On September 19, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, reported that it will present at the Phacilitate Immuno-Oncology Frontiers Conference (Press release, Oncolytics Biotech, SEP 19, 2017, View Source [SID1234520576]). Dr. Andres Gutierrez, Oncolytics’ Chief Medical Officer, will present at 4:00 pm CEST on September 21, 2017 at the Maritim Proarte Hotel. The conference takes place on September 20th and 21st in Berlin, Germany.

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!

Know more, wherever you are:
Latest on Oncolytics Biotech’s Cancer Pipeline, book your free 1stOncology demo here.

Dr. Gutierrez 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. His presentation will also review certain historical clinical programs, highlight the positive survival data from the IND 213 study in metastatic breast cancer (mBC) and the pooled safety database – the largest of any oncolytic virus.

"We want to share our extensive experience with REOLYSIN in the clinic to illustrate the specific expertise and efforts required to develop an oncolytic virus for intravenous administration and systemic exposure in oncology," said Dr. Gutierrez. "This experience helped us define a clear regulatory pathway for registration in metastatic breast cancer. With an overall agreement with the FDA on the phase 3 study design, details of the pivotal registration study will be made available following evaluation and completion of discussions with clinical advisors and potentially partners, as well as European regulators."

The Phacilitate Immuno-Oncology Frontiers conference hosts over 300 industry decision-makers and key external stakeholders to come together discuss and define a strategic roadmap to success for immuno-oncology developers, ensuring European patients gain access to the game-changing biotherapeutics of tomorrow. Immuno-Oncology frontiers Berlin is the only European event that offers extensive coverage of the latest emerging science whilst placing it in its wider strategic context as the basis of tomorrow’s successful business and commercialisation models.

About REOLYSIN
REOLYSIN 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 September 19, 2017 Realist Pharma ("Realist" or "the Company") reported that it has entered into a collaboration and contribution agreement with the Canadian Glycomics Network ("GlycoNet") to assist in development of Realist’s glycomimetic vaccines targeting multiple cancers (Press release, realist pharma, SEP 19, 2017, View Source [SID1234532040]). In the context of this agreement, GlycoNet will provide a $250,000 financial contribution as well as key expertise for the scale-up of manufacturing of key precursors, for the subsequent GMP manufacturing of material for upcoming clinical studies. The funds will support the laboratory of Dr. H. Uri Saragovi at the Lady Davis Institute in Montréal, who will lead the development of these products. GlycoNet will receive an equity consideration for this contribution.

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 indeed pleased to be collaborating with GlycoNet, an international leader in glycomics, on the development of our drug. Realist’s glycomimetic vaccines target the carbohydrate portions of well-known and widespread tumor markers, making an understanding of glycomics of signal importance to our future success," said Mark de Groot, Realist’s Chief Executive Officer. "While the initial focus of the collaboration is on the tumor marker gangliosides (TMGs) GD2 and GD3, Realist’s platform is expected to be able to address up to 20 different TMG targets in total."

"The research program developed by Realist and Dr. Saragovi at the Lady Davis Institute fits beautifully with GlycoNet’s mandate to advance glycomics for the benefit of Canadians by demonstrating the crucial role of glycomics in immuno-oncology. Realist’s novel discoveries demonstrate the relevance of glycomics for applications in human health and its potential for spurring job creation and start-up success in Canada," said Dr. Todd Lowary, GlycoNet Scientific Director. "We are extremely pleased to play a role in accelerating the commercial development of research that could lead to new cancer treatments as well as value creation in Canada."

On September 18, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III MURANO study, which evaluated Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing (progression-free survival [PFS] as assessed by investigator) when treated with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus Mabthera/Rituxan (Press release, Hoffmann-La Roche, SEP 18, 2017, View Source [SID1234520551]). No new safety signals or increase in known toxicities of Venclexta/Venclyxto were observed with the treatment combination of Venclexta/Venclyxto plus Mabthera/Rituxan. Venclexta/Venclyxto (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

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!

"Chronic lymphocytic leukaemia is considered incurable and becomes harder to treat with each relapse," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This is the first study to show that Venclexta/Venclyxto plus Mabthera/Rituxan can help people with this type of leukaemia live significantly longer without their disease worsening compared to a standard-of-care regimen. We will work with health authorities to bring this potential chemotherapy-free treatment option to the people who need it as quickly as possible."

In January 2016, Roche announced that the US Food and Drug Administration (FDA) granted breakthrough therapy designation for Venclexta/Venclyxto in combination with Mabthera/Rituxan for the treatment of relapsed or refractory CLL based on promising results from the phase Ib M13-365 study. Breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible.

Venclexta/Venclyxto was granted accelerated approval by the FDA in April 2016 for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. The MURANO study is part of the company’s commitment in the United States to convert the current accelerated approval of Venclexta/Venclyxto to a full approval. Data from the MURANO study will be presented at an upcoming medical meeting and submitted to global health authorities.

About the MURANO Study
MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomized study evaluating the efficacy and safety of Venclexta/Venclyxto in combination with Mabthera/Rituxan compared with bendamustine in combination with Mabthera/Rituxan. All treatments were of fixed duration. The study included 389 patients with relapsed or refractory CLL who had been previously treated with at least one but not more than three lines of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta/Venclyxto plus Mabthera/Rituxan (Arm A) or bendamustine plus Mabthera/Rituxan (Arm B). The primary endpoint of the study is investigator-assessed PFS. Secondary endpoints include PFS assessed by independent review committee (IRC), best overall response, complete response, duration of response, overall survival, event-free survival, time to next CLL treatment and minimal residual disease (MRD) status.

About Venclexta/Venclyxto
Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in CLL has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

Together, the companies are committed to further research with Venclexta/Venclyxto, which is currently being evaluated in phase III clinical trials for the treatment of CLL, along with studies in several other types of cancers. In the United States, Venclexta has been granted four breakthrough therapy designations by the FDA: in combination with Rituxan for people with relapsed or refractory CLL; as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine (LDAC) for people with untreated AML ineligible for intensive chemotherapy.

About Chronic Lymphocytic Leukaemia (CLL)
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.1 CLL mainly affects men and the median age at diagnosis is about 70 years2. Worldwide, the incidence of all leukaemias is estimated to be over 350,0001 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.3

On September 18, 2018 TOLREMO therapeutics AG ("TOLREMO"), a privately held research-stage biotechnology company, reported the completion of a fundraiser with private investors of 2.4 million Swiss Francs (Press release, TOLREMO, SEP 18, 2017, View Source [SID1234525826]). The proceeds will be used to advance the company’s discovery and development of breakthrough medicines to target drug resistance in cancer therapy.

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!

Dr. Stefanie Flückiger-Mangual, Chief Executive Officer and co-founder of TOLREMO, commented: "Cancer patients often respond favorably to modern therapies, but in many cases long-term survival is limited by the development of drug resistance. During several years of research at ETH Zurich, we discovered that, surprisingly, the development of drug resistance already starts early on following initiation of cancer therapy. We have developed a deep understanding of the molecular mechanisms involved in this and our goal is to intervene with these mechanisms in order to eradicate the seed of drug resistance and extend patient survival."

TOLREMO’s science-based drug discovery and development pipeline is fueled by a unique drug screening platform for which a patent has been filed. In addition to discovering and developing novel anti-drug resistance molecules, the platform is also used to identify novel ways of combining approved drugs to prevent drug resistance in cancer therapy.

Dr. Isaac Kobrin, Chairman of the Board and a co-founder of TOLREMO, commented: "We believe that TOLREMO is poised to reach several key milestones in the development of novel cancer therapies within the next 12 to 18 months. The currently raised funds of 2.4 million Swiss Francs are expected to cover that period and prepare the grounds for the future growth of the company."

On September 15, 2017 Roche reported that based on emerging safety data from clinical trials evaluating pembrolizumab in combination with either lenalidomide or pomalidomide in multiple myeloma, the FDA has requested that a Phase Ib and a Phase Ib/II TECENTRIQ study be placed on partial clinical hold (Press release, Hoffmann-La Roche, SEP 15, 2017, View Source [SID1234520536]). At Roche/Genentech we remain committed to patient safety and will continue to work closely with the FDA. It is our understanding that the FDA is evaluating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in combination with an immunomodulatory medicine to determine if it is a class-wide (anti-PD1/PDL1) concern in multiple myeloma/blood cancers or a specific concern with certain combinations with immunomodulatory medicines.

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 two studies include cohorts evaluating TECENTRIQ in combination with an immunomodulatory medicine (IMiDs) in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma. While the partial clinical hold is in place, patients who are currently enrolled in these trials and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled. Although the trials are early and ongoing, we have not seen evidence of similar findings of increased death or serious events with the use of TECENTRIQ in combination with immunomodulatory medicines.