On February 13, 2018 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that it will deliver an invited presentation on February 15th, 2018 at 4:15 PM as part of the Adoptive T- Cell Therapy Symposium at the Hilton San Francisco Union Square in San Francisco, CA (Press release, Atossa Genetics, FEB 13, 2018, View Source;molecular-medicine-tri-conference-on-thursday-february-15-2018 [SID1234523940]). The symposium will be held during the 25th Annual Molecular Medicine Tri-Conference, one of the world’s premier international events in the field of drug discovery, development and diagnostics.

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The presentation entitled "TRAP CAR-T and Related Cell Therapies: Can Local Delivery Solve Efficacy and Toxicity Challenges in Solid Tumor Immuno-Oncology?" will discuss Atossa’s proprietary intraductal microcatheter technology and its potential to deliver T-Cell and other immunotherapies directly to breast cancer tumors.

Janet Rea, MSPH, RAC, Senior Vice President of Regulatory, Quality and Clinical Affairs for Atossa will present. Ms. Rea joined Atossa in 2015 and has over 35 years of industry leadership experience. A Washington native, she obtained her B.S. degree in Microbiology from the University of Washington and was conferred a Master’s of Science of Public Health from the same institution.

About The Molecular Medicine Tri-Conference

The annual Molecular Medicine Tri-Conference has become one of the world’s leading international events in the field of drug discovery, development and diagnostics. The Tri-Conference unites an ecosystem of 3,700 innovative thinkers and thought leaders throughout biotech, pharma and academia from around the world. Spanning five days (February 11 – 16) the 2018 meeting includes 16 parallel conference tracks, 7 Symposia, and 25 in-depth short courses.

About Atossa’s CAR-T Technology

Much of the recent success in the field of chimeric antigen receptor therapy, or CAR-T, has relied on the systemic delivery (for example a needle injection into the blood stream) of the CAR-T which is intended to treat various non-solid tumor cancers, such as blood cancers. One concern with this systemic approach is that it does not target the location of the cancer and it can have adverse affects, including deadly "cytokine storms." Moreover, CAR-T treatments delivered systemically can be very expensive – as high as $500,000 per patient.

We are developing a novel method to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer. This approach uses our proprietary intraductal microcatheter technology for the potential transpapillary, or "TRAP," delivery of either T-cells that have been genetically modified to attack breast cancer cells or various immune-therapies. We believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells or immunotherapy; improved efficacy by placing the T-cells or immunotherapy in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells or immunotherapy potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. Moreover, our proprietary approach may be more cost effective if lower doses of therapy can be delivered compared to systemic CAR-T. Our approach is in the R&D stage and is currently not FDA approved. In 2018 we intend to commence studies that will help demonstrate safety and efficacy of this novel approach.

On February 13, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that a planned interim review of data supports continuation of its multicenter, investigator sponsored, study evaluating ME-344, a novel mitochondrial inhibitor, in patients with HER2-negative breast cancer (Press release, MEI Pharma, FEB 13, 2018, View Source [SID1234523949]). The interim study data show that ME-344 was generally well-tolerated and, consistent with previous preclinical data, demonstrate the potential to reverse resistance to antiangiogenic therapy. Based on the interim results, it was determined that completion of enrollment of the clinical study of ME-344 in combination with bevacizumab (marketed as Avastin) is warranted.

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"The interim data are very encouraging and I look forward to an opportunity to present the results at a medical meeting later this year," stated the study principal investigator, Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain.

Dr. Quintela-Fandino continued: "These preliminary data are consistent with our previously published preclinical studies and it is our hope that the data from the current clinical study will help advance our understanding of the escape pathways utilized by tumors against antiangiogenic agents. The therapeutic opportunity that is available to exploit the adaptive mechanisms of tumors via mitochondrial inhibition is quite novel and I am very excited to continue the trial and further explore the promising utility of ME-344 in combination with antiangiogenic therapeutics."

Inhibition of mitochondrial adenosine triphosphate (ATP) with drug candidates such as ME-344 may have significant potential in combination with antiangiogenic agents. Antiangiogenics are widely used biologic agents in oncology, but acquired resistance to antiangiogenics is a major problem in cancer therapeutics. Antiangiogenics reduce the rate of glycolysis as a mechanism to block tumor growth, however sustained tumor growth may be achieved via a shift to an alternative metabolic energy source such as mitochondrial ATP*. In such cases of tumor plasticity in the presence of treatment with antiangiogenics, targeting the alternative metabolic source would open an important therapeutic opportunity.

About the Study
The study is a multicenter, investigator sponsored, randomized, open label, clinical trial evaluating ME-344 in a total of 40 patients with HER2-negative breast cancer in combination with the VEGF inhibitor bevacizumab (marketed as Avastin). Patients are randomized one-to-one to either ME-344 plus Avastin or saline plus Avastin. The primary efficacy endpoint is inhibition of cell proliferation as measured by Ki-67 reductions. The interim data review was predefined to take place after 20 patients were randomized.

About ME-344
ME-344 is a novel, tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1**, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 results in a rapid loss of ATP and cancer cell death. ME-344 has demonstrated evidence of single agent activity against refractory solid tumors in a Phase 1 study.

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

On February 13, 2018 Cellectis (Paris:ALCLS) (NASDAQ:CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the issuance of two U.S. patents – US 9,855,297 and US 9,890,393 – for the invention of certain uses of RNA-guided endonucleases, such as Cas9 or Cpf1, for the genetic engineering of T-cells (Press release, Cellectis, FEB 13, 2018, View Source [SID1234523941]). The patents came into force on January 2nd, 2018 and February 13th, 2018, respectively.

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Both patents claim methods by which T-cells are gene edited using transient expression of CRISPR/Cas9 components. These inventions are based on the early work initiated by inventors at Cellectis when the CRISPR technology first came to light.

These therapeutic-focused patents follow the grant by the European Patent Office of patent No. EP3004337 for similar inventions and previous intellectual property that Cellectis has obtained over the last two decades for major gene editing technologies including meganucleases, TALEN, MegaTAL and CRISPR.

"Cellectis is a pioneering gene editing company that has always been keen to be at the forefront of all gene editing technologies," said Dr. André Choulika, Cellectis Chairman & CEO. "We have been the first to explore the potential of CRISPR in its early days in various applications, including therapeutics and plants. These early findings ultimately led to the grant of this set of new patents. As such, these patents only reinforce Cellectis’ leadership position in the gene editing industry."

Convinced of their strong value for the future development of engineered CAR T-cells, Cellectis will make these patents available for licensing to companies that are willing to use CRISPR technologies in T-cells. The technical knowledge in these patents could, for example, help users engineer allogeneic CAR T-cells while suppressing genes involved in checkpoint inhibitions, such as PD-1, engineer drug resistance, or remove MHC (Major Histocompatibility Complex) related genes. The technology could also be used to insert a DNA CAR construct by gene targeting a specific locus in the genome of T-cells.

The inventors of these patents are Dr. André Choulika, Chairman & CEO of Cellectis and one of the pioneers in the development of nuclease-based genome editing technologies; Dr. Philippe Duchateau, Cellectis Chief Scientific Officer and seasoned gene editing expert; and Dr. Laurent Poirot, Cellectis Head of Early Discovery and expert of gene functions in immune cells.

Claims 1 and 2 of US 9,855,297:

1. A method of preparing genetically modified primary T-cells for immunotherapy comprising the steps of: (a) transfecting mRNA encoding an RNA-guided endonuclease into the primary T-cells, wherein the RNA-guided endonuclease is expressed from the transfected m RNA; (b) introducing a DNA vector that encodes a specific guide RNA, wherein the specific guide RNA directs the RNA-guided endonuclease to at least one targeted locus in the T-cell genome into the primary T-cells; (c) cleaving at least one targeted locus in the T-cell genome with the RNA-guided endonuclease; (d) generating a genetic modification at the site of the cleavage; and (e) expanding the resulting genetically modified T-cells.

2. The method of claim 1, wherein the RNA-guided endonuclease is Cas9.

Claim 1 of US 9,890,393:

1. A method of preparing T-cells for immunotherapy comprising the step of:

(a) genetically modifying primary T-cells by introduction and/or expression into the cells of at least:

– a RNA-guided endonuclease; and

– a specific guide RNA that directs said endonuclease to at least one targeted locus in the T-cell genome,

wherein said RNA-guided endonuclease is expressed from transfected mRNA;

wherein said RNA-guided endonuclease comprises the amino acid sequence set forth in SEQ ID NO:1 or SEQ ID NO:2; and

(b) expanding the resulting cells.

On February 13, 2018 Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, will report its fourth quarter and full year 2017 financial results on Tuesday, February 27, 2018, after the U.S. financial markets close (Press release, Five Prime Therapeutics, FEB 13, 2018, View Source [SID1234523944]). Five Prime will host a conference call and live audio webcast on Tuesday, February 27, 2018, at 4:30 p.m. (ET)/1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

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The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 7184787.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.