“Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that the U.S. Food and Drug Administration (FDA) has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3.”
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“Merrimack Pharmaceuticals, Inc. MACK, +1.95% today announced the initiation of a global, open-label, biomarker-selected, randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody targeting ErbB3, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer.
” ‘This marks the first MM-121 trial we’ve initiated where only patients with a high heregulin biomarker profile will be enrolled into the study. It builds on our learnings from the previous MM-121 Phase 2 clinical trials we completed across lung, ovarian and breast cancers where we saw a clear trend of patients in those studies with this biomarker profile benefitting from combining MM-121 with standard therapies,’ said Akos Czibere, MD, PhD, MM-121 Global Development Lead at Merrimack. ‘This study is a significant step toward preparing a registration trial of MM-121 in non-small cell lung cancer, and further supports Merrimack’s systems biology approach and its impact on drug discovery and development. We look forward to applying our clinical biomarker findings to future studies with MM-121 and ultimately improving outcomes in patients who no longer respond to standard-of-care therapies.’ “
“AVEO Oncology (NASDAQ:AVEO) today announced the presentation of results from a first-in-human Phase 1 study of AV-203, AVEO’s ErbB3 (HER3) inhibitory antibody candidate. Among the results, the study established a recommended Phase 2 dose of AV-203, demonstrated good tolerability and promising early signs of activity, and reached the maximum planned dose of AV-203 monotherapy. The results were presented in a poster, entitled “First-in-human Phase 1 dose-escalation study of AV-203, a monoclonal antibody against ErbB3 in patients with metastatic or advanced solid tumors” (Abstract #11113, Poster #395, S Hall A2), at the Tumor Biology General Poster Session of the American Society of Clinical Oncology 2014 Annual Meeting, taking place May 30 – June 3, 2014, in Chicago.”
Editor’s note: This story is about a promising new drug called AV-203. In a clinical trial to test the drug in volunteer patients, AV-203 showed promise for treating several cancer types, including lung cancer.
Merrimack Pharmaceuticals is conducting a phase II clinical trial of the new drug MM-121. MM-121 is an antibody (a type of immune system protein) that targets a protein called ErbB3 or HER3, which plays a role in tumor growth and survival. ErbB3 is closely related to the protein EGFR. EGFR inhibitors like erlotinib (Tarceva) are used to treat non-small cell lung cancer (NSCLC). The study examines whether combining Tarceva with MM-121 is more effective than Tarceva alone. The trial involves three patients groups: group A (NSCLC patients without mutations in the EGFR gene who have not previously been treated with EGFR inhibitors), group B (patients with EGFR mutations who have not received EGFR inhibitors), and group C (patients who previously received EGFR inhibitors and whose cancer worsened despite the treatment). Group A enrollment has just been completed, group B enrollment is ongoing, and studies of group C were completed recently.
Abel EV, Basile KJ, Kugel CH 3rd, Witkiewicz AK, et al. J Clin Invest. Apr 1, 2013.
“The mechanisms underlying adaptive resistance of melanoma to targeted therapies remain unclear. By combining ChIP sequencing with microarray-based gene profiling, we determined that ERBB3 is upregulated by FOXD3, a transcription factor that promotes resistance to RAF inhibitors in melanoma…”