On December 4, 2017 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported an oral presentations will be given at the upcoming 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia on Saturday, December 9, 2017 (Press release, NantKwest, DEC 4, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2320823 [SID1234522350]).

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Presentation Title

CD19-Chimeric Antigen Receptor (CAR) Engineered Natural Killer (NK) Cell Therapy: Novel "Off the Shelf" Immunotherapy in CD20 Resistant B-Cell Non-Hodgkin Lymphoma (NHL) Cell Lines, Primary NHL Cells, and a Human Lymphoma Xenograft Model Target Activated Natural Killer (CD19.taNK) Cellular Therapy: A Novel Immunotherapeutic Approach to the Treatment of Non-Hodgkin Lymphoma (NHL)

Abstract #110: View Source

Presenter: Sneha Purvey, MD, Department of Hematology and Oncology, Tufts Medical Center, Boston, MA

Date: Saturday, December 9, 2017, 9:45AM, Building C, Level 1, C101 Auditorium (Georgia World Congress Center)

Presentation Summary

This oral presentation will present preclinical data on the company’s CD19.taNK program. CD19.taNK cell therapy is based on the use of engineered NK cells expressing a human anti-CD19 CAR that target CD19 expressing cells. The study was designed to more deeply understand the mechanism of action associated with NK-based therapy in B cell NHL and determine the potential for CD19.taNK cells as an "off the shelf" therapy.

The study author’s identified high levels of NK activating ligands indicative of a conserved mechanistic response to CD19-CAR NK cell therapy. In addition, the authors determined that CD19.taNK cell therapy induced significant single-agent cytolytic activity against a wide range NHL cells, including primary DLBCL cells, and cells resistant to standard anti-CD20 antibody.

"CD20 targeted antibody therapy represent one of the most effective and widely used therapeutic interventions in blood cancers. However, resistance is common, occurring in a large percentage of patients," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "For next generation therapies, such as our CD19.taNK cell therapy, circumventing resistance requires both a deeper understanding of the mechanisms of resistance and the mechanisms of action. We believe these study results provide encouraging data elucidating the significant, single-agent cytolytic activity of CD19.taNK cell therapy and takes us one step closer in our focus to transition this novel NK cell therapy to clinical cancer care."

On December 4, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported that it will present at the Oncolytic Virotherapy Summit (Press release, Oncolytics Biotech, DEC 4, 2017, View Source [SID1234522351]). Dr. Matt Coffey, Oncolytics’ President and Chief Executive Officer, will present on Wednesday, December 6 at 11:00 a.m. ET as part of a panel presentation and then present specifically on pelareorep in a Clinical Case Study presentation at 2:30 p.m. ET on the same day. The conference takes place on December 5th, 6th and 7th in Miami, Florida.

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"The Oncolytic Virotherapy Summit offers us another opportunity to highlight our extensive experience with pelareorep in the clinic and to illustrate its ability to induce an inflamed tumor phenotype amongst our peers and for potential partners," said Dr. Coffey. "Our clinical experience with pelareorep has led us to favorable feedback from the FDA following our end-of-phase 2 meeting which helps us define a clear regulatory path in metastatic breast cancer and a single 400-patient phase 3 registration study. Our phase 3 protocol will be made available following evaluation and completion of discussions with clinical advisors, potential partners and the EMA."

The panel presentation: "How Can We Improve The Efficacy of Oncolytic Virotherapies?", also including management from PsiOxus Therapeutics, Vyriad and Replimune Group, will cover:

Viral modulation of the tumor microenvironment
Increasing the viral impact with activated immune responses
Combination drug therapies to stimulate the immune response and prevent immunosuppression
Viral delivery for largest impact
Dr. Coffey’s individual presentation: "Clinical Progress and Robust Safety Findings of Using Reovirus as an Immuno-Oncology Viral Agent to Treat Cancer", will highlight:

The role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment
Overall survival data from the Company’s randomized phase 2 metastatic breast cancer study
The largest pooled safety database of any oncolytic virus
About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On December 4, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported positive overall survival data from the long-term follow-up part of the Phase 2a trial of BL-8040 for the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) (Press release, BioLineRx, DEC 4, 2017, View Source;p=RssLanding&cat=news&id=2320793 [SID1234522347]). The results demonstrate that the combination of BL-8040 with high-dose Ara-C (HiDAC) in this difficult-to-treat patient population significantly improved overall survival, compared with historical data of HiDAC monotherapy.

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The long-term survival results from the Phase 2a study derive from the expansion phase of the study, which included 16 patients (out of 42 total patients enrolled in the study). Participants were treated with BL-8040 as a monotherapy for two days, followed by a combination of BL-8040 and HiDAC for 5 days. The mean follow-up time was 338 days (29-853 days). BL-8040 in combination with HiDAC was found to be safe and well tolerated, and the response rate was 38% (6/16). Median overall survival was 11.1 (1-28) months, the estimated one-year survival rate was 37.5% and the estimated two-year survival rate was 28.5%, compared to historical data for patients treated only with HiDAC showing overall survival of approximately 6.1 months. Furthermore, the subset of patients exhibiting a response showed prolonged overall survival, with estimated one-year and two-year survival rates of 60%. Median overall survival for this group could not be calculated, since only two of these patients have relapsed.

The Phase 2a study assessed the efficacy of BL-8040, as a single agent and in combination with HiDAC, for the treatment of r/r AML. The majority of patients in the study were heavily pre-treated, and the treated patient population included patients who had relapsed following allogeneic stem-cell transplantation, as well as secondary AML patients – both conditions which represent difficult-to-treat populations with poor prognoses. Top-line results from the full study (n=42) were previously reported in March 2016, and showed an overall response rate (CR+CRi) of 38%, compared with historical data relating to HiDAC of approximately 20%.

Philip Serlin, Chief Executive Officer of BioLineRx, commented, "We are very pleased from the long-term follow-up results of this study, which continue to demonstrate the robust anti-leukemic activity of BL-8040 and show that combined treatment with HiDAC not only increases the response rate, but also increases overall survival time compared to historical data. We will continue to monitor the overall long-term survival of patients in this study, as we progress in the execution of our two other important studies in AML – our Phase 2a study in maintenance AML, which is part of our collaboration with Genentech, and our Phase 2b study in consolidation AML. The promising survival and response results we have seen in the r/r AML study, along with the future data readouts from the additional studies we’re currently running in this disease, have the potential to make BL-8040 a key player in the AML setting."

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 December 4, 2017 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that the company will webcast an investor and analyst event on Monday, December 11, 2017 during the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, GA (Press release, Seattle Genetics, DEC 4, 2017, View Source;p=RssLanding&cat=news&id=2320818 [SID1234522352]). Industry experts will discuss the ADCETRIS (brentuximab vedotin) phase 3 ECHELON-1 data, and members of the Seattle Genetics management team will discuss other program highlights.

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The event will take place from approximately 8:30 p.m. to 9:30 p.m. Eastern Time. The webcast will be available live and for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

On December 4, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported updated clinical data from the larotrectinib pediatric Phase 1 SCOUT clinical trial (Press release, Loxo Oncology, DEC 4, 2017, View Source [SID1234522348]). These data are being presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research in Atlanta.

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"Targeted therapy success stories in pediatric oncology are uncommon, and larotrectinib has invigorated the pediatric oncology community," said Brian Turpin, D.O., the presenting SCOUT principal investigator and assistant professor in the division of oncology at Cincinnati Children’s Hospital. "Larotrectinib’s near universal response rate and compelling durability of response in pediatric patients with TRK fusion cancers is likely to be practice changing. Furthermore, the first-ever TRK inhibitor response in a TRK fusion glioblastoma patient highlights the potential for larotrectinib in TRK fusion central nervous system tumors."

"We are grateful to the children and families who have enabled the development of larotrectinib through their participation in clinical trials," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology.

As of a July 17, 2017 data cut-off date, 24 pediatric patients were enrolled in the dose escalation portion of the Phase 1 trial, including 17 patients with TRK fusion cancers. TRK fusion patients carried primary diagnoses of infantile fibrosarcoma, thyroid cancer, and various soft tissue sarcomas.

TRK Fusion Patients (n=17)* Patients without TRK Fusions (n=7)
Independent Review Committee Assessed Response Investigator Assessed Response Investigator Assessed Response
Overall Response Rate
(ORR = PR+CR) 93%
(95% CI: 68% – 100%) 93%
(95% CI: 68% – 100%) 0%
Partial Response (PR) 80% 67%** 0%
Complete Response (CR) 13% 27% 0%
Stable Disease 7% 7% 0%
Progressive Disease 0% 0% 100%
* 2 patients not evaluable due to having non-measurable disease at baseline.
** Includes 2 patients with unconfirmed partial responses as of July 17, 2017, which were subsequently confirmed.

Among the 17 patients with TRK fusion cancers, 94% either remain on drug or received surgery with curative intent; four patients have been followed greater than one year and 12 have been followed greater than six months.

The larotrectinib adverse event profile is consistent with data previously presented publicly. The most common treatment-related adverse events at the Phase 2 dose included increased liver function tests, neutropenia, and nausea, all largely grade 1.

These data are being presented in a poster session on December 4, 2017 and an oral presentation on December 5, 2017. The poster and presentation will be available online at View Source at the time of their scheduled presentations.

About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated a 75 percent independently-reviewed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib has been granted Breakthrough Therapy Designation Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Loxo Oncology leads worldwide development and U.S. regulatory activities. Bayer leads ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

About TRK Fusion Cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.