Advancing Clinical Trials Endeavoring to Improve Odds Against Pancreatic Cancer

PALM BEACH, Florida, November 28, 2018 /PRNewswire/ --

Positive results from clinical trials are headlining the current market for pancreatic cancer treatments in the active biotech industry. Pancreatic cancer is one of the deadliest cancers in the world, but only $90 million is spent annually on research for cures. As the fourth leading cause of cancer-related death, pancreatic cancer represents a major threat to human health in the United States. Estimates show that more than 43,000 new diagnoses and 36,800 deaths were attributed to pancreatic cancer in 2010. This has created an immense opportunity for private research to develop treatments and aggressive therapies. Much of this spending takes place in the area of clinical trials, with companies actively working towards solutions in various forms. Private spending on research and trials are expected to continue rising as more and more patients are diagnosed each year, presenting an urgent need for treatments. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Amgen Inc. (NASDAQ:AMGN), Celgene Corporation (NASDAQ:CELG), Seattle Genetics Inc. (NASDAQ:SGEN), Tesaro Inc. (NASDAQ:TSRO).

Moleculin Biotech, Inc., (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that data from an independent test in animal models confirmed, as previously believed, that its immuno-stimulating STAT3 inhibitor achieves disproportionately high accumulation in the pancreas.

“Our own sponsored research suggested that WP1732 might be an ideal candidate for treating pancreatic cancer,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer. “Now, we have independent testing with radiolabeled drug confirming this in animal models. The propensity for such enhanced pancreatic distribution could be highly beneficial for a new pancreatic cancer drug.”

Walter Klemp, Moleculin’s Chairman and CEO added, “Published research shows that the growth and survival of pancreatic cancer requires activated STAT3 (p-STAT3) and our own research suggests that WP1732 may be one of the most effective inhibitors of p-STAT3 that has demonstrated activity in in vivo models. Confirming the disproportionately high accumumulation of WP1732 in the pancreas puts us one step closer to introducing an entirely new approach to treating pancreatic cancer. This is very encouraging and confirms the direction that Moleculin has taken with WP1732. We are heavily engaged in preparing the data necessary for an Investigational New Drug (IND) application with the FDA which we are targeted to file in 2019.” Read this and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/

Other recent developments in the biotech industry include:

Seattle Genetics Inc. (NASDAQ:SGEN) recently announced a new approval for ADCETRIS® (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S. Food and Drug Administration (FDA) for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. The approval is based on the successful outcome of the phase 3 ECHELON-2 clinical trial that compared ADCETRIS plus CHP to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). The FDA granted Breakthrough Therapy designation and Priority Review to this supplemental Biologics License Application (BLA) and reviewed it under the Real-Time Oncology Review Pilot Program leading to approval less than two weeks after submission of the complete application. “The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments,” said Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. “The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival.

Amgen Inc. (NASDAQ:AMGN) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for BLINCYTO® (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. The application included data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL, the largest prospective trial for MRD-positive ALL ever conducted. BLINCYTO, a bispecific CD19-directed CD3 T cell engager, is the first BiTE® immunotherapy to receive regulatory approval globally. MRD refers to the presence of cancer cells that remain detectable, despite a patient having achieved complete remission by conventional assessment.1 MRD is only measurable through the use of highly sensitive testing methods that detect cancer cells in the bone marrow with a sensitivity of at least one cancer cell in 10,000 cells-versus about one in 20 with a conventional microscope-based evaluation.

Celgene Corporation (NASDAQ:CELG) and bluebird bio inc. (BLUE) also announced the completion of enrollment for the KarMMa pivotal study of bb2121, the companies’ lead investigational anti-BCMA CAR T cell therapy candidate for patients with relapsed and refractory multiple myeloma. bb2121 is being developed as part of a Co-Development, Co-Promote and Profit Share Agreement between Celgene and bluebird bio. “We continue to be excited about bb2121 as a potential first-in-class BCMA-targeted therapy for patients with multiple myeloma,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “We would like to thank everyone who enabled this achievement, especially the patients and caregivers, and we congratulate the physicians and others involved in the KarMMa study, including our dedicated partners at bluebird bio. We look forward to seeing the data from this study and are progressing our broader bb2121 development program as we advance closer toward delivering this important new option to appropriate patients in need.”

Tesaro Inc. (NASDAQ:TSRO) recently announced initial data from the Phase 1 AMBER trial of TSR-022 (anti-TIM-3 antibody) in combination with TSR-042 (anti-PD-1 antibody) in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Conference in Washington, D.C. Additionally, Phase 1 GARNET data of TSR-042 in patients with previously treated recurrent/advanced non-small cell lung cancer (NSCLC) and Phase 1 monotherapy dose-escalation data for TSR-033 (anti-LAG-3 antibody) in a broad range of solid tumors were also highlighted in poster presentations. “The initial AMBER data featured at this year’s SITC conference are the first clinical data to be presented for an anti-TIM-3 antibody in combination with an anti-PD-1 antibody and demonstrated that the combination of TSR-022 and TSR-042 is active and generally well tolerated in NSCLC and melanoma patients who have progressed following anti-PD-1 treatment,” stated Mary Lynne Hedley, Ph.D., President and COO of TESARO. “Additionally, updated results from the GARNET trial demonstrated robust clinical activity of TSR-042 in previously treated, anti-PD-1 naive patients with recurrent or advanced NSCLC, the vast majority of which had TPS <50%. We look forward to presenting additional data from these studies in 2019.”

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