On September 13, 2018 Boehringer Ingelheim reported that it has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies (Press release, Boehringer Ingelheim, SEP 13, 2018, View Source [SID1234529439]). ViraTherapeutics developed the lead candidate VSV-GP (Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP)), which is being investigated alone and in combination with other therapies. The total transaction value of EUR 210 million is based on an option and share purchase agreement signed between the companies in August 2016.

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Oncolytic viral therapy is a cancer treatment approach with two modes of action. First, the virus specifically replicates in and kills cancer cells. Second, viral infection stimulates the immune system to recognize these same cancer cells, leading to immune-mediated killing of both infected and non-infected cancer cells, further enhancing tumor control. Boehringer Ingelheim and ViraTherapeutics are working to develop a next generation oncolytic viral therapy platform. The lead investigational candidate leveraging the platform, VSV-GP, has shown promising results in pre-clinical models, especially in combination with key immune modulatory principles Boehringer Ingelheim is developing.

"The acquisition of ViraTherapeutics with its exciting oncolytic virus platform is the conclusion of a trusting and close cooperation over two years," said Dr. Heinz Schwer, CEO of ViraTherapeutics. "We are highly optimistic that our VSV-based development programs and technology will complement Boehringer Ingelheim’s immuno-oncology franchise and will serve as a source of innovative, new treatment options for patients living with cancer."

"I want to thank the team around scientific founder Dorothee von Laer, CEO Heinz Schwer and COO Lisa Egerer for their dedication to research and scientific progress that led to a productive collaboration with Boehringer Ingelheim and ultimately to the early exercise of the purchase option," said Dr. Klaus Schollmeier, Chairman of ViraTherapeutics’ advisory board. "I also want to thank the investors and my fellow board members for their hands-on commitment to this project. I am convinced that ViraTherapeutics’ research will become core to Boehringer Ingelheim’s oncology product pipeline."

Using a dual approach for potential treatment options, specifically combining immuno-oncology approaches with tumor cell-directed treatments, is central to Boehringer Ingelheim’s cancer immunology research strategy. Oncolytic virus-based therapies are consistent with and complement that strategy.

"Our approach is rooted in transforming ‘cold’ tumors – or immunologically inactive tumors that are not responsive to the checkpoint blockers – to ‘hot‘ tumors – those that are most susceptible to immune system attack," said Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors responsible for Boehringer Ingelheim’s Research and Development. "We are committed to investing in early research with promise and where our expertise best complements the strengths of our partners. Together, we aim to discover breakthrough medical treatments to transform the lives of patients and win the fight against cancer."

ViraTherapeutics was a portfolio company of the two venture investors EMBL Ventures and the Boehringer Ingelheim Venture Fund (BIVF). BIVF is focused on strategic investment in highly innovative biotechnology and start-up companies to help drive innovation in medical science. The BIVF has EUR 250 million under management and currently supervises a portfolio of 22 active companies and is one of the most active investors in immuno-oncology world-wide.

On September 13, 2018 GT Biopharma Inc. (OTCQB: GTBP) and (Euronext Paris: GTBP) reported the positive results for two next generation Trispecific Killer Engagers (TriKEs) in solid tumors (Press release, GT Biopharma , SEP 13, 2018, View Source [SID1234539522]). These efforts were headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics and Dr. Martin Felices, Co-Director of the Translational Therapy Laboratory at the Masonic Cancer Center, University of Minnesota.

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Two animal models were tested. One in ovarian cancer and one in head and neck cancers. In the ovarian cancer model, animals that were treated with our CD16-IL15-B7H3 TriKE demonstrated significant tumor resolution. An additional observation was the persistence of natural killer (NK) cells in the treated animals which is thought to be directly related to its tumor-killing abilities. In the head and neck cancer animal model, animals treated with our CD16-IL15-EpCAM TriKE displayed a significant decrease in tumor burden.

Solid tumors represent approximately 80% of all cancers. In addition, there are tremendous unmet medical needs in both ovarian and head and neck cancers.

Dr. Martin Felices said, "These promising results certainly warrant further investigation. If these results are seen in human ovarian as well as head and neck cancers it can dramatically change the poor outcomes these patients currently face."

Dr. Daniel Vallera said: "Based on this compelling data we continue to be incredibly excited about the use of the TriKEs in solid tumors. This would be a ground-breaking advancement for the treatment of these hard to treat cancers."

GT Biopharma’s Chairman and Chief Executive Officer (CEO) Dr. Raymond Urbanski said: "These results further demonstrate the immense potential of our NK cell engager TriKE and TetraKE platforms for the treatment of both liquid and solid tumors. They could represent a complete paradigm shift in the treatment of cancer"

On September 12, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors, such as pancreatic, ovarian and colorectal cancers, reported that the Company received a positive reception after presenting at the prestigious 25th Annual NewsMakers in the Biotech Industry Conference last Friday, September 7th, at the Millennium Broadway Hotel and Conference Center in New York, as well as certain business updates discussed below (Press release, Propanc, SEPT 12, 2018, View Source [SID1234529404]). Management wishes to thank their gracious hosts at BioCentury for the opportunity to present at the prestigious conference, where only 45 companies were handpicked to present their stories to institutional investors in the biotech sector.

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The presentation was well attended, where James Nathanielsz, the Chief Executive Officer of the Company, discussed recent scientific advancements of its lead product candidate, PRP, and its ability to suppress the cancer stem cell population, which the Company plans to submit for publication to a peer reviewed scientific journal.

"We have demonstrated using both in vitro (cell line) and in vivo (animal) data that PRP effectively suppresses cancer stem cells ("CSCs") by suppressing key genes, which are critical to controlling their population and reducing the risk of tumor recurrence, clinically. Furthermore, we discovered a key gene target for drug developers, Rac1B, which increased as a result of PRP treatment. This gene suppresses cellular motility and proliferation of CSCs by ultimately inhibiting TGF-β, a known growth factor responsible for tumorigenesis and metastasis," said Mr. Nathanielsz. "We remain excited by these important discoveries, as suppressing the CSCs population whilst avoiding potential unwanted side effects towards normal stem cells means we have a targeted therapy that can control the spread of cancer. Metastasis, or spreading cancer, remains the main cause of patient death from cancer."

During the presentation at the conference, Mr. Nathanielsz explained the current anticipated timelines for commencing the Company’s engineering run and full scale GMP manufacturing batch of PRP, emphasising that management’s focus was to identify a suitable source of capital as it prepares for filling its drug product for clinical trials, as well as the goal of reducing the Company’s debt on the balance sheet by increasing equity investment. Management was pleased to receive interest at the conference and is currently looking into potential financing options with its advisors and investment banking team.

In addition, Mr. Nathanielsz met with Zack’s Small Cap Research during the conference, to discuss and evaluate the strength of the Company’s intellectual property portfolio, which management believes is greatly undervalued in comparison to other cancer stem cell companies, taking into consideration the Company’s recent advancements of two patents into national phase (i.e. the approval process for a patent within a jurisdiction from an individual patent office), with a third patent entering national phase in key global regions later this year.

"We wish to assure our shareholders that we are working extremely diligently to identify potential suitable sources of capital to support the growth of the Company, including advancing our lead product, PRP, as well as strengthening our balance sheet, as we look to progress towards commencing a first-in-human study of PRP. Presenting at the NewsMakers Conference was a fantastic opportunity to present to sophisticated healthcare investors managing billions of dollars in their portfolios, who understand the space we’re in, and appreciate the uniqueness of our technology. We will continue to provide shareholder updates as we progress with our goals," continued Mr. Nathanielsz.

The Company’s presentation was filed as an exhibit to the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on September 7, 2018, and is also available on the Company’s website at View Source

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

On September 12, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, announced today the closing of an oversubscribed $125 million financing (Press release, Atreca, SEP 12, 2018, View Source [SID1234529470]). This Series C round was led by a large U.S.-based, healthcare-focused fund, an existing Atreca investor. Participating in the round were other existing investors including Wellington Management Company LLC, and Cormorant Asset Management, based in Boston, and joined by new investors Aisling Capital, Boxer Capital of the Tavistock Group, EcoR1 Capital, Redmile Group, Samsara BioCapital, and funds managed by Tekla Capital Management.

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"This funding enables us to broaden and accelerate our discovery and pipeline generation efforts and to move our first candidate into clinical development," said John A. Orwin, President and Chief Executive Officer of Atreca. "This first candidate, generated by our unique Discovery Engine and via our proprietary Immune Repertoire Capture (IRC) technology, represents a novel and potentially fundamental new class of oncology immunotherapeutics. We appreciate the support of both our new and existing investors as we advance the Company to this next stage of development."

"Our oversubscribed Series C financing provides further validation of Atreca’s ability to discover and develop high-potential therapeutic candidates via its unique approach," said Brian Atwood, Chairman of the Board of Directors of Atreca. "The quality of the investor syndicate and magnitude of the round reflects the value we have built in our discovery capabilities and the progress we have made in our preclinical programs since our Series B financing just a year ago."

Cowen served as exclusive placement agent for the financing.

On September 12, 2018 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, reported top line data from its Phase 3 study of 1404, the Company’s prostate specific membrane antigen (PSMA)-targeted small molecule SPECT/CT imaging agent that is designed to visualize prostate cancer (Press release, Progenics Pharmaceuticals, SEP 12, 2018, View Source [SID1234529673]).

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The Phase 3 trial evaluated the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease. The study dosed 471 patients in the U.S. and Canada with low-grade prostate cancer, whose biopsy indicated a histopathologic Gleason grade of ≤ 3+4 severity and/or were candidates for active surveillance. Median PSA levels for patients dosed in trial was 5.58 ng/mL (range 0.69 – 16.03). In the study, 1404 detected clinically meaningful prostate cancer with specificity ranging among the three readers from 71-75% (95% confidence interval CI of 64% to 80%). The co-primary endpoint of sensitivity was not met and ranged amongst the three readers from 47-51% (95% CI of 41% to 56%). The trial protocol required the lower limit of the two-sided 95% CI for both specificity and sensitivity to exceed 60%.

The most frequent treatment related events included headache (2.3%), dizziness (1.1%) and fatigue (0.8%).

"These top line Phase 3 results of 1404 are inconsistent with the prior Phase 2 data which showed significantly higher sensitivity rates," stated Mark Baker, CEO of Progenics. "We are currently conducting a thorough analysis of the full data set to understand the factors that may have contributed to this outcome and determine the appropriate development path for this novel agent in patients with low-grade prostate cancer. We plan to complete this review in the next quarter."

Mr. Baker added, "We believe that PSMA-targeted imaging holds tremendous promise to improve the detection, staging and monitoring of prostate cancer. These results do not impact our view of the PyL PET imaging agent in patients with recurrent or metastatic prostate cancer as we head into our Phase 2/3 data readout next quarter, and we remain on track to initiate our second Phase 3 study by year-end. Our oncology therapeutic programs continue to move forward, including the ongoing commercial launch of AZEDRA for the treatment of pheochromocytoma or paraganglioma. In addition, we anticipate finalizing our clinical development plan with the U.S. FDA for 1095 in metastatic castration-resistant prostate cancer (mCRPC) in the fourth quarter and expect our partner Bayer to initiate a Phase 1 study of PSMA-TTC in patients with mCRPC by year end 2018."

Progenics Reports Phase 3 Results for 1404 Page 2

About the Phase 3 1404 Trial

The Phase 3 trial was a multi-center, multi-reader, open-label trial, comparing 1404 SPECT/CT imaging in men who had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a histopathologic finding of Gleason score ≤3+4 who were candidates for active surveillance and were undergoing routine biopsy or voluntary radical prostatectomy (RP) with or without a pelvic lymph node dissection. This study was designed to evaluate the sensitivity and specificity of 1404 SPECT/CT image assessments to correctly identify subjects with previously unknown clinically significant prostate cancer in two cohorts: low grade prostate cancer who had elected to undergo RP; and very low risk (VLR) prostate cancer per 2016 National Comprehensive Cancer Network Guidelines who were scheduled to undergo routine prostate biopsy. Subjects received a single dose of 1404 followed by whole body planar and SPECT/CT (pelvic) imaging. In accordance with standard of care procedures, subjects underwent either voluntary RP or prostate biopsy within 42 days after study drug dosing. 1404 image data was collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland and then compared against central histopathology as the truth standard.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with Technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 161,360 new cases of prostate cancer will be diagnosed and about 26,730 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.