On October 2, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer of Synlogic, effective immediately (Press release, Synlogic, OCT 2, 2018, View Source [SID1234530532]). Dr. Brennan joined Synlogic as chief medical officer in 2016 and has served as interim president and chief executive officer since May 2018.

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"After conducting a thorough search process, it was clear to the board of directors that Aoife is the right person to lead Synlogic at this time in the company’s evolution," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife stepped into the interim role and rapidly demonstrated her effectiveness. Her broad experience across multiple stages of drug development and therapeutic areas, her demonstrated leadership abilities, and her ambitious vision for Synlogic, make her uniquely qualified for the job. We are confident that under her leadership, Synlogic will be well-positioned to deliver Synthetic Biotic medicines to patients."

"I appreciate the confidence and support of the board of directors and am thrilled to be selected to lead Synlogic as we pioneer the development of a completely new class of living medicines," said Dr. Brennan. "We have made great progress to date, advancing two Synthetic BioticTM programs into the clinic. I look forward to continuing to execute on our plans for the clinical development of our lead candidates while capitalizing on the broad applicability and potential of our novel platform to build a pipeline of therapies for patients with serious and life-threatening diseases."

Prior to joining Synlogic, Dr. Brennan spent six years at Biogen in roles of increasing responsibility, most recently as vice president and head of the Rare Disease Innovation Unit, which included programs ranging from pre-clinical to commercial. She has also led programs across multiple therapeutic areas including the late-phase development of nusinersen for spinal muscular atrophy and treatments for Hemophilia B and Hemophilia A, ALPROLIX and ELOCTATE. Earlier, Dr. Brennan was director of clinical development at Tolerx, a start-up biotech company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed her post-graduate training in internal medicine, endocrinology and metabolism at the Royal College of Physicians in Ireland. Additionally, she completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

On October 2, 2018 NantKwest (Nasdaq:NK), a leading, clinical-stage natural killer cell based therapeutics company, reported that the company will be presenting at the upcoming Cantor Global Healthcare Conference onTuesday, October 2nd in New York City During the conference, company management will be presenting a corporate overview, as well as conducting one-on-one meetings to provide a corporate update, as well as review R&D and clinical activities (Press release, NantKwest, OCT 2, 2018, http://ir.nantkwest.com/news-releases/news-release-details/nantkwest-present-2018-cantor-global-healthcare-conference?field_nir_news_date_value[min]=2018 [SID1234529706]).

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Conference Details:

Event: Cantor Global Healthcare Conference
Date/Time: Tuesday, October 2, 2018 at 4:00pm
Location: New York, NY

On October 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting data from the Phase 1/2a LYMRIT 37-01 study investigating Betalutin (177Lu-lilotomab satetraxetan) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL) has been accepted for a poster presentation at the 60th Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018, San Diego, CA) (Press release, Nordic Nanovector, OCT 2, 2018, View Source [SID1234553494]).

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Title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, et al.

The Company will also have two non-clinical posters: one presenting Betalutin and one presenting the investigational anti-CD37 radioimmunoconjugate 212Pb-NNV003, which is under evaluation in a research collaboration between Nordic Nanovector and Orano Med (formerly AREVA Med).

Cell Cycle Kinase Inhibitors Potentiate the Effect of 177Lu-lilotomab Satetraxetan in Treatment of Aggressive Diffuse Large B-Cell Lymphoma

Authors: G.R. Rødland et al.

Targeted Alpha Therapy with 212Pb-NNV-003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)

Authors: A. Saidi et al.

The abstracts will be published on 1 November 2018 at 09:00am Eastern time at View Source

The 2018 Nobel Prize in Physiology or Medicine has been awarded jointly to James P. Allison and Tasuku Honjo for their almost 30 year old discovery of cancer therapy by inhibition of negative immune regulation. It was in the 1990s, when Dr James P. Allison’s laboratory at the University of California, Berkeley studied the T-cell protein CTLA-4. He was one of several scientists who had made the observation that CTLA-4 functions as a brake on T cells. In 1992, a few years before Allison’s discovery, Tasuku Honjo discovered PD-1, another protein expressed on the surface of T-cells. His research showed that PD-1, similar to CTLA-4, functions as a T-cell brake, but operates by a different mechanism.

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Fast forwarding to today and cancer immunotherapy is the established 4th pillar of cancer therapy and encompasses a highly diverse portfolio of treatment strategies from the early interferon-α/interleukin-2 therapies to the current progress of immune-checkpoint inhibitors and CAR-T therapies to make the immune system fight cancer.

The first approved immune-checkpoint inhibitor was Bristol-Myers Squibb’s ipilimumab (Yervoy) back in 2011 for the treatment of adult patients with previously-treated advanced melanoma. Then followed the approval of Opdivo (nivolumab) and Keytruda (pembrolizumab) in rapid succession. Currently there are seven approved immune-checkpoint inhibitors for the treatment of sixteen different tumor types, see table below. Just last Friday Regeneron and Sanofi reported that the U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

These approved drugs are just the tip of the iceberg with more than 500 immune-checkpoint drugs being developed world-wide for the treatment of cancer. No less than twenty of these are in late stage development.

The event of immune-checkpoint drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) have dramatically changed the possibility to harness the power of the immune system in fighting cancer not only as a monotherapy but, maybe more importantly, also as a combination therapy.

On October 1, 2018 InteRNA Technologies reported its results from a set of confirmatory in vitro and in vivo studies further validating the unique mechanism of action (MoA) of InteRNA’s lead microRNA drug candidate, INT-1B3, for the treatment of cancer (Press release, InteRNA Technologies, OCT 1, 2018, View Source [SID1234529688]). Most strikingly, the company was able to demonstrate that INT-1B3’s earlier reported long-term memory immune protection activity against re-challenge with tumor cells is cytotoxic CD8+ T cell-mediated. INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified microRNA 193a-3p mimic, a known tumor-suppressor microRNA, that has been shown to induce immune-modulation of the tumor microenvironment, reduction of metastases development leading to improved animal survival, and pronounced long-term immunity with a good safety and tolerability profile. The data were presented in two posters at the 14th Annual Oligonucleotide Therapeutics Society (OTS) Meeting, held in Seattle, WA from September 30 – October 3, 2018.

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"These confirmatory results are consistent with the original preclinical proof-of-concept data we presented at the AACR (Free AACR Whitepaper) Annual Meeting this year and thereby serve as a fundamental validation of INT-1B3’s differentiated mechanism of action," said Dr. Roel Schaapveld, CEO of InteRNA. "It is also very exciting that we were able to demonstrate that the pronounced long-term anti-tumor immunity we have seen is CD8+ T cell-dependent which further clarifies a key aspect of these promising effects. We are convinced that INT-1B3, next to its potential in combination regimens, represents a unique and novel monotherapeutic opportunity in immuno-oncology and we look forward to evaluating its efficacy in cancer patients."

The data presented at the 14th Annual OTS Meeting confirm and expand on the preclinical data presented at AACR (Free AACR Whitepaper) in April 2018 as summarized in the following announcement http://bit.ly/2NnruRI.

In a syngeneic orthotopic mouse model of triple negative breast cancer (TNBC 4T1), systemic administration of INT-1B3 was proven to efficiently modulate the immunosuppressive tumor microenvironment. Upon resection of the primary tumors, this resulted in: 1) the inhibition of tumor re-growth, 2) reduction of distant (lung and intraperitoneal) metastases development with significant impact on animal survival, and 3) long-term immunity to newly injected 4T1 tumor cells in the absence of further drug treatment. Most notably, CD8+ T cell depletion greatly impacted protection of surviving INT-1B3-treated animals against such re-challenge with 4T1 tumor cells, suggesting a CD8+ T cell-dependent long-term immune protection. Furthermore, the results presented in a second poster verify that upon transfection in a wide panel of human tumor cell lines, the microRNA 193a-3p mimic was able to inhibit tumor cell proliferation and survival, modulate the tumor cell cycle, induce apoptosis and/or senescence and decrease tumor cell migration and invasion. In addition, and consistent with results in cell-based assays, significant anti-tumor efficacy of INT-1B3 was demonstrated in several human xenografts and in an extended panel of syngeneic subcutaneous mouse tumor models. Based on these results, INT-1B3 provides a novel and promising therapeutic approach in the immuno-oncology armamentarium.

MicroRNAs are naturally occurring small RNA interfering molecules which represent a part of the body’s arsenal to regulate gene expression, each targeting a specific set of genes that have gained recent attention as a novel therapeutic approach in a variety of disease states. MicroRNA 193a-3p specifically is a known tumor suppressor microRNA that is downregulated in many cancers. InteRNA’s formulated and chemically modified synthetic mimic combines anti-tumor activity with modulation of the immunosuppressive tumor microenvironment, and long-term immunity upon systemic delivery to cancer cells upregulating microRNA 193a-3p’s original function across the pathways involved in the initiation and progression of cancer and the evasion of the immune system in parallel.

The posters entitled "A novel synthetic miR-193a-3p mimic (INT-1B3) targeting multiple hallmarks of cancer reveals potential for therapeutic intervention in oncology" (poster #114) and "INT-1B3, a novel synthetic microRNA mimic and its monotherapy potential in immune-oncology armamentarium" (poster #63) as well as the original proof-of-concept data were presented by InteRNA’s Chief Executive Officer, Dr. Roel Schaapveld and Chief Development Officer, Dr. Michel Janicot and are available on InteRNA’s website through the following link:
View Source