to drug discovery will lead to therapeutics with new mechanisms to modulate the human immune system."

The Fierce 15 celebrates the spirit of being "fierce"— championing innovation and creativity, even in the face of intense competition. Selection to the list is based on factors including the strength of a company’s technology, partnerships and venture backers and its competitive market position.

On October 2, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the Transparency Committee of the French Haute Autorité de Santé (HAS) has recommended that Axumin (fluciclovine (18F)) is included on the list of medicines approved in France for hospital use, in line with its European indication (Press release, Blue Earth Diagnostics, OCT 2, 2018, View Source [SID1234529924]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. The positive recommendation marks a further milestone in the roll-out of Axumin across Europe, following receipt of Marketing Authorisation from the European Commission in May 22, 2017.

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Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe. The company now has six European manufacturing and distribution agreements for Axumin in place, covering seventeen countries. Axumin is already commercially available in Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We’re delighted to announce another significant step towards our mission of making Axumin commercially available to clinicians and their patients across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin across Europe."