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Bexion Pharmaceuticals, Inc. Presentations Accepted at 2018 ASCO Annual Meeting

On April 16, 2018 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on rare brain tumors, reported that the four abstracts submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 1-5, 2018 in Chicago, Illinois have all been accepted (Press release, Bexion, APR 16, 2018, View Source [SID1234525565]).

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One of the accepted presentations is entitled "First-in-human, First-in-class Phase 1a Study of BXQ-350 for Solid Tumors and Gliomas".

The ASCO (Free ASCO Whitepaper) Annual Meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.

About BXQ-350

BXQ-350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).

Telix, INSERM & ARRONAX Enter into Translational Research Partnership

On April 16, 2018 Telix Pharmaceuticals Limited (ASX.TLX) ("Telix", the "Company"), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted
radiopharmaceuticals or "molecularly-targeted radiation" (MTR), has reported a research partnership with the French National Institute of Health and Medical Research (Institut national de la santé et de la recherche médicale or "INSERM") and the "Accelerator for Research in Radiochemistry and Oncology at Nantes Atlantic" (ARRONAX) (Press release, Telix Pharmaceuticals, APR 16, 2018, View Source [SID1234525562]).

INSERM is a leading translational research organization with a strong track record of industry engagement and technology development to benefit human health. ARRONAX is a unique cyclotron (particle accelerator) facility and a world-leader in the production of certain novel radioactive isotopes, including 211At (astatine). Together, INSERM and ARRONAX have created a highly capable nuclear medicine research cluster in Nantes with a track record of
cutting-edge translational research.

Under the research partnership, Telix will explore the feasibility of using several of its clinical targeting agents with astatine. Astatine is an "alpha emitter", a very high-energy radionuclide that is capable of significantly altering the tumour microenvironment when attached to a molecular targeting agent that is specific for cancer cells. The agreement will fund sufficient staff and facility time to conduct a number of studies over a two-year period, including
preparation for pilot clinical studies in the nuclear medicine department of University Hospital of Nantes. The agreement also accesses a portfolio of intellectual property that has been developed within the Nantes cluster that may lead to new products and indications for Telix’s therapeutic pipeline.

Telix Europe President Ms. Odile Jaume stated, "The Nantes nuclear research cluster is one of the finest translational environments in Europe, with a particular strength and capability in astatine, including production facilities and processes that are capable of making materials for human research. This collaboration has the potential to expand the clinical utility of Telix’s technology and build a set of ‘next generation’ products that may deliver even greater clinical utility to cancer patients."

Professor Michel Chérel (team leader, INSERM University of Nantes) and Dr Jean-Francois Gestin (radiochemistry development) noted, "We are pleased to be working with Telix to progress the use of astatine in a clinical setting. This partnership is a great example of translational research aiming at truly personalized medicine in France and beyond. The clinical translation of astatine therapy will be performed in the nuclear medicine department of
Nantes Centre Hospitalier Universitaire (CHU) and l’Institut de Cancérologie de l’Ouest (ICO) chaired by Professor Françoise Kraeber-Bodéré, in collaboration with the Labex IRON network (Innovative Radiopharmaceuticals in Oncology and Neurology) and "Le SIRIC ILIAD" (Imaging and Longitudinal Investigations to Ameliorate Decision-making in Multiple Myeloma and Breast Cancer)."

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Professor Ferid Haddad, Director of ARRONAX added, "Our facility has been established with the development of alpha-nuclide therapy in mind. To this end, this highly innovative partnership with Telix is an important step forward and we believe that it will result in the development of new cancer treatment strategies.

Dynavax Reports Interim Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck

On April 16,2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA , an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) (Press release, Dynavax Technologies, APR 16, 2018, View Source [SID1234525507]). These data were presented in a poster session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The results from this dose escalation study showed encouraging response rates in patients with advanced head and neck squamous cell carcinoma. In addition, the combination was well tolerated. The full poster presentation can be accessed at View Source

"Results from our Phase 1b/2 trial of SD-101 in combination with KEYTRUDA are promising in head and neck cancer, a condition for which patients typically have a poor prognosis," said Eddie Gray, Chief Executive Officer of Dynavax. "This is another tumor type in which SD-101, based on early data, has demonstrated encouraging activity while being well tolerated. As understanding of combination therapy matures we believe an effective immune stimulating agonist with an attractive tolerability profile will play a significant role in a wide range of tumors."

"On Tuesday, April 17, 2018 we are also presenting updated data from our Phase1b/2 study at AACR (Free AACR Whitepaper) from a cohort of melanoma patients, where a durable response was observed in patients naïve to anti-PD-1/L1 therapy as well as patients with prior treatment. We are excited about the overall results to date and believe this underscores the potential breadth of our immuno-oncology platform," Mr. Gray added.

Highlights from Poster Presentation of HNSCC Data

Interim data from evaluable patients showed an ORR of 33% (6 out of 18) (38% among patients who received at least one scan on study)

Well tolerated with no dose limiting toxicities

No increase in frequency or severity of the treatment-related adverse events that have been reported in clinical studies of KEYTRUDA as a monotherapy, nor evidence of a unique safety signal for the combination.

Biomarker analyses showed induced broad immune activity, including increase in CD8 T cells, and Th1 response in the tumor microenvironment, consistent with findings reported in advanced melanoma

Highlights from Abstract of Advanced Melanoma Durability Data

86% of initial responses were ongoing after a median of 18 months of follow up in patients that were naïve to anti-PD-1/L1 monotherapy (n=7)

2 of 12 evaluable patients with progressive disease on prior anti-PD-1/L1 monotherapy achieved a partial or stable disease response for at least 10.5 months

Medianprogression-free survival (PFS), duration of response, and median overall survival have not been reached

Treatment was well tolerated with no Grade 3 or higher treatment-related AEs in longer term follow up

Details for the poster presentation are as follows:

Durability of responses to the combination of SD-101 and pembrolizumab in advanced metastatic melanoma: Results of a phase Ib, multicenter study

Session Title: Phase I Trials in Progress

Abstract: CT139

Poster Board Number: 22

Date/Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM CDT

Location: McCormick Place South, Hall A, Poster Section 42

SD-101 in combination with KEYTRUDA generally was well tolerated. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia.

About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

Galera Therapeutics Announces Preclinical Data Demonstrating Potential of GC4419 to Improve Effectiveness of Radiation While Preventing Normal Tissue Toxicity

On April 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported that preclinical data on GC4419, a highly selective and potent small molecule dismutase mimetic, were presented during poster sessions at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago (Press release, Galera Therapeutics, APR 16, 2018, View Source [SID1234525450]).

/EIN News/ — "New therapies that enhance the efficacy of radiation on cancer cells while actually decreasing toxicity to normal tissue are desperately needed to improve therapeutic outcomes in cancer. We are encouraged that the data presented at AACR (Free AACR Whitepaper) demonstrate our lead candidate, GC4419, has these properties, underscoring its potential to become an important part of cancer radiotherapy," said Mel Sorensen, M.D., President and CEO of Galera. "We look forward to building upon positive results from our Phase 2b clinical trial of GC4419 in head and neck cancer with data like this, and with the Phase 1/2 trial of GC4419 in combination with stereotactic body radiation therapy in patients with locally advanced pancreatic cancer, which is underway at The University of Texas MD Anderson Cancer Center."
The radioprotector GC4419 ameliorates radiation induced lung fibrosis while enhancing the response of non-small cell lung cancer tumors to high dose per fraction radiation exposures

The studies from The University of Texas Southwestern Medical Center covered in this poster highlight that GC4419 can both significantly reduce the normal tissue toxicity of even high-dose radiation and increase tumor response to radiotherapy. Specifically, either pretreatment or mitigation with GC4419 significantly reduced pulmonary fibrosis in focally irradiated (54 Gy single dose) mice, similar to the reduction in severe oral mucositis seen in Galera’s clinical and pre-clinical studies. Separately, mice with H1299, A549, and HCC827 lung tumor xenografts were treated with GC4419 prior to irradiating the tumors with a single 18 Gy dose. Tumor growth in all three tumor types was significantly delayed (p = 0.0022), with the majority of mice apparently tumor-free at study end. Similar enhancements in tumor radiation response were seen with syngeneic lung (LLC) and breast (4T1) tumor models. Subsequent Tumor Cure Dose (TCD50) assays demonstrated that GC4419 enhanced the efficacy of radiation by a factor of 1.67.

GC4419 enhances the response of non-small cell lung carcinoma cell lines to cisplatin and cisplatin plus radiation through a ROS-mediated pathway
These studies from The University of Texas Southwestern Medical Center report that GC4419 synergistically decreased clonogenic survival in H460 and H1299 cells treated with either cisplatin or cisplatin plus radiation. Consistent with the mechanism in combination with radiation alone, GC4419 was found to reduce intracellular superoxide, increase intracellular hydrogen peroxide, and induce early apoptosis. H1299CAT cells were used to demonstrate that this enhancement of cisplatin and cisplatin plus radiation cancer cell killing is also due to elevation of H2O2. The results are particularly intriguing given that the combination of cisplatin and radiotherapy is the primary treatment modality in GC4419’s phase 2b trial in patients with head and neck cancer.

About GC4419
GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.
GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

DelMar Pharmaceuticals Announces Multiple Presentations at Annual Meeting of the American Association for Cancer Research

On April 16, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported four poster presentations being delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") annual meeting (Press release, DelMar Pharmaceuticals, APR 16, 2018, View Source [SID1234525448]).

On Sunday, April 15, 2018, DelMar presented a poster showing preclinical data demonstrating that VAL-083, a first-in-class small molecule chemotherapeutic, may be beneficial, either as a single-agent, or as part of combination therapy regimens, for difficult-to-treat, or resistant, pediatric high-grade gliomas, including diffuse intrinsic pontine glioma ("DIPG"). DIPG is a rare, inoperable childhood brain tumor with very poor prognosis and a bleak survival outlook. In a poster entitled, "Dianhydrogalactitol (VAL-083) has the potential to overcome major challenges in the treatment of DIPG," VAL-083 is shown to be active as a single-agent and synergistic with AZD1775, a Wee1 inhibitor, against DIPG cell lines with varying genetic profiles, including p53 and H3.3/H3.1 K27M mutations.

Today, DelMar will be presenting a poster showing preclinical data demonstrating that the combination of VAL-083 and PARP inhibitors may be an effective therapeutic approach for the treatment of cancer. The data show that VAL-083 can synergize PARP inhibitors in both a BRACA-proficient and –deficient setting. Multiple PARP inhibitors are currently approved for the treatment of recurrent breast and ovarian cancer. DelMar also presented data in this poster further demonstrating that VAL-083 is active as a single-agent against platinum-resistant ovarian cancer.
"These important data continue to support the broad potential of VAL-083 to provide a new treatment option against a range of cancers," said Saiid Zarrabian, DelMar’s interim president and chief executive officer. "Our ongoing clinical trials in MGMT-unmethylated GBM and planned trial in platinum-resistant ovarian cancer continue to leverage insights gained through more than 40 Phase 1 and Phase 2 clinical trials sponsored by the U.S. National Cancer Institute."

DelMar will present an update on two ongoing clinical trials for MGMT-unmethylated GBM tomorrow, Tuesday April 17, 2018:
A Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated, bevacizumab (Avastin)-naïve recurrent glioblastoma, currently being conducted in collaboration with the University of Texas MD Anderson Cancer Center; and
A Phase 1-2 clinical trial of VAL-083 in combination with radiotherapy in patients with newly diagnosed MGMT-unmethylated GBM, currently being conducted in collaboration with Sun Yat-sen University Cancer Center.
DelMar’s poster presentations can be viewed on the company’s website at:
View Source
About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class," DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute ("NCI"). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance in vitro. Further details regarding these studies can be found at:
View Source.
VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.