On June 6, 2016 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, reported the presentation of data from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of chemoradiotherapy-induced oral mucositis (OM), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Galera Therapeutics, JUN 7, 2016, View Source [SID:1234513124]). Study results suggest that GC4419 may reduce the incidence, severity and duration of severe OM in patients receiving chemoradiation therapy for the treatment of head and neck cancer, particularly when GC4419 is administered for the duration of chemoradiation therapy.

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The Phase 1b/2a trial assessed the safety and pharmacokinetics of GC4419, administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin therapy, in 43 patients evaluable for OM. Study endpoints also included assessments of the incidence, time to onset, duration, and severity of OM and initial tumor outcomes for several dosing schedules of GC4419. The study demonstrated that, compared to historic controls, GC4419 appeared to delay onset, shorten the duration and decrease the incidence of severe OM (defined as WHO Grades 3 and 4 OM). The data also showed that the effect of GC4419 was greater if the treatment was administered for the entire duration of IMRT, with larger reductions in all grades of OM experienced by patients receiving full therapy (6-7 weeks) compared to patients receiving partial therapy (3 weeks). For example, investigators reported that the cumulative overall incidence of Grade 4 OM was 25 percent in patients in the 3 week cohort, while patients receiving full therapy had 0 percent. The median duration of severe OM was 2.5 days in patients receiving full therapy, far shorter than the 3-4 week duration in matched historical controls. Patients who received partial therapy still experienced less than 25 percent of the duration of severe OM than reported for matched historical controls.

GC4419 had a safety profile consistent with the IMRT and cisplatin regimen. The most common adverse events were attributable to chemotherapy or head and neck cancer. The plasma half-life of GC4419 was approximately 1.5 hours, with minimal accumulation after repeated dosing. Only 4.3 percent of patients required breaks in IMRT of 5 consecutive fractions or more, as opposed to 15% in published reports of other studies of OM in comparable patients. Patients followed for up to 12 months after completion of IMRT have showed no evidence of tumor protection from GC4419 treatment, with follow-up ongoing.

"We are pleased to share the promising results of the Phase 1b/2a trial, which offer early insight into the potential safety profile and clinical benefit of GC4419 in reducing severe oral mucositis in patients with head and neck cancer," said J. Mel Sorensen, MD, President and CEO of Galera. "These findings support the continued clinical development of GC4419, as well as our pipeline of breakthrough drugs targeting oxygen metabolic pathways. Enrollment in a randomized Phase 2 trial of GC4419 is currently underway. In addition, we are conducting IND-enabling work on orally active dismutase mimetics."

About Oral Mucositis (OM)
OM is a common debilitating side effect of radiation treatment in head and neck cancer (HNC) patients. Severe OM, defined as Grade 3 or 4 OM on the World Health Organization Oral Mucositis Scale, occurs in 60 to 80 percent of HNC patients who receive radiation therapy. Importantly, severe OM may result in interruptions in radiation treatment, which can compromise the otherwise good prognosis for tumor control in many of these patients. In addition, patients suffer significant pain, may develop serious infections, and may be unable to eat solid food or even drink liquids. 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 is required. There is currently no drug approved to prevent or treat severe OM in head and neck cancer patients.

About GC4419
GC4419 is a superoxide dismutase mimetic, a small molecule drug that selectively targets the superoxide pathway by supplementing the activity of the superoxide dismutase enzyme family to accelerate the conversion of superoxide to hydrogen peroxide. This mechanism is thought to block the large burst of superoxide induced by radiotherapy, the initiating step in the development of OM, and has been shown to be protective of normal tissue but not tumor. In preliminary clinical studies, GC4419 markedly delayed the onset, shortened the duration and decreased the incidence of severe OM when administered intravenously prior to each dose of intensity modulated radiotherapy (IMRT) and cisplatin. GC4419 has now entered randomized Phase 2 development for the reduction of severe OM associated with chemoradiotherapy in head and neck cancer.

On June 7, 2016 Oxford University Innovation reported that it will be renamed Oxford University Innovation, in order to enhance the already strong links between Oxford University Innovation and the University1 (Press release, Oxford University Innovation, JUN 7, 2016, View Source [SID1234520264]). This will strengthen awareness of the company and its services within the wider University, and better portray the University’s ownership of the company.

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With a record 16 spinout companies launched and more than 450 academic consultancy contracts signed in the last 12 months, innovation activity in Oxford University is successful, growing, and making a significant contribution to the local economy. Professor Ian Walmsley, Pro-Vice-Chancellor (Research and Innovation) at the University of Oxford, added his voice to the recent Oxfordshire Green Paper2 concerning the future of the region, saying: "We are very pleased that the key regional leaders have joined to frame a vision for the future of Oxfordshire that brings together their aspirations for economic growth with improved quality of life and how innovation can contribute to achieving this vision."

Support for enterprise and innovation is at the heart of the University’s Strategic Plan3. The Oxford University Innovation Working Group4 recognised the vital role of Isis Innovation in technology transfer as a key service to Divisions, and made recommendations to establish still firmer connections. Various practical steps have already been taken to meet this objective, including establishing regular staffing at hotdesks in University departments. The new company name and branding – being introduced later this month – will further reinforce this.

An additional, secondary, consideration was the similarity of the current name to so-called Islamic State, which caused occasional business issues such as emails being blocked. However, the overriding reason for change – clearer definition of the link to the University – was compelling in its own right, and received unanimous support in our consultation process.

Managing Director of Isis Innovation, Linda Naylor, said, "Commercialising University research and expertise is important to enable wider society to benefit from the work of our world-leading academics. By changing our name to Oxford University Innovation the breadth of support from the University for entrepreneurial researchers will be more visible. We will also benefit from the global brand recognition of the University, allowing us to attract more clients and investors for the Intellectual Property-based technologies and for the many services that we provide to increase engagement with researchers. More successful engagements will contribute to greater impact from researchers’ work as well as greater financial returns to the University and individual researchers."

Further new initiatives supporting innovation within the University will be announced over the coming months.

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.

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"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.

On June 7, 2016 TapImmune, Inc. (OTCQB: TPIV), a clinical stage cancer immunotherapy company, reported that the Company has exercised its option agreement with Mayo Clinic and signed a worldwide license agreement to a proprietary HER2neu vaccine technology (Press release, TapImmune, JUN 7, 2016, View Source [SID:1234513125]). The license gives TapImmune the right to develop and commercialize the technology in any cancer indication in which the Her2neu antigen is overexpressed. This technology, developed in the laboratory of Keith Knutson, Ph.D. at Mayo Clinic, has completed Phase 1 clinical trials in HER2neu breast cancer patients.

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TapImmune recently announced positive Phase 1 clinical data for the technology in HER2neu breast cancer. The trial demonstrated that the experimental therapy was safe, well-tolerated, and provided a robust immune response across a broad patient population. Therefore, TapImmune plans to initiate a Phase 2 clinical trial at the start of 2017. Under the license agreement the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration covering the clinical trial will be transferred to TapImmune.

Dr. Glynn Wilson TapImmune’s CEO stated "This agreement confirms our intent to further develop and commercialize TPIV 100 and TPIV 110, our novel HER2neu vaccine technology. The HER2neu antigen is a well-established therapeutic target. Our immediate plans are to complete development of a Phase 2 vaccine formulation and to establish clinical protocols for Phase 2 studies. We are excited by the recent Phase 1 data and our future clinical programs will be aimed at developing this leading vaccine candidate as a stand-alone therapy or in combination with other immunotherapies."

Mayo Clinic and Dr. Knutson have a financial interest in the technology described in this press release. Revenue Mayo receives is used to support its not-for-profit mission in patient care, education and research.

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).

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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.