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 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova has accepted an invitation to present at the 98th Annual Meeting of the Chemical Society of Japan to be held in Funabashi-city, Chiba in Japan (Press release, MediciNova, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326908 [SID1234523151]). The presentation entitled "Drug Repositioning: An Experience at MediciNova" will be presented by Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.

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Presentation details are as follows:

Session Date and Time: March 21, 2018, 3:00 – 3:30 pm.

Session Title: Advanced Technology Program

Location: Nihon University, Funabashi City, Chiba, Japan

On January 16, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops virus-based immunotherapies, reported the dosing of the first patient in the Phase 2 trial evaluating TG4010 in combination with Opdivo (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by the tumor cells (Press release, Transgene, JAN 16, 2018, View Source [SID1234523195]).

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The Phase 2 clinical trial is exploring the tolerability and efficacy of the combination regimen of Transgene’s TG4010, an investigational active immunotherapy against MUC1 tumor-associated antigen, with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo (nivolumab), which acts by overcoming immune suppression, and standard platinum doublet chemotherapy.
This multi-center single-arm trial will enroll up to 39 patients (without EGFR activating mutations or ALK-rearrangements), both in the USA and Europe. The trial has objective tumor responses rate (ORR) as primary endpoint. The study will also assess the safety and tolerability of the regimen together with other efficacy and immunological parameters. The first results are expected in H2 2018.
More information on the trial can be found on clinicaltrial.gov (NCT03353675).
This trial is conducted by Transgene under a clinical collaboration agreement with Bristol-Myers Squibb, which is supplying nivolumab (see press release dated April 25, 2017).

"Advanced lung cancer remains a devastating disease, in particular for patients whose tumors express low or undetectable levels of PD-L1. We are excited to start a trial that combines our active immunotherapy TG4010, with nivolumab and chemotherapy as a first-line treatment" said Maud Brandely, Chief Medical Officer of Transgene. "We believe that this trial could confirm the promising efficacy data that we previously obtained with TG4010 in combination with chemotherapy, and show that the triple regimen could be an attractive treatment option in this patient population."

Elisabeth Quoix, M.D., Head of the Department of Pulmonology at the University Hospital of Strasbourg, and coordinating investigator of the trial, added: "The three complementary mechanisms of action of TG4010, nivolumab and chemotherapy are believed to enhance the immune cellular response and lead to an increase in antitumor activity. This combination regimen aims at achieving a higher response rate, and ultimately an improvement in the survival rate in advanced-stage NSCLC patients."

The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of increased response rate, progression-free survival and overall survival in a randomized, double-blind, placebo-controlled Phase 2b trial in first-line treatment of patients with advanced non-squamous NSCLC (Quoix et al. Lancet Oncol. 2015).

About TG4010
TG4010 is an active immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is based on a modified Vaccinia virus (MVA), and has been shown to induce an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC). Its mechanism of action and excellent safety profile make TG4010 a very suitable candidate for combinations with other therapies, including immune checkpoint inhibitors and chemotherapy. The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015).
TG4010 is being investigated in combination with nivolumab (ICI) for the 2nd-line treatment of advanced NSCLC (NCT02823990) and for 1st-line treatment of NSCLC in combination with nivolumab and chemotherapy in patients whose tumors express low or undetectable levels of PD-L1 (NCT03353675).

About Non-Small Cell Lung Cancer
Lung cancer is one of the most common malignancies worldwide with an estimated 1.8 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated 1.6 million deaths in 2012 (Source: GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease despite recent progress.

On January 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the United States Food and Drug Administration ("FDA") has provided positive feedback on the design of the currently ongoing Phase III Clinical Trial for Oraxol, an innovative oral formulation of paclitaxel combined with HM30181A (a novel P-gp inhibitor) (Press release, Athenex, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326701 [SID1234523137]). Specifically, the FDA indicated that if the study meets the primary endpoint with an acceptable Benefit/Risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States.

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The Oraxol Phase III clinical study (KX-ORAX-001) is a randomized controlled international clinical trial investigating the superiority of Oraxol over intravenous ("IV") paclitaxel in the treatment of patients with metastatic breast cancer. The primary endpoint is confirmed tumor response rate assessed by a blinded independent radiologic imaging analysis center using the RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. The study has a target sample size of 360 patients. The study has completed the first of two planned interim analyses. The second interim analysis based on 180 evaluable patients is planned for the middle of 2018. The positive US FDA feedback would allow an Oraxol US registration submission upon successful completion of this single Phase III study.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "This positive feedback from the U.S. FDA is an important step in bringing Oraxol closer to the doctors and patients. Our Phase III trial also recently received the unanimous recommendation to continue by an independent Data and Safety Monitoring Board. The recommendation was based on the positive overall response rate of Oraxol and the very low incidence of neuropathy, which is a severe dose-limiting side-effect of IV paclitaxel."

Dr. Johnson Lau, Athenex’s Chief Executive Officer, added, "We are delighted with the positive feedback from the FDA on the Phase III Clinical Study Design for Oraxol, which provides further validation of our regulatory pathway for Oraxol. With the recent allowance of the Oraxol Investigational New Drug application in China and the receipt of the Promising Innovative Medicine designation from the United Kingdom Medicines and Healthcare products Regulatory Agency, we continue to advance towards our goal of improving the lives of cancer patients worldwide."

Athenex previously announced that the Data and Safety Monitoring Board unanimously recommended the continuation of its Phase III clinical trial comparing Oraxol versus IV paclitaxel in the treatment of metastatic breast cancer after the interim analysis of the first 90 patients on October 5, 2017. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018, enabling Athenex to initiate clinical studies in China.

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).