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Foamix Pharmaceuticals Fourth Quarter and Fiscal Year 2017 Financial Results Conference Call & Webcast Scheduled for February 28

On February 13, 2018 Foamix Pharmaceuticals Ltd. (FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported that it will report its financial results for the quarter and year ended December 31, 2017, after the market close on Tuesday, February 27 (Press release, Foamix, FEB 13, 2018, View Source [SID1234524149]). Foamix will host a conference call and webcast at 8:30am Eastern Time on Wednesday, February 28.

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Conference Call & Webcast
Wednesday, February 28 @ 8:30am Eastern Time
Toll Free: 800-289-0438
International: 323-794-2423
Conference ID: 2903389
Webcast: View Source

Replays, Available through March 14:
Toll-Free: 844-512-2921
International: 412-317-6671
Conference ID: 2903389

Synlogic Presents Data from Immuno-Oncology Development Program Demonstrating Potent Anti-Tumor Immunity Following Administration of Novel STING Agonist-producing Synthetic Biotic™ Medicine

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.

"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.

Nohla Therapeutics Initiates Global LAUNCH Phase 2 Trial of NLA101 in Patients with AML

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.

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.

Nantkwest and Frankfurt University Hospital Announce First in Human Dosing of off-the-Shelf HER2.taNK (Car–natural Killer) Cell Therapy in Glioblastoma

On February 13, 2018 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, reported that the first patient has been dosed in a first-in-human, Phase I clinical study in glioblastoma of HER2.taNK, a novel, natural killer cell-based immuno-oncology therapy using CAR technology in patients (Press release, NantKwest, FEB 13, 2018, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2332072 [SID1234523952]). The study is being led by Dr. Michael Burger, principal investigator, together with co-principal investigators Professor Joachim Steinbach, Head of the Institute for Neuro-oncology at the Goethe University Hospital, and Professor Christian Senft, Department of Neurosurgery at the Goethe University Hospital in Frankfurt/Main, Germany.

Natural killer cells are a critical component of the innate immune system and the first line of defense against cancer and viral infections. HER2.taNK is a natural killer cell based therapeutic that has been engineered to incorporate a novel Chimeric Antigen Receptor (CAR) specific for the human epidermal growth factor receptor 2 (HER2).

HER2 is overexpressed in a large percentage of solid tumors, including breast cancer and glioblastoma, representing a well validated target.

The Phase I clinical study is designed to assess the safety, tolerability and efficacy of intracranial injection of HER2.taNK as a single agent therapy in patients with recurrent HER2-positive glioblastoma.

Glioblastoma is the most common and aggressive primary brain tumor in adults and currently incurable. Present standard of care includes surgical resection followed by radiotherapy and chemotherapy. Despite this aggressive treatment, median survival of glioblastoma patients is still only about 15 months, and recurrence remains almost inevitable.

HER2.taNK

NantKwest’s HER2.taNK is designed to provide precise tumor-cell specificity through the use of a CAR construct that employs a HER2-specific scFv antibody fragment for cancer cell recognition and a human CD28.CD3zeta signaling domain.

In pre-clinical studies, HER2.taNK specifically recognized HER2-expressing cells of different tumor origins and displayed high and selective antitumor activity in in vitro and in vivo models (View Source(16)30043-0). In addition, HER2.taNK demonstrated selective cytotoxicity against otherwise NK cell resistant glioblastoma cell lines and primary glioblastoma cultures. Antigen specificity and selective cytotoxicity of HER2.taNK was retained in vivo, resulting in antitumoral activity in orthotopic human glioblastoma xenograft models. In immunocompetent mice carrying HER2-expressing murine glioblastoma tumors, treatment with HER2.taNK induced an endogenous antitumor immune response resulting in tumor rejection and long-lasting resistance against tumor re-challenge at distant sites (View Source).

To better inform patient care, these clinical trials will incorporate a state-of-the-art, biomarker analysis using GPS Cancer, an integrated, multi-omics, whole genome, transcriptome and proteomics molecular analysis provided by NantHealth, an affiliated company. These comprehensive molecular analysis tools are designed to provide critical information to the clinical study team regarding the molecular alterations associated with the patient’s cancer, further enhancing patient care.

The single center, open label clinical study is estimated to enroll 30 participants with recurrent or refractory HER2-positive glioblastoma. A parallel HER2.taNK clinical study is also being planned for the United States that will further expand the study into other solid tumor types. Additional information regarding the clinical study can be found at View Source, NCT03383978.

Moleculin Announces Collaboration with Emory University to Develop Novel Treatment of Pediatric Brain Cancer

On February 13, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has entered into an agreement with Emory University to enable expanded cancer research on Moleculin’s WP1066 molecule for the possible treatment of medulloblastoma, a pediatric malignant primary brain tumor (Press release, Moleculin, FEB 13, 2018, View Source [SID1234523950]).

Physician-scientists at Emory University and Children’s Healthcare of Atlanta have requested support to continue research aimed at the development of a novel treatment of medulloblastoma using WP1066 and Moleculin has agreed to supply them with a pure form of WP1066 for preclinical testing for the potential treatment of medulloblastoma. Emory studies so far have indicated that medulloblastoma may be particularly vulnerable to the ability of WP1066 to block the activated form of STAT3, a key signaling protein believed to contribute to the growth and survival of many tumors, including medulloblastoma.

"This research seems to confirm what other studies have shown; namely that WP1066 is capable of tumor suppression of many human cancers including brain tumors transplanted into mice," commented Walter Klemp, Chairman and CEO of Moleculin. "This adds to a growing list of prestigious cancer research centers interested in using (exploring/developing) WP1066 to treat cancer patients."