On October 26, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer (Press release, Hoffmann-La Roche, OCT 25, 2017, View Source [SID1234521187]).

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“About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible.”

This sBLA for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, is based on data from the pivotal Phase III GOG-0218 trial. In newly diagnosed advanced ovarian cancer, the first treatment a woman receives after surgery is known as front-line treatment. The FDA is expected to make a decision on approval by June 25, 2018.

This is part of our broader development program for Avastin in ovarian cancer. Avastin is currently approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy. In addition, Genentech is evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the Phase III IMagyn050 trial (NCT03038100).

About the GOG-0218 Study
GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.64; 95% CI 0.54 – 0.77, p<0.0001). Secondary endpoints of the study included overall survival (OS) and objective response rate (ORR). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. The study was conducted by the Gynecologic Oncology Group (GOG) and their initial results were previously published in the New England Journal of Medicine.

About Ovarian Cancer
Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2017, nearly 22,000 women will be diagnosed with ovarian cancer in the U.S. and more than 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly, and/or frequent urination, are present, they can be associated by other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

About Avastin
With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and recurrent, platinum-resistant and platinum-sensitive ovarian cancer. In addition, Avastin is approved over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal cancer, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

On October 26, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) and TESARO, Inc. (“TESARO”) reported a three-year integrated drug discovery collaboration to discover and develop novel small molecule product candidates against an undisclosed immuno-oncology (IO) target (Press release, Evotec, OCT 25, 2017, View Source [SID1234521186]).

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Under the terms of the collaboration, Evotec will apply its integrated drug discovery platform, from lead discovery through nomination of a pre-clinical development candidate, to TESARO’s translational research pipeline to advance best-in-class oncology therapies. In particular, Evotec will leverage its industry leading structural biology platform to identify novel start points to progress into a full-blown drug discovery programme.

“TESARO is excited to work with Evotec to expand our discovery capabilities against immuno-oncology targets”, said Jeffrey Hanke, Ph.D., Executive Vice President, Research and Development, and Chief Scientific Officer of TESARO. “Evotec has a proven track record of enhancing its partners’ drug discovery efforts in oncology. We look forward to working with Evotec to accelerate the identification of new therapies to help patients facing cancer.”

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: “Oncology is one of Evotec’s core therapeutic areas of focus and we are pleased to enter into this exciting and innovative partnership with TESARO, a globally recognised oncology leader and one of the fastest growing biotech companies in the USA. This collaboration further demonstrates the value of our integrated research site in Toulouse and our world-leading structural biology group in Oxford. Using our integrated drug discovery platform, we are committed to helping TESARO drive innovation in this very important field of high-unmet medical need.”
No financial details of the collaboration were disclosed.

On October 25, 2017 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 it has submitted a request for Orphan Drug Designation (ODD) to the US Food and Drug Administration (FDA) for PRP, a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen (Press release, Propanc, OCT 25, 2017, View Source [SID1234521163]). The proposed orphan drug indication for PRP is the treatment of ovarian cancer.

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“Obtaining orphan drug designation from the FDA for our PRP therapy for ovarian cancer is a significant regulatory milestone that we are looking forward to, and will be a positive step forward in Propanc Biopharma’s ongoing efforts to develop effective treatments for metastatic cancer,” said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. “This will further reinforce our strategic investment in PRP, since we already achieved ODD status for pancreatic cancer, demonstrating significant progress in developing a potential best in class therapy that could transform treatment for patients with metastatic cancers, where limited treatment options are available. At the time the ODD is granted, we expect to be working closely with the regulatory authorities and clinical trial investigators to advance PRP promptly through the next stages of clinical development, ultimately filing a clinical trial application for First-In-Human studies in the UK early next year.”

Ovarian cancer is a disease with the lowest survival rate of all gynecological cancers, making it the seventh most common cause of cancer death in women worldwide. More than 60% of women present with stage III or stage IV metastasized cancer at the time of first diagnosis and have a five-year survival of less than 20%. The therapy is very complex and presupposes expertise in both surgery and oncology. Thus, to date therapy of ovarian cancer is a challenge and prognosis is rather poor, creating a high unmet medical need for new efficacious and safe treatment options.

Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Under the ODA, orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.

The rationale for developing PRP, a formulation of the pancreatic proenzymes trypsinogen and chymotrypsinogen for intravenous administration, in the proposed indication ovarian cancer is based on a set of in-vitro studies on cancer stem cells generated from various cancer cell lines as well as xenograft and orthotopic mouse models of ovarian cancer. In summary, these data indicate that the dramatic reduction of cellular markers associated with the process of epithelial-mesenchymal transition (EMT) as a consequence of PRP treatment can not only reverse the EMT process with the implication to stop tumor progression and metastasis, but also seem to repress the development of cancer stem cells (CSCs). Consequently, these results are strong indicators of the therapeutic potential of PRP that could be categorized as an anti-CSC therapeutic drug.

Further, recent scientific evidence demonstrates that EMT and CSCs play important roles in ovarian cancer chemoresistance, one of the main challenges in the treatment of recurrent ovarian cancer and responsible for the unfavourable outcome of this disease. Treatment of EMT and CSCs thus holds promise for improving current ovarian cancer therapies and prolonging the survival of recurrent ovarian cancer patients.

Preliminary early clinical data on the treatment of six patients with ovarian cancer have also been obtained using the two pancreatic proenzymes in the context of a UK “Specials” License treatment. Together, these data support the medical plausibility of the proposed indication and a distinctive benefit-safety profile of PRP for the treatment of ovarian cancer.

Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

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.

GSK delivers Q3 sales of £7.8 billion, +4% AER, +2% CER (Press release, GlaxoSmithKline, OCT 25, 2017, View Source [SID1234521161]).

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Total EPS 24.8p, +49% AER, +46% CER; Adjusted EPS 32.5p, +3% AER, flat CER


Financial highlights


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Sales growth in Pharmaceuticals and Consumer Healthcare; Vaccines sales flat

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Pharmaceuticals sales £4.2 billion +3% AER, +2% CER; Vaccines £1.7 billion +5% AER, flat at CER; Consumer Healthcare £2.0 billion +5% AER, +2% CER

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Improved Total operating margin of 23.9% (+4.9 points, including 0.2 points currency benefit) and EPS (24.8p), primarily reflecting reduced transaction-related charges related to valuations of Consumer Healthcare and HIV businesses

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Improved Adjusted Group operating margin of 31.5% (+1.0 point, no currency effect) primarily reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.0% (-0.3 points, no currency effect); Vaccines 41.3% (+1.6 points, including 0.3 points adverse currency effect); Consumer Healthcare 20.0% (+3.9 points, including 1.3 points currency benefit)

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YTD free cash flow £1.6 billion (9 months 2016: £1.3 billion)

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19p dividend declared for quarter. Continue to expect 80p for FY 2017

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Guidance for 2017 Adjusted earnings per share growth maintained at 3% to 5% CER

Product and pipeline highlights


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New product sales of £1.7 billion, +44% AER, +40% CER, driven by continued strong performance from Tivicay/Triumeq in HIV, Relvar/Breo Ellipta and Nucala in Respiratory and meningitis vaccines

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Trelegy Ellipta approved in the US for COPD and positive opinion received in Europe. Positive results from landmark IMPACT study show benefits of Trelegy Ellipta in reducing COPD exacerbations compared to dual therapies

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Shingrix vaccine for shingles approved in US and Canada

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Phase III results for Nucala (mepolizumab) in COPD published in New England Journal of Medicine with regulatory filings planned for this year

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In Oncology, CHMP PRIME designation granted for 2857916 (BCMA antibody-drug conjugate) for relapsed and refractory multiple myeloma and new data to be presented at an upcoming scientific conference; option exercised from Adaptimmune to develop T-cell therapy (NY-ESO-1) for multiple tumour types

On October 25, 2017 Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, reported that it has closed a private placement among HBM Healthcare Investments and its current shareholders raising $50 million (Press release, Y-mAbs Therapeutics, OCT 25, 2017, View Source [SID1234521160]).

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YmAbs’ Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased to welcome HBM as a significant shareholder in YmAbs, together with our existing shareholders, who continue to show strong support and commitment to bringing breakthrough immunotherapies to children faced with advanced cancers and clear unmet medical needs. This new financing sets YmAbs in a strong financial position to further advance its late stage oncology pipeline."

Dr. Claus Møller, Chief Executive Officer further notes, "This funding is an important financial achievement for YmAbs, and enables us to focus on bringing our lead compounds, burtomab and naxitamab, through the final steps of the regulatory pathway towards approval."

Andreas Wicki, Chief Executive Officer of HBM Healthcare Investments added: "We are delighted to add YmAbs to our portfolio of promising healthcare companies. YmAbs’ approach to immunotherapy shows great promise and will further advance innovation and product development in the pediatric oncology field. YmAbs is a young and rapidly growing company that we are excited to support and to accompany on the way to further success."