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 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that Dr. Jeffrey Miller, Deputy Director of the Masonic Cancer Center, University of Minnesota will be presenting at the Keystone Symposia: Emerging Cellular Therapies: T Cells and Beyond; ‘Novel Ways to Activate and Target NK Cells to Treat Cancer’ (Press release, GT Biopharma , FEB 13, 2018, View Source [SID1234539534]). This presentation will highlight GT Biopharma’s TriKE and TetraKE platforms.

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Dr. Miller will be presenting to leaders in the field of cell therapies at the conference on Feb. 14th from 5:00 -7:00 pm MT. He will be discussing GT Biopharma’s unique single-chain, tri-specific NK cell engager (TriKE) and tetra-specific NK cell engager (TetraKE) platforms targeting hematologic malignancies, sarcomas and carcinomas (solid tumors). The presentation will address both the TriKE and TetraKE constructs, as well as our second-generation anti-CD16-IL-15-anti-CD33 TriKE (OXS-C3550); another first-of-its-kind, single-chain, tri-specific NK cell engager (TriKE).

NK cell cancer-killing activity is expected to be increased by bringing the NK cells in close proximity to the cancer cells. This may be achieved by ‘engagers’ that bind to CD16 on the surface of NK cells and bind specific proteins (such as CD33) on the surface of cancer cells, thus forming an immune synapse between the NK cell and the cancer cell. Our lead TriKE, anti-CD16-IL-15-anti-CD33 (OXS-3550) is expected to be in the clinic in the second half of 2018. The TriKE constructs utilize the inclusion of interleukin-15 (IL-15), a peptide that leads to proliferation and activation of the NK cells. This further increases NK cancer-cell killing capabilities and improves their function in the tumor microenvironment (Vallera et al,2016).

Unlike traditional CAR-T platforms, TriKEs are potentially a cost effective cell therapy and not relegated to treating liquid tumors only. GT Biopharma believes that TriKEs are an antibody platform that can be tailored to treat any form of cancer, liquid or solid tumors.

Dr. Jeffrey Miller said, "I am pleased to present additional information regarding these immune-oncology platforms. As a researcher, I continue to believe that both have the potential to generate candidates with the ability to have a significant impact on the treatment of cancer and other diseases."

GT Biopharma Chief Medical officer (CMO) Dr. Raymond Urbanski said, "The TriKE and TetraKE concepts and constructs potentially have significant advantages over current and other development-stage therapies. Dr. Miller is a luminary in NK cell biology and its applications, and we continue to be excited by the potential opportunity related to this technology."

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.