GeneCentric Therapeutics Appoints Michael V. Milburn, PhD, President and Chief Executive Officer

On January 3, 2019 GeneCentric Therapeutics, Inc. reported the appointment of Michael V. Milburn, PhD, as Chief Executive Officer and President, and he will join GeneCentric’s Board of Directors (Press release, GeneCentric Therapeutics, JAN 3, 2019, View Source [SID1234532422]). Dr. Myla Lai-Goldman, founder, current CEO and President, will assume the newly-created role of Executive Chairperson of the Board of Directors, succeeding Clay Thorp, Founder and General Partner at Hatteras Venture Partners, as Board Chair.

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"We founded GeneCentric, with UNC researchers Chuck Perou and Neil Hayes, with a vision to develop cancer tests to match a drug to an individual patient in order to maximize the efficacy of cancer treatments and reduce adverse events," said Dr. Lai-Goldman. "We have made great progress in establishing a subtyping platform built around an expanding array of pan-cancer tests, applying the platform to lung, head and neck, bladder, and pancreatic cancer, and entering initial partnerships with pharmaceutical companies to enable precision drug development in oncology. Michael is well positioned to build on the scientific base we have established and drive our commercial efforts with pharmaceutical companies."

In addition to GeneCentric, Dr. Lai Goldman serves on the Board of Directors at West Pharmaceutical Services and Qvella Corporation as well as a Venture Partner with Hatteras Venture Partners.

"GeneCentric is at the forefront of developing RNA-based informatics and data science which will be key to developing the next generation cancer immunotherapies and chemotherapies," said Milburn. "Myla and the scientific founders and team have been instrumental in building a technology that is highly valued by our pharmaceutical partners to get the right cancer treatment to the right patient. This is a very exciting time for GeneCentric as we begin to deploy our cancer tests alongside cancer drugs."

Dr. Milburn joined GeneCentric in September of 2018 as Chief Scientific Officer and leads the development of its RNA-based technology platform for developing new cancer tests focused on pharmaceutical drug development. Previously, Dr. Milburn was CSO at Metabolon and led the R&D efforts that established the company as a premier metabolomics technology. Prior to Metabolon, he served as Senior Vice President of Research and Corporate Development at Sirtris Pharmaceuticals and Senior Vice President of Research at Plexxikon. He also held senior research positions at Structural Genomix and GlaxoWellcome.

Dr. Milburn received his PhD in Biophysical Chemistry from the University of California at Berkeley and was a post-doctoral research fellow at Harvard Medical School. Dr. Milburn has published over 100 peer-reviewed scientific articles and is an Adjunct Professor in the Department of Molecular and Structural Biochemistry at NCSU.

"Michael brings a broad range of expertise that spans drug development, biomarker discovery and diagnostic development and commercialization, along with a strong track record commercial execution that built significant value," said Clay Thorp, Founder and General Partner at Hatteras Venture Partners. "We look forward to his new leadership role at GeneCentric as they expand their cancer technology and expertise with pharmaceutical partners."

Cydan Announces Formation of Tiburio Therapeutics Inc. to Develop Treatments for Rare Neuroendocrine Tumors and Endocrine Diseases

On January 3, 2019 Cydan reported the launch of Tiburio Therapeutics Inc. (Tiburio), a private biopharmaceutical company focused on developing treatments for rare neuroendocrine tumors and rare endocrine diseases (Press release, Cydan Development, JAN 3, 2019, View Source [SID1234553930]). Tiburio will advance two compounds licensed from Ipsen for the treatment of non-functioning pituitary adenoma (NFPA) (TBR-760) and for additional rare endocrine diseases (TBR-065). As part of the launch, Tiburio raised a $31M Series A financing that will fund the company’s lead compound, TBR-760, through human proof-of-concept for the treatment of NFPA and further clinical assessment of TBR-065 as a treatment for rare endocrine diseases. In conjunction with the Tiburio financing, Abraham N. Ceesay has been appointed chief executive officer of the company. Tiburio is the third orphan drug company launched by Cydan, an orphan drug accelerator dedicated to creating therapies to improve the lives of patients living with orphan diseases.

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"Patients suffering from rare neuroendocrine tumors and endocrine diseases represent a significantly underserved patient population due to the lack of effective treatment options," said Abraham N. Ceesay, chief executive officer of Tiburio. "TBR-760 and TBR-065 represent potential breakthroughs in the treatment of debilitating neuroendocrine diseases and we, at Tiburio, are intently focused on advancing these compounds for the benefit of patients. We will immediately begin Phase 2 enabling studies with TBR-760 and anticipate enrolling patients with NFPA in a Phase 2 study in the 2nd half of 2019."

The development of NFPA, which is a non-metastatic tumor in the pituitary gland in the brain, can result in life-altering and potentially life-threatening consequences for patients. Currently there are no approved therapies to treat these tumors and patients must undergo transsphenoidal surgery and/or radiation to remove or shrink the tumor. TBR-760 is a dopamine-somatostatin chimeric molecule that inhibits NFPA cell proliferation and has the potential to shrink or halt tumor growth. In prior clinical trials, TBR-760 has been shown to have a favorable safety profile.

"The agreement with Cydan to license these two innovative compounds to Tiburio expands upon the work we’ve done to advance them through Phase 2 trials, providing a foundation for their safety profile and mechanism of action," said Alexandre LeBeaut, MD, executive vice president, research & development and chief scientific officer, Ipsen. "The Cydan team’s expertise makes them a natural choice to partner with to ensure these programs can have impact for patients in need."

"Nonfunctioning pituitary adenoma can have a significant and lasting impact on patients, often requiring multiple surgeries to control tumor size, as well as radiation therapy. These invasive neurosurgeries are associated with high-risk complications," said Shi Yin Foo, MD, PhD, MMSc, chief medical officer of Cydan and acting chief medical officer of Tiburio. "There are no approved therapies and the current treatment options for these patients are invasive, risky, and often ineffective in the longer term. We can do better for patients and believe TBR-760 represents a potentially game-changing therapy for patients."

"TBR-760’s unique mechanism of action offers an exciting potential treatment for patients living with NFPA," said Chris Adams, co-founder and chief executive officer of Cydan. "Following an extensive review of the prior TBR-760 preclinical and clinical data, the Cydan team launched our third company, Tiburio, to execute a rapid clinical and regulatory program to bring this drug to patients in need."

Tiburio was granted an exclusive world-wide license to both TBR-760 and TBR-065. Ipsen will receive a minority ownership in the company as well as development and commercial milestone payments and royalties on sales. Tiburio is responsible for all future development and commercialization costs for both compounds. Additional financial terms were not disclosed.

Investment in the $31M Series A came from Cydan’s syndicate of leading life sciences investors, New Enterprise Associates, Longitude Capital, Lundbeckfonden Ventures, and Alexandria Venture Investments.

About NFPA

The pituitary gland, a master regulator of endocrine function, is located below the base of the brain. A nonfunctioning pituitary adenoma (NFPA) is a non-metastatic pituitary tumor that arise from gonadotroph cells in the pituitary. Patients often present with symptoms related to the size of the NFPA tumor, including headaches, vision problems, changes in milk production, weight change, menstrual changes, fatigue, sleep disruption, and depression or cognitive/behavioral changes.

Current treatment is limited to transsphenoidal surgery (TSS), which is performed through the nose and sinus passage, and/or radiation to halt the growth of these tumors. However, these two treatment options come with serious and high-risk consequences. In addition to these interventions designed to remove or reduce the size of the tumors, patients often require a complex set of medications to manage the endocrine disruption and other symptoms caused by the tumors and side effects of TSS and radiation.

In the U.S. there are approximately 5,000 new cases of NFPA that require TSS each year and 40-50% of these tumors will regrow within the first 5 years after surgery. Additionally, there are approximately 50,000 patients living with NFPA who may benefit from therapy to control tumor growth.

About Abraham Ceesay, CEO Tiburio

Mr. Ceesay has over 17 years of experience in leading biopharmaceutical companies and commercializing innovative therapeutic products. Prior to joining Tiburio, he served as chief operating officer at scPharmaceuticals where he developed and led all operational and commercial aspects of the company. Mr. Ceesay was integral in raising more than $140 million in private and public capital as well as closing the company’s initial public offering. Prior to joining scPharmaceuticals, he served as vice president, Sales, Marketing, and Commercial Operations at Keryx Biopharmaceuticals and spent four years at Ironwood Pharmaceuticals as Vice President of Marketing, and held responsibility for the management of the U.S. P&L, leadership of the Linzess brand team and co-promotion collaboration with Forest Laboratories/Allergan. Previously he was at Genzyme/Sanofi, initially as a field sales specialist and ultimately as the director, Renal Global Marketing, in which capacity he led the global launch of Renvela and held global marketing responsibility for the company’s renal franchise (Renagel, Renvela, Hectorol). Mr. Ceesay serves on the Board of Advisors for Life Science Cares and the Board of Directors for Food for Free. He holds a bachelor’s degree from Ithaca College, and a Master of Business Administration from Suffolk University’s Sawyer School of Management.

Ophthotech Corporation to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 3, 2019 Ophthotech Corporation (NASDAQ: OPHT) reported that Glenn P. Sblendorio, Chief Executive Officer and President, will present an overview of the Company at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00 a.m. Pacific Time (1:00 p.m. Eastern Time) (Press release, Ophthotech, JAN 3, 2019, View Source [SID1234532407]).

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Investors and the general public are invited to listen to a live webcast of the presentation at www.ophthotech.com. Please connect to Ophthotech’s website several minutes prior to the start of the presentation to ensure adequate time for any software download that may be necessary. A replay will be available for 14 days following the presentation.

Amunix Announces Licensing Agreement with Merck for ProTIA Immune Activator Platform

On January 3, 2019 Amunix Pharmaceuticals Inc. ("Amunix"), a biopharmaceutical company focused on the discovery and development of novel immuno-oncology therapeutics, reported that it has entered into a licensing agreement with Merck, known as MSD outside the United States and Canada, for rights to develop therapeutics against an undisclosed target using Amunix’s proprietary protease-triggered immune activator (ProTIA) technology platform (Press release, Amunix, JAN 3, 2019, View Source [SID1234532423]).

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"We are very pleased to enter into the collaboration with Merck, an acknowledged leader in the field of novel cancer therapeutics," said Volker Schellenberger, Ph.D., President and CTO of Amunix. "The agreement with Merck is a testament to Amunix’s protein engineering expertise reflected in our ProTIA platform. This powerful new platform technology enables the rapid generation of tumor activatable cytokines, signaling peptides/proteins or immune cell engagers. We look forward to a productive and successful relationship."

"Amunix’s ProTIA technology offers the potential to create novel tumor-targeted molecules for evaluation in our immuno-oncology clinical development programs," said Rob Kastelein, Ph.D., Associate Vice President, Immune-Oncology Discovery, Merck Research Laboratories. "We look forward to working with the Amunix team."

Under terms of the agreement, Amunix will receive an upfront payment from Merck and is eligible to receive payments associated with the achievement of certain developmental milestones as well as royalties on sales of any products derived from the collaboration. Further financial details were not disclosed.

Actinium Pharmaceuticals, Inc. to Present at the 2019 Biotech Showcase™ in San Francisco

On January 3, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that Sandesh Seth, Actinium’s Chairman and Chief Executive Officer will present at the Biotech Showcase 2019 being held on January 7-9 (Press release, Actinium Pharmaceuticals, JAN 3, 2019, View Source [SID1234532408]). The conference will be held at the Hilton San Francisco Union Square. Details of Actinium’s presentation are as follows:

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Date: Monday, January 7, 2019
Time: 10:00 AM PT
Track: Yosemite A (Ballroom Level)
Venue: Hilton San Francisco Union Square

Members of Actinium’s Executive and Corporate Development teams will be available for 1-on-1 meetings during the conference. Those interested in scheduling a meeting with Actinium may do so by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer via email to [email protected].

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.