On October 31, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized radiofrequency ablation (RFA) in intermediate primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, OCT 31, 2016, View Source [SID1234516112]). The clinical data were presented by a leading liver cancer expert from South Korea, Professor Won Young Tak, M.D., Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea, on October 29, 2016 at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea. Dr. Hyunchul Rhim from Samsung Medical Center in Soeul, Korea, is the Chairman of the 3rd ACTA Conference and a principal investigator on the Company’s OPTIMA Study.

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Professor Tak’s presentation, entitled "Thermo-Sensitive Drug Assisted Ablation," highlighted data from Celsion’s latest HEAT Study post-hoc analysis, which suggests an overall survival benefit of over two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA ≥ 45 minutes) as well as findings from preclinical studies demonstrating a direct correlation between the duration of RFA heating, or dwell time, and the concentration of doxorubicin localized to the liver.

"There is clear evidence that the duration of the RFA regimen is critical when treating patients with ThermoDox, and the totality of the data presented to date demonstrate that ThermoDox plus optimized RFA has a strong potential to serve as a curative therapy for patients with liver cancer," said Professor Tak, lead investigator in South Korea for the Company’s HEAT and OPTIMA studies. "The OPTIMA trial is designed to validate this approach in an indication where there exists a strong unmet need for effective treatment options."

The Phase III OPTIMA study is a global pivotal, double-blind, placebo-controlled study evaluating ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone.

"Our OPTIMA Study investigators continue to recognize the value of findings from the HEAT study, and their continued interest reinforces substantial and mounting support for and the de-risking of our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of RFA for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Professor Tak’s presentation will be available on Celsion’s website under "News & Events – Scientific Presentations."
Celsion notes that NIH’s analysis will be discussed in detail during an oral session on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

About Celsion’s Phase III OPTIMA Study
Celsion’s Phase III OPTIMA Study is a global pivotal, double-blind, placebo-controlled study. The study is expected to enroll up to 550 patients in over 75 clinical sites in the North America, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan for the OPTIMA Study calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

On 29 October 2016, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH, 02196.HK) reported in its A-share announcement that Shanghai Henlius Biotech Inc. ("Henlius"), a holding subsidiary under its control, and AbClon Inc. ("AbClon") from Korea entered into a license agreement for monoclonal antibody AC101 (Press release, Fosun Pharmaceutical, OCT 31, 2016, View Source [SID1234517344]).

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AC101, an innovative monoclonal antibody developed by AbClon targeting gastric cancer and breast cancer, is currently under pre-clinical trial studies. Under the agreement, Henlius is granted the exclusive rights to develop and commercialize AC101 across the Great China region. This cooperation will put into play techniques and advantages of Henlius as an existing monoclonal antibody development platform of Fosun Pharma in further diversifying its product lines to enhance its competitiveness in the anti-tumor therapeutic area.

AC101 is the first novel monoclonal antibody discovered using AbClon’s proprietary antibody development platform New Epitope Screening Technology (Nest). Currently there is no similar product in any market worldwide. According to statistics from Global Data, the gastric cancer treatment market is projected to reach US$4.4 billion globally by the year 2024, and the HER2-positive breast cancer treatment market to reach US$12.7 billion by the year 2023.

At present, AC101 is still under pre-clinical trial studies and it is uncertain that it will be able to start clinical trials. Any clinical trial, registration, manufacture and other matters in relation to it in the relevant region is subject to approval of relevant pharmaceutical authorities.

Dr. Scott Liu, President and CEO of Shanghai Henlius indicated that, "Shanghai Henlius’ mission is to provide high-quality, affordable and accessible healthcare products worldwide. We are very excited to add another promising antibody product to our expanding portfolio. We believe AC101 in combination with the proprietary recombinant humanized anti-HER2 monoclonal antibody injection (trastuzumab biosimilar) developed by Henlius will enhance the efficacy against gastric cancer and breast cancer." Phase I clinical study for the proprietary recombinant humanized anti-HER2 monoclonal antibody (trastuzumab biosimilar) developed by Henlius has been completed and the results show that the new drug is safe and has the same efficacy as the corresponding proprietary drug Herceptin. Phase III clinical trial for the new drug will commence within this year.

Dr. Jong-Seo Lee, CEO of AbClon, also expressed his delight in having a licensing deal with Henlius, one of the most prominent monoclonal antibody pharmaceutical companies in China, and he looked forward to more partnerships with premier biopharmaceutical companies such as Henlius.

On September 30, 2016 MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, reported its financial results for the first half of 2016, ending on June 30, 2016, and operative highlights (Press release, MagForce, OCT 30, 2016, View Source [SID:SID1234515523]).

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Operative Highlights:

Brain Cancer NanoTherm(TM) Therapy at MagForce AG

In Europe, MagForce AG is continuing to expand the commercialization phase of its valuable NanoTherm(TM) therapy: The first phase was to install NanoActivators(R) in Germany and assist the neurosurgeons and radiologists as they became familiar with NanoTherm(TM) therapy and its applicability. The second phase was to initiate the Company’s commercialization efforts with the goal of increasing patient inquiries to 100 per month. The combination of clinical success and marketing efforts will result in the Company achieving the targeted patient inquiry level. MagForce is currently half way there. In the third phase, cross-border reimbursement processes have been optimized based on the fact that a majority of the patients requesting treatment require the implementation of the Cross-Border Directive of the European Union. However, the medical procedure for treating glioblastoma generally requires surgery and radiation resulting in the patient’s obligation to fund the country differential costs for surgery and radiation in his home country and the higher costs for these treatments in Germany, as well as for the NanoTherm(TM) therapy.

During 2016, MagForce has streamlined the implementation of the cross- border reimbursement process, however, due to the aggressiveness of glioblastoma, there is a limited time interval to achieve treatment. Toward that end, the Company will continue its efforts to increase the medical awareness of the value of NanoTherm(TM) therapy to allow earlier patient inquiries.

Phase four of the Commercialization Program will be to obtain domestic reimbursement for NanoTherm(TM) therapy in Germany and selected countries in the EU where MagForce has the CE Mark for the treatment of brain tumors.

As mentioned three months ago, Management is actively exploring financing options, such as third-party leases of NanoActivator(R) equipment, or other non-equity financing options in order to further accelerate MagForce’s expansion in Europe.

Prostate Cancer Therapy at MagForce USA, Inc.

In the USA, MagForce USA, Inc.’s has filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA) for NanoTherm(TM) therapy to treat Intermediate Risk Prostate Cancer in 2015. MagForce is still working with the FDA to update preclinical studies, which were conducted approximately ten years ago, to current US regulatory standards and continues making very good progress toward adapting NanoTherm(TM) therapy as a focal treatment for prostate cancer. NanoTherm(TM) therapy for the focal treatment of prostate cancer is viewed as a very promising complement to current treatment approaches. These preclinical studies are underway with interim results clearly supporting the earlier European data.

The purpose of the proposed Focal Thermal Ablation Registration study that will enroll up to 120 men is to demonstrate that NanoTherm(TM) can ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance. By ablating the lesions, patients will be able to maintain active surveillance and avoid surgery and other treatments with their well-known side effects.

"I am still confident we will achieve our original targets in terms of market entry and commercialization of NanoTherm(TM) therapy in the USA because we clearly have a "time safety factor" built in our business plan, plus we have accelerated the ambulatory prostate NanoActivator(R) chair development to ensure timely delivery of this device. In Europe, our commercial treatment rate is still too slow but the medical results are very gratifying. The experiences we made from our commercialization efforts over the past 18 months pinpointed how to reach our commercialization targets, and we are enforcing the respective implementation. We are on the right path and overall making progress with our brain cancer Commercialization Program in Europe," commented Dr. Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc. "In summary, I am very optimistic that MagForce will develop and expand our NanoTherm(TM) therapy into a valued therapy for the treatments of brain cancer and prostate cancer and move towards achieving the goals set in the five year target plan. The growing interest in applying NanoTherm(TM) therapy for the treatment of brain tumors and the progress of our work with the FDA are very encouraging. Thus, we are successfully moving forward on our exciting and challenging path."

Financial Results and Outlook:

Results of operations, net assets and financial position

MagForce adopted new revenue reporting rules for periods starting after December 31, 2015. In addition, MagForce reports for the first time Non- GAAP financial measures that are used by MagForce’s management to make operating decisions, as they facilitate internal comparisons of MagForce’s performance to historical results. MagForce’s management believes that Non- GAAP measures provide investors with means of evaluating, and an understanding of how MagForce’s management evaluates, MagForce’s performance and results on a comparable basis that is not otherwise apparent on a German GAAP basis, since many non-recurring, infrequent or non-cash items that MagForce’s management believes to be not indicative of the core performance of the business may not be excluded when preparing financial measures under German GAAP.

These Non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with German GAAP.

Due to the adoption of new revenue reporting rules (sec. 277 para. 1 HGB as amended by BilRuG) for periods starting after December 31, 2015, revenue includes also management recharges to subsidiaries that were included in other operating income in prior years. For additional information we refer to the Notes to the Interim Financial Statements.

Net loss (prior year: profit) for the first half year was EUR 3.2 million (prior year: EUR 0.5 million) while Non-GAAP net loss slightly decreased for the half year by EUR 0.1 million to EUR 2.2 million (prior year: EUR 2.3 million).

Compared to the prior year reporting period personnel expenses increased by EUR 0.2 million to EUR 1.7 million chiefly due to the formation of a new commercial team to accelerate the Company’s efforts to establish NanoTherm(TM) therapy in Germany and the EU. The additional expenses attached to this indispensable staffing were compensated by frugal use of MagForce’s resources in other areas of controllable expense spending.

Revenues and other operating income amounted to EUR 0.7 milllion (prior year: EUR 4.9 million), while Non-GAAP revenue and other operating income increased by EUR 0.1 million to EUR 0.7 million (prior year: EUR 0.6 million). Revenues and other operating income include revenues from commercial treatment of patients with NanoTherm(TM) therapy on a cash basis as well as reimbursement of treatment costs by third parties and recharges to subsidiaries. The Non-GAAP increase chiefly stems from higher personnel recharges to subsidiaries of EUR 0.4 million compared to EUR 0.3 million in the prior year period.

Revenue and other operating income were adjusted to Non-GAAP for the extension of the distribution and development rights for the countries Canada and Mexico in January 2015 amounting to EUR 3.0 million as well as the sale of two NanoActivator(R) devices to MagForce USA, Inc. in the first half year of 2015 in the amount of EUR 1.2 million. Revenue includes also management recharges to subsidiaries that were included in other operating income in prior years.

Cash outflows from operating activities amounted to EUR -3.4 million (prior year: EUR -3.8 million). Cash inflows from investing activities amounted to EUR 3.1 million (prior year: EUR 0.1 million), and cash flows from financing activities amounted to EUR 2.3 million (prior year: EUR nil).

Liquid funds of the Company including cash and cash equivalents of EUR 3.4 million (December 31, 2015: EUR 1.4 million) as well as short term loans of EUR nil (December 31, 2015: EUR 3.1 million) amounted to EUR 3.4 million at the end of the period (December 31, 2015: EUR 4.5 million).

On September 30, 2016 MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, reported its financial results for the first half of 2016, ending on June 30, 2016, and operative highlights (Press release, MagForce, OCT 30, 2016, View Source [SID:SID1234515523]).

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Operative Highlights:

Brain Cancer NanoTherm(TM) Therapy at MagForce AG

In Europe, MagForce AG is continuing to expand the commercialization phase of its valuable NanoTherm(TM) therapy: The first phase was to install NanoActivators(R) in Germany and assist the neurosurgeons and radiologists as they became familiar with NanoTherm(TM) therapy and its applicability. The second phase was to initiate the Company’s commercialization efforts with the goal of increasing patient inquiries to 100 per month. The combination of clinical success and marketing efforts will result in the Company achieving the targeted patient inquiry level. MagForce is currently half way there. In the third phase, cross-border reimbursement processes have been optimized based on the fact that a majority of the patients requesting treatment require the implementation of the Cross-Border Directive of the European Union. However, the medical procedure for treating glioblastoma generally requires surgery and radiation resulting in the patient’s obligation to fund the country differential costs for surgery and radiation in his home country and the higher costs for these treatments in Germany, as well as for the NanoTherm(TM) therapy.

During 2016, MagForce has streamlined the implementation of the cross- border reimbursement process, however, due to the aggressiveness of glioblastoma, there is a limited time interval to achieve treatment. Toward that end, the Company will continue its efforts to increase the medical awareness of the value of NanoTherm(TM) therapy to allow earlier patient inquiries.

Phase four of the Commercialization Program will be to obtain domestic reimbursement for NanoTherm(TM) therapy in Germany and selected countries in the EU where MagForce has the CE Mark for the treatment of brain tumors.

As mentioned three months ago, Management is actively exploring financing options, such as third-party leases of NanoActivator(R) equipment, or other non-equity financing options in order to further accelerate MagForce’s expansion in Europe.

Prostate Cancer Therapy at MagForce USA, Inc.

In the USA, MagForce USA, Inc.’s has filed an Investigational Device Exemption (IDE) with the USA Food and Drug Administration (FDA) for NanoTherm(TM) therapy to treat Intermediate Risk Prostate Cancer in 2015. MagForce is still working with the FDA to update preclinical studies, which were conducted approximately ten years ago, to current US regulatory standards and continues making very good progress toward adapting NanoTherm(TM) therapy as a focal treatment for prostate cancer. NanoTherm(TM) therapy for the focal treatment of prostate cancer is viewed as a very promising complement to current treatment approaches. These preclinical studies are underway with interim results clearly supporting the earlier European data.

The purpose of the proposed Focal Thermal Ablation Registration study that will enroll up to 120 men is to demonstrate that NanoTherm(TM) can ablate cancer lesions for patients who have Gleason Score 7 prostate cancer and are under active surveillance. By ablating the lesions, patients will be able to maintain active surveillance and avoid surgery and other treatments with their well-known side effects.

"I am still confident we will achieve our original targets in terms of market entry and commercialization of NanoTherm(TM) therapy in the USA because we clearly have a "time safety factor" built in our business plan, plus we have accelerated the ambulatory prostate NanoActivator(R) chair development to ensure timely delivery of this device. In Europe, our commercial treatment rate is still too slow but the medical results are very gratifying. The experiences we made from our commercialization efforts over the past 18 months pinpointed how to reach our commercialization targets, and we are enforcing the respective implementation. We are on the right path and overall making progress with our brain cancer Commercialization Program in Europe," commented Dr. Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc. "In summary, I am very optimistic that MagForce will develop and expand our NanoTherm(TM) therapy into a valued therapy for the treatments of brain cancer and prostate cancer and move towards achieving the goals set in the five year target plan. The growing interest in applying NanoTherm(TM) therapy for the treatment of brain tumors and the progress of our work with the FDA are very encouraging. Thus, we are successfully moving forward on our exciting and challenging path."

Financial Results and Outlook:

Results of operations, net assets and financial position

MagForce adopted new revenue reporting rules for periods starting after December 31, 2015. In addition, MagForce reports for the first time Non- GAAP financial measures that are used by MagForce’s management to make operating decisions, as they facilitate internal comparisons of MagForce’s performance to historical results. MagForce’s management believes that Non- GAAP measures provide investors with means of evaluating, and an understanding of how MagForce’s management evaluates, MagForce’s performance and results on a comparable basis that is not otherwise apparent on a German GAAP basis, since many non-recurring, infrequent or non-cash items that MagForce’s management believes to be not indicative of the core performance of the business may not be excluded when preparing financial measures under German GAAP.

These Non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with German GAAP.

Due to the adoption of new revenue reporting rules (sec. 277 para. 1 HGB as amended by BilRuG) for periods starting after December 31, 2015, revenue includes also management recharges to subsidiaries that were included in other operating income in prior years. For additional information we refer to the Notes to the Interim Financial Statements.

Net loss (prior year: profit) for the first half year was EUR 3.2 million (prior year: EUR 0.5 million) while Non-GAAP net loss slightly decreased for the half year by EUR 0.1 million to EUR 2.2 million (prior year: EUR 2.3 million).

Compared to the prior year reporting period personnel expenses increased by EUR 0.2 million to EUR 1.7 million chiefly due to the formation of a new commercial team to accelerate the Company’s efforts to establish NanoTherm(TM) therapy in Germany and the EU. The additional expenses attached to this indispensable staffing were compensated by frugal use of MagForce’s resources in other areas of controllable expense spending.

Revenues and other operating income amounted to EUR 0.7 milllion (prior year: EUR 4.9 million), while Non-GAAP revenue and other operating income increased by EUR 0.1 million to EUR 0.7 million (prior year: EUR 0.6 million). Revenues and other operating income include revenues from commercial treatment of patients with NanoTherm(TM) therapy on a cash basis as well as reimbursement of treatment costs by third parties and recharges to subsidiaries. The Non-GAAP increase chiefly stems from higher personnel recharges to subsidiaries of EUR 0.4 million compared to EUR 0.3 million in the prior year period.

Revenue and other operating income were adjusted to Non-GAAP for the extension of the distribution and development rights for the countries Canada and Mexico in January 2015 amounting to EUR 3.0 million as well as the sale of two NanoActivator(R) devices to MagForce USA, Inc. in the first half year of 2015 in the amount of EUR 1.2 million. Revenue includes also management recharges to subsidiaries that were included in other operating income in prior years.

Cash outflows from operating activities amounted to EUR -3.4 million (prior year: EUR -3.8 million). Cash inflows from investing activities amounted to EUR 3.1 million (prior year: EUR 0.1 million), and cash flows from financing activities amounted to EUR 2.3 million (prior year: EUR nil).

Liquid funds of the Company including cash and cash equivalents of EUR 3.4 million (December 31, 2015: EUR 1.4 million) as well as short term loans of EUR nil (December 31, 2015: EUR 3.1 million) amounted to EUR 3.4 million at the end of the period (December 31, 2015: EUR 4.5 million).

On October 28, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported five data presentations will be delivered at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, which will be held November 9-13, 2016 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland (Press release, Nektar Therapeutics, OCT 28, 2016, View Source [SID1234516075]). Investigators and researchers will present new clinical and preclinical data on NKTR-214, the Company’s immuno-stimulatory CD122-biased agonist, as well as preclinical data on NKTR-255, the Company’s IL-15 therapeutic candidate.

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Details of the oral clinical data presentation are as follows:

Title: A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: New Cancer Immunotherapy Agents in Development
Date: Wednesday, November 9, 2016, 11:10 a.m. – 12:20 p.m. Eastern Time

Details of the poster clinical data presentation are as follows:

Poster 387: A CD122-biased agonist increases CD8+T Cells and natural killer cells in the tumor microenvironment; making cold tumors hot with NKTR-214
Session: Tumor Microenvironment
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Details of the poster preclinical data presentations are as follows:

Poster 343: Anti-tumor activity of NKTR-214; a CD122-biased agonist that promotes immune cell activation in the tumor microenvironment and lymphoid tissues
Session: Promoting and Measuring Anti-Tumor Activity
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Poster 359: NKTR-214, an engineered cytokine, synergizes and improves efficacy of anti-cancer vaccination in the treatment of established murine melanoma tumors
Session: Therapeutic Cancer Vaccines
Date: Friday, November 11, 2016, 12:15 – 1:30 p.m. and 6:15 – 7:30 p.m. Eastern Time

Poster 342: NKTR-255: an IL-15-based therapeutic with optimized biological activity and anti-tumor efficacy
Session: Promoting and Measuring Anti-Tumor Activity
Date: Saturday, November 12, 2016, 11:45 a.m. – 1:00 p.m. and 6:45 – 8:00 p.m. Eastern Time