On February 13, 2018 Nohla Therapeutics Inc. (Nohla), a clinical stage biopharmaceutical company focused on the development of universal, off-the-shelf cell therapies to treat cancer and other critical diseases, reported the initiation of its Phase 2 LAUNCH clinical trial (Press release, Nohla Therapeutics, FEB 13, 2018, View Source [SID1234523955]). The open-label, multi-center, randomized, controlled, dose-finding LAUNCH trial will evaluate Nohla’s lead product candidate, NLA101, in adult patients with acute myeloid leukemia (AML) who are at risk for myelosuppression after receiving high-dose chemotherapy.

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The LAUNCH trial (NCT03301597) will enroll approximately 220 adult patients and will evaluate NLA101’s ability to reduce the rate of ≥ Grade 3 infections associated with chemotherapy-induced neutropenia, and identify the lowest effective cell dose of NLA101. Patients in the Phase 2 study will be randomized to one of three investigational treatment arms or a control arm. Patients randomized to an investigational treatment arm will be eligible to receive a single fixed dose of NLA101 after the first cycle of chemotherapy, and up to two additional identical NLA101 doses after subsequent cycles of chemotherapy. Additional information on this trial can be found at View Source Funding for the LAUNCH trial is supported by a $6.92 million grant from the California Institute for Regenerative Medicine.

"For patients receiving intensive chemotherapy, life-threatening infections are very common and typically lead to lengthy hospitalizations, increased reliance on supportive care, and delays or reductions in additional treatment," said Colleen Delaney, MD, Founder and Chief Medical Officer of Nohla. "We look forward to further clinical evaluation of NLA101 and the ability to reduce the rate of infections and toxicities associated with high-dose chemotherapy which could have a significant impact on clinical outcomes and patient quality of life."

"Although there have been improvements in therapeutic options for AML patients, they still face significant risk of infectious complications associated with chemotherapy-induced neutropenia," said Naval Daver, MD, Co-lead Investigator and Associate Professor at The University of Texas MD Anderson Cancer Center. "We are excited to participate in the LAUNCH trial as it will help determine NLA101’s ability to provide a durable recovery that may reduce multiple regimen-related toxicities of chemotherapy while potentially improving the efficacy of the primary treatment."

About NLA101
NLA101 is a universal, off-the-shelf stem and progenitor cell therapy designed to provide short-term bone marrow function, while also providing long term immunologic benefits with the potential for improved survival. Over 125 infusions of NLA101 have been administered across four clinical trials since 2009.

About AML
AML is a type of cancer that begins in the bone marrow. The disease progresses rapidly, with an overproduction of abnormal myeloid cells taking over the bone marrow and interfering with the production of normal white blood cells, red blood cells, and platelets. The standard treatment for AML includes high-dose chemotherapy, which can lead to risk of myelosuppression in approximately 80% of patients. Induction and consolidation chemotherapy is frequently followed by allogeneic hematopoietic stem cell transplantation. The American Cancer Society estimates that there will be approximately 19,520 new cases of AML in the US in 2018.

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.