On December 1, 2016 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, reported the presentation of promising preliminary data for the Company’s lead product candidate, eryaspase, also known as ERY-ASP or under the trade name GRASPA, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 3-6, 2016 in San Diego, California (Press release, ERYtech Pharma, DEC 1, 2016, View Source;p=irol-newsArticle&ID=2226733 [SID1234516898]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The research was conducted at The University of Texas MD Anderson Cancer Center. Dr. Philip Lorenzi,

Co-Director of the Proteomics and Metabolomics Core Facility and lead author of the poster, will present a summary of the findings from a preclinical study which demonstrates that eryaspase, L-asparaginase encapsulated in red blood cells (RBC), has differential dual activity on its main targets, asparagine and glutamine, when compared to non-encapsulated native asparaginase (L-ASP), during a poster session.

Abstract #1266: Red Blood Cell-Encapsulation of L-Asparaginase Favorably Modulates Target Selectivity and Pharmacodynamics

Date:

Saturday, December 3, 2016
Time:
5:30 – 7:30 p.m. PST
Location:
Hall GH of the San Diego Convention Center
Poster Session:
101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and
Survival, Excluding Iron: Poster I

The anticancer effect of asparaginase products is attributed to the systemic degradation of asparagine, a critical amino acid for the growth and survival of cancer cells. Asparaginase is also known to have a glutaminase effect. The degradation of glutamine has been demonstrated to be associated with clinical toxicity. The study aimed to characterize the transport and degradation of the different amino acids between the plasma and the RBC cytoplasm in the presence of L-ASP or eryaspase. Using a new bioanalytical method, MD Anderson researchers analyzed several metabolites to study differential conversion of asparagine and glutamine. In the presence of eryaspase, asparagine was rapidly and extensively converted to aspartic acid inside the RBC, whereas eryaspase displayed significantly decreased glutaminase activity as compared to L-ASP. The approximately 3.5-fold increase in selectivity for asparagine over glutamine may explain the observed decrease in frequency of adverse events in clinical trials with eryaspase compared to L-ASP. Altered target selectivity is believed to be an additional beneficial property of the encapsulation in the RBC, on top of improved half-life and decreased immunogenicity. The results also provided further evidence of the ‘bioreactor’ mode of action of eryaspase, demonstrating that the enzymatic activity is essentially happening inside the RBC.

Dr. Lorenzi at The University of Texas MD Anderson Cancer Center, stated, "This work presents what we believe to be the first known solution to a long-standing challenge associated with measuring the pharmacodynamics of L-asparaginase products. Using a stable isotope-based correction method, we are now able to accurately determine the concentration of amino acids present at the time of sample collection. In this study, we used this method to identify reduced selectivity for glutamine as a plausible explanation for the improved toxicity profile of GRASPA over L-asparaginase that has been observed in prior clinical studies."

Dr. Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH, added, "We are pleased with these findings and believe that GRASPA has the potential to offer a new treatment option for cancer patients. This preclinical work demonstrates the unique mechanism of action of GRASPA and the important role of the RBC membrane in modulating the enzymatic activity of the encapsulated L-ASP on both asparagine and glutamine. The toxic side effects of L-ASP are believed to stem from its activity in degrading glutamine. These preclinical observations from MD Anderson researchers provide further support for our previously reported findings and demonstrate an improved therapeutic index of GRASPA in a clinical setting. We look forward to sharing our research to date with the global hematology community at the ASH (Free ASH Whitepaper) Annual Meeting."

On December 1, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that Scott Maguire, CEO of Xenetic Biosciences, will present at the LD Micro Main Event 2016 Annual Conference on Wednesday, December 7, 2016 at 4:30 p.m. PT at the Luxe Sunset Boulevard Hotel in Los Angeles (Press release, Xenetic Biosciences, DEC 1, 2016, View Source [SID1234537807]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During his presentation, Mr. Maguire will provide a corporate update and discuss the Company’s clinical and regulatory progress for its in-house product candidates, as well as those being developed with Xenetic’s partners. Xenetic’s current in-house product pipeline includes Virexxa (sodium cridanimod), which is being evaluated for the treatment of endometrial cancer and triple negative breast cancer, and ErepoXen, a polysialylated form of erythropoietin (EPO), a hormone created by the kidneys to maintain red blood cell production and address anemia. Xenetic is also currently evaluating OncoHist for the treatment of acute myeloid leukemia (AML) in refractory patients.

Mr. Maguire will also discuss the Company’s up to $100 million license deal with Shire, one of the Company’s largest shareholders, along with the clinical status of their product candidate.

A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.

On December 1, 2016 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported data from an ongoing Phase 1/1b study of RXDX-105—Ignyta’s VEGFR-sparing, potent RET inhibitor—at the 2016 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany, highlighting RXDX-105’s clinical activity in patients harboring RET molecular alterations, with five out of nine patients with RET fusion-positive cancers who were RET inhibitor-naïve achieving a RECIST response (1 complete response, 3 partial responses, and 1 unconfirmed partial response), for a preliminary objective response rate (ORR) of 56% (Abstract number 437, Poster number P116) (Press release, Ignyta, DEC 1, 2016, View Source [SID1234516870]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This substantial update of our Phase 1/1b clinical data on RXDX-105 provides compelling evidence of its potent anti-tumor activity with promising durability and acceptable safety in patients with RET-fusion positive tumors," said Pratik Multani, M.D., Chief Medical Officer of Ignyta. "With approximately 500-fold higher potency against RET than VEGFR2 in vitro, RXDX-105 has the potential to address a critical unmet medical need in RET-positive patients for whom the clinical utility of multikinase inhibitors with both RET and VEGFR activity is constrained by safety liabilities and limited efficacy. We look forward to the continuation of the study to further explore the safety and efficacy of RXDX-105."

As of the November 2016, data cut-off, the findings showed:

Safety

A total of 91 patients with a range of solid tumors have been treated in the Phase 1/1b clinical trial, with 55 patients treated in the Phase 1 study and 36 patients treated in the Phase 1b study.

RXDX-105 continues to demonstrate a safety profile similar to what has been previously reported: across both studies, the most common treatment-related adverse events ( > 10% incidence) were rash (31%), fatigue (22%), diarrhea (20%), nausea (18%), hypophosphatemia (14%), vomiting (14%), muscle spasms (13%), and decreased appetite (10%);
The majority of treatment-related adverse events were Grade 1 or 2, and were reversible with dose modification;
The most common Grade 3 treatment-related adverse events ( > 5% incidence) were rash (9%), hypophosphatemia (7%), and ALT increase (6%);
One patient experienced a Grade 3 drug reaction with eosinophilia and systemic symptoms, in which the patient recovered with drug discontinuation. One patient experienced Grade 3 rash complicated by fatal alveolar hemorrhage. No other treatment-related Grade 4 or higher events were observed.
Toxicities commonly associated with VEGFR inhibition, such as hypertension, hypothyroidism, proteinuria, and neurotoxicity, were rarely observed ( < 5%).
Efficacy

Of the 36 patients treated in the Phase 1b study, 35 had RET or BRAF molecular alterations.

Nine RET inhibitor-naïve patients (n = 8 in the Phase 1b cohort; n = 1 in the Phase 1 cohort) with RET fusion-positive tumors were treated at a daily dose of 275 mg or 350 mg in the fed state, and were evaluable for response.

A preliminary ORR of 56% was observed in patients with RET fusion-positive solid tumors who were RET inhibitor-naïve (five out of nine treated patients had a RECIST response);
Of the five patients demonstrating a RECIST response, one patient with metastatic colorectal cancer (mCRC) achieved a complete response; three patients, all with non-small cell lung cancer (NSCLC), achieved a partial response; and one patient with NSCLC had an unconfirmed partial response;
Among the seven patients with RET fusion-positive NSCLC who were RET inhibitor-naïve, three achieved a partial response and one achieved an unconfirmed response (a second scan had not been obtained at the date of data cutoff), for a preliminary ORR of 57%;
Duration of response to RXDX-105 ranged from 2+ to 7+ months, with all responder patients currently continuing on treatment in active response; median duration of response, therefore, has not yet been determined;
Additionally, a previously disclosed Phase 1 patient with RET-mutated M918T medullary thyroid cancer had a confirmed partial response and continues on treatment after ten cycles.
These data confirm that RXDX-105 is active across a range of different histologies, with confirmed RECIST responses now observed in medullary thyroid cancer, NSCLC, and mCRC, and across a range of RET molecular alterations, including the M918T point mutation, and CCDC6-, EML4-, and PARD3-RET fusions.
Among the remaining patients treated in Phase 1b who were either RET fusion-positive and received prior RET inhibitor treatments (n = 4) or had BRAF molecular alterations (n = 23), durable disease control but no objective responses have been observed to date.

Based on the promising efficacy data observed thus far in patients with RET fusion-positive solid tumors who are RET inhibitor-naïve, this population will remain the primary focus of future development of RXDX-105. Enrollment in the Phase 1b study is ongoing to further explore the safety and efficacy of RXDX-105 in various molecular baskets at several doses.

On November 30, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will present clinical data from a Phase 1/2 clinical trial evaluating its immuno-oncology product, SD-101, in patients with low-grade, B cell lymphoma (Press release, Dynavax Technologies, NOV 30, 2016, View Source [SID1234516841]). The poster presentation will be made at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Abstract Name: SD-101, a Novel Class C CpG-Oligodeoxynucleotide Toll-like Receptor 9 Agonist, Given with Low Dose Radiation for Untreated Low Grade B-Cell Lymphoma: Interim Results of a Phase 1/2 Trial
Abstract Number: 2974
Date and Time: Sunday, December 4, 2016 from 6:00 p.m. EST to 8:00 p.m. EST
Session Name: 623. Mantle Cell, Follicular and Other Indolent B-Cell Lymphoma – Clinical Studies: Poster II
Location: San Diego Convention Center, Hall GH
Note: Abstract will also be published online on December 1, 2016, in the supplemental volume of the journal Blood
About SD-101

SD-101 is Dynavax’s proprietary, second-generation, Toll-like Receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. SD-101 activates multiple anti-tumor activities of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On November 30, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting the latest clinical data on its in-house developed halichondrin class microtubule dynamics inhibitor eribulin mesylate (product name: Halaven, "eribulin") will be presented at the San Antonio Breast Cancer Symposium (SABCS2016) taking place in San Antonio, the United States, from December 6 to 10 (Press release, Eisai, NOV 30, 2016, View Source [SID1234516843]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Three abstract poster presentations (including outcome research data) are to be given at the meeting, with the main presentation featuring the results of an interim analysis of a Phase Ib/II trial (Study 218) of eribulin in combination with the immune checkpoint inhibitor pembrolizumab in patients with metastatic triple-negative breast cancer.

Eisai positions oncology as a key franchise area and is aiming to discover revolutionary new medicines with the potential to cure cancer. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and to increase the benefits provided to, patients and their families as well as to healthcare providers.

Major Eisai abstracts accepted for presentation at SABCS2016 include:
Product Abstract title and scheduled presentation date and time (local time)
Eribulin

Abstract P5-15-02 Phase Ib/II study to evaluate eribulin mesylate in combination with pembrolizumab in patients with metastatic triple-negative breast cancer
Poster Presentation | December 9 (Fri), 17:00-19:00
Eribulin

Abstract No: OT2-02-02 A randomized, open-label, multicenter, Phase Ib/II study of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) versus eribulin mesylate alone in patients with human epidermal growth factor receptor 2 (HER2)-negative, high-hyaluronan metastatic breast cancer
Poster Presentation | December 8 (Thu), 17:00-19:00
Eribulin

Abstract No: P5-15-16 Utilization and outcomes of eribulin in triple-negative metastatic breast cancer:
real-world findings
Poster Presentation | December 9 (Fri), 17:00-19:00