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]).

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"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.

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"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]).

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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.

On May 17, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that clinical data from SL-801 and SL-701 trials have been selected for poster presentations at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 1-5, 2018, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, MAY 17, 2018, View Source [SID1234526753]). Abstracts are now available on the ASCO (Free ASCO Whitepaper) conference website.

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Details on the presentations are as follows:

Phase 2 Trial of SL-701 in Relapsed/Refractory Glioblastoma (GBM): Correlation of Immune Response with Longer-Term Survival

Abstract: 2058
Session: Central Nervous System Tumors
Presenter: David Peereboom, MD; Cleveland Clinic
Date: Saturday, June 2, 2018
Time: 1:15 – 4:45 PM CT
Interim Results from A Phase 1 Trial Of SL-801, A Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors

Abstract: 2560
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Presenter: Judy Wang, MD; Florida Cancer Specialists and Research Institute
Date: Monday, June 4, 2018
Time: 8:00 – 11:30 AM CT
About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.

On May 17, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a poster presentation of additional prostate cancer data (Abstract #229675) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held in Chicago, June 1-5, 2018 (Press release, Inovio, MAY 17, 2018, View Source [SID1234526752]). Previously reported data from a Phase 1b clinical trial demonstrated that Inovio’s cancer immunotherapy (INO-5150) slowed PSA rise in patients with biochemically recurrent prostate cancer. Additional analyses show clinically meaningful PSA stabilization post-administration of Inovio’s immunotherapy in patients with no documented disease progression during the study. Of note, this effect was also observed in the patients with the fastest PSA doubling at the time of study entry.

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The multi-center Phase 1b study enrolled 62 patients with biochemically relapsed prostate cancer following definitive local therapy. Under the trial design, eligible patients received INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA-5P device. Of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Additional analyses are underway to elucidate the correlation between immunologic efficacy and clinical benefit. For more information, please visit ClinicalTrials.gov (Identifier: NCT02514213).

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "The additional results from our Phase 1b INO-5150 study continue to support our rationale that Inovio’s T cell generating INO-5150 could be an important agent as an immunotherapy as it provides strong and durable immune responses in a particularly difficult-to-treat prostate cancer patient population. We remain diligent on establishing an outside partnership to further advance INO-5150 and I look forward to sharing additional observations from our prostate cancer development program later this year."

INO-5150 was generated using Inovio’s proprietary ASPIRE technology process to enable significant production of engineered PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

Independently, as part of the active, ongoing collaboration, two additional posters are being presented at the ASCO (Free ASCO Whitepaper) meeting that provide details on the ongoing trials of AstraZeneca/MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in abstract #TPS6093 and #5525.