On November 30, 2018 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Takeda Pharmaceutical Company Limited (Takeda), has exercised an option under its existing, multi-target collaboration and license agreement (Press release, Crescendo Biologics, NOV 30, 2018, View Source [SID1234531757]). Takeda has taken an exclusive licence to Humabodies directed to one of its oncology targets.

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This licence option exercise comes substantially earlier than planned and marks the highly successful delivery and further pre-clinical evaluation by Takeda of Humabody leads meeting its stringent criteria.

Dr Peter Pack, CEO of Crescendo, commented:

"The team at Crescendo has made great progress on our Humabody programmes, working closely with the Takeda team. To date, we have met all the technical milestones on time or earlier than planned, which is proof of our excellent collaboration. We are delighted that the option to license has been taken by Takeda ahead of schedule and look forward to further future successes."

Chris Arendt, Head, Oncology Drug Discovery Unit & Immunology Unit, Takeda, commented:

"At Takeda, we continue to research diverse modalities to bring transformative treatments to patients with cancer. Our decision to exercise the licence was based on the quality of the Humabody leads and the potential we see to develop improved and differentiated immuno-oncology therapies."

Takeda’s option is part of the existing multi-target collaboration and licence agreement announced in October 2016 where Takeda received the right to develop and commercialise Humabody-based therapeutics resulting from the collaboration. Under the agreement, Crescendo is eligible to receive clinical development, regulatory and sales-based milestone payments of up to $754 million plus royalties on Humabody-based product sales by Takeda.

On November 30, 2018 Karolinska Development (Nasdaq Stockholm: KDEV) reported that an investment consortium, including Redmile Group, invests SEK 512 million (EUR 50 million) in Aprea Therapeutics (Press release, Karolinska Development, NOV 30, 2018, View Source [SID1234531741]). Based on the investment, Karolinska Development has decided to increase the book value for its holding of Aprea. As a consequence, a positive effect on earnings by approximately SEK 60 million will be reported in the income statement for the fourth quarter 2018, to be published on 14 February 2019.

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An investment consortium, with Redmile Group in the lead, invests SEK 512 million (EUR 50 million) in Aprea Therapeutics. Redmile Group, which is a US venture capitalist firm focused on health care, will appoint a representative to Aprea Therapeutic’s Board of Directors.

The investment consortium also includes Rock Spring Capital, who like Redmile Group enters as a new owner, and 5AM Ventures, Versant Ventures, HealthCap, Sectoral Asset Management and Karolinska Development AB who all are previous owners of Aprea Therapeutics.

Aprea’s drug candidate APR-246 has shown initial positive results in a combination study with standard care azacitidine in patients with TP53 mutant myelodysplastic syndromes (MDS). Proceeds from the financing will be used to advance the clinical development of APR-246. Aprea is planning to begin a Phase III clinical study in myelodysplastic syndrome (MDS) and is nearing completion of a Phase Ib/II clinical trial in p53 mutated high-risk myelodysplastic syndromes (MDS) and oligoblastic acute myeloid leukemia (AML). The Phase II part of the study is ongoing, with updated data to be presented at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, 1-4 December 2018.

"The engagement from well-renowned international investors is based on the clear advances in Aprea’s development of its drug candidate APR-246 and confirms the quality of the project," says Viktor Drvota, CEO of Karolinska Development.

For more information, please visit www.aprea.com

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: [email protected]

Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: [email protected]

On November 30, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeoGenomics, Inc. (NASDAQ: NEO) reported a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients (Press release, Qiagen, NOV 30, 2018, View Source [SID1234531758]). The partnership between QIAGEN and NeoGenomics, a leading provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.

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Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, especially next-generation sequencing (NGS) tests, the collaboration with NeoGenomics will allow QIAGEN and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions. The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.

QIAGEN and NeoGenomics will discuss their efforts to expedite access for precision medicine solutions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego.

"As a leading provider of oncology testing for both clinical trials and patient care, NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests. Our collaboration with QIAGEN will ensure that patients have access to the most advanced companion diagnostics to target new cancer medicines, as soon as those medicines are approved. We are excited to work with QIAGEN to deploy cutting edge technologies to remain at the forefront of precision medicine" said Douglas M. VanOort, Chairman and CEO of NeoGenomics.

"We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics during clinical trials and upon approval by the FDA, supporting synchronized launches of new oncology drugs, to make a difference for patients," said Peer Schatz, CEO of QIAGEN. "Together with our Pharma partners, we are now planning to provide investigational use only (IOU) tests to NeoGenomics and other labs, enabling them to verify, set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval. The companion diagnostic services can be promoted by NeoGenomics through their national commercial teams starting with their FDA approval, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients. We look forward to discussing this approach further at ASH (Free ASH Whitepaper) 2018, and demonstrating our rapidly evolving Sample to Insight solutions to the world’s top hematology and oncology experts."

NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus. The master service agreement provides a flexible framework with multiple options for co-development, verification, setup, and launch of new companion diagnostics, including next-generation sequencing tests, for biomarker profiling paired with new targeted drugs.

As QIAGEN collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic. Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for QIAGEN´s pharmaceutical partners. For more information, please visit View Source

On November 30, 2018 IGEM Therapeutics (IGEM or "the Company"), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported it has secured an additional £3 million to close its Series A round at £5 million (Press release, IGEM Therapeutics, NOV 30, 2018, View Source [SID1234531742]). Two new investors, Alsa Holdings and UCL Technology Fund (co-managed by Albion Capital and UCLB, UCL’s commercialisation company) have joined initial investor Epidarex Capital who also committed further capital in this second close.

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The funding will enable IGEM to further develop its portfolio of IgE antibody candidates against a variety of cancers. The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. Pre-clinical proof of concept data repeatedly shows superior efficacy for IgE versus cognate IgG antibodies in a range of cancer models.

Alek Safarian, Chief Executive Officer of Alsa Holdings, commented: "We are excited by the promise that IGEM’s technology holds for major therapeutic advances in a host of oncology indications, and are looking forward to working with the management team to help bring new options to oncology patients in the future."

Dr Christoph Ruedig, Partner at Albion Capital commented: "The UCL Technology Fund strives to back innovative early stage companies that are seeking to translate ground-breaking research into commercial and societal impact. The pioneering work of Dr Sophia Karagiannis and her collaborators, which includes significant clinical development by clinical academics from UCL, highlight the profound potential of IgE antibody technology in cancer therapeutics. We are delighted to invest alongside Epidarex and Alsa and look forward to working with IGEM’s accomplished executive team."

Dr Peter Finan, Partner at Epidarex Capital, commented: "IGEM continues to make great progress on this disruptive platform. We look forward to working closely with Alsa and Albion to maximise IGEM’s potential"

Dr Tim Wilson, Chief Executive Officer of IGEM, commented: "This new financing will allow IGEM to continue to pioneer the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Alsa Holdings and UCL Technology/Albion to IGEM as well as receiving further investment from initial investor Epidarex Capital."

On November 30, 2018 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it was selected as a specialty pharmacy network partner for Astellas’ new product XOSPATA (gilteritinib) for the treatment of patients with relapsed or refractory FMS-like Tyrosine Kinase 3 (FLT3) mutation-positive acute myeloid leukemia (AML) (Press release, Onco360, NOV 30, 2018, View Source [SID1234531759]).

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"Onco360 is excited to be selected as one of only three specialty pharmacy providers for XOSPATA patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of XOSPATA unlocks a new treatment option for AML patients with extremely limited treatment alternatives. As a provider of this key treatment, Onco360 can support the highly specialized needs of AML patients and their physicians across the United States."

AML is the most common form of acute leukemia in adults in the United States (U.S.). Only 27 percent of patients diagnosed with AML survive for five years following initial diagnosis. FLT3 mutations occur in about 33 percent of AML patients and is an indicator of a poor prognosis. The American Cancer Society estimates that in 2018, approximately 19,500 new patients will be diagnosed with AML in the U.S.1 Previously, there were no U.S. Food and Drug Administration (FDA)-approved products for patients with relapsed or refractory FLT3 mutation-positive AML.

XOSPATA is a manufactured by Astellas Pharma Inc. and was approved by the U.S. FDA on November 28, 2018 based on positive clinical trial results.2 Full prescribing information can be found at www.xospata.com.

XOSPATA is immediately available to order through Onco360. Referral forms and information on how to order can be found at Onco360.com/Order.