On October 116, 2018 AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) reported that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer (Press release, AstraZeneca, OCT 16, 2018, View Source [SID1234530239]).

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Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US.i Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease.ii Five-year survival rates remain low in the US at 8.5%.iii

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer said: "Pancreatic cancer is an area of significant unmet medical need. This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, at MSD Research Laboratories, said: "Pancreatic cancer is a relatively less common, but life-threatening, form of cancer. The FDA granting Orphan Drug Designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need."

ODD status was granted for the treatment of ovarian cancer in October 2013. Earlier this year an amended ODD status was granted to include both fallopian tube and primary peritoneal cancers following the expanded US approval of Lynparza in August 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

The use of Lynparza in pancreatic cancer is being assessed in the ongoing Phase III POLO trial, which is testing Lynparza as maintenance monotherapy vs placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. Results from the POLO trial are expected in the first half of 2019.

About the POLO Phase III trial

POLO is a Phase III, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of Lynparza tablets (300 mg twice daily) as maintenance monotherapy compared with placebo, in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. The trial randomised 145 patients to receive Lynparza or placebo (3:2). The primary endpoint is progression-free survival.

About Lynparza

Lynparza (olaparib) was the first in class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP-enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.

Lynparza, which has the broadest clinical development programme of any PARP inhibitor, is being investigated in a range of DDR-deficient tumour types, and is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.

About the AstraZeneca and MSD Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On October 16, 2018 JHL Biotech reported that the National Medical Products Administration of the PRC (NMPA) has approved JHL’s Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer (Press release, JHL Biotech, OCT 16, 2018, View Source [SID1234530227]).

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Racho Jordanov, JHL Biotech, Co-Chairman and CEO stated, "We are very excited for our second biosimilar to be approved for clinical trials by the NMPA. This marks the second NMPA approval we have received in just four months and puts us another step closer to our vision of manufacturing biologics of the highest quality from
China for the world."

On October 16, 2018 Fresenius reported that it has confirms and narrows its Group guidance1 for FY/18. Group sales are expected to increase at the low end of the original 5% to 8%2 guidance range (in constant currency) (Press release, Fresenius, OCT 16, 2018, View Source [SID1234530132]). Fresenius expects net income3,4 growth at the low end of the original 6% to 9% guidance range (in constant currency). Excluding expenditures for the further development of the biosimilars business, net income3,5 growth is projected at the low end of the original ~10% to 13% guidance range (in constant currency). Narrowing the Group guidance ranges is due to updated expectations at Fresenius Medical Care, Fresenius Kabi and Fresenius Helios.

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Fresenius Medical Care adjusts its outlook for FY/18 as the business development in Q3/18 was below the company’s expectations. Fresenius Medical Care now expects sales growth of 2% to 3%6 in constant currency (previously: 5% to 7%6). Whilst Fresenius Kabi confirms its guidance of 4% to 7% organic sales growth, it now expects to reach the top end of this range. Fresenius Kabi sees a strong development across all product lines and regions with North America standing out. Fresenius Helios confirms and narrows its FY/18 organic sales growth outlook, and now projects growth at the low end of the original 3% to 6% range. The business development in Germany in Q3/18 was below the company’s expectations mainly due to a decline in admissions and additional catalogue effects. In line with market development in Germany, Fresenius Helios sees a trend towards outpatient treatments leading to fewer admissions in its hospitals.

On a comparable basis8, Fresenius Medical Care now expects FY/18 net income7 to increase by 11% to 12%8 in constant currency (previously: 13% to 15%8). On an adjusted basis9, Fresenius Medical Care now expects FY/18 net income7 to increase by 2% to 3%9 in constant currency (previously: 7% to 9%9). Fresenius Kabi increases its FY/18 EBIT outlook and now expects 1% to 3%10 growth in constant currency (previously: -2% to +1%10). The increase is driven by a strong development across all product lines and regions with North America standing out. FY/18 EBIT excluding expenditures for the further development of the biosimilars business is now expected to grow by ~9% to 11%11 in constant currency (previously: ~6% to 9%11). Fresenius Helios adjusts its FY/18 EBIT outlook and now expects 0% to 2% growth (previously: 5% to 8%), driven by lower sales growth in Germany. Moreover, preparatory structural activities for anticipated regulatory requirements (e.g. clustering), as well as a lack of privatization opportunities in the German market continue to weigh on earnings growth.

Fresenius Vamed confirms its outlook for FY/18 and expects organic sales growth in the range of 5% to 10% and FY/18 EBIT growth of 32% to 37%. The integration of the inpatient post-acute care business acquired from Helios Germany is fully on track.

Q3/2018 preliminary financial results

In Q3/18, Fresenius Group sales increased by ~3%12 (~4%12 in constant currency) to ~€8.2 billion (Q3/2017: €8.297 billion). Group net income3 before special items13 increased by ~8% (~8% in constant currency) to ~€445 million (Q3/2017: €413 million). Fresenius Medical Care has increased the provision for the FCPA (Foreign Corrupt Practices Act) related charge by €75 million (not tax deductible). As in 2017, this charge is treated as a special item. Group net income3 before special items13 and before expenses for the further development of the biosimilars business increased by ~13% (~13% in constant currency) to ~€474 million (Q3/2017: €423 million).

Fresenius will publish its detailed Q3/18 and Q1-Q3/18 financial results on October 30, 2018.

On October 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported the first patient has been dosed in a Phase 3 clinical trial of avasopasem manganese (GC4419) to reduce the incidence and severity of severe oral mucositis (SOM) in patients with head and neck cancer, its lead indication (Press release, Galera Therapeutics, OCT 16, 2018, View Source [SID1234530125]).

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The trial, "ROMAN: Reduction in Oral Mucositis with Avasopasem maNganese (GC4419)—Phase 3 trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer," is a randomized, double blind, placebo-controlled trial designed to evaluate the ability of avasopasem manganese to reduce the incidence and severity of radiation-induced SOM in adult patients with locally advanced, non-metastatic squamous cell head and neck cancer receiving seven weeks of radiation therapy plus cisplatin. In the United States, more than 50 percent of patients with cancer receive radiotherapy at some time in their treatment. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy develop SOM, as defined by the World Health Organization as Grade 3 or 4, which is the most debilitating side effect of the radiotherapy. There is currently no drug approved to prevent or treat SOM.

"This Phase 3 ROMAN trial of avasopasem manganese aims to confirm the statistically significant efficacy seen in our Phase 2b trial in a larger patient population, to ultimately support the submission of a New Drug Application to the U.S. Food and Drug Administration," said Jon T. Holmlund, M.D., Chief Medical Officer of Galera. "We are proud of our team for their incredible work getting this Phase 3 trial underway, bringing avasopasem manganese one step closer to addressing the urgent need for a treatment option for severe oral mucositis."

Patients in the pivotal trial will receive 90 mg of avasopasem manganese or placebo by infusion on the days they receive their radiation treatment. Patients will be randomized to one of the two treatment groups (3:2) and the trial will recruit approximately 335 patients across more than 70 trial sites in the U.S. and Canada. The primary endpoint will be the reduction in the incidence of SOM through treatment period, and the secondary endpoint will be the reduction in the severity of SOM. The trial will also assess the safety and tolerability of avasopasem manganese. Patients will be followed for tumor progression and overall survival.

"Our meetings with both the FDA and European Medicines Agency have been productive and have provided a clear path for the registration of avasopasem manganese," said Mel Sorensen, M.D., President and CEO of Galera. "We are pleased that avasopasem manganese has now entered the final stage of clinical development and look forward to collaborating with patients and their doctors in enrolling and completing this Phase 3 trial. We anticipate enrollment to take less than two years, and we will refine our timeline as the trial progresses."

About Avasopasem Manganese

Avasopasem manganese (GC4419) is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. It works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

Avasopasem manganese is being studied in the Phase 3 ROMAN trial of patients with head and neck cancer, its lead indication, for its ability to reduce the incidence and severity of radiation-induced severe oral mucositis. In Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial, avasopasem manganese demonstrated the ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. Avasopasem manganese is also currently being studied in combination with SBRT for its anti-tumor effect in a Phase 1/2 trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, it demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The FDA granted Breakthrough Therapy designation to avasopasem manganese for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to avasopasem manganese for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

About Oral Mucositis

Oral mucositis (OM) is a painful and problematic complication during cancer treatment, especially radiation therapy, caused by excessive superoxide generated during treatment that breaks down epithelial cells that line the mouth. Patients suffering from OM experience severe pain, inflammation, ulceration and bleeding of the mouth.

In the United States, more than 50 percent of patients with cancer receive radiotherapy at some time in their treatment. In patients with head and neck cancer, radiotherapy is a mainstay of treatment and approximately 70 percent of patients receiving radiotherapy develop severe oral mucositis (SOM) as defined by the World Health Organization as Grade 3 or 4, which is the most debilitating side effect of the radiotherapy.

SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. SOM may also inhibit patients’ ability to eat solid food or even drink liquids, and can cause serious infections. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. There is currently no drug approved to prevent or treat SOM in patients with head and neck cancer.

On October 16, 2018 MabVax Therapeutics Holdings, Inc. (OTC: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs, reported that the Company’s audited financial statements for 2017 and 2016 have been re-instated and brought current in quarterly filings with the Securities and Exchange Commission (the "SEC") (Press release, MabVax, OCT 16, 2018, View Source [SID1234530126]). The re-instatement of audited financial statements was made possible through the combined efforts of the Company working with its prior auditors to bring current their procedures through last Friday, a requirement necessary to reinstate the audited financial statements. What made the re-instatement possible is that the Court of Chancery of the State of Delaware (the "Court") on September 20, 2018, granted the Company’s Verified Petition for Relief Under 8 Del. C. § 205, captioned In re: MabVax Therapeutics Holdings, Inc., C.A. No. 2018-0549-TMR (the "Delaware Petition"), as submitted, and entered an order validating (i) conversions of the Company’s preferred stock into common stock that occurred between June 30, 2014 and February 12, 2018 and (ii) corporate acts that occurred during the same time period that we believed were approved by our stockholders but that, for reasons described in the Delaware Petition, may not have been approved by the requisite percentage of stockholder voting power during the same time period.

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

David Hansen, the Company’s President and CEO, commented, "The re-instatement of audited financial statements was an important step in enabling us to file our financial reports and becoming a current reporting company, which included our filing of both our annual report and our first and second quarter 10-Qs yesterday. Our next step will be to submit our application to the OTCQB market place. We remain focused on achieving our objectives, which are to continue overcoming recent challenges faced by the Company and to build shareholder value that will attract the interest of new potential partners."