On January 16, 2018 Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel, small molecule oncology therapeutics, reported that preclinical data from studies conducted at the University of Pennsylvania by its scientific founders was published in the journal eLife (Press release, Linnaeus Therapeutics, JAN 16, 2018, View Source [SID1234539506]).

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The paper, entitled "Activation of G protein-coupled estrogen receptor signaling inhibits melanoma and improves response to immune checkpoint blockade" was authored by Natale, et al.

For decades, research has associated female sex and a history of previous pregnancy with better outcomes after a melanoma diagnosis, but the mechanism for this protective effect has remained a mystery. This publication provides a potential explanation for this melanoma-protective effect. The mechanism is related to a cellular protein called the G protein-coupled estrogen receptor (GPER). When GPER was activated and combined with anti–PD-1 inhibitor drugs in mouse cancer models, the therapy dramatically extended survival in all animals and completely eliminated the tumor in up to 50 percent of the mice.

"The validation of our science by the acceptance of this paper in eLife underscores the importance of the G protein estrogen receptor ("GPER") as a therapeutic target," said Patrick Mooney, M.D., Chief Executive Officer of Linnaeus. "This data clearly demonstrates that using LNS8801 to target GPER should have therapeutic effects in various cancers, and we are excited to move this toward human studies in the future."

On January 16, 2018 MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, reported that its Chief Executive Officer, Michael Castagna, will present at NobleCon14 — Noble Capital Markets’ Fourteenth Annual Investor Conference on Monday, January 29, 2018 at 10:00 Eastern Standard Time at the W Hotel in Fort Lauderdale, Florida (Press release, Mannkind, JAN 16, 2018, View Source [SID1234523147]).

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A high-definition, video webcast of the presentation will be available the following day on the Company’s web site www.mannkindcorp.com, and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will be archived on the Company’s website and on the Noble websites for 90 days following the event.

On January 16, 2018 Gamida Cell, a leading cellular and immune therapeutics company, reported the initiation of a phase I study evaluating its proprietary NAM-expanded natural killer cells (NAM-NK Cells) in patients with relapsed or refractory CD20+ non-Hodgkin lymphoma (NHL) and multiple myeloma (Press release, Gamida Cell, JAN 16, 2018, View Source [SID1234523184]).

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"There is significant need for novel therapeutic approaches for refractory non-Hodgkin lymphoma and multiple myeloma, which are aggressive malignancies with limited treatment options," said Veronika Bachanova, M.D., Ph.D., hematologist/oncologist at University of Minnesota Health and lead investigator of the clinical study at the Masonic Cancer Center, University of Minnesota. "We initiated this phase I study based on encouraging preclinical data to bring a potential immunotherapeutic treatment approach to patients with these life-threatening cancers."

The phase I study is designed to determine the maximum tolerated dose of NAM-NK Cells; secondary endpoints include overall antitumor response and toxicity. The study is currently recruiting and will enroll approximately 24 patients aged 18 to 70 years old. Participants will undergo a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, and then receive two doses of NAM-NK Cells followed by a short course of interleukin-2 (IL-2). Monoclonal antibodies, rituximab for NHL or elotuzumab for multiple myeloma, are administered prior to and after the NAM-NK Cells infusion to facilitate tumor targeting and antibody dependent cellular cytotoxicity.

"NAM-expanded NK cells have demonstrated increased killing potential and increased in vivo persistence and proliferation in preclinical studies," said Tony Peled, Ph.D., chief scientific officer at Gamida Cell. "We are pleased to see the NAM-NK Cell program enter clinical testing and are committed to collaborating with Dr. Bachanova and her team at the Masonic Cancer Center."

About NAM-NK Cells
Gamida Cell applied the capabilities of its NAM technology to the expansion of highly functional NK cells. In addition to a higher killing potential, NAM-NK Cells secretes higher levels of inflammatory cytokines that facilitate recruitment and activation of other endogenous immune cells to attack tumors. NAM-NK Cells is in phase I development (NCT03019666) in patients with relapsed or refractory CD20+ non-Hodgkin lymphoma and multiple myeloma.

About the Masonic Cancer Center
Masonic Cancer Center, University of Minnesota is a comprehensive cancer center designated by the National Cancer Institute. For more than 25 years, researchers, educators, and care providers have worked to discover the causes, prevention, detection and treatment of cancer and cancer-related disease. Learn more about the Masonic Cancer Center and the phase I clinical trial at cancer.umn.edu.

On January 16, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported the upcoming presentation of updated safety results and clinical activity from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant colorectal cancer (CRC) (Press release, Array BioPharma, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326690 [SID1234523136]). These data will be presented at the 2018 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, California.

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BEACON CRC SAFETY LEAD-IN

Title:

Abstract #627: BEACON CRC Study Safety Lead-in (SLI) in Patients With BRAFV600E Metastatic Colorectal Cancer (mCRC): Efficacy and Tumor Markers

Presenter:

Eric Van Cutsem, M.D., University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium

Date:

Saturday, January 20

Times:

7:00 am – 7:55 am PT and 12:30 pm – 2:00 pm PT

Updated data on the safety and tolerability profile of the triplet combination and measures of efficacy, including mPFS, ORR, duration of response, as well as tumor marker data, will be available as part of the presentation on January 20. The presentation will be available as a PDF from the Publications section of the Array website starting January 20.

Array’s BEACON CRC Phase 3 trial safety lead-in abstract published on January 16 contains previously presented safety and clinical activity data, as well as new data on changes in tumor markers.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial and the Phase 3 COLUMBUS trial.

The U.S. Food and Drug Administration (FDA) is currently reviewing the New Drug Applications (NDAs) to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the European Medicines Agency (EMA) is reviewing the Marketing Authorization Applications for encorafenib and binimetininb.

Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. The BEACON CRC trial is being conducted with support from Pierre Fabre and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).

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