Array BioPharma Provides NEMO Update

On March 19, 2017 Array BioPharma Inc. (Nasdaq: ARRY) reported that it has withdrawn from the U.S. Food and Drug Administration’s (FDA) Division of Oncology Products 2 its new drug application (NDA) for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer (Press release, Array BioPharma, MAR 19, 2017, View Source;p=RssLanding&cat=news&id=2255017 [SID1234518174]).

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This action was based on thorough discussions and communications with the FDA, including exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on Friday, March 17, 2017. Based on feedback from the agency, Array concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.

Ongoing clinical trials for binimetinib will continue. This action will not impact the planned Phase 3 COLUMBUS trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.

About NRAS-Mutant Melanoma
Of the estimated 10,000 annual cases of metastatic melanoma in the United States, activating NRAS mutations are present in approximately 20 percent of these patients. The presence of an NRAS mutation is a poor prognostic indicator for these patients, and treatment options for this population remain limited beyond immunotherapy.

10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

AC Immune has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, DURECT, 2018, MAR 17, 2017, View Source [SID1234526000]).

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, GlaxoSmithKline, 2016, MAR 17, 2017, View Source [SID1234518177])

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Threshold Pharmaceuticals and Molecular Templates Agree to Combine

On March 17, 2017 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, and Molecular Templates, Inc., a privately held biopharmaceutical company, today jointly announced that they have entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction (Press release, Threshold Pharmaceuticals, MAR 17, 2017, View Source [SID1234518202]). The transaction will result in a combined company focused on the development of novel treatments for cancer.

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Longitude Capital, a U.S. based venture capital firm, will invest $20 million at the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of $20 million.

Molecular Templates’ proprietary technology has been used to create a new class of biologic drug candidates known as Engineered Toxin Bodies or ETBs. ETBs have the affinity of an antibody, the ability to induce cellular internalization against non-internalizing receptors, and a novel mechanism of cell-kill (ribosome inhibition) in oncology. Molecular Templates is also using its technology to deliver foreign class I antigens into tumor cells to boost immune recognition of the tumor in a novel approach to immuno-oncology. The Molecular Templates technology has the advantage of being able to generate "off the shelf" therapeutics that do not require patient cell harvesting or transplantation.

Molecular Templates’ lead product candidate, MT-3724, is an ETB that targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias. A Phase 1 trial with MT-3724 in relapsed and refractory non-Hodgkin’s lymphoma (NHL) has demonstrated good safety and efficacy in elderly, heavily pre-treated patients. In addition to MT-3724, Molecular Templates has preclinical programs targeting HER2 and PD-L1 and has received $15.2 million in new funding commitments from The Cancer Prevention and Research Institute of Texas for its program targeting CD38. Molecular Templates was previously awarded a CPRIT grant for $10.6M that has funded development of its MT-3724 program.

"The merger of our two companies provides Threshold shareholders with a significant equity stake in a biopharmaceutical company with a promising cancer therapy, MT-3724, as well as an innovative and unique technology platform that has generated preclinical drug candidates to treat multiple myeloma, breast cancer and melanoma," said Barry Selick, Ph.D. and Chief Executive Officer of Threshold. "Following an extensive and thorough review of strategic alternatives, we believe this transaction combines promising drug candidates, a solid management team and the resources to create significant value for shareholders and important new cancer therapies for patients."

Eric Poma, Ph.D., Chief Executive Officer of Molecular Templates, commented, "The combined company will have two exciting clinical-stage compounds in evofosfamide and MT-3724 and a unique biological platform with a differentiated mechanism of action in oncology. Longitude’s commitment to invest in the company is a strong testament to the promise inherent in the combined companies’ clinical assets and technology platform."

Threshold’s financial advisor for the transaction is Ladenburg Thalmann & Co. Inc., and Threshold’s legal counsel is Cooley LLP. Molecular Templates’ legal counsel are Mintz Levin Cohn Ferris Glovsky and Popeo PC and Pillsbury Winthrop Shaw Pittman LLP.