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.

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.

On September 12, 2018 Celltrion, Inc. (KRX:068270) reported that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018 (Press release, Celltrion, SEPT 12, 2018, View Source [SID1234529405]). Rituxan is a Biogen and Genentech USA, Inc.’s rituximab product.

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The ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

"We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10," said Woosung Kee, Chief Executive Officer of Celltrion. "The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price."

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.

1 Rituxan is a registered trademark of Biogen and Genentech USA, Inc.

About CT-P10

Celltrion’s CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.’s Rituxan, is currently approved in more than 47 countries across the globe. CT-P10 is the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and launched in Europe in 2017. The final U.S. prescribing information for CT-P10 will include the specific uses for which the product is indicated in the U.S. Rituximab, the active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells