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Inivata raises £4m to realise the potential of ctDNA analysis to improve cancer treatment through simple blood tests

On September 23, 2014 Inivata, a clinical cancer genomics company focused on harnessing the potential of circulating tumour DNA (ctDNA) analysis to improve cancer testing and treatment, reported it has raised £4m in a funding round led by Imperial Innovations and including Cambridge Innovation Capital and Johnson & Johnson Development Corporation (Press release, Cancer Research Technology, SEP 23, 2014, View Source [SID1234523223]).

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Inivata is focused on developing clinical applications of ctDNA through collaborations with clinical oncologists at prominent academic institutions, leading community treatment centres and innovative biopharmaceutical companies.

Novel applications of ctDNA are enabled by Inivata’s technology platform which includes its proprietary, enhanced TAm-Seq technology. TAm-Seq, which is licensed to Inivata from Cancer Research Technology and the University of Cambridge, allows the detection and analysis of genomic material from a cancer patient’s cell-free ctDNA collected through routinely accessible blood samples. This non-invasive approach – a liquid biopsy – offers a revolution in how cancer is detected, monitored and treated. Inivata’s founders are recognised leaders in the clinical genomics and ctDNA fields having developed pioneering ctDNA and novel treatment approaches in Cancer Research UK-funded laboratories at the University of Cambridge.

Inivata works with industry and academics to develop new clinical applications for ctDNA analysis which will bring real benefits to physicians, patients, pharmaceutical companies and payers. Inivata’s goal is to provide physicians with the information they need to provide the best outcomes for patients and effective design for clinical trials.

Michael Stocum, CEO of Inivata, said: "There is major focus on ctDNA analysis which promises the ability to improve monitoring and treatment of cancer based on information from routine blood samples. We are taking a collaborative approach to the development of clinical applications for ctDNA analysis which have the potential to transform how the disease is understood and treated.

"Nitzan Rosenfeld and his team are leaders in the field. I am excited to be working with our scientific founders, and with this significant fund raising secured we are now focused on working with pharmaceutical, clinical and academic partners to identify applications and rapidly realise the potential of the enhanced TAm-Seq approach."

Rob Woodman of Imperial Innovations said: "The oncology molecular testing and treatment market is large and growing. Inivata is well-placed to capitalise on this market growth by bringing real benefits to physicians, patients, pharmaceutical companies and payers."

Robert Tansley of Cambridge Innovation Capital said: "The research by Dr Rosenfeld’s team is ground breaking and offers new options in cancer monitoring to better manage treatment response prediction. This investment will secure the development of this technology in Cambridge and facilitate its translation into the clinic for the benefit of patients."

Keith Blundy, Chief Executive Officer of Cancer Research Technology and Inivata board member, said: "We’re delighted to be involved in taking this promising technology developed by Cancer Research UK scientists to the next level. Developing technologies that allow clinicians to monitor how tumours respond to treatment non-invasively and in real-time forms a crucial part of Cancer Research UK’s commitment to deliver the promise of precision cancer medicine to patients."

Circle Pharma Announces Receipt of Seed Funding and Initiation of Two Collaborations

On September 22, 2014 Circle Pharma, Inc., a newly created, early-stage biotechnology company, reported that it has received seed funding from Pfizer Inc. and QB3’s seed-stage venture fund, Mission Bay Capital, LLC, and has initiated two collaborations with Pfizer to develop cell permeable macrocyclic peptide therapeutics (Press release, Circle Pharma, SEP 22, 2014, View Source [SID1234638553]).

"We are very pleased to have launched Circle with the backing of Pfizer and Mission Bay Capital, and to have initiated two exciting collaborative projects with Pfizer," said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "In addition to these collaborations, Circle will be undertaking development work against our own therapeutic targets. We are open to additional collaborations with partners who share our excitement in the potential of permeable macrocyclic peptides, which, we believe, could be applicable to a large number of important therapeutic targets."

Circle’s technology is based in part on research sponsored by Pfizer through an agreement with QB3.

About Macrocyclic Peptides
Macrocyclic peptides have the potential to provide access to therapeutic targets that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited to this point by the need for a greater understanding of how to design macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Indeed, today, most clinical programs testing macrocyclic peptides are aimed at extracellular protein targets because of the challenge of identifying cell permeable macrocycles. The ability to design potent macrocycles with inherent permeability is expected to give access to a large number of important therapeutic targets that have been out of reach to this point.

Xenetic Biosciences to Hold Business Update Conference Call September 23 at 6:00 a.m. Eastern Time

On September 22, 2014 Xenetic Biosciences, Inc. (OTCBB: XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that it will hold a business update conference call on Tuesday, September 23, 2014 at 11:00 a.m. GMT (6:00 a.m. EDT) (Press release, Xenetic Biosciences, SEP 22, 2014, View Source [SID1234537818]). M. Scott Maguire, chief executive officer, and Colin Hill, U.K. chief financial officer and board member, will provide a business update and answer questions.

To access the conference call, U.K.-based participants should call 0800 368 0649; London-based participants should call 020 3059 8129; and, participants in all other locations should call +44 20 3059 8125. A telephone replay will be available for seven days following the call’s conclusion. Replay dial-in numbers are as follows: United Kingdom 0121 260 4861; United States 866-268-1947; and all other locations + 44 121 260 4861. Please provide conference ID 7591229 when accessing the replay. In addition, a replay of the call will be posted to the Investor Relations section of www.xeneticbio.com in the "Events and Presentations" tab.

Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name

On September 22, 2014 ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), reported that it has signed an exclusive, global license agreement with Plasma Technologies LLC ("PlasmaTech") for the development and commercialization of its proprietary plasma fractionation process (Press release, Access, SEP 22, 2014, View Source [SID:1234510400]). Concurrently, the Company announced a new corporate management team and its intention to strategically refocus and rebrand the company as PlasmaTech Biopharmaceuticals, Inc., and its plans to pursue a national listing for its common shares.

Under the terms of the licensing agreement, the Company will pay a license fee of $5 million in a combination of cash and common stock subject to the achievement of certain events, including, a regulatory approval milestone payment in common shares upon the first FDA regulatory approval of a drug derived from the PlasmaTech fractionation process, and a tiered royalty on annual net sales of plasma fractions produced with the proprietary fractionation process. Upon execution of the agreement, to support the Company’s new strategic positioning, its Board of Directors appointed Mr. Scott Schorer as Chief Executive Officer and Mr. Harrison Wehner as President and Chief Financial Officer of PlasmaTech BioPharmaceuticals, Inc.

"Following the recent completion of the European license agreement for MuGard with Norgine, and receiving FDA Marketing Clearance for ProctiGard, we are pleased to announce the next phase in our corporate development: an important global license agreement and the addition of key senior management to the company," stated Steven Rouhandeh, Chairman of Access Pharmaceuticals, Inc. He continued, "The PlasmaTech novel fractionation process can fundamentally change the economic model for the plasma protein therapeutics market, and provides the opportunity for our company to participate in the high-growth area of plasma biologicals. We are rebranding the Company to better align its image with future product opportunities. We thank Jeffrey Davis for his service and look forward to his continued advice and guidance as a director."

The global market for drugs derived from human blood plasma fractionation is currently greater than US$15 billion, and is growing at a rate close to 10% annually. Despite this significant market opportunity, little innovation in fractionation technology has occurred in decades. PlasmaTech has developed and patented a new extraction process for plasma biologics that may fundamentally change the economics of blood plasma fractionation, and makes possible the extraction of several additional therapeutically useful plasma proteins. The Company believes that PlasmaTech’s proprietary fractionation process is expected to significantly enhance yields of key value blood proteins, including alpha-1 antitrypsin, expanding market opportunities while greatly enhancing margins. The Company obtained rights to utilize and sub-license to other pharmaceuticals firms, the recently patented improved methods for the extraction of therapeutic biologics from human plasma. The Company believes that PlasmaTech’s lead product opportunity, alpha-1 antitrypsin (ATT), will offer a low-risk, high revenue, short time-to-market respiratory product (AAT) for treatment of inherited COPD (pulmonary emphysema), among other indications. Additionally, the ability to extract several additional therapeutically useful and important proteins, due to the process being less destructive than historical fractionation processes, may enable the Company to seek new therapeutic applications and address high-value-added orphan indications.

"I am pleased to be joining PlasmaTech Biopharmaceuticals at this exciting time in its development," stated Scott Schorer, Chief Executive Officer. "The innovative and disruptive fractionation technology can translate into significant value for shareholders, both directly and through multiple partnering and sub-licensing opportunities. I look forward to working with all of the Company’s stakeholders in maximizing this significant opportunity."

"The base technology of the plasma fractionation business has evolved very little since the original Cohn cold ethanol process, developed in the 1940’s," stated Harrison Wehner, President and Chief Financial Officer. "The ability to greatly enhance yields of specific proteins using our technology will enable expanded supplies to meet the growing needs of these types of drugs globally. We look forward to working with global plasma fractionators, contract manufacturers and eventually pharmaceuticals companies to implement this proprietary process, produce proteins and drive value for the Company’s shareholders."

Mr. Scott Schorer has been appointed Chief Executive Officer of PlasmaTech Biopharmaceuticals. He has served over 18 years in a variety of senior management and board positions, including as CEO and President, and has experience in all aspects of operations including research and development, intellectual property, manufacturing, sales and marketing. Additionally, Mr. Schorer has extensive experience as advisor to operating companies, venture capital firms and private equity firms. Previously, he was President, Americas, of Systagenix Wound Management, was President & CEO of Innovative Spinal Technologies, and was Co-Founder, President & CEO of CentriMed. Mr. Schorer served with distinction in the US Army, 82nd Airborne, and holds a B.E and B.A. from Dartmouth College and Thayer School of Engineering.

Mr. Harrison Wehner has been appointed President and Chief Financial Officer. Mr. Wehner has over 20 years experience in investment banking advising on equity and debt finance and mergers and acquisitions advisory assignments. Previously, Mr. Wehner held various senior banking roles at Canaccord Genuity, CitiGroup, and UBS where he worked on a variety of banking transactions in the healthcare sector, including advisory and transactional experience in the blood fractionation business. Mr. Wehner holds a BA from The College of William and Mary, and an MBA from the Ross School of Business at the University of Michigan.

The Company is planning to schedule an investor conference call shortly to update investors on the recent developments.

(Press release, Inovio, SEP 22, 2014, View Source [SID:1234504553])