July 2016 – Page 55 – 1stOncology™: Cancer Intelligence Service

Sun Pharma Launches Gemcitabine InfuSMART, World’s First Licensed Ready-to-administer Bag for Oncology Treatment

On July 11, 2018, as part of its business strategy to build a meaningful and differentiating presence in Global Oncology Therapy market, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) reported the roll-out of Gemcitabine InfuSMART in Europe (Press release, Sun Pharma, JUL 11, 2016, View Source [SID1234525572]). InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag. Until now, compounding of oncology products was done at compounding centres or compounded in hospital pharmacies, an extra step before the medicine can be administered to patients. With the roll-out of Gemcitabine InfuSMART, Sun Pharma becomes world’s first pharmaceutical company to manufacture and launch a licensed RTA oncology product. This innovatively differentiated product will have a shelf life of two years. Over the next few months, Sun Pharma will launch Gemcitabine InfuSMART across Netherlands, UK, Spain, Germany, Italy & France.

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Sun Pharma received regulatory approval to produce Gemcitabine InfuSMART in eight key SKUs. The InfuSMART concept involves dose banding practice whereby, through agreement between prescribers and pharmacists, standardized doses of intravenous cytotoxic drugs are used for ranges (or ‘bands’) of doses calculated for individual patients. More InfuSMART oncology products are currently in Sun Pharma’s pipeline to be rolled out in the future.

Commenting on the roll-out of InfuSMART in Europe, Ms Hellen de Kloet, Business Head – Western Europe & ANZ, Sun Pharma said, "Sun Pharma’s Gemcitabine InfuSMART ready-to-administer infusion products provide the combined advantage of long stable compounded medicine along with safety. Its ready availability for treatment can make a difference to the healthcare worker and patients. Traditionally such medicines are compounded at hospitals (in-house) or outsourced to compounding pharmacies making it a time-consuming and potentially hazardous process. Launch of InfuSMART will help us remain a meaningful player in the global oncology therapy market by offering differentiating cancer treatment solutions. We believe there are opportunities for us to expand our portfolio of ready-to-administer products across multiple therapies where time and safety are an important element of treatment."

The NHS (UK) has been encouraging development of licensed RTA products. It has issued guidelines for hospitals for procuring such medicines. The launch of Gemcitabine InfuSMART offers Sun Pharma a definite first-mover advantage in Europe for cancer treatment. The Gemcitabine InfuSMART RTA infusion bag is developed at Sun Pharma’s R&D centre in India.

According to WHO, cancer figures amongst the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer related deaths in 2012. The number of new cases is expected to rise by about 70% over the next two decades. Among men, the five most common cancers diagnosed in 2012 were lung, prostate, colorectum, stomach, and liver cancer. Among women the five most common cancers diagnosed were breast, colorectum, lung, cervix and stomach.

Rosetta Genomics Receives U.S. Patent Allowance for microRNA-based Ovarian Cancer Treatment

On July 11, 2016 Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, reported that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. Patent Application No. 14/505,548, entitled "Compositions and methods for treatment of Ovarian Cancer," which covers a method of treatment for ovarian cancer through the administration of an inhibitor of miR-27a (Press release, Rosetta Genomics, JUL 11, 2016, View Source [SID:1234513828]).

In addition, the Israel Patent Office has allowed Application No. 200247, entitled "Compositions and Methods for Modulating Cell Proliferation and Cell Death," which claims cover the use of miR-34a or its variants for treating p53-negative cancers. This application covers a core element of Rosetta Genomics’ microRNA technology in the development of cancer therapeutics associated with p53-negative cancers, including lymphoma, breast cancer, ovarian cancer, liver cancer, skin cancer, certain types of lung cancer, and others. The patent is jointly owned with Yeda R&D Co. Ltd., the technology transfer company of the Weizmann Institute of Science in Rehovot, Israel. This technology is licensed to Mirna Therapeutics.

The Company also received a notice of allowance for Israel Patent Application No. 212978, entitled "MicroRNAs and Uses thereof," which covers human miR-29c*, a sequence at least 90% identical to it, and its complement; including a probe and a vector comprising the miR or its complement. This application corresponds to U.S. Patent No. 8,461,315.

"These patent grants further strengthen our international intellectual property position and complement already granted patents. Our growing patent estate continues to be a valuable asset for Rosetta as it provides protection for our core product portfolio, supports our research and development efforts and offers multiple opportunities to monetize patents outside our core diagnostics platforms," stated Kenneth A. Berlin, President and Chief Executive Officer.

"We believe the new U.S. patent may be of great value in the development of new treatment options for platinum-resistant ovarian cancer patients. Our goal is to monetize this U.S. patent and the related technology through a potential partnership," added Mr. Berlin.

CytRx Announces Initial Results of Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcoma; Subsequent Analysis to Be Announced Fourth Quarter 2016

On July 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS) (Press release, CytRx, JUL 11, 2016, View Source;p=RssLanding&cat=news&id=2184496 [SID:1234513826]).

In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events. Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed. This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.

For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator’s choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

"While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma," said Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin’s potential in this very challenging disease."

Treatment-related adverse events for aldoxorubicin were consistent with those observed in prior studies. Aldoxorubicin was not associated with clinically significant cardiac, kidney or liver toxicities. The Company plans to present updated results of the study at an upcoming medical meeting.

"The complexity, in terms of tumor diversity and primary location, makes soft tissue sarcoma extremely difficult to treat, especially in the relapsed and refractory setting, resulting in few treatment advances over the last four decades," said Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer of CytRx. "This first-of-its-kind study in STS included a comparator arm with multiple regimens, allowing for treatments to be matched to specific sarcoma subtypes. Despite a requirement for this challenging study design, aldoxorubicin demonstrated markedly greater activity over investigator’s choice therapy. That said, the unforeseen clinical hold that interrupted this study impacted the outcome of the current evaluation, underscoring a need for a subsequent analysis."

"In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of our global Phase 2b trial of aldoxorubicin in small cell lung cancer. We are deeply grateful for the continued support and commitment of the patients, their families, the investigators and clinical support professionals participating in the Phase 3 trial."

Celldex Therapeutics Initiates Phase 1/2 Clinical Trial of New Product Candidate CDX-014 in Advanced Renal Cell Carcinoma

On July 11, 2016 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that enrollment has opened in its Phase 1/2 study of CDX-014 in advanced renal cell carcinoma (RCC) (Press release, Celldex Therapeutics, JUL 11, 2016, View Source [SID:1234513825]). CDX-014 is a novel antibody-drug conjugate that targets the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1). TIM-1 expression is upregulated in several cancers, most notably renal cell and ovarian carcinomas, and is associated with a more malignant phenotype of RCC and tumor progression1,2. TIM-1 has very restricted expression in healthy tissue. The study is open to patients with both clear cell and papillary RCC.

"Although significant advances have been made in the treatment of metastatic renal cell carcinoma, patients who progress through currently approved therapies have extremely limited options," said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex Therapeutics. "Selectively targeting TIM-1, which is expressed in the majority of metastatic renal cell carcinomas, presents a novel approach that could provide new options for patients. CDX-014 has also demonstrated an ability to effectively kill tumor cells without negatively impacting immune response in preclinical studies, which may make it an ideal candidate for future combination therapy. We are pleased to initiate this first study of CDX-014, further broadening our pipeline to meet the needs of patients with difficult to treat cancers."

The Phase 1 dose-escalation portion of the study will evaluate cohorts of patients receiving increasing doses of CDX-014 to determine the maximum tolerated dose and a recommended dose for Phase 2 study. The Phase 2 portion of the study will enroll approximately 25 patients to assess the anti-tumor activity of CDX-014 at the recommended dose in advanced renal cell carcinoma as measured by objective response rate (RECIST 1.1). Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. The study is being conducted in the United States and is expected to include approximately 10 sites. Patients must have advanced/metastatic clear cell or papillary renal cell carcinoma and have experienced progressive disease after at least two prior lines of therapy, including at least one VEGF-targeted tyrosine kinase inhibitor, or be otherwise inappropriate candidates for all approved therapies. Data analysis will be conducted separately in clear cell RCC and papillary RCC, as well as by the total population.

1Vila, Kaplan, et al. Kidney Int. 2004; 65(5): 1761-1773.
2Cuadros, Trilla, et al. Eur J Cancer. 2013; 49 (8): 2014-2047.

About CDX‑014
CDX-014 is a fully human monoclonal antibody-drug conjugate (ADC) that targets T-cell immunoglobulin mucin-1 (TIM-1). TIM-1 expression is upregulated in several cancers, most notably renal cell and ovarian carcinomas, and has very restricted expression in healthy tissue. The TIM-1-targeting antibody, CR014, is linked to a potent cytotoxic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. CDX-014 is designed to be stable in the bloodstream, but to release MMAE upon internalization into TIM-1-expressing tumor cells, resulting in a targeted cell-killing effect. CDX-014 is in development for the treatment of advanced/metastatic clear cell or papillary renal cell carcinoma.

AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor known as Diffuse Intrinsic Pontine Glioma (DIPG)

On July 11, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain (Press release, AbbVie, JUL 11, 2016, View Source [SID:1234513814]).1

Though brainstem tumors are extremely rare among adults, they comprise approximately 10-15 percent of all pediatric brain tumors. DIPG is the most common subtype of tumor in this anatomical region and the second most common malignant brain tumor of childhood, with an estimated 200-400 children affected each year in the United States.2,3,8

The FDA granted the Rare Pediatric Disease Designation based on a proposed pediatric sub-study "nested" within the ongoing Phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma, conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).4,5

"Pediatric patients with high grade gliomas have a rare and fatal disease.2 This Rare Pediatric Designation, a first for AbbVie, is an important advancement as we continue to evaluate ABT-414 and its potential to help this group of patients who desperately need a new treatment option," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "The proposal of including a nested cohort within an adult global trial is an endeavor that we hope may bring more treatments to pediatric patients."

About ABT-414
ABT-414 is an investigational monoclonal antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.6 AbbVie is evaluating it for the treatment of adult patients with EGFR-amplified glioblastoma, an aggressive malignant primary brain tumor.6,7 In 2014, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency granted Orphan Drug Designation for the treatment of adult glioblastoma and glioma, respectively.4,5 In 2016, the FDA granted Rare Disease Designation to ABT-414 for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Gliomas (DIPG). ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About Pediatric High Grade Gliomas
Diffuse Intrinsic Pontine Glioma (DIPG) is a type of high grade glioma (HGG).8 HGG represents one of the most common central nervous system (CNS) tumors among adults; however, they comprise only approximately 8-12 percent of all CNS tumors in pediatric patients.2 Pediatric HGG are highly aggressive tumors that account for a significant amount of morbidity and mortality among children.2 Despite numerous treatment approaches, five-year survival outcomes range from 15-35 percent and the majority of children succumb to their disease.2,9

About Glioblastoma
Glioblastoma is the most common and most aggressive type of malignant primary brain tumor.7 Prior to diagnosis, patients may experience headache, vision problems, nausea/vomiting, personality changes and seizures.7 For adults with more aggressive glioblastoma, treated with concurrent Temozolamide and radiation therapy, median survival is about 14.6 months.9 Treatment for glioblastoma remains challenging.7 Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.9

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Month: July 2016

Sun Pharma Launches Gemcitabine InfuSMART, World’s First Licensed Ready-to-administer Bag for Oncology Treatment

Rosetta Genomics Receives U.S. Patent Allowance for microRNA-based Ovarian Cancer Treatment

CytRx Announces Initial Results of Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcoma; Subsequent Analysis to Be Announced Fourth Quarter 2016

Celldex Therapeutics Initiates Phase 1/2 Clinical Trial of New Product Candidate CDX-014 in Advanced Renal Cell Carcinoma

AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor known as Diffuse Intrinsic Pontine Glioma (DIPG)