On May 17, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it will present data at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), to be held June 14-17, 2018 in Stockholm, Sweden, showing that BL-8040, combined with high dose cytarabine (HiDAC), significantly enhanced overall survival of difficult-to-treat relapsed or refractory AML (r/r AML) patients in a Phase 2a clinical trial (Press release, BioLineRx, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349648 [SID1234526758]).

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 Phase 2a study consisted of 42 patients in two cohorts: dose-escalation (range 0.5-2.0 mg/kg) and dose-expansion at the selected dose of 1.5 mg/kg. Patients with r/r AML were treated daily with BL-8040 monotherapy for two days followed by combined administration of BL-8040 and HiDAC for 5 days for 1-2 cycles. Efficacy endpoints included response rate (CR/CRi), overall survival, duration of response and event free survival. BL-8040 in combination with HiDAC was safe and well tolerated at all BL-8040 dose levels (range 0.5-2.0 mg/kg). The response rate for all dosing levels was 29% and median overall survival was 9.1 months, compared with historical data on overall survival of 6.1 months for HiDAC alone. In patients receiving the dose selected for expansion (n=23), the response rate was 39% and median overall survival was 9.2 months with 1-year and 2-year survival rates of 31.6% and 21.1%, respectively. Furthermore, median overall survival for responding patients (CR/CRi) at the 1.5 mg/kg dose was 16.7 months, with 1- and 2-year survival rates of 50% and 37.5%, respectively.

"We are extremely encouraged with the overall survival data continuing to flow from this proof-of-concept study. The study included a very difficult-to-treat patient population, in which 81% were either refractory to one or two inductions, or experienced progression-free survival of less than 12 months after first-line therapy. These data continue to give us confidence in the AML space, where we have two important studies ongoing – a large, randomized controlled Phase 2b study in consolidation AML, and a Phase 1b/2 study in maintenance AML under our collaboration with Genentech," said Philip A. Serlin, Chief Executive Officer of BioLineRx.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On May 17, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that two abstracts on its lead product candidate BPX-501 have been selected for presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden on June 14-17, 2018 (Press release, Bellicum Pharmaceuticals, MAY 17, 2018, View Source [SID1234526757]).

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 presentations will include updated interim survival results from pediatric patients with primary immunodeficiencies (PIDs) and acute myelogenous leukemia (AML) who are undergoing a curative haplo-HSCT with BPX-501.

Oral Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Primary Immunodeficiencies Abstract: S871
Session Title: Stem cell transplantation – Clinical II
Date: Saturday, June 16
Time: 4:00 – 4:15 p.m. CEST

Poster Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Acute Myelogenous Leukemia Abstract: PS989
Session Title: Acute myeloid leukemia – Clinical
Date: Saturday, June 16
Time: 5:30 – 7:00 p.m. CEST

The BPX-501 clinical presentations at the conference will include updated information beyond that included in the abstracts currently available online on the EHA (Free EHA Whitepaper) conference website.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

On May 17, 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 the first patient was enrolled in a Phase 3 clinical trial in China of pamiparib (BGB-290), an investigational PARP inhibitor, in patients with platinum-sensitive recurrent ovarian cancer (Press release, BeiGene, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349570 [SID1234526756]).

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 are pleased to announce the initiation of this Phase 3 trial of pamiparib in China as a potential maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer. This trial is designed to provide important confirmatory clinical data that could enable registration in the maintenance setting, as well support our planned initial regulatory submission for the treatment of patients with advanced ovarian cancer who carry a germline BRCA1/2 mutation," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

"In China there are currently no approved PARP inhibitors, despite the multiple approvals of PARP inhibitors in other regions of the world and in a variety of settings. Our development program in ovarian cancer is designed to address the limited treatment options that currently exist for these patients in China," commented Lai Wang, Ph.D., Senior Vice President and Head of China Development of BeiGene.

The Phase 3 randomized, double-blind, placebo-controlled, multi-center trial is designed to evaluate the efficacy of maintenance therapy with pamiparib versus a placebo in patients with recurrent ovarian cancer who achieved a complete response or partial response after platinum-based chemotherapy, as measured by progression-free survival (PFS) determined by independent review. Secondary objectives include PFS per RECIST version 1.1 determined by investigator, overall survival, objective response rate, duration of response, time to response, safety, and tolerability. Approximately 215 patients are planned to be enrolled in this trial at 15-20 cancer centers in China.

"As we look to improve the current 30 to 40 percent five-year survival rate for patients with advanced ovarian cancer, I look forward to evaluating pamiparib as a potential new maintenance therapy. We are excited to build upon the knowledge base we have of pamiparib from its Phase 1 and 2 studies as well as from other PARP inhibitors in ovarian cancer," said Professor Ding Ma, M.D., Director of Obstetrics and Gynecology, Tongji Medical College of Huazhong University of Science and Technology; and Principal Investigator of the trial.

For more information about the trial, patients and physicians should email [email protected].

About Ovarian Cancer in China

In China, over 50,000 women are diagnosed with ovarian cancer and more than 22,000 die from the disease each year1. More than 70 percent of patients are diagnosed with advanced disease2. The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 85 percent of patients with epithelial ovarian cancer who achieve a full remission following first-line therapy will develop recurrent disease3.

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is being evaluated in pivotal clinical trials in China. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.

On May 17, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that the Company and its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) will present long-term clinical outcomes for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who failed first line treatment and were subsequently treated with tab-cel (tabelecleucel) in Phase 2 studies (Press release, Atara Biotherapeutics, MAY 17, 2018, View Source [SID1234526755]). The poster will be featured during the upcoming 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), which will be held in Stockholm, Sweden, June 14-17, 2018.

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!

"Long-term outcomes including survival, durability of treatment responses and safety continue to highlight the potential compelling benefit of tab-cel for patients with EBV-associated lymphomas," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "Under the current standard of care, EBV+ PTLD is an aggressive cancer that often rapidly progresses to death after diagnosis. We remain focused on advancing our late-stage clinical development and working closely with global health authorities to bring tab‑cel to patients with this life-threatening disease as expeditiously as possible."

Results to be presented at the EHA (Free EHA Whitepaper) meeting demonstrate the median survival for tab-cel treated patients with EBV+ PTLD following hematopoietic cell transplant (HCT) who failed rituximab was not reached after 23.3 months of follow-up. The expected median survival for patients with EBV+ PTLD following HCT who have failed rituximab first line therapy is 16-56 days.1,2

The median survival for tab-cel treated patients with EBV+ PTLD following SOT who failed rituximab was 21.3 months, which compares favorably to the expected 12 to 13-month median survival in patients with EBV+ PTLD following solid organ transplant (SOT) who fail to achieve a complete response to first-line therapy with single-agent rituximab.3 One-year overall survival for patients with EBV+ PTLD following HCT and SOT who failed rituximab was 68 and 64 percent, respectively. Tab‑cel was generally well-tolerated with low incidence of treatment-related serious adverse events (SAEs), consistent with previous studies.

Based on the findings from the Phase 2 studies, two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel in patients with EBV+ PTLD who have failed rituximab following HCT or SOT. Results from the first tab-cel Phase 3 study and submission of an EU conditional marketing authorization application are expected in the first half of 2019.

The abstract is available in the program section of the EHA (Free EHA Whitepaper) Annual Congress website and details for the poster presentation are as follows:

Abstract PF401: Long Term Outcomes of Tabelecleucel (Allogeneic Third-Party EBV-Targeted Cytotoxic T Lymphocytes) for Rituximab-Refractory Post-Transplant EBV+ Lymphomas: A Single Center Experience
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Presentation Date & Time: Friday, June 15; 5:30 p.m. to 7:00 p.m. CEST
Authors:Susan Prockop, Ekaterina Doubrovina, Amy Feng, Guenther Koehne, Parastoo Dahi, Esperanza Papadopoulos, Craig Sauter, Stephanie Suser, Willis Navarro, Akshay Sudhindra, Richard O’Reilly
Location: Poster area, Älvsjö building, Stockholm International Fairs and Congress Centre (Stockholmsmässan)

About EBV+ PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas, and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition. Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.

About tab-cel (tabelecleucel; formerly known as ATA129)
Atara’s most advanced T-cell immunotherapy in development, tab-cel, is a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted tab-cel Breakthrough Therapy Designation for EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT), and in October 2016, tab-cel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tab-cel for an expedited approval pathway. In addition, tab-cel has orphan status in the U.S. and EU. Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and Atara is planning a Phase 1/2 study in NPC. Tab-cel is also available to eligible patients with EBV-associated hematologic and solid tumors through an ongoing multicenter expanded access protocol clinical study, positive interim results of which were presented in December 2017 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

On May 17, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new preclinical data for CG’806, its pan-FLT3/pan-BTK inhibitor, will be presented in a poster presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Aptose Biosciences, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349693 [SID1234526754]).

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!

CG’806 Poster Presentation Details:

CG’806, A NON-COVALENT PAN-FLT3/PAN-BTK INHIBITOR, EXHIBITS UNIQUE BINDING TO WILD TYPE AND C481S MUTANT BTK AND GREATER POTENCY THAN IBRUTINIB AGAINST MALIGNANT B CELLS

Date & Time: Friday, June 15 2018, 5:30 p.m. – 7:30 p.m. CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Biology & Translational Research
Abstract Number: PF337
Location: Poster area, Stockholmsmässan: Mässvägen 1, 125 80 Älvsjö, Sweden

The accepted abstract is available online on the EHA (Free EHA Whitepaper) conference website (click here).

About CG’806
CG‘806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG’806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.