1stOncology™: Cancer Intelligence Service – Page 16792 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Delcath Issues $35 Million in Senior Convertible Notes to Support Melphalan/HDS Clinical Development and CHEMOSAT European Commercialization

On June 7, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported it has entered into a securities purchase agreement with an institutional investor to issue $35.0 million of senior convertible notes (the Notes) and related common stock purchase warrants (Press release, Delcath Systems, JUN 7, 2016, View Source;p=RssLanding&cat=news&id=2175682 [SID:1234513107]). The Notes will be issued at an 8% original issue discount. The aggregate proceeds of $32.2 million will be used to fund the Company’s ongoing operations, commercial activities and clinical development programs, including its global Phase 3 trial with Melphalan/HDS in hepatic dominant ocular melanoma (the FOCUS Trial) and its global Phase 2 program with Melphalan/HDS in hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Of the $32.2 million in aggregate proceeds, $3 million will be unrestricted and immediately and freely available for use by the Company and its subsidiaries. The remaining $29.2 million will be subject to a cash covenant restricting its use and requiring it to be held in certain control accounts of the Company. Subsequently, $3.0 million of the restricted cash shall become unrestricted cash on the 20th trading day after the later of the stockholder approval of the transaction in accordance with NASDAQ rules, or the six-month anniversary of the closing date (such 20th trading day, the Trigger Date). Thereafter, the remaining $26.2 million of restricted cash will become unrestricted in equal quarterly installments starting the 30th trading day after the Trigger Date, such that the balance will become unrestricted by December 29, 2017, subject to the fulfillment of certain equity conditions.

The Notes will be convertible, at the option of the holder, at 110% of the market price (the Conversion Price) into a fixed number of common shares. The market price will be determined on the closing date and will be based on the Volume Weighted Average Price (VWAP) of the three trading days immediately prior to the closing date. Commencing on the 20th trading day after the six-month anniversary of the closing date, and for each 20th trading day period thereafter, the Notes will amortize in equal installments payable in common stock (at the installment conversion price with pre-delivery and a $0.05 floor), subject to the fulfillment of certain equity conditions, or, at the Company’s option, in cash.

The Company has the right to redeem the notes with restricted cash or any other cash of the Company, at its option, at any time after the earlier of March 31, 2017 or such time as at least $18 million of restricted cash shall have become unrestricted cash under the terms of the Notes.

Roth Capital Partners acted as sole placement agent for the offering.

"This committed financing provides us with the resources to advance our clinical development plan through the end of 2017 while also supporting our commercialization programs in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath. "We are positioned to achieve important clinical inflection points in our FOCUS trial and our global Phase 2 program in HCC and ICC, which we believe represent the fastest path to U.S. FDA approval and ultimately the generation of shareholder value. This financing will be valuable to our efforts to expand global access to our Melphalan/HDS for the benefit of patients suffering with primary and metastatic liver cancers."

In addition to the Notes, the Company will issue common stock purchase warrants in a quantity equal to 85% of the number of shares of common stock the institutional investor would receive if the Notes were converted in full at the initial Conversion Price on the closing date (without regards to any limitations on conversion set forth therein). The warrants will be initially exercisable one year after their initial issuance date and expire five years thereafter. The warrants will include a one-time, downward-only reset of the warrant exercise price based on the market price on the maturity date, and for 75% of the warrants a corresponding adjustment of the number of warrant shares such that the aggregate exercise price of the warrants remains the same after the reset.

For additional information concerning the details of the financing, please refer to the Form 8-K to be filed by Delcath with the Securities and Exchange Commission.

The Notes, warrants and shares of common stock issuable upon conversion or exercise thereof have not been registered under the Securities Act or any applicable state securities laws and may not be offered or sold absent such registration or pursuant to an available exemption from such registration requirements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Study Reveals Racial Disparities in Multiple Myeloma Treatment Patterns

On June 7, 2016 Celgene Corporation (NASDAQ:CELG) reported the presentation of a study comparing treatment patterns, healthcare costs and overall survival between African American and Caucasian Medicare beneficiaries with newly diagnosed multiple myeloma (Press release, Celgene, JUN 7, 2016, View Source [SID:1234513105]). The study, which was presented by Dr. Sikander Ailawadhi of the Mayo Clinic at a poster session during the 52nd ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill, discussed disparities observed in treatment initiation between the two studied populations and the impact of these disparities on patient outcomes.

"African Americans may be more at risk for developing multiple myeloma than Caucasians, however, they often can have a better prognosis when they get the proper care," said Dr. Manali Patel of the Stanford Cancer Center and an investigator in the study. "Through studies like this, we are trying to better understand potential modifiable drivers of these disparities to improve outcomes for African Americans living with multiple myeloma."

The study found that elderly African Americans with multiple myeloma had lower rates of receiving access to autologous stem cell transplant (3% vs 6%, p < 0.01) and novel combination therapies (66% vs 74% among patients with pharmacological therapy, p < 0.01) compared to Caucasians with the disease. The median times from diagnosis to therapy initiation (2.3 vs 1.7 months, p < 0.05) and novel therapy initiation (5.3 vs 3.1 months, p < 0.05) were also significantly longer for African Americans than Caucasians. The study found, however, that overall survival (OS) was comparable between African Americans and Caucasians (26.7 vs 30.0 months, p = 0.27) and total healthcare costs were similar across cohorts, although African Americans had higher costs for hospitalizations, emergency visits, and skilled nursing facility.

The study evaluated 2,200 Caucasian and 536 African American multiple myeloma patients in the Surveillance, Epidemiology, and End Results Program (SEER) Medicare database from 2007 and 2011, with the index date being defined as the first date of diagnosis with multiple myeloma. Patients were required to be continuously enrolled in Medicare Part A, B, and D for six months before (baseline period) and at least six months after the index date (study period), unless they died.

"Treatment disparities exist between African American and Caucasian patients suffering from multiple myeloma," said Dr. Mohamad Hussein, Vice President of Global Medical Affairs for Celgene. "At Celgene, we believe it is imperative to improve education, awareness and treatment access among African Americans, particularly since they are more predisposed to being diagnosed with the disease."

Researchers determined that differences in disease aggressiveness and other clinical characteristics at baseline between African Americans and Caucasians should be explored in future studies as they can impact treatment outcomes.

Multiple myeloma is the second most common form of blood cancer in the United States, and the most common blood cancer among African Americans. African Americans are twice as likely to be diagnosed with multiple myeloma. Novel therapeutic advances made in multiple myeloma over the past decade have significantly improved outcomes for patients when they receive access to timely care and treatment.

To address this disparity in multiple myeloma, Celgene created the "Standing in the Gaap for African Americans with Multiple Myeloma" program in 2015 to raise awareness about how multiple myeloma affects African Americans differently and to improve the quality of care they receive. In addition to addressing treatment disparities and access for African Americans with multiple myeloma, the program is committed to understanding the genetic differences between African American patients and other patients to better guide current treatment decisions and future research. In addition, the program aims to improve enrollment of African American multiple myeloma patients in clinical trials, which is critical to accelerating knowledge gathering and new discoveries for this highly fatal disease.

Trillium Therapeutics Announces Presentation on TTI-621 Immune Checkpoint Inhibitor Targeting CD47 at European Hematology Association 21st Annual Congress

On June 7, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will present its TTI-621 (SIRPaFc) immune checkpoint inhibitor program at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Annual Congress, to be held in Copenhagen from June 9- 12 (Press release, Trillium Therapeutics, JUN 7, 2016, View Source [SID:1234513089]).

Details of Trillium’s presentation are as follows:

Presentation Type: Electronic Poster
Abstract #: E1373
Title: The CD47-blocking Cancer Immunotherapeutic TTI-621 has Anti-Tumor Effects Across a Broad Range of Hematological Malignancies

TG Therapeutics, Inc. Announces First Patient Enrolled in the Registration-Directed UNITY-DLBCL Phase 2b Trial

On June 07, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the enrollment of its first patient in its registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with TGR-1202, the Company’s orally available PI3K delta inhibitor, as well as TGR-1202 alone, in patients with previously treated Diffuse Large B-Cell Lymphoma (DLBCL) (Press release, TG Therapeutics, JUN 7, 2016, View Source [SID:1234513116]).

The study, entitled "A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 alone in Patients with Previously Treated Diffuse Large B-Cell Lymphoma," is being led by Owen A. O’Connor, MD, PhD, Professor of Medicine and Experimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center. The primary objective of the study is to assess the efficacy of TGR-1202 alone and in combination with TG-1101 in patients with previously treated DLBCL as measured by Overall Response Rate (ORR). The study will also provide important information as to the contribution of each asset, TGR-1202 and TG-1101, to the combination of both agents. In addition to monitoring for safety and efficacy this study will analyze the impact of cell of origin (GCB vs. ABC ), mutational status and select biomarkers of efficacy.

Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, "We are excited to announce the enrollment of our first patient in our UNITY-DLBCL Phase 2b trial. We believe the foundation of our company lies in the approval of TG-1101 + TGR-1202, our proprietary ‘1303′ combination, across a wide variety of b-cell disorders and this trial marks another important step forward in achieving our goal. DLBCL is an area of significant unmet medical need, with no approved treatment options available for patients with relapsed/refractory disease and limited activity seen with other novel agents in this patient population. We are encouraged by the early data we have seen in our Phase I/II studies, as presented at the recent ASCO (Free ASCO Whitepaper) meeting, and look forward to evaluating the combination in this registration-directed trial."

ImmunoCellular Therapeutics Treats First Patient in ICT-107 Phase 3 Registrational Trial in Newly Diagnosed Glioblastoma

On June 7, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported that the first patient has been treated in the phase 3 registrational trial of ICT-107, the Company’s lead cancer immunotherapy product candidate, in newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, JUN 7, 2016, View Source [SID:1234513108]). ICT-107 is a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of 414 HLA-A2-positive subjects, which will be conducted at approximately 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have identified as an appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.

"Treating our first US patient in the phase 3 registrational trial for ICT-107 is a major milestone achievement for our Company, for patients with brain cancer and their families and for our shareholders," said Andrew Gengos, ImmunoCellular President and Chief Executive Officer. "ImmunoCellular is now one of the very few companies in the cancer immunotherapy arena that we believe to be in the final stage of clinical development. What we think differentiates our phase 3 program from any other in newly diagnosed glioblastoma is that it is based on data and insights from a placebo-controlled phase 2 trial, and it uses the overall survival primary endpoint which is the only efficacy endpoint US and EU regulatory authorities will currently accept for registration. We think we have designed into the phase 3 trial a set of protocol improvements that give ICT-107 the best probability of success. We want to express our sincere appreciation to the medical oncology community worldwide for their ongoing support of our phase 3 trial and look forward to treating our first patients in Canada and Europe in the third quarter of 2016."

The principal investigator on the trial is Prof. Dr. Michael Weller, Chairman, Department of Neurology, University Hospital Zurich, Switzerland. Dr. Weller serves as the Chairman of the German Glioma Network of the German Cancer Council, and serves as President of the European Association for Neuro-Oncology (EANO). He is also the Chairman of the Brain Tumor Group of the European Organisation for Research and Treatment of Cancer (EORTC). A world expert in glioblastoma treatment and research, Dr. Weller has provided extensive support to ImmunoCellular relative to interpretation of the phase 2 results and design of the phase 3 trial protocol, and served as the Company’s clinical expert in our end of phase 2 presentation to the European Medicines Agency (EMA).

Dr. Weller commented: "Glioblastoma has remained to be one of the most difficult to treat type of cancer for decades. Conventional treatments such as radiotherapy and chemotherapy seem to have reached their limits. In contrast, there is now emerging evidence that harnessing the patient`s immune system to actively combat this deadly tumor may change this. Moreover, modern medicine increasingly tries to move away from "one-size-fits-all" approaches to more individualized approaches. ICT-107 meets these requirements in an ideal way, being an innovative design of immunotherapy taking into consideration biological characteristics of both the patients and their tumors. The phase 3 trial is well designed and will benefit from important insights from the encouraging results of the placebo controlled phase 2 trial."

ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been honored with a $19.9 million award from the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to implement the phase 3 registration trial. To support timely patient enrollment at participating sites across ten countries, ImmunoCellular has established agreements with the European Organisation for Research and Treatment of Cancer (EORTC), the Alliance for Clinical Trials in Oncology (the Alliance) in the US, and the Canadian Brain Tumor Consortium.

For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.