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]).

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 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.

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!

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.

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!

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])

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!


Amgen Submits Biologics License Application for Investigational BiTE® Immunotherapy Blinatumomab

On September 22, 2014 Amgen reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab (Press release Amgen, SEP 22, 2014, View Source [SID:1234500759]). The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

BiTE antibody constructs represent an innovative immunotherapy approach that helps the body’s immune system target cancer cells. Blinatumomab, the first of the BiTE antibody constructs, has received both orphan drug designation and breakthrough therapy designation from the FDA for the treatment of ALL. The FDA states that breakthrough therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions, requires preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on at least one clinically significant endpoint.

“We look forward to working with regulatory authorities to make blinatumomab available for adult patients with acute lymphoblastic leukemia, who experience high relapse rates and have limited treatment options,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The filing for blinatumomab brings us a step closer to first realizing the potential of BiTE technology and represents our commitment to evaluating this novel approach in a broad range of difficult-to-treat cancers.”

The submission includes data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.

“Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL,” said Anthony S. Stein, M.D., clinical professor, Hematology/Oncology at City of Hope. “Blinatumomab has the potential to significantly advance treatment options for patients living with this difficult-to-treat disease, and the BLA submission marks an important step toward achieving this goal.”

In the U.S., it is estimated that more than 6,000 cases of ALL will be diagnosed in 2014, and in the European Union, more than 7,000 cases of ALL are diagnosed each year. In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.