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Aduro Biotech Receives Milestone Payment From Janssen for Submission of Investigational New Drug Application for ADU-741 in Prostate Cancer

On November 18, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has received a milestone payment from Janssen Biotech, Inc. for Aduro’s submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer (Press release, Aduro BioTech, NOV 18, 2015, View Source [SID:1234508278]). The IND will enable Janssen, Aduro’s license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer (mCRPC).

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"We are very pleased with our productive partnerships with Janssen," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "ADU-741 for prostate cancer is the second LADD-based therapy that Janssen plans to advance into the clinic, in addition to ADU-214 for lung cancer. We believe this further validates the power of combining our innovative LADD technology platform with Janssen’s expertise in oncology clinical development. We look forward to continued development of these compounds in collaboration with Janssen, while at the same time, progressing our internal pipeline of immuno-oncology therapeutics toward commercialization."

In May 2014, Aduro entered into an agreement granting Janssen an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on Aduro’s novel LADD immunotherapy platform. Under the agreement facilitated by Johnson & Johnson Innovation, Aduro received an upfront payment, milestone payments associated with submission of the IND, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $346 million as well as royalties on worldwide net sales upon successful launch and commercialization.

About LADD

LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

Threshold Pharmaceuticals Enters Into Definitive Co-Promotion Agreement for Evofosfamide With Merck KGaA, Darmstadt, Germany

On November 18, 2015 Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) reported that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck KGaA, Darmstadt, Germany pursuant to the companies’ License and Co-Development Agreement entered into on February 2, 2012 (Press release, Threshold Pharmaceuticals, NOV 18, 2015, View Source [SID:1234508277]). Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide (previously known as TH-302) in the U.S. subject to Food and Drug Administration (FDA) approval of evofosfamide. Evofosfamide is Threshold’s investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015.

Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany’s sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440 million.

"We are pleased to have reached an agreement with our partner Merck KGaA, Darmstadt, Germany on definitive terms for our option to co-promote evofosfamide in the U.S.," said Barry Selick, Ph.D., Chief Executive Officer at Threshold. "The ability to co-promote and field a sales force represents one of two key options allowing Threshold to participate in the commercial phase of evofosfamide’s lifecycle should it receive FDA approval. Importantly, the license agreement also provides us with an option to co-commercialize evofosfamide in the U.S., depending upon achieving certain milestones, which would allow us to share in up to fifty percent of the profits from the sale of the drug. Threshold is well positioned to integrate a commercial arm to its oncology discovery and development organization."

About Evofosfamide

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic. Evofosfamide is currently in two Phase 3 trials, both of which are fully recruited: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS) (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Top-line data for both trials are expected around the end of 2015. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.

Merck and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma

On November 18, 2015 Merck and Pfizer reported that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen (Press release, Merck KGaA, NOV 18, 2015, View Source [SID:1234508276]).

Breakthrough Therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over current available therapies. MCC is a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.3 There is currently no therapy approved specifically for the treatment of metastatic MCC.4

The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from the global Phase II study, JAVELIN Merkel 200, which is assessing the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen. Results from this Phase II study are planned for presentation at upcoming scientific congresses in 2016. The designation represents a significant milestone and has the potential to speed the development of avelumab for metastatic MCC patients.

JAVELIN Merkel 200 is a multicenter, single-arm, open-label Phase II study with a primary objective of overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which enrolled 88 patients, is being conducted in sites across Asia Pacific, Australia, Europe and North America.

"Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients," said Dr. Luciano Rossetti, Head of Global Research & Development at Merck’s biopharma business. "With this Breakthrough Therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options."

"In less than two months, the alliance between Merck and Pfizer has achieved its third regulatory milestone for avelumab, including Orphan Drug designation and Fast Track designation granted in September and October," said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "We are very pleased with the progress of the JAVELIN clinical development program and we are looking forward to presenting additional data on the potential of this investigational compound in Merkel cell carcinoma and other tumor types in 2016."

The clinical development program for avelumab now includes more than 1,400 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g., bladder) cancer.

Spectrum Pharmaceuticals Divests Rights to ZEVALIN® (ibritumomab tiuxetan) in Japan and Select Other Ex-US Countries to Mundipharma

On November 18, 2015 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the divestment of ZEVALIN rights in Japan and other countries in Asia Pacific (excluding China and India), Middle East, Africa and Latin America, to Mundipharma (Press release, Spectrum Pharmaceuticals, NOV 18, 2015, View Source [SID:1234508275]). Spectrum will receive an up-front payment of $15 million plus $5 million in profits on initial ZEVALIN supply. Spectrum will continue to own ZEVALIN rights for US, Canada, and Europe.

"This divestiture is consistent with Spectrum’s strategy of focusing on our strong late state pipeline and increasing our operational effectiveness," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "While providing non-dilutive cash, this deal lets us concentrate our efforts on developing drugs like SPI-2012 and poziotinib that have the potential to compete in blockbuster markets. This deal also helps us lower our cost of operations related to territories that are not strategic for Spectrum’s growth. Mundipharma will be able to take over Spectrum’s operations in Japan, and with reinvigorated efforts be able to better serve non-Hodgkin lymphoma patients in select ex-US countries."

About ZEVALIN and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma who achieve a partial or complete response to first-line chemotherapy.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

Important ZEVALIN Safety Information

Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.

Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.

Tragara and Lee’s Pharmaceuticals sign an exclusive concession agreement to develop and sell TG02 in the Greater China market and Southeast Asia

On November 16, 2015 Private clinical swelling dedicated to the development of new cancer therapies The cancer research company Tragara Pharmaceuticals (Tragara Pharmaceuticals, Inc., hereinafter referred to as "Tragara") reported that Li China Cancer Medical Co., Ltd. (hereinafter referred to as "Li’s Pharmaceutical Factory") subsidiary of China Cancer Medical Co., Ltd. (China) Oncology Focus Limited) has obtained the TG02 concession for oral multi-kinase inhibitors granted by Tragara (Press release, Lee’s Pharmaceutical, NOV 17, 2015, View Source [SID1234532913]). Lee’s Pharmaceutical Factory Is a biopharmaceutical company listed on the main board of the Hong Kong Stock Exchange (stock code: 950), with more than 20 in the Chinese pharmaceutical industry. Year of operation history.

Under the terms of the agreement, Lee’s Pharmaceuticals acquired exclusive rights to develop and sell TG02 in the following countries, including: China Mainland, Hong Kong, Macau, Taiwan, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines Bin, Singapore, Thailand and Vietnam. Tragara will receive upfront payments for prepaid cash, related potential periodic payments and The tiered royalties for net sales. Lee’s Pharmaceuticals will be responsible for the development, registration and commercialization of TG02 within its scope of license. Industrialization related expenses. In the early stages, Lee’s Pharmaceuticals will focus on the clinical development of TG02 for hepatocellular carcinoma treatment. both sides Research and development results and related data will be shared.

In the United States, TG02 is currently being combined with the new-generation protease inhibitor carfilzomib for phase 1b clinical trials in patients with multiple myeloma. Research stage. The concept has been validated in this study and Tragara will continue to recruit more patients to participate in the study. For MYC- The first phase of over-expressed solid tumors is in the planning stage.

Tragara also announced today that the company recently completed a $13 million Series C private placement financing. Lee’s Pharmaceutical Factory and Existing investors have participated in the financing, including investors in Domain Associates Ventures, Morgan Taylor Venture capital firms (Morgenthaler Ventures), ProQuest Investments investment companies and RusnanoMedInvest Investment Company.

"We are honored to work with Tragara to develop TG02 in Greater China and Southeast Asia. I believe TG02 will be very A new treatment option for patients with multiple hepatocellular carcinoma (HCC)." Dr. Li Xiaoyu, Chief Executive Officer and Executive Director of Lee’s Pharmaceuticals "We are currently developing a PD-L1 monoclonal antibody, an oncolytic virus and a proprietary chemical, plus one Targeted therapeutics, which will give our group a dominant position in the field of cancer treatment, and successfully self-developed combined drugs. "

"We are very pleased to work with Lee’s Pharmaceuticals to develop and accelerate the development of TG02 on a global scale. This collaboration is not only About the development of TG02 for the treatment of hepatocellular carcinoma (HCC), and will also serve as a platform to establish an over-expression table for MYC oncogenes Clinical proof of solid tumors. We are full of expectations for cooperation with Lee’s Pharmaceuticals. President and head of Tragara Executive Officer Thomas M. Estok said.