Atreca Announces John A. Orwin Appointed President and CEO Atreca Co-Founder Dr. Tito A. Serafini Will Serve as Chief Strategy Officer Lead Anti-Cancer Candidate Slated to Enter Clinical Testing in 2019

On April 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that John A. Orwin, formerly CEO of Relypsa, has been appointed President and Chief Executive Officer of Atreca (Press release, Atreca, APR 19, 2018, View Source [SID1234525531]). He will also serve on the Company’s Board of Directors. Mr. Orwin replaces Atreca co-founder Dr. Tito A. Serafini in this role. Dr. Serafini will assume the newly created position of Chief Strategy Officer, responsible directly for research, preclinical development, technology, and intellectual property. Dr. Serafini also will remain on Atreca’s Board of Directors.

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"John Orwin is a seasoned leader with a very strong track record in scaling up clinical-stage companies. He brings core capabilities that will complement Tito’s vision and his ability to drive Atreca’s innovative science and the development and application of its broadly enabling technology platform," stated Brian Atwood, Atreca’s Chairman, and Founder and former President and CEO of Cell Design Labs. "We believe their combined talents and expertise will be highly synergistic, further differentiating the Company from others in the space and accelerating Atreca’s progress."

Mr. Atwood continued, "During Tito’s tenure leading Atreca, the Company went from early concept through the buildout of its Immune Repertoire Capture (IRC) technology, the creation of a discovery engine generating multiple scientific discoveries and a large collection of preclinical assets, and the rapid advancement of a lead candidate, with an anticipated IND filing in mid-2019. We are proud of the corporate culture of excellence Tito established, attracting a fantastic team and leading life sciences institutional investors, and for the considerable accomplishments achieved under his leadership."

"I am enthusiastically committed to Atreca, a company that I believe can both continue to transform the way new therapies are discovered and ultimately deliver life-changing treatment options to patients in need," said Dr. Serafini. "John’s joining the Company as CEO will have a profoundly positive impact on Atreca, given his successful track record scaling R&D companies, building out their clinical development organizations, manufacturing capabilities, and commercial and G&A functions. This is a very exciting time for Atreca, and I am thrilled with the Company’s prospects for continued and accelerated growth."

Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhône-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.

"Under the collective vision of Tito and his team, Atreca has become the first mover in discovering and advancing candidates based on its unique approach of understanding the active adaptive immune response at the single cell level in patients," commented Mr. Orwin. "The Company has differentiated itself through its foundational technology, its discovery engine, its strategy for advancing candidates, and in terms of productivity, having generated a library of nearly 1,000 antibodies targeting public tumor antigens. I look forward to contributing to the next chapters of the Company’s evolution, including preparations to bring the first candidates into clinical development in 2019 and 2020."

Onconova Presents Data on Dual Inhibitor of CDK4/6 + ARK5 at American Association for Cancer Research 2018 Annual Meeting

On April 19, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported an advance in pre-clinical development and the presentation of new data for investigational ON 123300, a novel dual inhibitor of CDK4/6 + ARK 5 with potential application across a variety of cancers (Press release, Onconova, APR 19, 2018, View Source [SID1234525549]).

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CDK inhibitors have emerged as promising and potentially targeted large market cancer therapies. ON 123300 has the potential to overcome many of the limitations of current generation CDK4/6 inhibitors. Onconova believes that ON 123300 may act as a single agent, due to the unique targeting of ARK5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors.

Onconova and HanX Biopharmaceuticals, the Company’s Greater China collaboration partner for ON 123300, recently completed the pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (FDA). These discussions provided guidance for the manufacturing of ON 123300 and the pre-clinical development plan for the submission of an IND application.

The data from preclinical studies demonstrates that there is a differential metabolism of ON 123300 in male versus female rodents. As a result, the drug exposure is almost 2-3 fold higher in female rats. Based upon preclinical animal liver microsome studies, this differential effect appears to be limited to rodents, and is not observed in preclinical studies with human liver microsomes. Based on the metabolism data from other species, relevant species have been selected along with the dosing strategy to be implemented in GLP toxicological studies to be conducted by HanX. As a part of the pre-clinical development program, Onconova and HanX announced a collaborative program in December 2017, wherein the remaining IND enabling studies will be funded by and conducted by HanX.

Onconova previously reported that ON 123300 was found to be as active as Palbociclib (Pfizer’s Ibrance) in a preclinical Rb + ve xenograft model. Moreover, the molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib based upon this model.

Ramesh Kumar, President and CEO of Onconova, commented, "At the end of March, we received pre-IND guidance from the FDA, which provides a path towards filing an IND and then starting clinical trials. Our partner, HanX, has initiated GMP manufacturing and will be initiating GLP pre-clinical studies based on the guidance provided by the FDA, and we look forward to advancing ON 123300 into clinical development."

Faming Zhang, Ph.D., founder and Chairman of HanX, commented, "We are pleased to have completed the process chemistry and have initiated GMP manufacturing for ON 123300. GLP toxicology studies are planned and we will be undertaking additional preclinical studies to enhance the profile of this novel compound. In collaboration with Onconova, our goal is to simultaneously file the IND in the USA and China, as soon as possible. Once an IND is in place, HanX plans to initiate Phase 1 studies in China and also participate in more advanced global clinical trials."

A copy of the presentation is available by visiting the Scientific Presentations section of Onconova’s website.

Emergent BioSolutions to Release First Quarter 2018 Financial Results and Conduct a Conference Call on May 3, 2018

On April 19, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported that it will host a conference call on Thursday, May 3, 2018 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2018, recent business developments, revenue guidance for the second quarter of 2018, and revenue and net income guidance for full year 2018 (Press release, Emergent BioSolutions, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343377 [SID1234525532]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93329114

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

TESARO to Announce First-Quarter 2018 Financial Results on May 3, 2018

On April 19, 2018 TESARO, Inc. (NASDAQ:TSRO) reported that it will announce first-quarter 2018 financial results on Thursday, May 3, 2018, after the close of the U.S. financial markets (Press release, TESARO, APR 19, 2018, View Source [SID1234525550]). TESARO’s senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on May 3, 2018 to discuss the Company’s operating results for the quarter in greater detail, as well as the status of its development programs.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

TESARO will host a conference call and live audio webcast to discuss its first-quarter financial results.

WHEN: Thursday, May 3, 2018 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com

A replay will be available for 30 days at www.tesarobio.com.

Personal Genome Diagnostics’ TMB Analysis Used in Groundbreaking NEJM Study Showing Promising Checkpoint Inhibitor Efficacy in Early Stage Lung Cancer

On April 19, 2018 Personal Genome Diagnostics Inc. (PGDx) reported that its wholeexome analysis platform contributed to an important new study published in the New England Journal of Medicine (NEJM) showing promising efficacy for a leading checkpoint inhibitor in early stage lung cancer (Press release, Personal Genome Diagnostics, APR 19, 2018, View Source [SID1234525533]).1 The study also showed that patients who had higher tumor mutation burden (TMB) according to the PGDx analysis had better responses to the checkpoint inhibitor than those with lower tumor mutation loads. The study was conducted by cancer researchers from Johns Hopkins University, including PGDx co-founder Victor Velculescu, MD, PhD, and the Memorial Sloan Kettering Cancer Center (MSK). Earlier this year, PGDx announced an agreement with MSK for developing, registering and commercializing products and services that include tumor mutation burden biomarker status.

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The NEJM study reported that non-small cell lung cancer (NSCLC) patients who received the anti-PD-1 agent nivolumab before undergoing surgery for their cancer experienced fewer relapses than patients who did not.
The nivolumab-treated patients also showed signs of anti-tumor immunity stimulated by the immuno-oncology
therapy. Importantly, the study showed a direct correlation between TMB and checkpoint inhibitor response– patients with higher mutation burden scores as measured by the PGDx platform had a better response to
nivolumab—the more tumor mutations, the better the response. TMB scores were even better predictors of
response to nivolumab than measurements of PD-1 itself.

John Simmons, PhD, Director of Translational Science at PGDx, commented, "We are proud that our pioneering
work in whole exome analysis has made our platform a standard for many in the field of oncology. The analysis
generated using the PGDx exome platform (shown in Figure 3 in the NEJM study) shows a striking correlation
between tumor mutation load and response to immune checkpoint blockade. We believe that the high-quality
mutation detection approach developed at PGDx, including our proprietary VariantDxTM bioinformatics pipeline,
contributed to the strength of the results."

Dr. Simmons added, "This study also highlights the clinical relevance of TMB, even in early stage disease prior
to therapy. Whole exome analysis has been the ‘gold standard’ driving the field’s understanding of how mutation
load affects clinical response to checkpoint blockade, but it isn’t currently practical for routine clinical use. Our
ongoing initiative to translate our expertise and research applications into standardized IVD testing products for
measuring TMB and other cancer biomarkers is intended to ensure wide accessibility and use of these tools by
drug developers and physicians."

"This study is an excellent example of how the advanced scientific work of our distinguished founders gives us
the opportunity to contribute to groundbreaking cancer research while reinforcing our credibility with our industry
partners," said Doug Ward, CEO of Personal Genome Diagnostics. "Our leading VariantDx bioinformatics
analysis pipeline that informed this study and fuels our PGDx assays has allowed PGDx to be a leader in
immuno-oncology testing. We look forward to working with our growing network of partners to deliver accurate,
accessible diagnostic tests that indicate the most effective therapies for patients–an essential part of the
genomic revolution that is transforming cancer treatment."

PGDx has expertise in cancer genome analysis ranging from sample preparation and sequencing to data
interpretation and analysis. The company uses next-generation sequencing (NGS) and its proprietary algorithms
to identify alterations in complex cancer genomics and has developed novel technologies for non-invasive
approaches to cancer diagnostics. PGDx is also developing and will commercialize a portfolio of clinically
validated, regulated tissue and liquid biopsy cancer tests, enabling worldwide access to standardized NGS
testing.
1 – Neoadjuvant PD-1 Blockade in Resectable Lung Cancer, P.M. Forde, J.E. Chaft, K.N. Smith, V. Anagnostou, T.R.
Cottrell, M.D. Hellmann, M. Zahurak, S.C. Yang, D.R. Jones, S. Broderick, R.J. Battafarano, M.J. Velez, N. Rekhtman, Z.
Olah, J. Naidoo, K.A. Marrone, F. Verde, H. Guo, J. Zhang, J.X. Caushi, H.Y. Chan, J.-W. Sidhom, R.B. Scharpf, J. White, E.
Gabrielson, H. Wang, G.L. Rosner, V. Rusch, J.D. Wolchok, T. Merghoub, J.M. Taube, V.E. Velculescu, S.L. Topalian, J.R.
Brahmer, and D.M. Pardoll, New England Journal of Medicine, April 16, 2018