On May 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended March 31, 2019 (Press release, Oncolytics Biotech, MAY 3, 2019, View Source [SID1234535703]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”Our primary focus remains the breast cancer program and the timely completion of our AWARE-1 study of pelareorep in combination with the immune checkpoint inhibitor Tecentriq. We remain on track to report interim data in the second half of this year,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. ”We expect the results of this important study to confirm the clinical utility of using T cell clonality as a biomarker for patient response to pelareorep, as well as pelareorep’s ability to prime the immune system to recognize cancer cells and enhance the potential efficacy of checkpoint inhibitors. This data will assist in the final design of our registrational study of pelareorep as a treatment for metastatic breast cancer and serve to confirm the broader utility of this biomarker, currently established in pancreatic cancer and multiple myeloma, across multiple cancer types.”

Selected highlights since January 1, 2019

Clinical & Scientific Updates

Announced the identification of T cell clonality as a potentially predictive and prognostic biomarker of pelareorep therapy in a poster presentation delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 annual meeting
Treated the first patient in the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Published data in the journal Blood Advances highlighting the synergistic effect of pelareorep in combination with proteasome inhibitor bortezomib for the treatment of multiple myeloma
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Chief of Oncology at Asklepios Klinik Altona
Anticipated Milestones

Publish and present findings at leading U.S. and European oncology conferences including ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and ASH (Free ASH Whitepaper)
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Expect to report interim data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1
* Guidance provided by principal investigator

Financial

At March 31, 2019, the company reported $14.2 million in cash and cash equivalents
As at May 2, 2019, the company had an unlimited number of authorized common shares with 20,298,482 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,567,510 options and share units
Operating expense for the first quarter of 2019 was $1.8 million compared to $1.8 million in the first quarter 2018
Research and development expense for the first quarter of 2019 was $3.2 million compared to $2.9 million in the first quarter 2018
The net loss for the first quarter of 2019 was $4.9 million compared to $4.7 million in the first quarter 2018, which equates to a loss of $0.27 per share in 2019 compared to a net loss of $0.31 per share in 2018, on a consolidated basis
About Pelareorep

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 and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 3, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Health Canada has approved the supplemental New Drug Submission that expands the use of ADCETRIS (brentuximab vedotin) in combination with AVD (Adriamycin, vinblastine and dacarbazine) chemotherapy in patients with previously untreated Stage IV Hodgkin lymphoma (HL) (Press release, Seattle Genetics, MAY 3, 2019, View Source [SID1234535704]). The approval is based on positive results of the phase 3 ECHELON-1 clinical trial that compared ADCETRIS plus AVD to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). In addition, a supplemental New Drug Submission was recently submitted to Health Canada for ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL) based on the positive phase 3 ECHELON-2 clinical trial results. Health Canada granted a Priority Review Designation for this submission. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL.

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"The Health Canada approval of ADCETRIS in combination with AVD chemotherapy in advanced-stage (Stage IV) Hodgkin lymphoma represents the first major advance for patients in decades," said Kerry Savage, M.D., Medical Oncologist at the BC Cancer Agency, Professor of Medicine at the University of British Columbia and investigator on both the phase 3 ECHELON-1 and ECHELON-2 clinical trials. "Advanced-stage Hodgkin lymphoma tends to be more aggressive and difficult to treat. This new ADCETRIS-containing regimen demonstrated superior efficacy when compared to the standard of care ABVD chemotherapy in the phase 3 ECHELON-1 clinical trial supporting the Health Canada approval and represents a meaningful advance for this Hodgkin lymphoma patient population."

"Currently, up to 30 percent of newly diagnosed patients with advanced-stage Hodgkin lymphoma will experience disease progression after treatment with the current standard of care, representing a significant need for improved treatment options," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "With this new indication for ADCETRIS, physicians and eligible patients in Canada have access to this important new regimen for treating Stage IV Hodgkin lymphoma. We also recently submitted a supplemental New Drug Submission application to Health Canada, which was granted Priority Review Designation, for ADCETRIS in combination with chemotherapy in frontline PTCL, a milestone supporting our plans to expand ADCETRIS globally to patients in need."

In March 2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the results of the phase 3 ECHELON-1 clinical trial. In November 2018, the FDA approved ADCETRIS in combination with CHP for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, and for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On May 3, 2019 Allergan plc (NYSE: AGN) reported that its Board of Directors has declared a cash dividend of $0.74 per ordinary share for the second quarter of 2019 (Press release, Allergan, MAY 3, 2019, View Source [SID1234535688]). The dividend will be paid on June 14, 2019 to shareholders of record at the close of business on May 14, 2019.

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On May 3, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), the clinical stage immuno-oncology corporation, reported that the 2019 International Conference on Malignant Lymphoma (ICML) will publish an abstract on the company’s combination immunotherapy trial titled, "Phase 2 Study: DPX-Survivac with Intermittent Low Dose Cyclophosphamide and Pembrolizumab in Patients with recurrent/refractory Diffuse Large B-Cell Lymphoma – The SPiReL trial (Press release, IMV, MAY 3, 2019, View Source [SID1234535705])."

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"DLBCL is our first indication for DPX-Survivac in combination with Merck’s’ Keytruda (pembrolizumab) and we have been encouraged by the previously announced early data in this patient population with rapidly progressing cancer and short life expectancy," said Frederic Ors, Chief Executive Officer at IMV. "Given the high level of unmet need in recurrent/refractory DLBCL, we look forward to working with our partners at Sunnybrook Research Institute to provide an update on this important program."

ICML will publish the full trial-in-progress abstract on June 12, 2019 via the 15-ICML ABSTRACT BOOK, a supplement to Hematological Oncology. IMV will provide an update on the Phase 2 clinical data related to this study at that time.

About the SPiReL Study

SPiReL (DPX-Survivac with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or Recurrent/refractory Diffuse Large B-Cell Lymphoma) is a Phase 2 non-randomized, multi-centre, open-label study. Primary Investigator Neil Berinstein, MD, Affiliate Scientist, Sunnybrook Research Institute, Professor of Medicine/Immunology, University of Toronto, is leading the trial, which is expected to enroll 25 evaluable participants whose recurrent DLBCL expresses survivin, a tumor antigen expressed in approximately 60 percent of DLBCL patients. The study’s primary endpoint is to document the objective response rate. Secondary objectives include measuring tumor regression, and documenting the toxicity profile and durations of response. In addition, researchers will perform analyses to assess circulating antigen specific immune responses and changes in tumor-infiltrating T cell immune responses within the tumor microenvironment. Investigators also plan to assess potential biomarkers of immune and clinical response.

About ICML

The International Conference on Malignant Lymphoma (ICML) is focused on the scientific community involved in the study and treatment of lymphoid neoplasms. The main aim of ICML is to facilitate the presentation of the most recent data—basic, translational and clinical—on lymphoma and encourage the discussion among hematologists, clinical oncologists, radiation oncologists, pediatricians, pathologists, and leading researchers from all over the world.

On May 3, 2019 bluebird bio, Inc. (Nasdaq: BLUE) reported that the Company will host an Analyst Day, Thursday, May 9, at 8:30 am ET at The Maxwell Hotel NYC, New York, NY (Press release, bluebird bio, MAY 3, 2019, View Source [SID1234535689]).

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In addition, members of the management team will present at the Bank of America Merrill Lynch Health Care Conference 2019, Tuesday, May 14, at 3:00 pm PT at the Encore Hotel, Las Vegas, NV.

To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.