AngioDynamics to Report Fiscal 2019 First Quarter Financial Results on September 27, 2018

On September 13, 2018 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the first quarter of fiscal year 2019 before the market open on Thursday, September 27, 2018 (Press release, AngioDynamics, SEPT 13, 2018, View Source [SID1234529419]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13683219.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, September 27, 2018, until 11:59 p.m. ET on Thursday, October 4, 2018. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13683219.

Boehringer Ingelheim acquires all ViraTherapeutics shares

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.

Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial Into First-Line Therapy and Doses First Patient

On September 12, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that it has initiated two new cohorts for first-line, locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR or HER2 exon 20 insertion mutations in its current Phase 2 non-small cell lung cancer (NSCLC) clinical trial (Press release, Spectrum Pharmaceuticals, SEPT 12, 2018, View Source [SID1234529403]). Spectrum also announced that it has dosed the first patient in the expanded patient population.

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"Given the exciting preliminary poziotinib clinical data in NSCLC patients with EGFR exon 20 mutations who have received prior systemic therapy, we are happy to extend our participation in Spectrum’s trial to explore poziotinib’s activity in the first-line setting," said Jonathan Goldman, M.D., Associate Professor of Hematology and Oncology, Associate Director of Drug Development and Director of Clinical Trials in Thoracic Oncology at UCLA Health. "Current available therapies for NSCLC patients with exon 20 insertion mutations have been shown to be minimally effective. We do not have good options for these patients as we do in other settings with actionable mutations. This clinical trial expansion is a welcome milestone for patients and physicians battling this disease."

The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 mutations currently consists of a Phase 2 pivotal, Spectrum-sponsored, multi-center global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe, and a Phase 2 investigator-initiated study at the University of Texas MD Anderson Cancer Center. Spectrum’s ZENITH20 study now includes four cohorts, with each cohort being an independent study with pre-specified statistical hypotheses and statistical power. The protocol amendment incorporating the two new cohorts was designed based on input from the FDA. The two previously-treated cohorts will enroll up to 87 patients each, and the two first-line cohorts will enroll up to 70 patients each. For each cohort, the primary endpoint is objective response rate; the secondary endpoints are disease control rate, duration of response, safety and tolerability; and the exploratory endpoints are progression-free survival and quality of life.

About Poziotinib

Poziotinib is a novel, orally administered Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly, this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer and gastric cancer. Spectrum received an exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals.

Propanc Biopharma Provides Shareholder Update after Presenting at the 25th Annual NewsMakers in the Biotech Industry Conference

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.

Atreca Raises $125 Million to Expand its Preclinical Pipeline and Advance its First Program into Clinical Trials

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.