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.

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!

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.

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!

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

Argos Therapeutics Reports Results of Interim Analysis of the ADAPT Trial and Announces Review of Strategic Alternatives

On April 19, 2018 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial (Press release, Argos Therapeutics, APR 19, 2018, View Source [SID1234525551]).

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!

As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.

The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.

Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.

Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company’s common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.

MabVax Therapeutics Antibody Program Results Featured in Three Presentations at 2018 American Association for Cancer Research (AACR) Annual Meeting

On April 18, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that three poster presentations on the Company’s antibody development programs were made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois at McCormick Place (Press release, MabVax, APR 18, 2018, View Source [SID1234525497]).

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!

MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We successfully shared the significant progress we have made through these clinical and preclinical studies that continue to establish our growing body of data supporting the development of MVT-1075 for the treatment of pancreatic cancer and other CA19-9 cancers, MVT-2163 as a immunoPET imaging agent, and our most advanced research program focused on the Tn and sTn cancer antigen targets."

MabVax Poster Presentation Details

Jonah Rainey, Ph.D., Executive Director, Antibody Research at MabVax presented a poster on Sunday April 15th entitled: "A fully human antibody binds Tn and sTn carbohydrate antigens specifically on serine residues, without need for polypeptide interaction."

Dr. Rainey’s presentation included results from the Company’s successful human antibody discovery and engineering efforts that resulted in creating a panel of anti-Tn antibodies with specificity and affinity for the Tn and sTn epitopes. This observation was confirmed by a binding array analysis performed by a well-known independent academic based consortium. These antibodies bind preferentially to a particular presentation of the Tn epitope that exhibits a pharmaceutically useful pattern that is expressed on ovarian and breast cancers, including triple-negative breast cancer.

Paul Maffuid, Ph.D., Executive Vice President, Research & Development MabVax Therapeutics presented a poster on Tuesday April 17th entitled: "Phase 1 dose escalation study of 177Lu-HuMab-5B1 (MVT-1075) in combination with MVT-5873 as radioimmunotherapy (RIT) in subjects with relapsed / refractory pancreatic cancer or other CA19-9+ malignancies."

Dr. Maffuid’s presentation summarized results from the first cohort of three patients treated in the Phase 1 clinical trial of the Company’s MVT-1075 radiopharmaceutical product in late stage pancreatic cancer. These results at the initial dose support a high uptake of the on-target lesions with a prolonged time of residence and accumulation on target lesions. The predominant treatment-related toxicities in the first cohort included expected and manageable (Grade 1-3) changes in hematologic and liver function parameters.

Though the current data set is small, clinical biodistribution studies with the immunoPET imaging agent MVT-2163 in a prior Phase 1 study were used to successfully predict the absorbed organ doses of MVT-1075 and in particular red marrow which is the dose limiting organ. In addition, the studies completed to date were sufficient to establish a fractionated dosing schedule of MVT-1075 combined with image-based dosimetry as a feasible RIT Phase 1 dosing strategy, permitting within cycle patient specific dose adjustments to achieve a selected target red marrow exposure. A fourth patient has been treated in a second cohort at a planned escalated dose.

Jonah Rainey, Ph.D., Executive Director, Antibody Research at MabVax was a co-presenting author of a second poster on Tuesday April 17th entitled: "PEGylated Hyaluronidase Increases Tumor Uptake of 89Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive Hyaluronan-Accumulating Pancreatic Cancer Model"

This poster was the result of a preclinical collaboration with Halozyme Therapeutics, Inc. combining the use of MabVax’s immunoPET imaging agent MVT-2163 with Halozyme’s PEGylated Hyaluronidase, PEGPH20 to determine if the enzymatic degradation of HA could improve the uptake of MVT-2163 on tumor lesions as measured by in vivo PET imaging and ex vivo gamma counting, in a CA19-9-positive, HA-rich human pancreatic tumor xenograft model. PEGPH20 increased both the tumor uptake and the tumor-to-liver ratios of MVT-2163 as well as decreased liver uptake in a CA19-9 positive xenograft mouse model of HA-accumulating pancreatic cancer. The increased tumor uptake and the decreased liver uptake support further investigation into the potential diagnostic utility for the combination of PEGPH20 and MVT-2163.

To access the three full abstracts, please click here.

About MVT-1075

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. MVT-1075 has the potential to deliver a more potent HuMab-5B1-based product, by using small doses of a radioisotope coupled to the Company’s MVT-5873 antibody to target pancreatic cancer cells and kill them.

About the HuMab-Tn Antibody Targeting Tn and sTn

HuMab-Tn is a fully human antibody discovered by MabVax from a patient vaccinated with a pool of cancer glycans, including Tn. The antibody has been affinity-matured and demonstrates highly selective Tn/sTn glycan binding. Further, the antibody recognizes a wide array of cancers, particularly ovarian and breast including approximately 90% of triple negative breast cancers tested.

About MVT-2163

MVT-2163 is an immunoPET imaging agent product that combines the established PET imaging capabilities of 89Zr with HuMab-5B1 tumor specific targeting. It has the potential to aid in identifying the best surgical treatment options for patients with pancreatic cancer and as a potential companion diagnostic with treatment options.

Medigene participates at five upcoming conferences

On April 18, 2018 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported its participation at the following upcoming conferences (Press release, MediGene, APR 18, 2018, View Source [SID1234525515]):

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!

Kempen Life Sciences Conference
Date: 18 – 19 April 2018
Location: Amsterdam, Netherlands

16th CIMT (Free CIMT Whitepaper) Annual Meeting
Date: 15 – 17 May 2018
Location: Mainz, Germany

The American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting
Date: 16 – 19 May 2018
Location: Chicago, USA

UBS Global Life Science Conference
Date: 21 – 23 May 2018
Location: New York, USA
Dr. Thomas Taapken, CFO of Medigene, will hold a company presentation on 22 May.

3rd Annual Advances in Immuno-Oncology Congress
Date: 24 – 25 May 2018
Locations: London, UK
Prof. Dolores Schendel, CEO and CSO of Medigene AG, will present on "T cell receptor discovery to match medical needs worldwide" on May 24.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

For more information, please visit www.medigene.com