On December 4, 2017 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Operating Officer, will present at the BMO Capital Markets Prescriptions for Success Healthcare Conference on Thursday, December 14, 2017 at 11:30am ET (Press release, Cellectis, DEC 4, 2017, View Source [SID1234522361]). Mr. Knickerbocker will become President and Chief Executive Officer of Five Prime on January 1, 2018.

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source or directly at https://cc.talkpoint.com/bmoc001/121417a_as/?entity=8_N6Q3JCG. Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On December 4, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that the Company has made significant recent progress towards full scale Good Manufacturing Process (GMP) manufacture of its lead product, PRP, for First-In-Human studies, expected to commence in 2018 (Press release, Propanc, DEC 4, 2017, View Source [SID1234522367]). Research and development activities conducted with its European Contract Manufacturing Organization (CMO) experienced in the production of biopharmaceuticals, have been successful in developing a process capable of purifying and stabilizing the two active drug substances of the PRP formulation, trypsinogen and chymotrypsinogen, which is an important requirement during the manufacturing process. As a result, the Company is set to commence engineering runs of manufacturing the finished drug product, prior to full scale GMP manufacture of PRP for human trials. PRP is a solution for once-daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.

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"We are delighted with the excellent progress made with our CMO in progressing PRP to its current stage of development and we are excited about our plans to move into First-In-Human studies next year," said Dr Julian Kenyon, Propanc Biopharma’s Chief Scientific Officer. "Purifying and stabilizing each active drug substance of PRP has been technically challenging. This is due to the nature of the proenzymes which are able to auto-activate themselves, which is not unexpected for biological molecules of this nature. The work conducted by our research and development team to meet this challenge has been first class and we look forward to progressing PRP through to clinical development."

The Company expects to file its first Clinical Trial Application (CTA) for a First-In-Human study in the UK next year, initially treating late stage cancer patients with solid tumors, before progressing into two larger Phase II Proof of Concept studies in both pancreatic and ovarian cancer patients. Preclinical animal studies demonstrating proof of concept, in vivo, as well as the completion of a GLP-compliant, 28-day repeat-dose toxicology study, which helps to confirm the starting dose in humans by identifying the No Observable Adverse Effect Level (NOAEL) in an animal species, has the management team confident it has undertaken the steps necessary to achieve the best possible results in its planned human studies. This is further supported by the FDA granting Orphan Drug Designation of PRP for the treatment of one of its lead indications, pancreatic cancer, with a second application filed for ovarian cancer under evaluation.

"I am pleased with the progress of PRP and look forward to preparing our lead product for First-In-Human studies next year," said Professor Klaus Kutz, Propanc Biopharma’s Chief Medical Officer. "The Company has undertaken significant work to prepare for this important milestone, and believe the product can benefit patients suffering from aggressive solid tumors, which are most often incurable. Extending life meaningfully, but without compromising the quality of life for patients, without the side effects normally associated with standard treatment regimens, remains a high priority. We remain hopeful that PRP can become a breakthrough product for many patients worldwide."

Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

On December 4, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it will hold a R&D Update on December 11, 2017 at 8:00 PM Eastern Time (2:00 AM CET / 1:00 AM GMT on December 12) (Press release, Genmab, DEC 4, 2017, View Source [SID1234522362]). The event will take place in Atlanta, Georgia and will also be webcast live and archived on the company’s website. The meeting will include updates on daratumumab, including presentations by key opinion leaders on data from daratumumab studies presented at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) as well as a review of tisotumab vedotin, including data previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September. Genmab speakers will also discuss the company’s product pipeline, 2017 progress and key goals for 2018.

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The following cancer experts and senior Genmab staff will be at the event:

Key Opinion Leaders:

Professor Maria Victoria Mateos, University Hospital of Salamanca
Professor Philippe Moreau, University Hospital of Nantes
Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute
Professor Ignace Vergote, Catholic University of Leuven

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
David Eatwell, Executive Vice President and CFO, Genmab
Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
Dr. Kate Sasser, Corporate Vice President, Clinical Biomarkers, Genmab

The R&D Update will take place at the Omni Atlanta Hotel at CNN Center, International Ballroom AB, North Tower M2. Those wishing to attend in person should email [email protected].

The event may also be attended via webcast. To view this webcast, visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.

This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

On December 3, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has approved FoundationOne CDx, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care1 (Press release, Hoffmann-La Roche, DEC 3, 2017, View Source [SID1234522343]). FoundationOne CDx supports physicians in clinical decision-making by providing a report that describes the unique genomic profile of the patient’s tumour as well as associated approved therapies and relevant clinical trial information. FDA approval of this assay, based on its clinical and analytical validation, now means the service can be used as a companion diagnostic for therapy selection when people have been diagnosed with solid tumours.

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"The approval of FoundationOne CDx represents a major advance in the personalisation of cancer care, facilitating access for patients in the US to a comprehensive pan-tumour companion diagnostic that will help identify approved treatment options based on the molecular footprint of each individual’s cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs."

FoundationOne CDx is the first FDA-approved pan-tumour comprehensive companion diagnostic assay to:

assess all four classes of genomic alterations in 324 genes known to drive cancer growth, providing information to help guide the decisions of treating physicians;

identify patients with advanced cancer who are likely to respond to targeted therapies, based on their individual genomic profile; and,

report genomic signatures, including microsatellite instability (MSI) and tumour mutational burden (TMB), and report genomic alterations in other genes [relevant to other therapies] for use by physicians for patient management according to professional guidelines in oncology.

Of the 17 therapies currently approved for inclusion in the report, twelve are approved as first-line treatment options for their respective indications. The number of on-label targeted therapies in the report is expected to increase over time as Foundation Medicine and its partners gain FDA approval for additional biomarkers on the platform.
The approval of FoundationOne CDx also represents the first next generation sequencing (NGS)-based companion diagnostic for Alecensa (alectinib), an FDA-approved monotherapy for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)2. Alecensa is approved in both the front-line setting and for people who have progressed on or are intolerant to crizotinib. Including ALK-rearrangements in a larger comprehensive panel may ensure that more patients are identified and eligible for treatment based on their ALK-positive status.

Roche acquired a majority stake in Foundation Medicine in April 2015, and since then, has been actively commercialising Foundation Medicine’s portfolio of services in countries outside the US, with more than 20 countries on three continents already having launched FoundationOne.

About FoundationOne CDx
FoundationOne CDx is a comprehensive genomic profiling service for solid tumours that provides potentially actionable information with the molecular profiling of 324 genes known to drive cancer growth. FoundationOne CDx is intended to be used as a comprehensive companion diagnostic for patients with certain types of NSCLC, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients that may benefit from treatment with one of 17 targeted therapies following the detection of alterations in the EGFR, ALK, BRAF, ERBB2, KRAS, NRAS, and BRCA1/2 genes.

FoundationOne CDx is an NGS-based in vitro diagnostic for detection of base substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements in 324 genes, as well as genomic signatures including MSI and TMB, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. FoundationOne CDx is intended to be used by physicians as decision-making support in consideration of a patient’s genomic profile for therapy selection and patient management according to professional guidelines in oncology for cancer patients.

On December 3, 2017 Vernalis plc (LSE: VER) reported that it has entered into a drug discovery collaboration with Daiichi Sankyo Company, Limited utilizing Vernalis’ fragment and structure-based drug discovery platform against undisclosed oncology targets (Press release, Vernalis, DEC 3, 2017, http://www.vernalis-research.com/respubs/research-press-releases/729-vernalis-plc-enters-into-research-collaboration-with-daiichi-sankyo [SID1234531525]).

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The financial terms of this collaboration are not disclosed.

Ian Garland, CEO of Vernalis, commented: "We are delighted to be working with Daiichi Sankyo on this project. This is another excellent endorsement of our market leading fragment and structure-based drug discovery platform and we look forward to a successful collaboration with Daiichi Sankyo."