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TapImmune Announces Progress In Its Phase 2 Ovarian Cancer Clinical Trial

On January 24, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, reported that Memorial Sloan Kettering Cancer Center (MSKCC) successfully completed the first safety cohort in its Phase 2 ovarian cancer study (Press release, TapImmune, JAN 24, 2017, View Source [SID1234517564]). The study is designed to examine the efficacy of the TapImmune lead investigational product candidate, TPIV 200, in combination with AstraZeneca’s investigational checkpoint inhibitor, durvalumab.

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The Phase 2 ovarian cancer study is sponsored by MKSCC under the leadership of Dr. Jason Konner. This clinical milestone allows MSKCC to increase the number of patients that can be enrolled and will subsequently increase the study’s enrollment rate. Patients in this study are resistant to platinum chemotherapy and have few treatment options. Since TPIV 200 and durvalumab have not been used before in combination, the protocol required the start of the study to proceed cautiously for the first four patients. There have been no safety issues to date, and the enrollment is now allowed to proceed at a faster rate.

"This study and the TapImmune-sponsored Phase 2 study in triple negative breast cancer study represent the company’s progress in clinical development of its lead product, TPIV 200," said Glynn Wilson, Chairman and CEO of TapImmune, Inc. "We also recently announced the opening of our second ovarian cancer study with FDA Fast Track designation in platinum-sensitive patients. As we have previously stated, TapImmune has Fast Track designation for TPIV 200 as maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy."

Onxeo Completes Enrollment in Phase III Study of Livatag® for the Treatment of Hepatocellular Carcinoma

On January 24, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported the completion of enrollment in ReLive, the international Phase III clinical trial evaluating Livatag for the treatment of advanced hepatocellular carcinoma (HCC) (Press release, Onxeo, JAN 24, 2017, View Source [SID1234517561]).

"Advanced HCC is a particularly severe form of liver cancer with a high mortality and very few treatment options", commented Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the ReLive study. "All patients have now been enrolled in the Phase III trial of Livatag and the DSMB recommendations point towards an adequte safety profile. We hope this treatment will become a new option for patients with advanced HCC for whom there is a strong unmet therapeutic need and we are now looking forward to the preliminary efficacy data expected within a few months."

The ReLive trial is evaluating the efficacy of intravenous (IV) administration of Livatag (doxorubicin transdrug) in patients with advanced HCC after failure or intolerance to sorafenib compared to the best standard of care chosen by the physician. In line with Onxeo’s international development plan, the company has conducted this Phase III trial in 11 countries (Europe, USA, MENA*).

To date, 390 patients have been randomized, with about 260 patients in the Livatag treatment group and 130 in the the comparative group (best standard of care). The completion of patient randomization is an important milestone that confirms the expected timeline of issuing the preliminary efficacy outcomes of the study mid-2017.

"Completion of enrollment in ReLive marks a significant milestone for the HCC community. This is a major step forward in the development of Livatag as a new therapeutic option in a pathology for which there is a strong need for new treatment. It is also a major achievement for Onxeo, which demonstrates its ability to complete a large international Phase III trial and marks a major value creation catalyst, in line with the expected publication of preliminary results in mid-2017," concludes Judith Greciet, Chief Executive Officer of Onxeo. "On behalf of Onxeo, we would like to extend our warmest thanks to the investigators and coordinators of the clinical sites for their active participation that enabled us to carry out this trial".

From a safety standpoint, nine DSMB** reviews of the ReLive study have already been conducted over the course of the study. During these reviews, the experts did not identify unexpected adverse effects or signals and unanimously recommended each time the continuation of the trial without modification. These repeated positive recommendations – based on data from the administration of almost 1,000 Livatag infusions – seem to indicate an adequate safety profile of the drug to date. These findings are important because they reflect the likelihood that this profile will be acceptable to both physicians and regulators.

Livatag, an innovative therapeutic approach to hepatocellular carcinoma
Livatag is a nanoparticle formulation of doxorubicin, developed using Onxeo’s proprietary Transdrug technology designed to facilitate the penetration of the drug into the tumor cell and increase the target DNA exposure to the drug, thereby bypassing the mechanisms of multi-drug resistance developed by tumor cells. By specifically accumulating in the liver cells and overcoming resistance to doxorubicin, Livatag represents a potentially significant breakthrough in the treatment of hepatocellular carcinoma.

Hepatocellular Carcinoma, an aggressive form of primary liver cancer
Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer. The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especiallynon-alcoholic steato-hepatitis, a growing cause of cirrhosis and HCC.

TG Therapeutics Announces Orphan Drug Designation for the Combination of TG-1101 and TGR-1202 for the Treatment of Diffuse Large B-cell Lymphoma

On January 24, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) (Press release, TG Therapeutics, JAN 24, 2017, View Source [SID1234517546]).

The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory DLBCL as well as the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated chronic lymphocytic leukemia (CLL).

"We are pleased to receive orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 in diffuse large B-cell lymphoma. This status complements our already strong proprietary protection portfolio which includes composition of matter patents issued for both TG-1101 and TGR-1202, as well as orphan drug designation already granted for the combination in CLL," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. Mr. Weiss continued, "DLBCL is an area of significant unmet medical need and we are highly encouraged by the early clinical data we have seen in DLBCL patients treated with 1101 plus 1202 and look forward to evaluating this further in our ongoing Phase 2b registration directed trial."

ABOUT ORPHAN DRUG DESIGNATION

Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

ABOUT DIFFUSE LARGE B-CELL LYMPHOMA

According to the American Cancer Society, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast growing) type of non-Hodgkin lymphoma (NHL), a cancer that starts in cells called lymphocytes, which are part of the body’s immune system. Diffuse large B-cell lymphoma is the most common type of NHL in the United States, accounting for about 30% of newly diagnosed cases of NHL. DLBCL occurs in both men and women and can affect any age group, although its prevalence increases with age, with the average age of diagnosis being in the mid-60s.

Cellectar Biosciences Announces Additional US Patent Granted for CLR 131 and CLR 125 in a Broad Range of Solid Tumors

On January 24, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has granted patent number 9,550,002, which covers method of use for the company’s lead compound, CLR 131, as well as CLR 125, for the treatment of cancer (Press release, Cellectar Biosciences, JAN 24, 2017, View Source [SID1234517543]). The granting of this patent follows the company’s previous announcement of patent allowances for the use of the company’s phospholipid drug conjugate (PDC) delivery platform in these tumor types.

"This patent strengthens our radiotherapeutic intellectual property portfolio and further demonstrates Cellectar’s commitment to optimizing our PDC technology platform," said Jim Caruso, president and CEO of Cellectar. "While we are currently focused on developing CLR 131 for hematologic malignancies such as multiple myeloma, the claims granted provide additional development optionality for Cellectar or a potential partner."

The granted patent covers the use of CLR 131 for the potential treatment of a broad range of malignant solid tumors, which include adrenal, lung, ovarian or cervical, prostate, liver, breast and colon, as well as melanoma or subcutaneous cancers.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About CLR 125
CLR 125 is a broad-spectrum, cancer-targeting, radiotherapeutic, which may be uniquely suited to treat micro-metastatic disease. CLR 125 uses the radioisotope iodine-125 conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform. Similar to CLR 131, the selective uptake and retention of CLR 125 has been observed in malignant tissues during pre-clinical studies. Funded by a recent NCI SBIR award, the company evaluated the feasibility and safety of CLR 125 for the treatment of triple-negative breast cancer (TNBC) in the (neo) adjuvant setting. This program was successfully completed and demonstrated appropriate biodistribution, tolerability, and dose response.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

Genmab Announces 2016 Net Sales Figures for DARZALEX® (Daratumumab)

On January 24, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 572 million in 2016 (Press release, Genmab, JAN 24, 2017, View Source [SID1234517538]). Net sales were USD 471 million in the U.S. and net sales in the rest of the world were USD 101 million. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

DARZALEX was approved in the U.S. in November 2015 and in Europe in May 2016. Net sales of DARZALEX in the U.S. in 2015 were USD 20 million, resulting in royalty income of DKK 16 million to Genmab.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, non-Hodgkin’s lymphoma, NKT-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.