On November 17, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that scientists from MD Anderson Cancer Center will be presenting data from a preclinical study evaluating poziotinib in lung cancer at the 17th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer taking place in Vienna, Austria, December 4-7, 2016 (Press release, Spectrum Pharmaceuticals, NOV 17, 2016, View Source [SID1234516662]).

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"Poziotinib has shown promising efficacy in preclinical models of non-small cell lung cancer (NSCLC) with exon 20 insertion mutations," said John Heymach, MD, PhD, Chairman, Professor, and David Bruton Junior Chair in Cancer Research, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "Tumors with these mutations have generally not been responsive to approved EGFR inhibitors, and there is an unmet need for better therapies for these patients. Computational modeling suggests that poziotinib may overcome steric hindrance of the drug binding pocket induced by the exon 20 insertion mutations. Based on these results, we are in the process of initiating a Phase 2 study in lung cancer that we plan to start in the near future."

"Poziotinib has already shown promising data in breast cancer, and we are excited that it may now have application in lung cancer as well," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Lung cancer is the leading cause of cancer deaths in the world. Due to the mutations in the genes, lung cancer often becomes unresponsive to treatments. Patients who have exon 20 insertion mutations have few options, if any. We look forward to working closely with MD Anderson Cancer Center to continue development of this drug in this area of unmet medical need."

17th IASLC World Conference on Lung Cancer

Abstract Title:
Poziotinib overcomes de novo resistance of EGFR exon 20 insertion mutations in NSCLC
Oral Presentation Schedule:
December 7, 2016 Session "Novel Strategies in Targeted Therapies"
Abstract Link:
View Source

About Poziotinib

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.

On November 15, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported it has selected INC Research (Nasdaq: INCR), a leading, global Phase I to IV contract research organization, to oversee its NCI-supported Phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies (Filing, 8-K, Cellectar Biosciences, NOV 17, 2016, View Source [SID1234516654]). The company anticipates that its $2M NCI grant will cover approximately 50 percent of the study’s cost, and the terms of the grant allow Cellectar to pursue an additional $3M for a pivotal Phase III trial of the company’s lead radiotherapeutic compound.

Cellectar plans to leverage the results of its 80-patient, Phase II study to optimally design its pivotal trial of CLR 131 in multiple myeloma and other hematologic malignancies. The multi-armed study will include relapse/refractory patients with multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL), who have been treated with standard therapy for their underlying malignancies. The company recently accelerated its guidance and announced plans to initiate the trial during the first quarter of 2017.

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"INC Research has outstanding experience in cancer clinical research and a strong reputation within the hematology community. With strong investigator relationships, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial," said Jim Caruso, president and CEO of Cellectar. "Given the accelerated initiation of our Phase II study to the first quarter of 2017 and that we will utilize as many as 15 participating sites, we can confidently plan on providing initial efficacy data in the second half of 2017."

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 preclinical 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 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 over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

On November 17, 2016 Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, reported that Celgene Corporation, through an affiliate, has acquired the company’s assets related to its proteasome inhibitor, marizomib (MRZ), which is in development for glioblastoma and relapsed and/or refractory multiple myeloma (Press release, Celgene, NOV 17, 2016, View Source [SID1234527214]).

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Under the terms of the agreement, Celgene will make an upfront payment plus additional regulatory, approval and sales milestone payments. Specific financial terms were not disclosed. "This acquisition validates the potential of marizomib based on early clinical results. Our vision is to become a leading early stage oncology drug development company, and this first opt-in by Celgene brings us a step closer to achieving that goal," said Mohit Trikha, Ph.D., chief scientific officer, Triphase Accelerator Corporation. "Just as importantly, this transaction affords us the opportunity to accelerate our efforts on advancing other assets in our pipeline."

"Consistent with our deep commitment and passion for the patients, glioblastoma is an area of significant unmet medical need, and Celgene is committed to helping these patients. We are pleased with Triphase Accelerator’s rapid and high quality work to date, and we value the exceptional collaboration we have with them to advance marizomib," said Celgene’s President of Hematology Oncology, Michael Pehl.

Going forward Celgene has full responsibility for the development of marizomib and will pay Triphase to complete the ongoing clinical studies with marizomib, including a Phase 1 study in relapsed refractory multiple myeloma, a Phase 2 study in recurrent glioma and a Phase 1 study in newly diagnosed glioma.

About Marizomib
Marizomib is a novel, brain-penetrant proteasome inhibitor, which inhibits all three proteasome subunits.

Triphase Accelerator is developing marizomib in both intravenous (IV) and oral formulations as a proteasome inhibitor for hematologic malignancies and solid tumors. The IV formulation has been evaluated in more than 300 patients in multiple clinical studies in patients with solid and hematologic malignancies, either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, or an immunomodulatory drug.

The company is currently evaluating marizomib in a proof-of-concept clinical study in combination with bevacizumab (Avastin) in patients with Grade IV malignant glioma (glioblastoma), and has received Orphan Drug designation for marizomib in glioblastoma in the United States from the FDA. In addition, Triphase Accelerator is currently developing marizomib in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, and has received Orphan Drug designation for marizomib in multiple myeloma in the United States and the European Union. Triphase Accelerator is also evaluating an oral formulation in preclinical studies.

Marizomib has not been approved for any use in any country.