On May 11, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 31, 2018 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAY 11, 2018, View Source [SID1234526538]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of ovarian cancer.

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"Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1. With sound fundamentals and a strong balance sheet, we are well positioned to complete enrollment in our ongoing 550 patient global, pivotal Phase III OPTIMA Study in primary liver cancer and to initiate our 130 patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer in June 2018 and reporting clinical findings from the Phase I cohort of 12 patients of the OVATION II by the end of 2018," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our GEN-1 immunotherapy has generated impressive results to-date. We expect to report final progression-free survival data from our Phase IB clinical trial (the OVATION I Study) by the end of the second quarter of 2018. These data will provide additional insights into GEN-1’s clinical and safety profile and reinforce our confidence in GEN-1’s potential to serve as a highly effective first-line therapy in newly diagnosed patients with ovarian cancer."

Recent Developments

ThermoDox

ThermoDox Highlighted at the International Liver Congress 2018 Symposium. On April 12, 2018, the Company announced a presentation and discussion of ThermoDox and the evolving treatment landscape for primary liver cancer or hepatocellular carcinoma (HCC), as part of a company-sponsored symposium at the International Liver Congress 2018, in Paris, France. The symposium titled, "Emerging Horizons in HCC: From Palliation to Cure," featured presentations by co-chairs and HCC experts, Ghassan Abou-Alfa, M.D., a board-certified medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, and Riccardo Lencioni, M.D., FSIR, EBIR, professor at the University of Pisa School of Medicine.

Dr. Abou-Alfa’s presentation, "New Developments in Targeted Therapies for HCC: The Mounting Wave of Immuno-Oncology," discussed recent developments in treating HCC, including the role of tyrosine kinase inhibitors (TKIs), immuno-oncology and CAR-T therapies, as well as advancements in chemotherapy and combination treatment with local therapy. Prof. Lencioni’s presentation, "Rethinking Our Approach to Intermediate-Size HCC" focused on the increasing incidence and burden of HCC globally, the limited overall survival benefit with current therapies at later stages of disease progression, and the potential for ThermoDox to provide enhanced survival benefit with standardized radiofrequency ablation. The slides from Prof. Lencioni’s presentation are available on Celsion’s corporate website at www.celsion.com.

Data Monitoring Committee Unanimously Recommended Continuation of the OPTIMA Study in Primary Liver after its Planned Safety and Data Review from 411 Patients; Enrollment Now at 85%. On April 9, 2018, the Company announced that the independent Data Monitoring Committee for the Company’s 550-patient, pivotal Phase III clinical study of ThermoDox in combination with radiofrequency ablation for primary liver cancer (the OPTIMA Study), unanimously recommended that the study continue according to protocol to its data readout. The DMC’s recommendation was based on the Committee’s assessment of safety and data integrity of the first 75% of patients randomized in the trial as of February 5, 2018 and concluded that the integrity of the study is intact and that ThermoDox is safe for continued enrollment of newly diagnosed, intermediate-stage patients. An analysis of blinded data from the intent-to-treat population, consolidated for both arms, indicated that median progression free survival (PFS) was 20.8 months. This compares favorably to the HEAT Study median PFS of 13.8 months and is consistent with the hypothesis-generating estimates from the HEAT Study manuscript published in the October 2017 issue of the peer-reviewed medical journal, ‘Clinical Cancer Research.’ The OPTIMA Study’s design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.

The DMC analysis in April 2018 was the last planned interim analysis prior to enrollment completion in the third quarter of 2018 with results from the first interim efficacy analysis available in the first half of 2019.

Presentation of ThermoDox HEAT Study Manuscript by Lead Author, Dr. Won Young Tak, at Korean Liver Cancer Association’s 12th Annual Scientific Meeting. On Feb. 12, 2018, the Company announced that an abstract discussing the Company’s Phase III HEAT study evaluating ThermoDox in combination with radiofrequency ablation was one of six selected for presentation as part of the lecture of the Presidential Selection at the Korean Liver Cancer Association’s 12th Annual Scientific Meeting in Seoul, South Korea. Dr. Tak’s presentation highlighted learnings from the Company’s 701 patient HEAT Study and included results from simulation studies and findings from the post hoc subgroup analysis. Dr. Tak noted that key findings from the study and analyses of ThermoDox plus RFA suggested that the therapeutic effect of ThermoDox plus RFA may be improved when the RFA dwell time for solitary lesions is greater than or equal to 45 minutes.

Dr. Tak’s presentation explored the hypothesis prompted by these findings: ThermoDox, when used in combination with RFA standardized to a minimum dwell time of 45 minutes (sRFA ≥ 45 min), may increase the overall survival (OS) of patients with hepatocellular carcinoma. The final OS analysis from the HEAT Study demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox and standardized RFA provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) was 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox plus standardized RFA group translated into a 25.4-month (more than 2.1 years) survival benefit over the standardized RFA-only group – totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox plus standardized RFA group versus 53 months for the standardized RFA-only group.

GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program and Recent Clinical and Translation Research Data by Ovarian Cancer Expert at Oppenheimer & Co. Investor Event. On March 5, 2018, the Company announced that Premal H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, and investigator in Celsion’s GEN-1 development program presented, "Ovarian Cancer: New Horizons and Treatments" at an investor event hosted by Oppenheimer & Co. in New York City on March 1, 2018.

Dr. Thaker’s presentation highlighted the following:

GEN-1 is a novel new approach that is designed to deploy the anti-cancer mechanism of the potent, broad-spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein.

In a Phase I study of GEN-1, 14 newly diagnosed patients with Stage III/IV ovarian cancer were intraperitoneally administered GEN-1 plus neoadjuvant chemotherapy. Results from the study demonstrated immunological changes consistent with the ability of GEN-1 to increase local (peritoneal) levels of IL-12 and its downstream anti-cancer cytokines and reduction in vascular endothelial growth factor (VEGF; potent angiogenic factor that contributes to tumor angiogenesis) levels with little change in systemic circulation.

The study showed no serious systemic toxicities. These clinical findings, including a partial or complete response in 86% of patients, R0 resections in 100% of patients treated at the highest dose cohort and recently reported progression-free survival (PFS) of over 21 months compared to historical controls for PFS of approximately 12 months, support further evaluation of GEN-1’s safety and efficacy in patients with Stage III/IV ovarian cancer.

Corporate Development

Corporate Presentations at Two Investor Conferences. In March 2018, the Company presented at two investor healthcare conferences:

The B. Riley FBR Inaugural China Healthcare Investing & Partnering Symposium. The conference was held March 15-17, 2018 at The InterContinental Hotel Hangzhou, China.

The Oppenheimer 28th Annual Healthcare Conference. The conference was held March 20-21, 2018 at The Westin New York Grand Central in New York City.

The webcast of Celsion’s presentation at the Oppenheimer conference has been archived on the "News & Investors" section of Celsion’s corporate website at www.celsion.com.

Raised $27.5 Million in Gross Proceeds During the Fourth Quarter of 2017, and an Additional $1.3 Million in Gross Proceeds During the First Quarter of 2018. Recent minimally dilutive equity offerings totaling approximately $28.8 million in gross proceeds during the fourth quarter of 2017 through January 2018 have strengthened the Company’s balance sheet and will be used to support the Company’s development efforts and potentially significant clinical milestones for ThermoDox and GEN-1 clinical programs into the third quarter of 2019.

The Company raised $17.0 million in gross proceeds through the exercise of outstanding common stock warrants in early October 2017.

In October 2017, the Company completed an underwritten equity offering of shares of common stock and warrants to purchase common stock with Oppenheimer & Co. The gross proceeds of the offering were approximately $6.6 million.

In November 2017 and January 2018, the Company raised $5.2 million in gross proceeds off its ATM Equity Facility with Cantor Fitzgerald.

Financial Results

For the quarter ended March 31, 2018, Celsion reported a net loss of $4.5 million, or a loss of $0.25 per share, compared to a net loss of $5.2 million, or a loss of $3.09 per share, in the same period of 2017.

Net cash used for operating activities was $4.7 million for the quarter ended March 31, 2018, compared to $3.1 million for the same period of 2017. Cash, cash equivalents, short-term investments and interest receivable at March 31, 2018 was $20.8 million. Cash provided by financing activities was approximately $1.2 million during the quarter ended March 31, 2018.

Research and development costs were $2.7 million for the quarter ended March 31, 2018, compared to $3.5 million for the same period of 2017. Clinical development costs for the Phase III OPTIMA Study were $1.3 million for the quarter ended March 31, 2018 compared to $1.6 million for the same period of 2017. R&D costs for other development programs were lower because of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer.

General and administrative expenses were $1.7 million for the quarter ended March 31, 2018, compared to $1.5 million for the same period of 2017. This modest increase was due to higher professional fees and an increase in non-cash stock option compensation expense.

As the Company paid off its Venture Debt Facility with Hercules Technology Growth Capital, Inc. during 2017, the Company did not have any interest expense in the first quarter of 2018. Interest expense was $0.1 million for the first quarter of 2017.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss its first quarter 2018 financial results at 11:00 a.m. EDT on Friday May 11, 2018. To participate in the call, interested parties may dial 1-888-298-3457 (Toll-Free/North America) or 1-719-325-4917 (International/Toll) and ask for the Celsion Corporation First Quarter 2018 Earnings Call (Conference Code: 6550185) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on Friday, May 11, 2018 and will remain available until Friday, May 25, 2018. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 (Toll-Free/USA) or 1-719-457-0820 (International/Toll) using Conference ID: 6550185. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT on Friday, May 11, 2018.

On May 11, 2018, DelMar Pharmaceuticals, Inc. (the "Company") presented the presentations to describe its business and preclinical program (Presentation, DelMar Pharmaceuticals, MAY 11, 2018, View Source [SID1234526539]).

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On May 10, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMblaze370 study evaluating the combination of Tecentriq (atezolizumab) and Cotellic (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib (Press release, Hoffmann-La Roche, MAY 10, 2018, View Source [SID1234526414]). The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

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More than 95% of patients in IMblaze370 have microsatellite stable (MSS) tumours and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with Tecentriq alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.

Safety for the combination of Tecentriq and Cotellic appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.

"While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future."

Roche has an extensive clinical trial development program for Tecentriq, with more than 50 studies ongoing, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMblaze370 study
IMblaze370 is a Phase III, multi-centre, open-label, three-arm, randomised study in people with difficult-to-treat locally advanced or metastatic colorectal cancer who have received at least two prior regimens of chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to Cotellic plus Tecentriq and Tecentriq monotherapy. The study enrolled 363 people who were randomised (2:1:1) to receive:

Tecentriq plus Cotellic, or
Tecentriq, or
regorafenib (control arm)
People in the combination arm received Cotellic on days 1 to 21 plus Tecentriq on day 1 and day 15 in a
28-day cycle, until loss of clinical benefit. People in the monotherapy arm received Tecentriq on day 1 of each
21-day cycle, until loss of clinical benefit. People in the control arm received regorafenib on days 1 to 21 in a
28-day cycle, until loss of clinical benefit. The primary endpoint was overall survival. Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).

About colorectal cancer
Colorectal cancer (CRC) is caused by the abnormal growth of epithelial cells which form the lining of the colon or rectum. It is the third most common cancer in the world and one of the leading causes of cancer-related death.1 In 2012, approximately 1.4 million new cases of the disease were diagnosed globally and 694,000 deaths were caused by the disease.1 Although advances in screening have reduced mortality for CRC, 20% of people with CRC have metastatic disease at initial diagnosis.2,3

About the Tecentriq and Cotellic combination
Based on our pre-clinical data and Phase Ib data there was a strong scientific rationale to support the further investigation of the combination of Tecentriq and Cotellic. The IMblaze370 data will be further examined in order to better understand the results and presented at an upcoming medical meeting. Roche is continuing to investigate the Tecentriq and Cotellic combination in other tumour types, including the IMspire150 and IMspire170 studies in melanoma.

About Tecentriq (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the re-activation of T cells. TECENTRIQ may also affect normal cells.

About Cotellic (combimetinib)
Cotellic is a prescription medicine used with Zelboraf for the treatment of people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery and has a certain type of abnormal BRAF gene. Cotellic is not used to treat melanoma with a normal BRAF gene. Cotellic was discovered by Exelixis Inc. (Nasdaq: EXEL) and was developed by Roche in collaboration with Exelixis. Cotellic is also being investigated in combination with several in several tumour types such as non-small cell lung cancer, melanoma and colorectal cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

On May 10, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it will release its financial results for the first quarter ended March 31, 2018 on Tuesday, May 15, 2018 during pre-market hours (Press release, Cancer Genetics, MAY 10, 2018, View Source [SID1234526470]). The Company will hold a conference call at 8:30 a.m. Eastern on Tuesday, May 15, 2018 to discuss the financial results and provide an update on its strategic direction and key organizational improvements being made by the Company.

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CONFERENCE CALL & WEBCAST
Tuesday, May 15, 2018, 8:30 a.m. Eastern Time
Domestic: 800-289-0438
International: 323-794-2423
Conference ID: 4878415
Webcast: View Source
Replay – Available through May 29, 2018
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 4878415

On May 10, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its first quarter 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348539 [SID1234526486]).

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"Our January 2018 financing puts us in a strong position to advance and expand our robust TIL product pipeline. We continue enrollment in our ongoing trials and have expanded our melanoma study to enroll an additional 25 patients. We are initiating investigation of TIL therapy in new indications as part of our collaboration with MD Anderson, and one of those studies investigating our LN-145 TIL product in patients with sarcomas and ovarian cancers, is now active," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We also recently received orphan-drug designation from the FDA for autologous tumor infiltrating lymphocytes for the treatment of patients with cervical cancer with a tumor size of greater than 2 cm in diameter."

Recent Achievements and Upcoming Milestones

Manufacturing

TIL therapy manufacturing in Europe is now fully operational at PharmaCell B.V., a subsidiary of Lonza Group Ltd., in the Netherlands.
Clinical

As part of a collaboration program, Iovance and MD Anderson Cancer Center (MDACC) initiated a new Phase 2 clinical study, 2017-0672 (NCT03449108). The clinical trial site is currently active and screening patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study will treat patients with LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process.
Enrollment in the melanoma study, C-144-01, was expanded from 60 patients to up to 85 patients, 60 of which will be in Cohort 2 utilizing the company’s Gen 2 manufacturing process. The sample size in the study was expanded as Iovance may use the study in support of a potential registration of LN-144.
As of May 2018, Iovance has expanded to over 50 clinical sites for its four company-sponsored studies. Of the 50 total sites, four sites are now active for the Iovance IOV-LUN-201 study to treat checkpoint naïve patients with NSCLC.
Regulatory

As of May 2018, Iovance had received approvals to commence clinical trials in six countries in Europe including Switzerland, the Netherlands, France, Hungary, Spain and the United Kingdom.
In early May 2018, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.
Research

A late-breaking abstract, titled Anti-OX40 agonistic antibody enhances ex vivo CD8+ TIL expansion with increased T-cell effector function, was presented on Monday, April 16, 2018 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL.
In conjunction with one of the Phase 2 clinical trials being conducted as part of Iovance’s alliance with MDACC, Iovance has access to the supply of the 4-1BB agonist antibody, urelumab, for use in the manufacturing of TIL.
Iovance has obtained non-exclusive rights to uses of 4-1BB agonists, including uses of urelumab, in the manufacturing of TIL for adoptive cell therapy through an intellectual property license agreement with Moffitt Cancer Center.
The company entered into a material transfer agreement with RXi Pharmaceuticals Corporation to evaluate potential uses of sd-rxRNA compounds in the development of TIL therapies which could be applied to various cancer types.
Corporate

In January 2018, the company closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $11.50 per share, before underwriting discounts. The shares sold at closing included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the company, were $172.5 million with net proceeds to the company of $162.0 million.
In March 2018, the company announced the appointment of Michael Weiser, M.D., Ph.D., to Iovance’s Board of Directors. Dr. Weiser is the chair of Iovance’s Compensation Committee and serves on Iovance’s Nominating & Corporate Governance and Audit Committees.
First Quarter 2018 Financial Results

Net loss for the quarter ended March 31, 2018 was $26.5 million, or ($0.31) per share, compared to net loss of $20.7 million, or ($0.33) per share for the same period ended March 31, 2017.

Research and development expenses were $19.9 million for the quarter ended March 31, 2018, an increase of $4.3 million compared to $15.6 million for the same period ended March 31, 2017. The increase in research and development expenses was primarily attributable to a $2.2 million increase in payroll related expenses and consulting fees due to higher head count and dedicated consultants as the Company expanded its research efforts and clinical development programs, and a $2.0 million increase attributable to higher clinical trial costs due to an increase in patient enrollment and an increase in the number of clinical sites for the clinical trial of the Company’s lead product candidate, LN-144, for the treatment of metastatic melanoma, and the initiation of clinical trials of LN-145 for the treatment of cervical, head and neck cancers in 2017. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $7.0 million for the quarter ended March 31, 2018, an increase of $1.7 million compared to $5.3 million for the same period ended March 31, 2017. The increase was primarily attributable to a $0.9 million increase in payroll related expenses due to an increase in head count, and a $0.6 million increase in professional service and legal expenses primarily to support the expansion of the Company’s intellectual property portfolio.

At March 31, 2018, the company held $297.1 million in cash and cash equivalents, compared to $145.4 million at December 31, 2017. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $190 to $210 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these first quarter 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 2995797. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from May 10, 2018 at 7:30 p.m. ET to May 17, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID number for the replay is 2995797. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source