On November 1, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting promising results from a research collaboration to develop a novel CD37-targeting alpha therapy for B-cell malignancies has been published (Press release, Nordic Nanovector, NOV 1, 2018, View Source [SID1234553489]). The complete results will be presented in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018 in San Diego, CA, USA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The research collaboration was established in June 2015 with Orano Med (formerly known as AREVA Med) to develop and investigate a next-generation targeted alpha therapy, comprising Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) and lead-212 (212Pb), for the treatment of B-cell malignancies.

The results published in the abstract relate to promising findings from preclinical studies investigating the dose-dependent efficacy and tolerability of 212Pb-NNV003 in human cell and mouse models of chronic lymphocytic leukaemia (CLL) and Burkitt’s lymphoma (a type of non-Hodgkin’s lymphoma, NHL).

In the studies, 212Pb-NNV003 was found to be well tolerated and led to a 90-100% survival rate in mouse models of CLL and NHL.

Jostein Dahle, Chief Scientific Officer of Nordic Nanovector, said: "There is a strong scientific rationale for combining our CD37-targeting approach with other cytotoxic payloads, including radionuclides and toxins. CD37 is an important target for B-cell malignancies as it is selectively expressed on the surface of B-cell malignancies. Alpha-particles have demonstrated good potential for targeted cancer therapies because their high energy is limited to a very short distance of just a few cell widths resulting in localised cytotoxicity while sparing surrounding healthy tissues. The development of 212Pb-conjugated CD37-targeted alpha therapy therefore offers the potential to treat leukaemias and lymphomas where there is no substantial tumour mass and tumour cells are near healthy tissues. We look forward to further results from this research programme."

Abstract 4422

Abstract title: Targeted Alpha Therapy with 212Pb-NNV-003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)

Authors: A. Saidi et al.

Session Name: 642. CLL: Therapy, excluding Transplantation: Poster III

Date: Monday, 3 December 2018

Presentation Time: 6:00 PM – 8:00 PM Pacific time

Location: San Diego Convention Center, Hall GH

The abstract is available at View Source and the poster will be published on the Nordic Nanovector website to coincide with the session.

About ASH (Free ASH Whitepaper)

The ASH (Free ASH Whitepaper) annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

On November 1, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data for its approved and investigational medicines across a range of blood diseases, and including several first-in-class medicines, will be presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from 1-4 December, 2018 (Press release, Hoffmann-La Roche, NOV 1, 2018, View Source [SID1234530483]). Ten Roche medicines will be featured in more than 70 abstracts, including 25 oral presentations, across 15 blood diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to sharing progress from our broad development programme in haematology at ASH (Free ASH Whitepaper) this year, reflecting our approach to understand mechanisms of blood diseases at the molecular level," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are excited to be presenting data across multiple blood diseases, including studies of several first-in-class medicines with the potential to transform standards of care and improve patients’ lives."

Hemlibra (emicizumab), which represents the first new class of medicine in nearly 20 years for people with haemophilia A, will be featured in 12 abstracts at the congress. New data in children younger than 12 with haemophilia A with and without factor VIII inhibitors will be presented, including the full results from the pivotal HAVEN 2 study evaluating three different Hemlibra dosing options (once weekly, every two weeks or every four weeks) in children with haemophilia A with factor VIII inhibitors. Additionally, treatment preference data from the pivotal HAVEN 3 study in people with haemophilia A without factor VIII inhibitors and the pivotal HAVEN 4 study in people with haemophilia A with and without factor VIII inhibitors will be presented. Hemlibra was recently approved by the US Food and Drug Administration (FDA) for the treatment of haemophilia A without factor VIII inhibitors and is the only haemophilia treatment that can be administered subcutaneously and at multiple dosing options for all people with haemophilia A, with and without factor VIII inhibitors.

Roche will also share data for medicines for a range of blood cancers, across multiple lines of treatment. Highlights include updated results from the phase III MURANO study evaluating Venclexta/Venclyxto (venetoclax) in chronic lymphocytic leukaemia (CLL). In addition, data evaluating Venclexta/Venclyxto in acute myeloid leukaemia (AML) will be featured, including two phase Ib/II combination studies (M14-358 study and M14-387 study). Venclexta/Venclyxto was recently approved in Europe and the United States as a treatment for relapsed or refractory CLL, and is currently under review by the FDA for the treatment of previously untreated AML in combination with a hypomethylating agent or in combination with low dose cytarabine, with a decision expected by end of year. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Updated efficacy data from the phase II GO29365 study evaluating polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate, in combination with MabThera/Rituxan (rituximab) plus bendamustine, in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), will also be presented. The results of the DLBCL portion of the GO29365 study will be submitted to health authorities around the world for approval consideration. Data from the phase III GALLIUM study of Gazyva/Gazyvaro (obinutuzumab) in previously untreated follicular lymphoma which support the prognostic value of minimal residual disease status at the end of induction treatment will also be presented.

Finally, Roche will present early data for two novel T-cell engaging bispecific antibodies in non-Hodgkin lymphoma (NHL), which includes initial efficacy and safety results from the first clinical trials for the investigational medicines mosunetuzumab and CD20-TCB. These bispecific antibodies redirect T-cells to engage and eliminate malignant B-cells. This builds on Roche’s extensive history and expertise in the development of anti-CD20 antibodies for the treatment of numerous B-cell malignancies.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.

Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH18.

About Roche in haematology
For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we are investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera//Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), and Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, Roche’s pipeline of investigational haematology medicines includes Tecentriq (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule which inhibits the interaction of MDM2 with p53 (idasanutlin/RG7388). Roche’s dedication to developing novel molecules in haematology expands beyond malignancy, with the development of Hemlibra (emicizumab), a bispecific monoclonal antibody for the treatment of haemophilia A.

On November 1, 2018 BeiGene, Ltd. (NASDAQ: BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present data on its investigational anti-PD-1 antibody tislelizumab and its investigational BTK inhibitor zanubrutinib at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 1-4, 2018 in San Diego, CA (Press release, BeiGene, NOV 1, 2018, View Source/phoenix.zhtml?c=254246&" target="_blank" title="View Source/phoenix.zhtml?c=254246&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2374795 [SID1234530502]). The presentations will include data from BeiGene’s new drug applications (NDAs) submitted in China for tislelizumab in patients with relapsed/refractory classical Hodgkin lymphoma and zanubrutinib in patients with mantle cell lymphoma. Additionally, BeiGene will host an investor meeting and webcast from the ASH (Free ASH Whitepaper) Annual Meeting on December 3 at 8:00 pm PST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Presentations:
Title: Safety and Activity of the Investigational Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Mantle Cell Lymphoma from a Phase 2 Trial
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Prognostic Markers and Therapies in Mantle Cell Lymphoma and Waldenstrom’s Macroglobulinemia
Date: Saturday, December 1, 2018
Time: 12:45 PST
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: Yuqin Song, M.D., Ph.D.

Title: Tislelizumab (BGB-A317) for Relapsed/Refractory Classical Hodgkin Lymphoma: Preliminary Efficacy and Safety Results from a Phase 2 Study
Session Name: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—ClinicalStudies: Immunotherapy and Targeted Strategies
Date: Monday, December 3, 2018
Time: 11:15 PST
Location: San Diego Convention Center, Room 6F
Presenter: Yuqin Song, M.D., Ph.D.

Poster Presentation:
Title: Updated Safety and Activity of the Investigational Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Mantle Cell Lymphoma
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
Date: Saturday, December 1, 2018
Time: 18:15-20:15 PST
Location: San Diego Convention Center, Hall GH
Presenter: Stephen Opat, M.D.

Investor Webcast:
Date and Time: Monday, December 3, 2018 at 20:00 PST (Tuesday, December 4 at 12:00 China Standard Time)
Webcast: A live webcast and replay of the event will be available on BeiGene’s investor website, View Source

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1 in pre-clinical studies. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK). Zanubrutinib was discovered in BeiGene’s research facilities in Beijing, China, and is being developed globally by BeiGene as a monotherapy and in combination with other therapies to treat various hematologic malignancies.

On November 1, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that two abstracts related to the company’s lead product candidate, tipifarnib, have been accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 1-4, 2018 in San Diego (Press release, Kura Oncology, NOV 1, 2018, View Source [SID1234530518]). The following abstracts were published today are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tipifarnib in Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (AITL) and CXCL12+ Peripheral T-cell Lymphoma (PTCL): Preliminary Results from an Open-Label, Phase 2 Study (Abstract # 2937)
Session Name: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Poster II
Date: Sunday, December 2, 2018
Presentation Time: 6:00 p.m. – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH

Identification of Tipifarnib Sensitivity Biomarkers in T-cell Tumor Cell Lines (Abstract # 2851)
Session Name: 621. Lymphoma-Genetic / Epigenetic Biology: Poster II
Date: Sunday, December 2, 2018
Presentation Time: 6:00 p.m. – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH

Following presentation at the meeting, the posters will be available on Kura’s website at www.kuraoncology.com.

On November 1, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Jeong A Park from the Department of Pediatrics of Memorial Sloan-Kettering Cancer Center (MSK) will present preclinical data from the Company’s bispecific GD2 antibody in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, CA on December 3, 2018, at 9:00 PM Eastern (Press release, Y-mAbs Therapeutics, NOV 1, 2018, View Source [SID1234530534]). An abstract of the poster presentation will be made available online by ASH (Free ASH Whitepaper) on November 1, 2018 at 12:00 PM Eastern.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bispecific GD2 antibodies were tested in solid tumors in preclinical models with T-cells and were shown to exert anti-tumor effect against GD2(+) tumor xenografts or PDX tumors. Further, the bispecific GD2 antibodies induced rapid and quantitative T-cell homing to tumors, mediating antibody dependent T-cell mediated cytotoxicity (ADTC) against GD2, and were shown to infiltrate tumors with little to no immune response, also known as cold tumors