On March 12, 2015 Kura Oncology reported several milestones (Press release, Kura Oncology, MAR 12, 2015, View Source [SID:1234502257]).

LICENSE AGREEMENT WITH JANSSEN PHARMACEUTICA

The Company announced it has entered into an agreement with Janssen Pharmaceutica NV for an exclusive license to develop and commercialize tipifarnib in the field of oncology. Tipifarnib, a protein farnesyl transferase inhibitor, is a Phase 2-ready program that has demonstrated encouraging clinical activity in certain cancer patient populations and that may be further optimized using an appropriate patient selection strategy.

Under the terms of the agreement, Kura Oncology assumes sole responsibility for development and commercialization of tipifarnib in the field of oncology. Kura Oncology intends to advance tipifarnib into Phase 2 clinical trials in 2015 to evaluate its activity in patient populations where certain solid tumors are driven by activating mutation in the oncogene HRAS as well as in patients with hematologic malignancies.

$60 MILLION PRIVATE PLACEMENT

In addition, Kura Oncology announced that it completed a private placement of its common stock to new institutional investors and existing investors that resulted in gross proceeds of approximately $60 million to the Company, including approximately $7.5 million in bridge notes that converted into common stock at the closing. EcoR1 Capital was the lead investor in this financing, which included significant participation from Fidelity Management & Research Company, ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, Nextech Invest, as well as a number of other well-known healthcare investors. Proceeds from the private placement will be used for the development of the Company’s drug candidates, including tipifarnib, as well as preclinical pipeline programs.

“Tipifarnib has demonstrated compelling and durable anti-cancer activity in certain patient subsets and represents a promising clinical development opportunity with the right patient selection strategy,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We intend to leverage advances in next-generation sequencing as well as emerging information about cancer genetics to identify patients most likely to benefit from tipifarnib.” Dr. Wilson added, “We are additionally pleased to be able to attract the support of such a high caliber group of institutional healthcare investors. We expect the proceeds from this financing will allow us to rapidly move forward with the clinical development of tipifarnib as well as advance our preclinical programs towards the clinic.”

Leerink Partners LLC served as lead placement agent and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD) and Livingston Securities LLC served as co-placement agents for the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

REVERSE MERGER AND PUBLIC REPORTING COMPANY

In conjunction with the private placement, Kura Oncology completed a reverse merger with Zeta Acquisition Corp III, a public reporting company with no prior business operations. Stockholders of Kura Oncology, including those that participated in the private placement, received shares of Zeta Acquisition in exchange for their Kura Oncology shares, and the former Kura Oncology stockholders now hold 100 percent of the resulting company’s equity in the same proportion as the stockholders owned immediately following the private placement. Zeta Acquisition has been renamed Kura Oncology, Inc. and will implement the pre-merger business plan of Kura Oncology. Kura Oncology intends to file a registration statement covering the resale of shares of common stock held by new and existing shareholders within 60 days after the closing. Following the effectiveness of that registration statement, Kura Oncology will seek to have its common stock quoted on the OTC Markets.
ABOUT TIPIFARNIB

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown compelling and durable anti-cancer activity in certain patient subsets and a well-established safety profile. Preclinical and clinical data suggest that, in the right genetic context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics, Kura Oncology will seek to identify patients most likely to benefit from tipifarnib. The company plans to initiate a Phase 2 clinical trial of tipifarnib in patients who have tumors characterized by HRAS mutations in the second quarter of 2015 and a Phase 2 clinical trial in patients with peripheral T-cell lymphomas in the third quarter of 2015.
ABOUT KURA ONCOLOGY

Kura Oncology is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines for the treatment of solid tumors and blood cancers. Kura Oncology brings together a proven team of drug developers and biotech entrepreneurs, including Troy Wilson, Ph.D., J.D., President and CEO, Kevan Shokat, Ph.D., Professor of Molecular and Cellular Pharmacology at UCSF and Chairman of the Kura Oncology Scientific Advisory Board, Yi Liu, Ph.D., Chief Scientific Officer, Pingda Ren, Ph.D., Senior Vice President of Chemistry and Pharmaceutical Sciences and Antonio Gualberto, M.D., Ph.D., Chief Medical Officer. Kura Oncology’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines.

On March 12, 2015 Epizyme reported that it has reacquired global rights to its EZH2 program, including EPZ-6438, from its partner Eisai Co. Ltd, or Eisai (Press release, Epizyme, MAR 12, 2015, View Source [SID:1234502256]). Under the terms of the agreement, Epizyme will be solely responsible for global clinical development, manufacturing and commercialization in all countries outside of Japan, where Eisai will retain rights. EPZ-6438, a first-in-class inhibitor of EZH2, is currently being evaluated in a Phase 1/2 clinical study for the treatment of B-cell non-Hodgkin lymphoma (NHL) and INI1-deficient solid tumors, such as synovial sarcoma and malignant rhabdoid tumor.

“Over the past seven years, we have been deliberately building Epizyme as an independent, fully integrated oncology company. Obtaining global control of EPZ-6438, a very promising clinical asset, represents an important milestone in the evolution of the Company,” said Robert Gould, Ph.D., President and Chief Executive Officer, Epizyme. “As we began to see the quality and duration of the responses, including two complete responses, in relapsed and refractory NHL and INI1-deficient patients treated with EPZ-6438 as a monotherapy, it became clear to us that having worldwide development and commercialization responsibility for a targeted therapeutic like 6438 would be transformative for Epizyme.”

“With the continued emergence of clinical data on EPZ-6438, it is apparent that this is a therapy with tremendous potential to benefit a variety of patient populations,” said Takashi Owa, Ph.D., Chief Innovation Officer, Eisai Product Creation Systems. “As we re-focus our resources on our later stage programs across therapeutic areas, we believe that Epizyme is well positioned to move EPZ-6438 development forward aggressively. We are pleased that the structure of this agreement allows us to participate in the future success of EPZ-6438.”

Following completion of the transition of EPZ-6438 from Eisai to Epizyme, Epizyme plans to conduct a five-arm Phase 2 study in approximately 150 patients with NHL. This study will evaluate EPZ-6438 in the following patient cohorts:

Diffuse large B-cell lymphoma, germinal center B-cell-like (GCB) type with wild-type EZH2
Diffuse large B-cell lymphoma, GCB type with mutant EZH2
Follicular lymphoma with wild-type EZH2
Follicular lymphoma with mutant EZH2
Diffuse large B-cell lymphoma, non-GCB type

The cohort of patients with diffuse large B-cell non-GCB type is expected to include predominantly patients with wild-type EZH2, since the frequency of EZH2 mutations is approximately 5 percent in this sub-population of diffuse large B-cell lymphoma.

In addition, Epizyme plans to initiate a Phase 2 study in adults with INI1-deficient tumors, including synovial sarcoma, and a Phase 1 study in children with INI-1 deficient tumors, including malignant rhabdoid tumors. Epizyme will also continue the clinical pharmacology studies that are part of the Eisai / Epizyme clinical plan.

“We are pleased to lead the development of EPZ-6438, and look forward to further exploring and defining its clinical activity and safety in a range of hematological and solid tumor indications,” said Peter Ho, M.D., Ph.D., Chief Development Officer, Epizyme.

Terms of the Agreement

Under the terms of the agreement, Epizyme will be responsible for global development, manufacturing and commercialization. Epizyme will fund 100 percent of global development costs, and Eisai will fund 100 percent of Japan-specific development costs.

Epizyme will make a $40 million upfront payment to Eisai, with a total of up to $20 million in potential clinical milestone payments and up to $50 million in potential regulatory milestone payments. Epizyme will pay Eisai a royalty at a percentage in the mid-teens on sales of EPZ-6438 outside of Japan, and Eisai will pay Epizyme a royalty at a percentage in the mid-teens on sales in Japan. Eisai will have a limited right of first negotiation for Asia rights if Epizyme decides to license Asia rights to a third party.