On July 29, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that as part of its clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 will be combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI sponsored platform study (Press release, Inovio, JUL 29, 2019, View Source [SID1234537835]).

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This innovative combination trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. INO-5151 is a combined formulation of INO-5150 (with SynCon antigens encoding for PSA and PSMA) and INO-9012 (DNA vector expressing interleukin 12). Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design (called PORTER Study: ClinicalTrials.gov Identifier: NCT03835533).

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Inovio is pleased that PICI selected our novel DNA-based immunotherapies to join in this unique combination trial targeting a major unmet medical need. This study demonstrates how Inovio is working with top cancer immunotherapy pioneers to investigate the potential significance of Inovio’s T cell activating immunotherapy in an innovative immuno-oncology combination regimen. Our collaboration with PICI allows us to leverage strategic partnerships with academia, non-profits, and pharma while working with PICI’s team of world-renowned experts from leading cancer centers at the forefront of cancer research."

Metastatic castration resistant prostate cancer, the lethal form of prostate cancer, has shown limited benefit from immune checkpoint inhibition as a monotherapy, with two randomized Phase 3 trials with ipilimumab failing to show a clinically meaningful survival benefit, and a large Phase 2 trial with pembrolizumab demonstrating a modest rate of objective responses.

Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI’s novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

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.

Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On July 29, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report second quarter 2019 financial results and provide a corporate update on Thursday, August 8, 2019 at 8:30 am ET (Press release, Protalix, JUL 29, 2019, View Source;p=RssLanding&cat=news&id=2404998 [SID1234537874]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1 (844) 358-6760; International: +1 (478) 219-0004. Conference ID number: 1497319.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On July 29, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that the VA North Texas Health Care System and its non-profit affiliate, the Dallas VA Research Corporation, have joined Anixa’s ongoing prostate cancer Cchek study (Press release, Anixa Biosciences, JUL 29, 2019, View Source [SID1234537839]). Study enrollment will be led by Dr. Manoj Reddy, Radiation Oncologist, and Dr. Jeffrey Gahan, Chief of Robotic Surgery.

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"We are pleased to see the continued expansion in Cchek collaboration partners to now include the VA North Texas Health Care System. We look forward to working with Dr. Reddy and Dr. Gahan as we further the development of our artificial intelligence based prostate cancer diagnostic test," stated Dr. Amit Kumar, CEO of Anixa.

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."