On December 14, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for United States Patent Application Serial No. 13/933,844 entitled, "Improved Analytical Methods for Analyzing and Determining Impurities in Dianhydrogalactitol (Press release, DelMar Pharmaceuticals, DEC 14, 2016, View Source [SID1234517069])." Schedule your 30 min Free 1stOncology Demo! The patent has also been granted in Australia and is being prosecuted in other international jurisdictions as part of more than 100 patent filings from thirteen patent families representing claims covering VAL-083 until 2036.
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"This patent provides DelMar with ownership of essential manufacturing controls required under good manufacturing practice (GMP) guidelines," said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. "This is an important component of our strategy to establish a strong international patent portfolio as the foundation to support the global development of VAL-083 in multiple cancer indications."
DelMar is preparing to advance VAL-083 into a pivotal Phase III clinical trial in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
The Company has also recently presented data and outlined plans for expansion of VAL-083 into new indications, including newly diagnosed GBM, ovarian and lung cancer. DelMar’s most recent abstract entitled "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer" was presented at the 17th World Congress on Lung Cancer in Vienna, Austria on December 7, 2016.
Further details regarding DelMar’s scientific presentations can be found at View Source
The USPTO issues a Notice of Allowance after it makes a determination that a claimed invention is novel and nonobvious in light of all known technology in existence, and that a patent should be granted from such an application. Based on the timing of this Notice of Allowance, DelMar Pharmaceuticals expects the forthcoming US patent to be issued in early 2017.
Author: [email protected]
CytomX Announces U.S. FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Study of Anti-PD-L1 Probody Therapeutic, CX-072
On December 14, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer (Press release, CytomX Therapeutics, DEC 14, 2016, View Source [SID1234517068]). The company plans to immediately initiate the study and open clinical sites to support patient enrollment. Schedule your 30 min Free 1stOncology Demo! "Initiating the first clinical program emerging from the Probody platform is a major milestone for CytomX," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "CX-072 has the potential to become a differentiated centerpiece of combination cancer therapy by targeting the tumor microenvironment, while sparing healthy tissues. We are partnering with clinical trial sites to bring this innovative treatment option to patients as quickly as possible."
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About PROCLAIM
PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module to be initiated is the PROCLAIM-072 clinical study, an open-label, dose-finding phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:
Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients.
Clinical data from PROCLAIM-072 is expected to begin to emerge in late 2017 and throughout 2018.
Argos Therapeutics Enters into Strategic Research Agreement with Personalis, Inc.
On December 14, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that it has entered into a strategic research agreement with Personalis, Inc., a precision medicine company, focused on genomics solutions for immuno-oncology, cancer, and genetic disease (Press release, Argos Therapeutics, DEC 14, 2016, View Source [SID1234517066]). Schedule your 30 min Free 1stOncology Demo! Personalis will serve as the primary genomic analysis service provider to support ongoing research efforts to demonstrate that Argos’ lead product candidate, rocapuldencel-T, specifically targets patient-specific neoantigens without the need to identify them first. Argos will utilize the Personalis ACE ImmunoID next-generation sequencing (NGS) platform to evaluate tumor samples collected during clinical development of Argos’ tumor-specific dendritic cell technology to treat renal cell carcinoma. The analytically validated ACE ImmunoID platform offers the unmatched accuracy through whole exome and transcriptome sequencing for tumor/normal evaluation coupled with leading edge bioinformatics and sample tracking to ensure timely delivery of results including neoantigen identification and tumor mutational burden.
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"We are pleased to work with Argos and to offer the Personalis ACE ImmunoID platform to support the mechanism of action of its precision immunotherapy clinical trials and research," said John West, CEO of Personalis. "As precision medicine continues to gain momentum, we recognize the importance of work done by companies such as Argos to bring truly personalized medicine into reality and we are delighted to be their partners in transforming cancer treatment."
"The Personalis technology is a key component to our efforts to further understand the mechanism of action of our lead product, rocapuldencel-T for the treatment of advanced renal cell cancer. We hope to demonstrate that rocapuldencel-T specifically targets neoantigens found only in the patients’ tumors to explain why we observe tumor regression without autoimmunity to the unaffected contralateral kidney," said Dr. Charles Nicolette, chief scientific officer and vice president of research and development for Argos.
Invenra and AgonOx Enter Collaboration to Discover Therapeutic Antibodies Against Novel Immuno-Oncology Target
On December 13, 2016 Invenra, Inc., a pre-clinical stage bio-pharmaceutical company focused on next-generation therapeutic human antibodies, bispecifics and antibody derivatives, and AgonOx, a biotechnology company developing a pipeline of immunotherapy drugs targeting key regulators of the immune response to cancer, reported a collaboration to identify and characterize a panel of fully human therapeutic monoclonal antibodies (mAbs) against a novel immuno-oncology target that AgonOx has identified utilizing its discovery platform (Press release, Invenra, DEC 13, 2016, View Source [SID1234539840]). Financial details of the deal were not disclosed.
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Invenra’s proprietary platform is based on ultra-high throughput technology allowing function forward screening of full-length antibodies using Invenra’s mAbSeq technology, where antibodies can be directly and quickly interrogated in a multi-plexed fashion with a diverse set of immunotypic and biologically relevant assays. The Invenra technology allows rapid identification of high affinity mAbs with the broadest epitope coverage possible while simultaneously performing direct phenotypic screening to isolate those mAbs with the most relevant biological activity, thus leading to the election of the best lead compounds for further development.
AgonOx’s approach to target discovery begins with genomic and proteomic analyses of tumor-
infiltrating lymphocytes isolated from human tumor biopsies. Candidates identified by these analyses are further validated using in-vitro assays and predictive in vivo murine cancer models. Andrew Weinberg, President of AgonOx, said "Collaborating with Invenra strengthens our efforts to develop immuno-oncology drug candidates through their novel antibody platform and complements our mission of discovering and delivering science that can change the standard of care for patients with cancer. Invenra has first-rate scientists that we hope to work with for years to come."
Roland Green, CEO and president of Invenra, said, "This collaboration is a major milestone for Invenra as a company and a validation of our innovative technology. We are delighted to be collaborating with the excellent team at AgonOx to identify best-in-class antibodies against their novel immuno-oncology target. In addition, this collaboration with AgonOx fits well within our business model, whereby we are partnering with a select group of companies while continuing to develop our own internal proprietary pipeline of therapeutic product candidates."
CytomX Announces Selection by Bristol-Myers Squibb of First Clinical Candidate Probody From Collaboration
On December 13, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported that Bristol-Myers Squibb Company has selected a clinical candidate for its CTLA-4 Probody program under the strategic oncology collaboration established in May 2014. Achieving this milestone results in a $2 million payment to CytomX (Press release, CytomX Therapeutics, DEC 13, 2016, View Source;p=irol-newsArticle&ID=2229234 [SID1234517063]).
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"Selecting a candidate for the CTLA-4 Probody program is a pivotal development in our partnership with CytomX Therapeutics and builds on our I.O. leadership," said Carl Decicco, Ph. D., Head of Discovery at Bristol-Myers Squibb. "We are studying the CTLA-4 Probody for its potential to deliver a next-generation anti-CTLA-4 therapy as we continue to explore transformational immuno-oncology medicines."
CTLA-4, a clinically validated inhibitory immune checkpoint protein, is the most advanced target from the companies’ collaboration, which now also includes three additional, unnamed targets in discovery.
"Advancing our CTLA-4 Probody program to clinical candidate stage with Bristol-Myers Squibb underscores the potential of the Probody platform to transform the field of immuno-oncology by delivering safer, more effective therapies," said Sean McCarthy, D.Phil., President and Chief Executive Officer of CytomX. "This partnership milestone, taken together with CytomX’s recently filed Investigational New Drug application for CX-072, a wholly owned PD-L1-directed Probody therapeutic, highlights the potential of our innovative platform to deliver a new generation of anti-cancer treatments."
About the Collaboration Agreement
Under the terms of the May 2014 agreement, CytomX granted Bristol-Myers Squibb exclusive worldwide rights to discover, develop and commercialize Probody therapeutics for up to four oncology targets. Bristol-Myers Squibb made an upfront payment of $50 million to CytomX in 2014, and is providing research funding over the course of the research term. Upon the selection of the third and fourth targets, Bristol-Myers Squibb paid CytomX selection payments. CytomX is also eligible to receive additional preclinical payments and up to $298 million in development, regulatory and sales milestone payments for each collaboration targe