Aduro Biotech to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 3, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, is scheduled to present at the 37TH Annual J.P. Morgan Healthcare Conference in San Francisco, California on Thursday, January 10, 2019 at 11:30 am PST (Press release, Aduro Biotech, JAN 3, 2019, View Source;p=RssLanding&cat=news&id=2381999 [SID1234532455]).

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcast will remain available for replay on Aduro’s website for 30 days.

Kiadis Pharma to present at Biotech Showcase 2019

On January 3, 2019 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, reported that it is scheduled to present at the Biotech Showcase(TM) 2019 at the Hilton San Francisco Union Square in January 2019 (Press release, Kiadis, JAN 3, 2019, View Source [SID1234533320]).

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Biotech Showcase 2019
January 7-9, 2019
Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San Francisco, CA
Hilton/Yosemite A, Ballroom Level
Arthur Lahr, CEO, will present on Monday, January 7 at 3:30pm PST.

The Kiadis management team will also host one-on-one meetings from January 7-10 in San Francisco

Mavupharma Selects First Immuno-Oncology Clinical Candidate MAVU-104, an Oral STING Pathway Enhancer

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.

Tragara Pharmaceuticals Appoints Scott Megaffin as Chief Executive Officer and Changes Name to Adastra Pharmaceuticals

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."

Bristol-Myers Squibb Provides 2019 EPS Guidance

On January 3, 2019 Bristol-Myers Squibb (NYSE:BMY) reported EPS guidance for full-year 2019 (Press release, Bristol-Myers Squibb, JAN 3, 2019, View Source [SID1234532386]).

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Bristol-Myers Squibb is providing its 2019 GAAP EPS guidance range at $3.75 to $3.85 and non-GAAP EPS guidance range at $4.10 to $4.20. Key 2019 GAAP and non-GAAP guidance assumptions include the combined dilution of $0.09 from the UPSA divestiture and U.S. Pension liabilities transactions.

The EPS guidance for 2019 excludes the impact of the Celgene acquisition or any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2019 EPS guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information."

Bristol-Myers Squibb will provide full line-item guidance for when the company reports its results for the fourth quarter 2018 on January 24, 2019.

Bristol-Myers Squibb is providing its 2019 GAAP EPS guidance range at $3.75 to $3.85 and non-GAAP EPS guidance range at $4.10 to $4.20. Key 2019 GAAP and non-GAAP guidance assumptions include the combined dilution of $0.09 from the UPSA divestiture and U.S. Pension liabilities transactions.

The EPS guidance for 2019 excludes the impact of the Celgene acquisition or any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2019 EPS guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information."

Bristol-Myers Squibb will provide full line-item guidance for when the company reports its results for the fourth quarter 2018 on January 24, 2019.