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."

On January 3, 2019 Mavupharma (Mavu) reported that it has selected its first immuno-oncology clinical development candidate, MAVU-104, a novel innate immune modulator (Press release, Mavupharma, JAN 3, 2019, View Source [SID1234537639]).

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MAVU-104 is a first-in-class, orally active, small molecule inhibitor of ENPP1, a phosphodiesterase that negatively regulates the STING (Stimulator of Interferon Genes) pathway. STING signaling plays a crucial role in the generation of an immune response directed at the tumor, and enhancing STING signaling has been shown to induce cures in multiple preclinical cancer models. Inhibiting ENPP1 activity with MAVU-104 allows for highly-controlled enhancement of STING signaling in all tumors and lymph nodes without any injections.

"With our approach, which focuses on blocking a key negative regulator of the STING pathway, as opposed to directly stimulating STING itself, the degree and duration of innate immune activation are tunable, which avoids both overstimulation of the pathway and high levels of cytokine release," stated Mike Gallatin, Ph.D., Mavu’s president and co-founder. "Having selected our first immuno-oncology drug candidate, we are now focused on the path to IND for MAVU-104, which we expect to file in the second half of 2019."

Mavu’s approach may have significant advantages over other developmental therapies that stimulate the STING pathway. Published studies on the direct STING agonists in clinical development show that these therapies are administered via direct injection into the tumor(s) and may induce release of pro-inflammatory cytokines into systemic circulation, which has been associated with side effects.

Previously, Mavu presented data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 meeting showing that ENPP1 inhibition leads to tumor shrinkage and can be combined with other immunotherapies to induce long-term cures and durable immunologic memory in mouse models of cancer.

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.

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.

On January 3, 2019 Tragara Pharmaceuticals Inc. reported the appointment of Scott Megaffin as Chief Executive Officer and a member of the Board of Directors effective immediately (Press release, Tragara Pharmaceuticals, JAN 3, 2019, View Source [SID1234539282]). Megaffin brings extensive leadership experience in clinical stage companies in oncology, specialty and critical care. He replaces Tom Estok, who will remain active with the company as an advisor and continue in his role on the Board of Directors.

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The addition of Megaffin comes at the time of a strategic pivot for the company that includes a change of name to Adastra Pharmaceuticals Inc. As part of this strategy, Adastra has expanded its operations beyond San Diego with the opening of an office in Princeton, N.J. This is consistent with the Adastra strategy to grow and attract new pharmaceutical talent in the New Jersey area. Adastra, which is derived from the Latin phrase "to the stars," is a name that reflects the boundless motivation and dedication of each team member to the development of best-in-class therapeutics for patients with cancer.

"Scott has the right experience to drive forward all of the Adastra strategic imperatives and continued program advancement of TG02," said Dennis Podlesak, Adastra Chairman and Partner of Domain Associates. "The Board would like to acknowledge and thank Tom for his vision and dedication in getting us to this point. We have advanced TG02 in clinical studies in collaboration with healthcare providers in the United States and Europe for adult patients diagnosed with glioblastoma multiforme (GBM). Furthermore, we have prepared for the start of an exploratory study in pediatric patients with diffuse intrinsic pontine glioma (DIPG). Between now and the first quarter of next year, Adastra will have a series of clinical milestones and data read-outs that we expect will enable the company to explore multiple development and business paths forward."

Prior to joining the company, Megaffin was President of Churchill Pharmaceuticals LLC, where he successfully marshalled the company through a transaction that resulted in the sale of company assets before an FDA approval, while simultaneously preparing the company for its own possible commercialization activities. Before this, he held numerous global strategic and operational positions of increasing responsibility with Onconova Therapeutics Inc., Cephalon Inc., Adolor Corp., Yamounchi and Bristol-Myers Squibb Co. He has led six global product launches and clinical development programs in a variety of therapeutic categories, including oncology, hematology, virology, critical care, anti-infectives, pain and inflammation. Megaffin earned a B.S. in Biology from Pittsburg State University.

TG02 is a highly differentiated orally delivered inhibitor of cyclin-dependent kinase 9 (CDK9) with high penetration of the blood brain barrier, overcoming a major challenge in GBM drug development. TG02 exerts inhibitory effects on RNA Polymerase II phosphorylation, leading to depletion of the key cancer cell survival protein, Myc, thus committing cancer cells to apoptosis. TG02 has demonstrated broad anti-tumor activity across cell lines and shows a positive synergistic effect when added to standard of care treatments for GBM. Currently, the National Cancer Institute (NCI) and European Organisation for Research and Treatment of Cancer (EORTC) are enrolling patients in trials of TG02 in GBM. In addition, Adastra will initiate a study of TG02 in DIPG in the second quarter of this year.

Megaffin added, "I am very happy to take on this role at Adastra during this transformational year for the company. The TG02 trials in GBM are progressing nicely, and we are entering into the start of the DIPG study in the pediatric patient population. When evaluating the opportunity to join the company, I reviewed the data in hand for TG02 and became excited by its potential for the benefit of patients. GBM and DIPG are both devastating brain cancers and represent high unmet treatment needs. TG02 presents Adastra with regulatory opportunities of rapid advancement into registrational studies in the near future. We look forward to reporting our progress in 2019 as we focus sharply on clinical programs as well as exploring possible pipeline expansion opportunities."