On October 10, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its third-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Thursday, Oct. 25 (Press release, Merck & Co, OCT 10, 2018, View Source [SID1234529843]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 2169459. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 2169459. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On October 10, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the publication of a peer-reviewed scientific paper on the mechanism of action for VAL-083, the Company’s product candidate, in Cell Death and Disease by Nature Publishing Group (Press release, DelMar Pharmaceuticals, OCT 10, 2018, View Source [SID1234530251]).

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The paper, entitled "Dianhydrogalactitol induces replication-dependent DNA damage in tumor cells preferentially resolved by homologous recombination," details the mechanism of action for VAL-083 (dianhydrogalactitol) involving S-phase dependent DNA double stand breaks (DSB) and homologous recombination (HR) DNA repair. This peer-reviewed publication further validates VAL-083’s unique anti-tumor mechanism and differentiates it from the standard-of-care. In addition, this research supports the use of VAL-083 in combination with drugs targeting cancer cells in S-phase, including topoisomerase inhibitors. Furthermore, the results suggest VAL-083 as a potential treatment option for tumors with impaired HR DNA repair, such as high-grade ovarian carcinomas, or tumors treated with PARP inhibitors.

The research was conducted in the laboratory of Dr. Mads Daugaard at the Vancouver Prostate Center, one of the world’s most respected cancer research institutes. Using non-small cell lung cancer (NSCLC) as a model system for cancer cells, the research group showed that VAL-083-induced cytotoxicity materialized when the cells entered the S-phase of the cell cycle. The resulting DNA damage subsequently triggered irreversible cell cycle arrest and ultimately cancer cell death. Further analysis revealed that cancer cells attempted to use their HR DNA repair pathway to reverse VAL-083-induced DNA damage and cancer cells with an impaired HR repair pathway were therefore particularly sensitive to VAL-083.

DelMar is currently studying VAL-083 in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated glioblastoma multiforme (GBM). As demonstrated in prior publications, the DNA repair protein MGMT is overexpressed in over 60% of GBM patients which causes resistance to the standard-of-care (temozolomide). In contrast to temozolomide, which targets the O6-position of guanine vulnerable to MGMT repair, VAL-083 targets the N7-position of guanine. This distinct mechanism-of-action differentiates VAL-083 from temozolomide and nitrosoureas, allowing VAL-083 to overcome MGMT-related chemoresistance, thereby addressing a significant unmet medical need.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class," bifunctional DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

VAL-083 has been granted orphan drug designations by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.

On October 10, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has extended its collaboration agreement with Moffitt Cancer Center for an additional year (Press release, Helix BioPharma, OCT 10, 2018, View Source [SID1234530409]).

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During the first year of the collaboration, a new pancreatic adenocarcinoma mouse model suitable for testing L-DOS47 in combination with immunotherapy was developed. Preliminary studies in this model showed that L-DOS47 may increase the activity of a PD-1/PD-L1 inhibitor in treating pancreatic cancer. In addition, work was initiated to demonstrate that certain imaging techniques may be useful in directly measuring tumor acidity. Helix is hoping to use this non-invasive technique in the clinic soon.

In year two of the project, work will include not only the study of L-DOS47 in combination with PD-1/PDL1 inhibitors, but also in combination with other drugs in the pancreatic model. Analysis of the immune response that is occurring in the tumor upon L-DOS47 combination treatment will also be characterised. Results from these studies will add to the current understanding of how tumor acidity affects the tumor immune response. Data from these studies will also support Helix’s plan to increase the clinical application of L-DOS47 with various combination treatments, including immunotherapies with checkpoint inhibitors.

"We are strongly encouraged by our preliminary data that this may be an effective approach to improving outcomes to a variety of therapies" said Dr. Robert Gillies, Martin Silbiger Endowed Chair, Moffitt Cancer Center. "We know that tumor acidity is an important contributor to therapy resistance, and thus neutralizing acidity with L-DOS47 should have a positive effect in combination with chemotherapies and immune checkpoint blockade".

"This years’ Nobel prize in Physiology or Medicine was awarded for the discovery of cancer therapy by inhibition of negative immune regulation." said Heman Chao, Ph.D., Chief Executive & Scientific Officer of Helix. "We are very excited to work with the Moffitt team in applying L-DOS47 in immunotherapy and we look forward to using L-DOS47 with PD-1/PD-L1 inhibitors in the clinic which could result in significant benefits to patients."

On October 10, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported that updated efficacy and safety data from the fully enrolled cohort of epithelioid sarcoma (ES) patients in its ongoing Phase 2 trial of tazemetostat will be presented in a poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress to be held October 19-23 in Munich, Germany (Press release, Epizyme, OCT 10, 2018, View Source [SID1234529845]). Tazemetostat is the company’s potent, selective, orally available, first-in-class EZH2 inhibitor.

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The Phase 2 study ES cohort completed enrollment in 2017 with a total of 62 patients. Detailed data will be presented at the Congress, including objective response rate (ORR), the study’s primary endpoint, and other important endpoints in this disease including duration of response, overall survival (OS), disease control rate and safety. For the first time, an analysis of ORR, durability and OS will be presented in both treatment-naive patients and in relapsed and/or refractory patients from the fully enrolled study cohort. Data will be presented by the study’s primary investigator, Mrinal Gounder, M.D., attending physician, Sarcoma Medical Oncology and Early Drug Development Service, and assistant professor, Memorial Sloan Kettering Cancer Center.

"We are excited to share these updated efficacy and safety data on tazemetostat in patients with epithelioid sarcoma, a rare and deadly cancer," said Robert Bazemore, president and chief executive officer of Epizyme. "We remain committed to bringing this potential therapy to patients living with ES, and are confident as we progress towards our first NDA submission in the first half of 2019."

In addition to the ES data, Epizyme will present data from the company’s Phase 2 study of tazemetostat in adult patients with INI1-negative tumors in two additional poster discussions and during one oral session at ESMO (Free ESMO Whitepaper). A complete list of the tazemetostat presentations at ESMO (Free ESMO Whitepaper) are listed below:

Epithelioid Sarcoma Poster Discussion Session
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults: (epithelioid sarcoma cohort)
Abstract No.: 1615PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Mrinal Gounder, M.D.

Proffered Paper (Oral Presentation) Session
Title: Molecular characterization of epithelioid sarcoma (ES) tumors derived from patients enrolled in a phase 2 study of tazemetostat
Abstract No.: 1892O
Date: Saturday, October 20, 2018; 11:12 a.m. – 11:24 a.m. CEST
Location: Hall B3 – Room 21
Presenter: Mrinal Gounder, M.D.

Poster Discussion Sessions
Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (INI1-negative tumors cohort)
Abstract No.: 1611PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Silvia Stacchiotti, M.D.

Title: A phase 2, multicenter study of the EZH2 inhibitor tazemetostat in adults (rhabdoid tumor cohort)
Abstract No.: 1612PD
Date: Monday, October 22, 2018; 11:50 a.m. CEST
Location: Hall B3 – Room 23
Presenter: Robin L. Jones, MRCP, M.D.

Conference Call Information
Epizyme Management will host a conference call on Monday, October 22, 2018 at 8:30am EDT. To participate in the conference call, please dial 877-844-6886 (domestic) or 970-315-0315 (international) and refer to conference ID 8780088. The webcast can be accessed in the Investor Relations section of the company’s website at www.epizyme.com. The replay of the webcast will be available in the investor section of the company’s website for 60 days.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

On October 9, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place from 19-23 October, in Munich, Germany (Press release, Hoffmann-La Roche, OCT 9, 2018, View Source [SID1234529810]). These data include positive Phase III results from Roche’s cancer immunotherapy development programme across multiple tumour types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumour-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumours.

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"We look forward to presenting the first positive Phase III study of a cancer immunotherapy combination in breast cancer, which showed encouraging results for Tecentriq plus nab-paclitaxel in people with metastatic triple-negative breast cancer, specifically in the PD-L1-positive population," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will also share new data from our pivotal analysis of entrectinib for people with NTRK gene fusion-positive solid tumours, an example of our continued commitment to developing next-generation personalised treatments."

An audio webcast for analysts and investors to discuss key data presented on the Roche Group’s oncology portfolio and pipeline during the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, will be held on Monday 22 October 2018 from 6:00 – 7:15 pm CEST. Further details are available here.

Follow Roche on Twitter via @Roche and keep up to date with ESMO (Free ESMO Whitepaper) 2018 Congress news and updates by using the hashtag #ESMO18.

Key Presentations
Breast cancer:
Primary results will be presented from the positive, Phase III, randomised IMpassion130 study investigating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), an aggressive type of the disease which currently has limited treatment options. Abstract LBA1_PR (Presidential Symposium 1) Saturday, 20 October, 16:30 -16:45 CEST: Hall A2 – Room 18

As reported earlier this year by Roche, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival (OS) improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.

Data from the IMpassion130 study will also be featured as part of ESMO (Free ESMO Whitepaper)’s press programme on Saturday, 20 October.

Tumour-agnostic:
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumours. Abstract LBA17 (oral) – Sunday, 21 October, 11:24 – 11:36 CEST: Hall B3 – Room 22

Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib. Roche is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalised healthcare solutions.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

Lung cancer:
Key data to be presented at ESMO (Free ESMO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.

OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC). Abstract LBA53 (oral) – Monday, 22 October, 09:15 – 09:30 CEST: Hall A1 – Room 17

PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomised, multicentre, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Abstract LBA10 (Presidential Symposium 3) – Monday, 22 October, 17:30-17:45 CEST: Hall A2 – Room 18

Liver cancer:
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin as treatment for patients with unresectable or advanced hepatocellular carcinoma (HCC). HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. Earlier this summer the US FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO (Free ESMO Whitepaper) include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease. Abstract LBA26 (oral) – Sunday, 21 October, 11:54 – 12:09 CEST: Hall A1 – Room17

Overview of key data featuring Roche medicines at ESMO (Free ESMO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies