On July 29, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that members of the management team will participate in the following upcoming investor conferences (Press release, Arcus Biosciences, JUL 29, 2019, View Source [SID1234537858]):

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BTIG Biotechnology Conference on Monday, August 12, 2019, at 12:00 pm Eastern Time in New York. Juan Jaen, Ph.D., President, will participate in a panel discussion entitled, "Solid Tumors Beyond PD-1 Monotherapy."
2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019, at 8:35 am Eastern Time in New York. Juan Jaen, Ph.D., President, and Rekha Hemrajani, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. To access the live audio webcast of the fireside chat, please visit the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for 30 days following the live event.

On July 29, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Brian Stuglik, a member of the Board of Directors, has been named Chief Executive Officer (CEO) (Press release, Verastem, JUL 29, 2019, View Source [SID1234537857]).

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"Brian brings deep commercial and biopharmaceutical leadership experience that we believe will accelerate the growth of COPIKTRA and progress overall company goals," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "Throughout his career, Brian has demonstrated an ability to deliver results through a clear strategic vision, focused teams and excellent execution. We are confident that he will capitalize on the significant opportunities in front of the company on behalf of patients, customers and our shareholders."

Mr. Stuglik has more than three decades of experience in US and International pharmaceutical development, product strategy and commercialization, with a focus on Oncology. He spent the majority of his career at Eli Lilly and Company, culminating in his role as Global Vice President and Chief Marketing Officer, Oncology Global Marketing, advancing Lilly Oncology from a single approved product to a portfolio of marketed or late-stage compounds across more than 10 cancer types. In May of this year, he took on a strategic oversight and advisory role to Verastem Oncology’s commercial organization.

"I am honored to join the Verastem Oncology team as CEO and am energized to build on our commitment to patients as we realize the full potential of COPIKTRA and the pipeline," said Mr. Stuglik. "Being a member of the Board of Directors and, more recently, serving as a strategic partner to the team, I have great confidence in Verastem Oncology’s ability to rapidly progress our mission to improve the lives of cancer patients."

Mr. Stuglik will continue to serve as a member of the Board of Directors and will lead the company’s executive team. As recently announced, Dan Paterson, formerly the Chief Operating Officer has assumed the role of President and Chief Operating Officer and Rob Gagnon has expanded his role to Chief Business and Financial Officer.

As previously announced, the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019.

On July 29, 2019 Rainier Therapeutics, Inc., a privately held clinical stage drug development company, reported that updated interim results from the FIERCE-22 trial evaluating vofatamab in combination with pembrolizumab in metastatic bladder cancer will be presented at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, which will take place September 27 to October 1, 2019 in Barcelona, Spain (Press release, Rainier Therapeutics, JUL 29, 2019, View Source [SID1234537856]).

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"We look forward to presenting updated interim results on clinical activity from our FIERCE-22 trial at ESMO (Free ESMO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes longer term follow-up of vofatamab in combination with pembrolizumab in patients with metastatic urothelial carcinoma (bladder cancer), providing a preliminary look at overall survival."

Poster Presentation Details:

Clinical Activity of Vofatamab (V), an FGFR3 Selective Antibody in Combination with Pembrolizumab (P) in Metastatic Urothelial Carcinoma (mUC), Updated Interim Analysis of FIERCE-22

Abstract: 2673

Poster Display Session 3
Presentation Number: 917P
Date: Monday, September 30, 2019
Presentation Time: 12:00 p.m. to 1 p.m.
Location: Poster Area Hall 4

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

About FIERCE-22

FIERCE-22 is a Phase 1b/2 trial evaluating vofatamab, a FGFR3-targeted antibody, in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and preliminary efficacy in the treatment of patients with locally advanced or metastatic bladder cancer who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

On JUly 29, 2019 Biodesix Inc. and Immodulon Therapeutics Limited, the immune-oncology company, reported that they have entered into a biomarker research collaboration (Press release, Biodesix, JUL 29, 2019, View Source [SID1234537855]). The partnership will focus on the analysis of the circulating proteome of advanced pancreatic cancer patients treated with IMM-101 using the Biodesix Diagnostic Cortex machine learning platform.

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The Biodesix proprietary machine learning platform builds on recent advances in the artificial intelligence field to uncover clinically relevant and elaborate biomarker patterns and relationships. This enables personalized approaches to therapy selection and a better understanding of complex diseases like cancer. IMM-101 is Immodulon’s investigational immunotherapeutic candidate under development for various tumour types, including advanced pancreatic cancer.

Dr Jaap Kampinga, Immodulon’s CEO, said, "In the IMAGE 1 randomised clinical trial, metastatic pancreatic cancer patients receiving IMM-101 and gemcitabine benefitted from a 59 percent increase in median overall survival compared to those receiving gemcitabine alone. There was considerable variability, as is typical in pancreatic cancer, with some patients surviving much longer than others. From this collaboration and by utilizing the Biodesix Diagnostic Cortex in identifying blood-based proteomic biomarkers, we hope to facilitate selection of those patients most likely to respond to IMM-101. This could improve the efficiency of treatment and patient care, and accelerate our clinical trial programmes."

"Our proprietary Diagnostic Cortex machine learning-based biomarker discovery platform is well suited to advancing the clinical research for IMM-101," said David Brunel, Biodesix CEO. "This research collaboration with Immodulon builds on our track record of developing companion diagnostics to optimize treatments with the potential to deliver much needed therapies to critically ill patients."

On July 29, 2019 PharmaMar Group (MSE:PHM) has reported total revenues of €41.4 million for the first six months of 2019, compared to €66 million in the same period of 2018 (Press release, PharmaMar, JUL 29, 2019, View Source [SID1234537854]). Much of this variation in total revenues between periods is explained by the difference in license agreement revenues. In relation to these agreements, a licensing and commercialization agreement for lurbinectedin (Zepsyre) was signed in April with Luye Pharma Group, Ltd for the territories of China, Hong Kong and Macao, for which PharmaMar received a non-refundable payment of $5 million. This agreement covers certain activities that must be carried out in connection with the agreement, and therefore the initial payment already received will be recognized in PharmaMar’s income statement in line with the progression of these activities. As a result, up to 30 June 2019, 629 thousand Euros from this agreement were recognized as revenue, compared to €22.4 million in the same period of the previous year.

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Sales of Yondelis in the second quarter were almost 12% higher than in the first quarter of the same year, 2019. Sales of Yondelis in the first six months of the year were €36.3 million, compared to €38.8 million in the first half of the previous year.

In terms of expenses, the main expenditure items decreased between periods, with a notable reduction in R&D expenses, this standing at €27.9 million for the six months ending 30 June 2019, compared to €40.4 million in the same period of the previous year.

The decrease in R&D is-31% between periods. This variation has occurred mainly through the oncology segment (€-11.6 million). This is due to the fact that, in the first half of 2018, in addition to the phase III ATLANTIS trial with lurbinectedin for the treatment of small cell lung cancer, a number of other clinical trials were open 2 and active, those trials no longer being active in the first half of 2019, although they do remain open until being definitively concluded.

As a result, at the end of the first half of 2019, the Group’s profit for the period was €-21 million.

Finally, up to 30 June, following the sale of Zelnova Zeltia, the PharmaMar Group recorded total cash and cash equivalents of €43 million and reduced net debt to €46 million, compared to €66 million at the beginning of the year.

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