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]).

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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.

On February 13, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2017 fourth quarter and full year financial results on Tuesday, February 27, 2018, after the close of the financial markets (Press release, Jazz Pharmaceuticals, FEB 13, 2018, View Source;p=RssLanding&cat=news&id=2332219 [SID1234523946]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss fourth quarter and full year 2017 financial results and provide a business and financial update and guidance for 2018 financial results.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 4179828

A replay of the conference call will be available through March 6, 2018 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 4179828

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.

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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.

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, reported that it will report its fourth quarter and full year 2017 financial results on Tuesday, February 27, 2018, after the U.S. financial markets close. 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 (Press release, Five Prime Therapeutics, FEB 13, 2018, View Source [SID1234524647]).

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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.

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.

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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.