On November 30, 2018 Eureka Therapeutics, Inc., a clinical stage biopharmaceutical company with the goal of curing cancer by developing novel T-cell therapies that harness the evolutionary power of the immune system, reported that five abstracts, including four oral presentations and one poster discussion, highlighting clinical programs in multiple myeloma and NHL using binding domains developed by Eureka, have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4 in San Diego, California (Press release, Eureka Therapeutics, NOV 30, 2018, View Source [SID1234531755]).

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The data presented at this meeting underscores the potential potency of antibodies generated from Eureka’s proprietary E-ALPHA discovery platform, which includes the human BCMA and CD19 binding domains used in the CAR-T and ARTEMIS T-cell therapies presented at ASH (Free ASH Whitepaper). The E-ALPHA platform comprises a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow to develop highly specific antibodies against target antigens.

"We are pleased to be working with Eureka on our multiple myeloma programs," said Eric Smith, M.D., Ph.D., Director of Translational Development, Cellular Therapeutics Center at Memorial Sloan Kettering Cancer Center (MSK) and co-inventor of CARs for the targeting of multiple myeloma. "Working with Eureka to identify fully-human BCMA and other multiple myeloma targeted binding domains has the potential to avoid host anti-CAR immunity that may develop when using murine derived antibodies as binders. We look forward to continue working with Eureka on developing the next generation of T-cell therapies."

"We are delighted that data involving Eureka’s assets are being reported in many presentations at ASH (Free ASH Whitepaper) – in particular the exciting clinical data from the BCMA/multiple myeloma programs that we developed in collaboration with Memorial Sloan Kettering in 2012 and licensed to Juno Therapeutics (now Celgene) in 2016," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "In addition, the updated data from the 21-patient proof-of-concept study of our ARTEMIS T-cell therapy (ET190L1 ARTEMIS) for CD19-positive r/r NHL continues to show that our ARTEMIS T-cells have been well tolerated with no observed cytokine release syndrome (CRS) or neurotoxicity, validating the potential of our ARTEMIS platform to deliver safer T-cell therapy than the currently available CAR-T therapies."

The accepted abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) website.

Multiple Myeloma

CAR T Cell Therapy Targeting G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D), a Novel Target for the Immunotherapy of Multiple Myeloma
Author: Eric L. Smith, MD, PhD
Abstract #589
Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Development of Novel Immunotherapeutic Approaches in Multiple Myeloma
Monday, December 3, 2018: 7:00 AM, Ballroom 20D
Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived BCMA Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial
Author: Sham Mailankody, MBBS
Abstract #959
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:30 PM, Ballroom 20A
JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE)
Author: Sham Mailankody, MBBS
Abstract #957
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:00 PM, Ballroom 20A
Fully Human BCMA Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma
Author: Damian J. Green, MD
Abstract #1011
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapy
Monday, December 3, 2018: 6:45 PM, Ballroom 20D
Non-Hodgkin Lymphoma

ET190L1-ARTEMIS T Cell Therapy Results in Durable Disease Remissions with No Cytokine Release Syndrome or Neurotoxicity in Patients with Relapsed and Refractory B-Cell Lymphoma
Author: Zhitao Ying, MD, PhD
Abstract #1689
Poster Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster I
Saturday, December 1, 2018, 6:15 PM-8:15 PM, Hall GH
About E-ALPHA Antibody Discovery Platform
Eureka’s proprietary E-ALPHA antibody discovery platform is composed of a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow with specificity screens designed to develop highly specific antibodies against target antigens. The E-ALPHA platform is designed to enable Eureka to rapidly discover, iterate upon and improve our antibodies. Eureka’s E-ALPHA platform enables Eureka to develop highly specific antibodies for both conventional targets, such as cell surface markets, and T-cell receptor targets, such as intracellular peptides displayed by the major histocompatibility complex, with the goal of addressing solid tumors.

About ARTEMIS T-cell Receptor Platform
Eureka’s proprietary ARTEMIS T-cell receptor platform was designed to create potentially safer and more effective T-cell therapies. In pre-clinical studies against CD19-positive malignancies, Eureka’s ARTEMIS T-cells matched the cancer killing potency of currently available CAR-T therapies but with a dramatic reduction in the levels of inflammatory cytokines released. Cytokine release syndrome (CRS) and neurotoxicity are serious side effects associated with currently available CAR-T therapies.

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.

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.

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]