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Nov 21, 2013

Array BioPharma President/CSO Resigns

  • Kevin Koch, Ph.D., has resigned as president and CSO of Array BioPharma “to pursue other opportunities,” the company said today, offering no further explanation.

    "The board and executive team thank Dr. Koch for his leadership and contributions to the success of Array over the past 15 years,” Ron Squarer, Array’s CEO, said in a brief statement that summed up the company’s drug development record under the former president/CSO. During that time, Array noted, it advanced 19 novel compounds into clinical trials, of which 14 remain in active development.

    "Array remains committed to its world-class discovery organization and its existing research partnerships,” the statement concluded. The company's partners on various programs include Amgen, AstraZeneca, Celgene, Genentech, Loxo Oncologym, and Novartis.

    Dr. Koch’s departure comes just weeks after the company reported a widening loss in its first fiscal quarter, losing $15.7 million in Q1 2013 versus $11.8 million in the year-ago quarter. A dip in license and milestone revenue resulted in a 10% decline in total revenue, to $14.228 million.

    But Array also reported progress in several clinical programs for its drug candidates. In disclosing its quarterly results Oct. 31, the company said it expected to launch a Phase III trial for its lead in-house compound ARRY-520 in patients with relapsed and refractory multiple myeloma (RRMM) “in mid-2014.” That trial will evaluate ARRY-520 in several hundred patients with RRMM, comparing Kyprolis plus ARRY-520 to Kyprolis alone, with progression-free survival (PFS) as the primary endpoint.

    In addition, Array said it will launch two Phase II trials. One will compare Kyprolis plus ARRY-520 versus Kyprolis alone in 75 RRMM patients with PFS as the primary endpoint. “This trial, which is expected to begin next month, is designed to provide near-term confirmation of the combinability observed in the ongoing MD Anderson ARRY-520 plus Kyprolis trial,” Array said at the time. The second trial will assess ARRY-520 as a single agent in a robust global Phase II trial in patients with RRMM including both low- and high-alpha-1-acid glycoprotein patients.

    Phase III trials were launched last month on two compounds for which Array has partnered with pharma giants.

    Last month AstraZeneca launched a pivotal trial for a compound Array sold a decade ago, the MEK inhibitor selumetinib, a second-line therapy in patients with KRAS-mutant advanced or metastatic NSCLC. The study (SELECT-1) will evaluate the safety and efficacy of selumetinib in combination with docetaxel with PFS as the primary endpoint.

    AstraZeneca launched a study in August assessing the efficacy and tolerability of selumetinib combined with radioactive iodine as adjuvant therapy in patients with differentiated thyroid cancer with high risk of recurrence. And AstraZeneca plans to start a study later this year assessing the efficacy and tolerability of selumetinib in combination with dacarbazine in patients with metastatic uveal melanoma.

    Novartis launched the Phase III COLUMBUS trial with the Array-discovered MEK162 and the Novartis BRAF inhibitor, LGX818, in BRAF-mutant melanoma. The 900-patient trial will compare the efficacy and safety of LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF mutation.

    Array also disclosed late last month progress on two other compounds:

    • ARRY-614—Array said it completed patient enrollment complete in a clinical trial assessing the in-house compound in patients with low/intermediate-1 myelodysplastic syndromes (MDS).
    • ARRY-330 (ONT-380)—Collaboration partner Oncothyreon recently launched a trial of the orally active, reversible, and selective small molecule HER2 inhibitor in patients with brain metastases from HER2+ breast cancer, a trial conducted under the sponsorship of the Dana-Farber Cancer Institute. Oncothyreon plans to start additional studies this year, Array said.


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