October 2018 – Page 80 – 1stOncology™: Cancer Intelligence Service

Fresenius confirms and narrows Group guidance for FY/18 and publishes preliminary results for Q3/18

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.

Galera Therapeutics Announces Dosing of First Patient in Pivotal Phase 3 ‘ROMAN’ Clinical Trial of Avasopasem Manganese (GC4419)

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]).

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.

MabVax Therapeutics Audited Financial Statements Reinstated

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.

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."

Catalent And Verastem Oncology Partner On Newly Launched, FDA Approved COPIKTRA™ (duvelisib) Capsules

On October 16, 2018 Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, reported it welcomed the approval of Verastem Oncology’s COPIKTRA (duvelisib) capsules by the U.S. Food and Drug Administration (FDA) (Press release, Catalent, OCT 16, 2018, https://www.catalent.com/index.php/news-events/news/Catalent-and-Verastem-Oncology-Partner-on-Newly-Launched-FDA-Approved-COPIKTRA-duvelisib-Capsules [SID1234530088]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.

COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Catalent has had a multi-year collaboration with Verastem Oncology, initially providing development and analytical support, and later clinical development and manufacturing services from its facility at Kansas City, Missouri.

"We are proud to partner with Verastem as part of the team delivering COPIKTRA capsules to patients. Catalent’s Kansas City facility is focused on oral and biologic programs, primarily with smaller pharmaceutical firms, to deliver products to patients with poorly met or unmet disease states," commented Matt Mollan, Catalent’s General Manager at Kansas City. "Like Verastem, Catalent is committed to advancing therapies with the potential to make a significant impact for patients, their caregivers and physicians. We look forward to building on this strong relationship through supplying clinical trial materials as well as commercial manufacturing and testing."

Robert Forrester, President and Chief Executive Officer of Verastem Oncology, added, "We selected Catalent as our development partner because of their experience and record of bringing similar therapies through clinical trials and on to successful commercialization. We are pleased to partner with Catalent in order to deliver this important new medicine to patients."

Catalent’s 450,000 square-feet Kansas City, Missouri facility provides a range of fully integrated support services, from formulation development and analytical testing, to clinical- and commercial-scale manufacturing and packaging of various oral dose forms.

Use of COPIKTRA is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

ICYMI…Immunomic Therapeutics Presents at the 2018 BIO Investor Forum…Watch webcast here

On October 16, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company reported that it will presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18 (Press release, Immunomics, OCT 16, 2018, View Source [SID1234530090]). William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18. William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.