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GT BIOPHARMA ANNOUNCES DR. JEFFREY MILLER, RENOWNED NK CELL CANCER SPECIALIST, WILL PRESENT AT CELL THERAPY SYMPOSIA

On February 13, 2018 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that Dr. Jeffrey Miller, Deputy Director of the Masonic Cancer Center, University of Minnesota will be presenting at the Keystone Symposia: Emerging Cellular Therapies: T Cells and Beyond; ‘Novel Ways to Activate and Target NK Cells to Treat Cancer’ (Press release, GT Biopharma , FEB 13, 2018, View Source [SID1234539534]). This presentation will highlight GT Biopharma’s TriKE and TetraKE platforms.

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Dr. Miller will be presenting to leaders in the field of cell therapies at the conference on Feb. 14th from 5:00 -7:00 pm MT. He will be discussing GT Biopharma’s unique single-chain, tri-specific NK cell engager (TriKE) and tetra-specific NK cell engager (TetraKE) platforms targeting hematologic malignancies, sarcomas and carcinomas (solid tumors). The presentation will address both the TriKE and TetraKE constructs, as well as our second-generation anti-CD16-IL-15-anti-CD33 TriKE (OXS-C3550); another first-of-its-kind, single-chain, tri-specific NK cell engager (TriKE).

NK cell cancer-killing activity is expected to be increased by bringing the NK cells in close proximity to the cancer cells. This may be achieved by ‘engagers’ that bind to CD16 on the surface of NK cells and bind specific proteins (such as CD33) on the surface of cancer cells, thus forming an immune synapse between the NK cell and the cancer cell. Our lead TriKE, anti-CD16-IL-15-anti-CD33 (OXS-3550) is expected to be in the clinic in the second half of 2018. The TriKE constructs utilize the inclusion of interleukin-15 (IL-15), a peptide that leads to proliferation and activation of the NK cells. This further increases NK cancer-cell killing capabilities and improves their function in the tumor microenvironment (Vallera et al,2016).

Unlike traditional CAR-T platforms, TriKEs are potentially a cost effective cell therapy and not relegated to treating liquid tumors only. GT Biopharma believes that TriKEs are an antibody platform that can be tailored to treat any form of cancer, liquid or solid tumors.

Dr. Jeffrey Miller said, "I am pleased to present additional information regarding these immune-oncology platforms. As a researcher, I continue to believe that both have the potential to generate candidates with the ability to have a significant impact on the treatment of cancer and other diseases."

GT Biopharma Chief Medical officer (CMO) Dr. Raymond Urbanski said, "The TriKE and TetraKE concepts and constructs potentially have significant advantages over current and other development-stage therapies. Dr. Miller is a luminary in NK cell biology and its applications, and we continue to be excited by the potential opportunity related to this technology."

Celyad to Host Key Opinion Leader Meeting on CAR-T Therapy for the Treatment of Blood Cancers

On February 13, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company, reported that it will host a Key Opinion Leader luncheon on the topic of CYAD-01 (CAR-T NKG2D) cell therapy for the treatment of blood cancers in New York City on Tuesday, February 20 (Press release, Celyad, FEB 13, 2018, View Source [SID1234532519]).
The meeting will feature a presentation by Key Opinion Leader Marco Davila, MD, PhD (Moffitt Cancer Center), who will discuss the evolving treatment landscape of CAR-T therapies in development, as well as the unmet medical need for treating patients with blood cancers, including Acute Myeloid Leukemia (AML). Dr. Davila will be available to answer questions at the conclusion of the event.

Celyad’s management team will provide details about the clinical strategy of its lead candidate, CYAD-01, an autologous CAR-T NKG2D cell therapy in clinical development for patients with hematological and solid cancers.

Marco Davila, MD, PhD is an Associate Member of the Blood and Marrow Transplantation Department at the Moffitt Cancer Center and an Associate Professor of Oncologic Sciences at the University of South Florida. His research is dedicated to developing gene-engineered cell therapies that target cancer cells in animal models of cancer. The goal of this research is to identify optimal cell therapies that can then be evaluated in cancer patients. He has also been the Principal Investigator on several clinical trials using genetically engineered T-cells targeted against malignant B cells. Dr. Davila’s laboratory at the Moffitt Cancer Center is interested in developing further chimeric antigen receptors (CARs) that can target hematologic and solid tumor malignancies. His work has been published in many peer-reviewed medical journals.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Neurocrine Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

Chi-Med Completes Enrollment of 527 Patients in Pivotal Phase III FALUCA Trial with Fruquintinib in Lung Cancer

On February 13, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported it has completed patient enrollment of FALUCA, its Phase III pivotal trial of fruquintinib in advanced, third-line, non-small cell lung cancer ("NSCLC") patients in China (Press release, Hutchison China MediTech, FEB 13, 2018, View Source [SID1234523945]). Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of lung, colorectal and gastric cancers. Top-line FALUCA data is expected to be reported in late 2018 when the overall survival ("OS") data is mature and, subject to a positive outcome, would be followed by a second New Drug Application ("NDA") submission thereafter. Fruquintinib’s first NDA, for the treatment of colorectal cancer, was submitted to the China Food and Drug Administration ("CFDA") in June 2017.

About Fruquintinib

Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy. VEGFR plays a pivotal role in tumor-related angiogenesis.

About FALUCA

FALUCA is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study of fruquintinib targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Patients were randomised at a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. Randomization was stratified by EGFR gene status and history of treatment by VEGF inhibitors. The primary endpoint is OS, with secondary endpoints including progression free survival ("PFS"), objective response rate (ORR), disease control rate (DCR) and duration of response (DoR). Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299.

It was initiated following a similar Phase II clinical trial in 91 third-line NSCLC patients that succeeded in meeting its primary efficacy endpoint of PFS, with no unexpected safety issues. Results were highlighted in an oral presentation at the 17th World Conference on Lung Cancer on December 6, 2016 (clinicaltrials.gov identifier NCT02590965)

Other Fruquintinib Development Programs

Lung cancer in China: Along with FALUCA, fruquintinib is concurrently being studied in a Phase II study in combination with Iressa (gefitinib) in first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Preliminary results were highlighted in an oral presentation at the 18th World Conference on Lung Cancer on October 16, 2017.

Colorectal cancer in China: The CFDA acknowledged acceptance of the NDA for fruquintinib for the treatment of patients with advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was subsequently awarded priority review status in view of its significant clinical value, according to a CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held on June 5, 2017 (clinicaltrials.gov identifier NCT02314819). The FRESCO study followed an initial Phase I trial in 40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients.

Gastric cancer in China: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol (paclitaxel), known as the FRUTIGA study, for the treatment of over 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier NCT03223376). The FRUTIGA study followed a Phase I/II clinical trial in 34 patients that demonstrated that combination therapy of fruquintinib and Taxol in such patients was generally well-tolerated with promising tumor response (clinicaltrials.gov identifier NCT02415023).

In China, fruquintinib is jointly developed with Eli Lilly and Company.

United States bridging trial: In December 2017, Chi-Med initiated a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.

ERYTECH Selects Triple Negative Breast Cancer as Next Indication for Eryaspase

On February 13, 2018 ERYTECH Pharma (Euronext: ERYP- Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the selection of Triple Negative Breast Cancer as the next target indication for broadening the scope of eryaspase (GRASPA) development in solid tumors (Press release, ERYtech Pharma, FEB 13, 2018, View Source [SID1234523942]).

L-asparaginase is a cornerstone treatment in acute lymphoblastic leukemia (ALL), especially for pediatric patients, but the excessive toxicity of conventional L-asparaginase formulations has limited its use in other indications.

The positive Phase 2b result of eryaspase (L-asparaginase encapsulated in red blood cells) in metastatic pancreatic cancer, reported in 2017, represents, to our knowledge, the first-ever evidence of clinical benefit of an asparaginase-based product in a solid tumor indication. In this 141-patient randomized Phase 2b study, eryaspase in combination with chemotherapy demonstrated a 40% reduction in risk of death rate (HR=0.60; p=0.009) compared to chemotherapy alone.

Following these very encouraging results, ERYTECH conducted a comprehensive evaluation to determine other potential solid-tumor indications for developing eryaspase. Metastatic Triple-Negative Breast Cancer (TNBC) has now been selected as the next indication to expand the potential use of eryaspase in solid tumors. TNBC is an aggressive and metabolically active form of breast cancer with high rates of symptomatic metastases. A recent publication in Nature1 supports the hypothesis that restricting availability of asparagine can reduce metastatic progression of cancer cells in breast cancer. One of the most striking observations from our Phase 2b trial in pancreatic cancer was the 40% reduction of new lesions in the eryaspase arm compared to the control arm.

"TNBC is a heterogenous subgroup of breast cancer associated with poor patient outcome and high risk of recurrence compared to other breast cancer subtypes. Aside from BRCA1/2 mutation status, treatment options for TNBC remain limited," commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH. "There is growing evidence of altered metabolism in TNBC. The evaluation of eryaspase in metastatic TNBC provides a promising new therapeutic approach, which capitalizes on reprogramming of the metabolic pathways in this disease."

Gil Beyen, Chairman and CEO of ERYTECH, added, "The selection of TNBC as the second solid tumor indication for evaluating eryaspase anti-tumor activity brings hope for improving the health of these women. The safety profile of eryaspase provides additional rationale for combination with currently existing therapies to increase treatment options in TNBC."

The development in TNBC complements ERYTECH’s pipeline of programs, which focus on the development of therapies that target amino acid metabolism of tumor cells. Set-up activities of a Phase 2 proof-of-concept clinical study have started and ERYTECH expects to enroll the first patient in Q3 2018.

About Triple-Negative Breast Cancer (TNBC)

Breast cancer is the most commonly diagnosed cancer in women globally with nearly 1.8 million new cases diagnosed annually2. It is estimated that over 600,000 women each year are diagnosed with breast cancer in the United States and Europe in aggregate3. Approximately 10-20% of breast cancers are TNBC, a form of breast cancer that lacks expression of estrogen receptor (ER), progesterone receptor (PR) and does not overexpress HER24. TNBC is associated with a poorer prognosis when compared to other breast cancer subtypes. As commonly utilized hormone therapy and HER2 targeting agents are not treatment options for women with TNBC, there is significant unmet need for novel therapeutic approaches in this subtype of breast cancer.