On March 31, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported the presentation of positive overall survival data from an open-label, randomized, Phase 2 study designed by the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer Institute of Canada – NCIC) (Press release, Oncolytics Biotech, MAR 31, 2017, View Source [SID1234518366]). The 74-patient study, powered to 90 percent, assesses the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer. Data from the study (IND 213), will be presented during the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 1-5, in Washington, DC.

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The abstract reports that in the intention-to-treat (ITT) patient population there was an improvement in median OS (secondary endpoint) from 10.4 months on the control arm to 17.4 months on the test arm (Hazard ratio 0.65, 80% CI 0.46-0.91, p=0.1), meeting the pre-specified significance level for the 90 percent powered study. Consistent with REOLYSIN acting as an immune therapy agent, there was no meaningful improvement in either progression free survival (the primary endpoint), or response rate (secondary endpoint). The Company is now planning a registration study in metastatic breast cancer with overall survival as the primary endpoint.

"This is the first controlled, randomized study where the systemic administration of an immuno-oncology viral agent (REOLYSIN), was well tolerated and had a significant impact on the overall survival of relapsed metastatic breast cancer patients when used in combination with paclitaxel," said Dr. Karen Gelmon, Head, Investigational Drug Program, Experimental Therapeutics, Department of Medical Oncology, British Columbia Cancer Agency.

"There is an emerging pattern, from this and other studies with REOLYSIN, where patients obtain significant benefit in overall survival, despite limited impact on response rates and/or progression-free survival," said Dr. Andres Gutierrez, Chief Medical Officer of Oncolytics. "This is a well-established pattern for other immunotherapies, like checkpoint inhibitors, which have been approved on an overall survival primary endpoint in melanoma, NSCLC and head and neck cancers. These phase 2 data also support the established mode of activity of REOLYSIN where selective cell lysis of permissive cancer cells is followed by an anti-tumor immune response, which may be responsible for the meaningful survival benefit for patients. Taking into account the specific findings from this study, we continue to believe that REOLYSIN is not solely an oncolytic agent, but has key attributes of an immuno-oncology agent as well."

The abstract, authored by Bernstein et al, "A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC)" is now available on the AACR (Free AACR Whitepaper) website. CCTG will be making a poster presentation, #8466, at the AACR (Free AACR Whitepaper) Annual Meeting, on Tuesday Apr 4, 2017 from 1:00 PM – 5:00 PM, in Washington, DC.

Oncolytics would like to thank the patients that participated in this study, the CCTG and all the physicians and nurses involved.

About Breast Cancer
The American Cancer Society estimates there will be 255,180 new cases of breast cancer diagnosed in the United States and 41,070 deaths from the disease in 2017.

On March 31, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that updates on several of its preclinical programs are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Washington, D.C (Press release, Mateon Therapeutics, MAR 31, 2017, View Source [SID1234518365]).

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"These abstract presentations show the breadth of some of our early preclinical development programs," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "As this work matures, we look forward to it complementing our current core clinical programs in platinum-resistant ovarian cancer and acute myeloid leukemia."

Poster presentations by Mateon and/or its collaborators at the AACR (Free AACR Whitepaper) annual meeting are as follows:

Abstract #2952 – The novel Cathepsin L/K inhibitors KGP94 and KGP207 prevent M0 to M2 macrophage differentiation and macrophage mediated pro-tumor functions.
Section: Tumor Microenvironment 3
Date and Time: Monday, April 3, 2017, 1:00 p.m. – 5:00 p.m. Eastern Time

Abstract #3203 – Targeting tumor hypoxia with prodrug conjugates of potent small molecule inhibitors of tubulin polymerization
Section: Novel Molecular Targets 2
Date and Time: Tuesday, April 4, 2017, 8:00 a.m. – 12:00 p.m. Eastern Time

Abstract #4899 – The small molecule Cathepsin L and K inhibitor KGP-94 impairs the metastatic phenotype of osteosarcoma cells
Section: Therapeutic Intervention of Cancer and Metastases
Date and Time: Tuesday, April 4, 2017, 1:00 p.m. – 5:00 p.m. Eastern Time

The above abstracts have been published and can be viewed on the AACR (Free AACR Whitepaper) Annual Meeting website.

On March 31, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported the presentation of eight nonclinical posters based on its molecules and antibody-based technologies at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, D.C (Press release, MacroGenics, MAR 31, 2017, View Source [SID1234518363]). Three of these posters are being presented by the Company’s collaboration partners, Janssen Research & Development, LLC and ImmunoGen, Inc.

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"MacroGenics’ record of antibody-based therapeutic innovation continues," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Beyond our broad, growing pipeline of clinical assets across immuno-oncology and autoimmune disorders today, we have maintained our investment in preclinical research to yield our future product candidates for delivering therapeutics to patients in need. The posters featured at AACR (Free AACR Whitepaper) reflect advances in our DART and TRIDENT multi-specific platform technologies, including the ability to target multiple checkpoints with a single recombinant molecule and T cell-mediated cytotoxic mechanisms as well as the deployment of multiple linker-drug conjugate technologies with novel cancer targets. I’m very excited about the potential for each of these programs."

MacroGenics AACR (Free AACR Whitepaper) 2017 Poster Presentations

Each of the posters featured at AACR (Free AACR Whitepaper) relating to a MacroGenics-developed molecule are described below and after their presentation at AACR (Free AACR Whitepaper), may be accessed under "Events & Presentations" in the Investors section of the Company’s website at View Source

B7-H3-targeted Antibody-drug Conjugate: "Preclinical Development of a Duocarmycin-Based Antibody-Drug Conjugate (ADC) Targeting B7-H3 for Solid Cancer" (presentation date is Sunday, April 2 from 1:00 — 5:00pm ET; poster section 2, board #23).
ADAM9 ADC: "ADAM9: Target Validation, Antibody Discovery and Preclinical Data Supporting ADAM9 as an Antibody-Drug Conjugate Therapeutic Target for Solid Tumors" (presentation date is Sunday, April 2 from 1:00 — 5:00pm ET; poster section 2, board #19).
ADAM9 ADC: "Novel Antibody-Drug Conjugates Targeting ADAM9-expressing Solid Tumors Demonstrate Potent Preclinical Activity" (presentation date is Sunday, April 2 from 1:00 — 5:00pm ET; poster section 2, board #18). This poster is being presented by ImmunoGen, Inc.
CD137 DART: "Tumor-Antigen Expression-Dependent Activation of the CD137 Costimulatory Pathway by Bispecific DART Proteins" (presentation date is Tuesday, April 4 from 8:00am — 12:00pm ET; poster section 26, board #15).
PD-1 x CTLA-4 DART: "Co-targeting PD-1 and CTLA-4 Inhibitory Pathways with Bispecific DART and TRIDENT Molecules" (presentation date is Tuesday, April 4 from 8:00am — 12:00pm ET; poster section 26, board #10).
Duvortuxizumab (MGD011): "Potent Antitumor Activity of Duvortuxizumab, a CD19 x CD3 DART Molecule, in Lymphoma Models" (presentation date is Tuesday, April 4 from 8:00am — 12:00pm ET; poster section 26, board #9). This poster is being presented by Janssen.
Duvortuxizumab (MGD011): "Quantitative Prediction of Human Pharmacokinetics for Duvortuxizumab from Cynomolgus Monkey Data: a Translational Pharmacokinetic Modeling Approach" (presentation date is Tuesday, April 4 from 1:00 — 5:00pm ET; poster section 3, board #29). This poster is being presented by Janssen.
5T4 x CD3 DART: "A 5T4 x CD3 Bispecific DART Molecule with Extended Half-life for T-cell Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)s" (presentation date is Tuesday, April 4 from 1:00 — 5:00pm ET; poster section 26, board #23).

On March 31, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that larotrectinib (LOXO-101) data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting taking place April 1 – 5, 2017, in Washington, DC (Press release, Loxo Oncology, MAR 31, 2017, View Source [SID1234518362]).

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The abstract and poster describe initial clinical data across the larotrectinib program for all patients with TRK fusion primary CNS cancers. The cases include three patients with glioblastoma: one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial. In the cases described, larotrectinib showed preliminary evidence of anti-tumor activity. The expanded access patient, described in detail in the abstract, had progressed through prior radiation, temozolomide and bevacizumab and demonstrated a brief mixed radiographic response on larotrectinib in the context of a molecularly complex tumor (select regions of the tumor harbored a TRK fusion, while others did not). The two patients treated in NAVIGATE, described in the poster, were enrolled following progression on chemoradiation and temozolomide (both cases) and bevacizumab (one case). The NAVIGATE patients remain on therapy at four months with radiographic evidence of treatment effect, as of a March 13, 2017 data cut-off date. Glioblastomas are highly aggressive CNS tumors, particularly in the post-bevacizumab setting where median overall survival is typically three to six months. Global regulatory discussions have established that primary CNS tumors, including glioblastoma, will not be included in the primary efficacy analysis dataset intended to support initial drug approval, though they are being enrolled in a dedicated treatment arm of NAVIGATE.

"Glioblastomas have historically defied rational targeted therapy approaches, so we are encouraged that larotrectinib may have a role in treating TRK fusion presentations of this devastating disease. We hope these early data lead to increased molecular profiling and referrals to appropriate clinical trials," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We knew it would be necessary to evaluate these patients separately from our primary efficacy dataset, which relies on a RECIST overall response rate primary endpoint. Given the limitations around response assessment in neuro-oncology, randomized survival trials remain the gold standard for evaluating new drugs in primary CNS cancers. However, patients with systemic tumors that have metastasized to the brain are included in our primary efficacy dataset, though they have been exceedingly uncommon. As illustrated in our adult Phase 1 dataset and this AACR (Free AACR Whitepaper) poster, we are pleased with larotrectinib’s ability to enter the CNS in a tolerated fashion and address TRK fusion tumors."

Abstracts from the AACR (Free AACR Whitepaper) Annual Meeting 2017 are available online on the conference website.

The details of the poster presentation are as follows:

Date: April 5, 2017, 8:00am – 12:00pm ET
Title: Potential role of larotrectinib (LOXO-101), a selective pan-TRK inhibitor, in NTRK fusion-positive recurrent glioblastoma
Session: Late-Breaking Research: Experimental and Molecular Therapeutics II
Abstract Code: LB-302
Poster Board Number: 10
Session Location: Poster Section 34

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) 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 ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease 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.

On March 31, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported that it has completed the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT) (Press release, Kite Pharma, MAR 31, 2017, View Source [SID1234518361]).

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"Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy."

In December 2015 axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017.

"The Leukemia & Lymphoma Society (LLS) applauds Kite for achieving this significant milestone and bringing this promising therapy closer to patients with lymphoma who desperately need new options," said Louis J. DeGennaro, Ph.D., LLS President and Chief Executive Officer. "LLS has supported companies that are working to dramatically change cancer treatment through the development of immunotherapy for the past two decades, and we immediately recognized the great opportunity to support Kite’s CAR-T program in 2015 through our Therapy Acceleration Program (TAP). Partnerships created through TAP, now in its tenth year, have the potential to bring several breakthrough therapies, such as axicabtagene ciloleucel, to patients in the coming year."

The ZUMA-1 pivotal trial for axicabtagene ciloleucel for the treatment of patients with aggressive NHL was supported in part by funding from LLS’ TAP.

About axicabtagene ciloleucel

Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.