On February 13, 2018 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported the signing of a license deal for the Chinese territory and a global co-development agreement between MOLOGEN and ONCOLOGIE Inc. for its lead compound lefitolimod (Press release, Mologen, FEB 13, 2018, View Source [SID1234527267]). The signed agreement is conditional upon an initial payment of EUR 3 million received by MOLOGEN. ONCOLOGIE is an oncology-focused drug development company with headquarters in Boston and operations in Shanghai. The company is backed by top-tier international investors and has the objective to develop novel personalized medicines in the field of immuno-oncology. The signed agreement with ONCOLOGIE includes the development, manufacture and commercialization of lefitolimod in China and a planned global co-development program.

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"We are delighted to partner our lead compound lefitolimod with ONCOLOGIE. Their approach of an innovative biomarker-driven development strategy for novel cancer immunotherapies has convinced us that partnering with them will expand the opportunities for success of lefitolimod. With the combined licencing and co-development deal for our flagship compound lefitolimod we have achieved one of the main milestones in implementing our strategy. In ONCOLOGIE we have found a partner with a highly dedicated and experienced international team who will not only drive lefitolimod development in China to achieve market approval but will also strongly support our global development efforts. Together we will strive to unleash lefitolimod’s full market potential in China and on a global level", said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.

"We are happy to partner with MOLOGEN on lefitolimod, a best-in-class TLR9 agonist with exciting potential. This program complements ONCOLOGIE’s strategy for biomarker-driven global development and has multiple opportunities for treating indications prevalent in the Asian market", said Dr Laura Benjamin, Chief Executive Officer of ONCOLOGIE.

As previously announced, MOLOGEN had started negotiations on such a deal with the Chinese iPharma. After a certain exclusivity period had expired, MOLOGEN opened the licencing process also for additional parties. Discussions and negotiations with ONCOLOGIE have now been successfully completed and the deal could be signed. The terms of the signed agreement with ONCOLOGIE describe development, manufacture and commercialization of lefitolimod in China and a planned global co-development program.

The contract comprises two parts: First, a license agreement including sublicense rights under which MOLOGEN grants ONCOLOGIE an exclusive license for the development, manufacturing and commercialization for MOLOGEN’s lead compound lefitolimod in the following territory: China, Hong Kong and Macao, Taiwan and Singapore. Second, a commitment for global co-development leveraging novel biomarker plans from ONCOLOGIE. MOLOGEN is to receive an initial payment of EUR 3 million as well as a EUR 2 million equity investment by ONCOLOGIE within the next 12 months. Besides the initial payment and the equity investment, the parties agreed on further development and commercialisation milestones. They are due upon reaching predefined development steps as well as market approval. In addition, commercial milestones are defined which are due upon reaching certain sales thresholds. The total payments can amount to above EUR 100 million and will be paid over several years. Additionally, MOLOGEN will receive low double digit royalties on sales. MOLOGEN and ONCOLOGIE will share the economic returns from global joint development pursuant to both parties’ contributions.

All costs relating to development, registration, marketing and commercialization of lefitolimod in the territory are to be covered by ONCOLOGIE.

On February 13, 2018 Medtronic plc (NYSE: MDT) reported that it will report financial results for the third quarter of fiscal year 2018 on Tuesday, February 20, 2018 (Press release, Medtronic, FEB 13, 2018, View Source;p=RssLanding&cat=news&id=2332167 [SID1234523948]). A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source The news release will include summary financial information for the company’s third quarter of fiscal year 2018, which ended on Friday, January 26, 2018.

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Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its third quarter of fiscal year 2018. The webcast can be accessed at View Source on February 20, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal 2018 fourth quarter financial results on Thursday, May 24, 2018, and for fiscal year 2019, the company plans to report its fiscal first and second quarter financial results on Tuesday, August 21, 2018, and Tuesday, November 20, 2018, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

On February 14, 2018 Kuraray reported Business Results for the Fiscal Year Ended
December 31, 2017 (Press release, Kuraray, FEB 13, 2018, View Source [SID1234524012]).

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On February 13, 2018 Synlogic (Nasdaq: SYBX), a clinical-stage company applying synthetic biology to probiotics to develop novel living medicines, reported the presentation of positive preclinical data from its Synthetic Biotic immuno-oncology (IO) program at the Keystone Symposium Lymphocytes and their Roles in Cancer (Press release, Synlogic, FEB 13, 2018, View Source [SID1234523992]). The meeting is being held jointly with a related session, Emerging Cellular Therapies T-cells and Beyond, from February 11 to 15, 2018.

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"These data provide compelling, early scientific evidence supporting the development of our Synthetic Biotic medicines as potential novel immunotherapeutic agents for the treatment of various cancers," said J.C. Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. "The results demonstrate that we can design Synthetic Biotic medicines that dramatically modulate the tumor microenvironment, by generating potent and efficacious antitumor immunity, turning what is known as a "cold" tumor "hot" and resulting in greatly enhanced response rates. Our Synthetic Biotic medicines can be administered by intratumoral injection enabling achievement of these beneficial effects locally and without systemic toxicity. Moreover, we can engineer additional activities into this new class of living medicines that enhance and sustain the anti-tumor response. In the coming year we intend to advance these IO program candidates into IND-enabling studies."

The data presented at the meeting demonstrate the antitumor effects of treatment with a probiotic strain of E.coli engineered to produce inducible levels of STING (STimulator of INterferon Genes) agonist (SYN-STING). The STING pathway plays a critical role in the control of tumor growth at both steady state and following a variety of cytolytic and immune-based therapies. SYN-STING can be delivered directly into the tumor enabling its localized site of action in the tumor microenvironment. The approach of using intra-tumoral injection elicits innate responses in the tumor but not in the circulation, decreasing the risk of adverse events that may arise from the production of systemic interferon.

Specifically, the data demonstrated that the production of ci-di-AMP by SYN-STING results in the local upregulation of interferon beta by macrophages and dendritic cells in vitro, andthe rapid rejection of established B16F10 tumors in vivo. Treatment results in an early rise in a variety of potent cytokines, including interferon beta, followed by the activation of effector T cells in the tumor-draining lymph nodes and upregulation of molecules associated with a cytolytic T cell response in the tumor. Taken together, these data demonstrate the ability of Synthetic Biotic medicines to dramatically modulate the tumor microenvironment, generating potent and efficacious antitumor immunity.

About Synthetic Biotic Medicines
Synlogic’s innovative new class of Synthetic Biotic medicines leverages the tools and principles of synthetic biology to genetically engineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s two lead programs target a group of rare metabolic diseases – inborn errors of metabolism (IEM). Patients with these diseases are born with a faulty gene, inhibiting the body’s ability to break down commonly occurring by-products of digestion that then accumulate to toxic levels and cause serious health consequences. When delivered orally, these medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect. Synthetic Biotic medicines are designed to clear toxic metabolites associated with specific metabolic diseases and have the potential to significantly improve symptoms of disease for affected patients.

On February 13, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for women’s health and endocrine diseases, reported corporate updates and reported financial results for the third fiscal quarter ended December 31, 2017 (Press release, Myovant Sciences, FEB 13, 2018, http://investors.myovant.com/news-releases/2018/02-13-2018-210634955 [SID1234523951]).

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"We continue to execute on each of our ongoing global Phase 3 development programs of relugolix for the treatment of endometriosis-associated pain, heavy menstrual bleeding associated with uterine fibroids, and advanced prostate cancer with the goal of completing enrollment in each program this year," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "In addition, in October, we secured flexible financing commitments of up to $140 million, which will help support the continued advancement of our Phase 3 programs."

Third Fiscal Quarter 2017 Business Highlights

Positive results in two Phase 3 clinical studies conducted by Takeda Pharmaceutical Company Limited ("Takeda") to evaluate the efficacy and safety of relugolix for the treatment of uterine fibroids.

On October 2, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with leuprorelin for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. Relugolix met the study’s primary endpoint, the proportion of patients achieving a pre-defined reduction in menstrual bleeding, demonstrating an 82.2% response rate, and was observed to be statistically non-inferior to leuprorelin (p = 0.0013). The incidence of adverse events in the study was generally similar between treatment groups and consistent with the mechanism of action of the study medications.
On November 9, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with placebo for the treatment of pain associated with uterine fibroids. Of the women treated with relugolix, 57.6% achieved a marked improvement in pain symptoms compared to 3.1% treated with placebo (p < 0.0001). Adverse events in the study were consistent with the mechanism of action of relugolix and adverse events observed in previous clinical studies.
Takeda plans to submit the data from both studies to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids. Myovant will be solely responsible for obtaining FDA approval for relugolix in the United States.
Secured flexible financing commitments of up to $140 million. On October 16, 2017, Myovant announced that it had secured up to $140 million in flexible financing commitments from NovaQuest Capital Management ("NovaQuest") and Hercules Capital, Inc. ("Hercules"). The NovaQuest financing is comprised of a note purchase commitment of up to $60 million and an equity purchase commitment of up to $40 million. An additional $40 million of debt financing capacity is committed in the form of a term loan facility from Hercules. Myovant plans to use the net proceeds from both financings to fund the ongoing Phase 3 development of relugolix in uterine fibroids, endometriosis and advanced prostate cancer. Pursuant to the agreements, upon closing, Myovant issued notes and shares of common stock of approximately $33 million under the financing commitments.

Third Fiscal Quarter 2017 Financial Summary

Research and development (R&D) expenses for the quarter ended December 31, 2017 were $34.9 million, compared to $6.2 million for the comparable period in 2016. The increase over the prior year period is primarily due to costs associated with the progress in our five ongoing Phase 3 clinical trials of relugolix which were initiated in 2017. R&D expenses for the three months ended December 31, 2017 consisted primarily of clinical trial-related costs of $28.4 million, personnel expenses of $3.2 million, share-based compensation expense of $1.0 million, and costs billed to us under the services agreements with Roivant Sciences Ltd. and Roivant Sciences, Inc. ("the Services Agreements") of $1.9 million, including personnel expenses and third-party costs associated with our ongoing clinical trials and other research programs.

General and administrative (G&A) expenses for the quarter ended December 31, 2017 were $6.6 million, compared to $2.9 million for the same period in 2016. G&A expenses for the three months ended December 31, 2017 consisted primarily of personnel-related and general overhead expenses of $2.7 million, share-based compensation expense of $2.3 million, legal and professional fees of $0.6 million and costs of $1.0 million billed to us under the Services Agreements, including personnel expenses, overhead allocations and third-party costs.

Interest Expense for the quarter ended December 31, 2017 was $0.9 million and consisted of interest expense accrued and paid under the financing agreements with NovaQuest and Hercules as well as the associated amortization of debt discount and issuance costs. There was no interest expense for the comparable prior year period.

Net loss for the quarter ended December 31, 2017 was $41.8 million, or $0.70 per share, compared to a net loss of $8.1 million or $0.15 per share for the same period in 2016. The increase in net loss was driven by the increase in costs associated with our ongoing LIBERTY 1 and LIBERTY 2, SPIRIT 1 and SPIRIT 2, and HERO Phase 3 clinical studies which were initiated in 2017, as well as increased personnel expenses to support Myovant’s growing operations.

Cash and committed funding totaled $235.9 million at December 31, 2017 consisting of $128.9 million of cash and financing commitments totaling $107.0 million available under our financing agreements with NovaQuest and Hercules.

About Relugolix

Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that has been evaluated in over 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects are consistent with suppression of these hormones. In the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain and the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, relugolix will be evaluated with and without low-dose hormonal add-back therapy, the addition of which is expected to decrease potential side effects such as bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix in men with advanced prostate cancer.