On May 5, 2015 Merrimack reported the initiation of a randomized, double-blinded, placebo-controlled Phase 2 clinical trial of MM-141, a bispecific antibody targeting IGF-1R and ErbB3, in combination with nab-paclitaxel and gemcitabine, versus nab-paclitaxel and gemcitabine alone in patients with newly-diagnosed metastatic pancreatic cancer who have high serum levels of free IGF-1
(Press release, Merrimack, MAY 5, 2015, View Source [SID:1234503584]).

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"Pancreatic cancer is the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2020. Merrimack is committed to advancing the standard of care for patients with inoperable, metastatic pancreatic cancer. We are taking steps to move our therapeutics forward based on matching them to the biology of individual tumors," said Chrystal Louis, M.D., Medical Director of MM-141 at Merrimack. "Data from our Phase 1 trial supports further clinical evaluation of MM-141 in patients with high serum levels of free IGF-1. Patients with this biomarker profile may have the greatest potential of benefit from the use of MM-141 combined with standard chemotherapies, and we look forward to further validating this in our Phase 2 trial."

As part of this trial, 146 front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1 will be randomized (1:1) to receive either MM-141 plus nab-paclitaxel/gemcitabine or nab-paclitaxel/gemcitabine alone. Eligible patients for the trial must have received no prior radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. The primary endpoint of the trial is progression free survival (PFS). Secondary endpoints include overall survival, objective response rate, safety and tolerability. Merrimack plans to conduct the trial at sites in the United States, Canada and Europe. Initial trial sites located at St. Jude Heritage in Fullerton, California and Northwestern University in Chicago, Illinois are now open to screen patients in the United States. For more information, please visit clinicaltrials.gov (Identifier: NCT02399137).

About MM-141

MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). IGF-1R and ErbB3 complexes both activate a major signaling pathway that allows tumor cells to grow and develop resistance to chemotherapy. MM-141 has been tested in a Phase 1 dose-escalation clinical trial. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for MM-141 for the treatment of pancreatic cancer. This orphan drug designation could provide Merrimack with seven-year marketing exclusivity and other benefits for MM-141 when approved by the FDA

On May 5, 2015 ArQule and Beryllium Discovery reported a collaborative research and development agreement to identify and unlock the therapeutic potential of small molecule compounds by combining ArQule’s chemistry and drug development expertise with Beryllium’s discovery platforms (Press release, ArQule, MAY 5, 2015, View Source [SID:1234503580]). The Beryllium platforms integrate structure-guided drug discovery, biophysics and cell biology.

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The therapeutic targets to be pursued by the parties include PD-1 (programmed cell death protein 1) and PDL-1 (programmed death ligand 1), two proteins believed to play major roles in suppressing or limiting the response of the immune system. Molecules that bind to and inhibit the effects of these targets may help direct the immune system to combat a variety of tumors.

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"We are excited by the potential synergy in combining complementary technologies and expertise to pursue cost-effective, shared-risk development pathways for the selection of compounds identified from ArQule’s small molecule library or rationally designed through Beryllium’s fragment-based research capabilities and ArQule chemistry technology," said Brian Schwartz, chief medical officer of ArQule. "We are prioritizing the scope of our collaboration based on the recognition that immuno-oncology represents a promising area of research with potential applications across a number of cancers."

"We welcome the opportunity to combine our functional and structural biology platforms with ArQule’s chemistry and drug development capabilities," said Dalia Cohen, Ph.D., chief scientific officer of Beryllium. "We believe that there are significant synergies between the two companies, and we are excited to work together. ArQule’s chemistry know-how and clinical development expertise are a perfect complement to Beryllium’s strengths in target-centric drug discovery."