Turnstone Biologics Unveils Novel Vaccinia Oncolytic Viral Immunotherapy Platform

On November 30, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company leading the next generation of oncolytic viral therapies, reported its pre-clinical data today supporting the development of a new Vaccinia therapeutic platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Meeting in Miami (Press release, Turnstone Biologics, NOV 30, 2018, View Source [SID1234531756]). This platform was developed by Dr. John Bell and his colleagues at The Ottawa Hospital Research Institute and the University of Ottawa, and engineered to be potent, highly selective and immune-stimulatory. Furthermore, the versatility of the platform enables additional therapeutic agents to be encoded in the virus and produced at tumor sites. This single platform virus has the potential to create a portfolio of diverse products. Turnstone has exclusively licensed this technology.

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This proprietary Vaccinia virus can be delivered systemically and is designed to target and kill cancer cells throughout the body, modulate the tumor microenvironment and stimulate both innate and adaptive immune responses. The virus also contains a very large transgene capacity, allowing for the insertion of multiple therapeutic agents. These agents will be produced selectively at tumor sites as the virus replicates only in the tumor cells, effectively enabling a local combination therapy from a single therapeutic promoting cancer cell killing. Turnstone is conducting IND-enabling studies on TBio-6517, its lead product candidate from this platform, consisting of the Vaccinia virus expressing three potent immune modulators, and anticipates initiating clinical studies in 2019.

"The decades-long search for immunotherapies and combinations that are safe and effective for a range of cancers has proven challenging," said Dr. Bell. "While previous Vaccinia therapies have shown promise, we believe that we have selected and designed significant improvements into this platform, potentially allowing us to safely and effectively combine multiple modes of action into a single therapy."

"This is an exciting time for Turnstone as we unveil another novel viral immunotherapy platform technology in our continued pursuit to develop transformative technologies that advance the treatment of cancer," said Mike Burgess, MBChB, Ph.D., President, Research and Development at Turnstone Biologics. "We are rapidly advancing our lead candidate from this proprietary platform, TBio-6517, to the clinic with the goal of achieving effective and durable outcomes for a greater number of cancer patients."

The oral presentation entitled "Utilizing Novel Oncolytic Vaccinia Virus for Selective Expression of Immunotherapeutic Proteins in Metastatic Tumors" includes key proof-of-concept data:

Cancer Cell Selectivity: The Turnstone Vaccinia virus was shown to rapidly kill more than 80% of cancer cells across multiple cell lines while sparing normal cells, exhibiting high tumor specificity in mouse models.
Potent Oncolytic Activity: The Turnstone Vaccinia virus replicated in human lung, sarcoma, melanoma, ovarian, gastic and thymic tumor explants, and showed efficacy with improved safety in the HT29 colon cancer tumor model.
Transgene Expression: TBio-6517 demonstrated selective expression of its three encoded immunomodulators at the sites of tumors in preclinical models, with no evidence for exposure in the peripheral blood.

TG Therapeutics, Inc. Recaps Triple Therapy Data Presentations at the Upcoming 60th American Society of Hematology Annual Meeting and Exposition

On November 30, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that recapped the schedule of data presentations for the Company’s lead compounds, umbralisib (TGR-1202), the Company’s once-daily PI3K delta inhibitor, and ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, at the upcoming 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, being held December 1-4, 2018, at the San Diego Convention Center (Press release, TG Therapeutics, NOV 30, 2018, View Source [SID1234532245]).

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Presentations at the ASH (Free ASH Whitepaper) 2018 meeting include the following:

Oral Presentation Details:

Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation
Publication Number: 297
Oral Session: 642. CLL: Therapy, excluding Transplantation: Cellular Therapy and Immunomodulation in CLL
Session Date and Time: Sunday, December 2, 2018; 7:30 AM – 9:00 AM PT
Presentation Time: 8:00 AM PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: Anthony R. Mato, MD, Memorial Sloan-Kettering Cancer Center, New York, NY
Poster Presentation Details:

Title: Combination of Umbralisib, Ublituximab, and Bendamustine Is Safe and Highly Active in Patients with Advanced Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Abstract Number: 4197
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date and Time: Monday, December 3, 2018; 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Matthew A. Lunning, DO, University of Nebraska Medical Center, Omaha, NE
The above referenced abstracts are available online and can be accessed on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Following each presentation, the data presented will be available on the Publications page of the Company’s website at View Source

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 2, 2018 beginning at 7:30 PM PT with featured presentations beginning promptly at 8:00 PM PT. The event will take place in the Presidio A/B room, at the Marriott Gaslamp in San Diego, California. The event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at View Source, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG TherapeuticsDecember 2018 Investor & Analyst Event.

Crescendo Biologics announces early licensing by Takeda of first oncology-targeted Humabody®

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.

Financing of SEK 512 million secured in Karolinska Development’s portfolio company Aprea Therapeutics

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]

QIAGEN and NeoGenomics collaborate to offer cancer patients Day-One access to innovative companion diagnostics for newly approved drugs

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