Cerus has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cerus, NOV 4, 2016, View Source [SID1234516265]).

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On November 4, 2016 Redx Pharma Plc reported that it will present the pre-clinical profile of its reversible Bruton’s tyrosine kinase (BTK) inhibitor at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on 5 December 2016 in San Diego, California (Press release, Redx Pharma, NOV 4, 2016, View Source [SID1234524712]). The compound, named RXC005 (also known as REDX08608), is a novel, potent and selective, reversible BTK inhibitor that is equipotent against wild-type and mutant C481S BTK. C481 mutant BTK protein is currently estimated to be responsible for around 60% of the observed Ibrutinib resistance in patients with chronic lymphocytic leukaemia.

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The Company is progressing studies to prepare the RXC005 program for first-in-human clinical trials. The aim is to commence these trials late 2017.

The Abstract for the presentation is available on the ASH (Free ASH Whitepaper) Conference website:
View Source;

Dr Neil Murray, CEO of Redx, said: We’re delighted to present the compelling pre-clinical profile of our reversible BTK inhibitor RXC005 at the prestigious American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

RXC005 has the potential to become a potent therapy for chronic lymphocytic leukaemia patients by tackling the growing resistance to Ibrutinib treatment. We aim to initiate first-in-human clinical studies for RXC005 late 2017.

On November 4, 2016 Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, reported the achievement of additional milestones under its licensing agreement with CANbridge Life Sciences for the development and commercialization of lead candidate APG101 (INN: asunercept) in China, Macao, Hong Kong and Taiwan, triggering further paymentsto Apogenix (Press release, Apogenix, NOV 4, 2016, View Source [SID1234524576]). The milestones are related to the successful implementation of the technology transfer necessary for the production of this CD95 ligand inhibitor at the Chinese production site.

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Over the course of the past few months, Apogenix and CANbridge have successfully transferred the necessary cell banks, assays, protocols, and know-how for the manufacturing of asunercept to China. The manufacturing process has proven to be very robust with product quality and process yields of the active substance comparable to the manufacturing process developed by Apogenix

CANbridge also reported that clinical development of asunercept is now underway in Taiwan. The recently initiated Phase I/II trial is evaluating asunercept plus temozolomide (TMZ) during and after radiation therapy in 55 patients with newly diagnosed glioblastoma. The study design consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II part will evaluate efficacy and safety.

"We are very pleased with the progress of our collaboration with CANbridge and the achievement of additional milestones," said Thomas Hoeger, Ph.D., CEO of Apogenix. "With the successful technology transfer and the initiation of the Phase I/II trial in Taiwan,the clinical development of asunercept in Asia in now well underway. We look forward to CANbridge initiating further trials in China soon."

James Xue Ph.D., Chairman and CEO of CANbridge: "The complex transfer of asunercept production technology and know-how has been very efficient due to the excellent collaboration between the CANbridge and Apogenix teams. In particular, we were impressed by the exceptional level of enthusiasm and professional handling during the entire process."

About Asunercept (APG101)
Apogenix’s lead immuno-oncology candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. Asunercept is being developed for the treatment of solid tumors and malignant hematological diseases. By blocking the CD95 ligand, which negatively regulates erythrocyte production in myelodysplastic syndromes (MDS) patients, asunercept directly addresses the cause of the disorder and could thus potentially provide a cure for MDS. The World Health Organization (WHO) has recently assigned the international nonproprietary name (INN) "asunercept" for APG101.

Amethyst NSCLC Trial: Phase 2 Trial of MGCD265 in Patients (pts) with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor (MET)

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On November 4, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that data from three drug candidates in its development pipeline will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo (Press release, GlycoMimetics, NOV 4, 2016, View Source [SID1234516348]). The ASH (Free ASH Whitepaper) meeting will take place December 3 to 6, 2016, at the San Diego Convention Center.

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The oral presentation and six posters to be shared at the ASH (Free ASH Whitepaper) meeting will review the results of pre-clinical and clinical research on the pan-selectin antagonist, rivipansel, that GlycoMimetics is developing in partnership with Pfizer, Inc.; the company’s E-selectin antagonist, GMI-1271; and the company’s dual E-selectin/CXCR4 antagonist, GMI-1359. The data presented will show significant progress in a clinical trial for acute myeloid leukemia (AML), pre-clinical data further expanding on the mechanism and potential for therapeutic benefit in sickle cell anemia, and pre-clinical data on effects of GMI-1359 in models of hematologic malignancies. The company will present updates with interim data from an on-going Phase 1/2 trial of GMI-1271 in patients with AML. This will include an update on patients enrolled in the Phase 1 portion of the trial as well as data on evaluable patients enrolled to date in the two Phase 2 arms of the study. The Phase 2 portion includes one arm enrolling patients with relapsed or refractory disease and one arm enrolling patients over the age of 60 with newly diagnosed disease.

"We are delighted to have multiple abstracts accepted at ASH (Free ASH Whitepaper), highlighting the success and breadth of our growing pipeline," said Rachel King, Chief Executive Officer of GlycoMimetics. "Our new clinical and preclinical data show the scientific rationale for continuing development of all three drug candidates, as well as significant momentum in our clinical program for GMI-1271 in AML."

Details of the data to be presented at ASH (Free ASH Whitepaper), including session times and locations, include:

Oral Presentation (submitted by Pfizer, Inc.)

Abstract #270-Rivipansel: A Small Pan-Selecting Antagonist Improves Cerebral Perfusion and Inhibits Leukocyte Adhesion and in Murine Sickle Cell Disease Model. Sunday, Dec. 4, 7:30-9:00 a.m. PT, Room 7AB.

Posters (all poster sessions are in the San Diego Convention Center, Hall G)

Abstract #4049–A Phase I/II Study of GMI¬1271, a Novel E¬Selectin Antagonist, in Combination with Induction Chemotherapy in Relapsed/Refractory and Elderly Previously Untreated Acute Myeloid Leukemia; Results to Date. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #3826–E¬Selectin Antagonist GMI¬1271 Shows a Favorable Safety, PK and Bleeding Profile in Phase I Studies of Healthy Volunteers. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #2823–Vascular E-Selectin Protects Leukemia Cells from Chemotherapy By Directly Activating Pro-Survival NF-Kb Signaling – Therapeutic Blockade of E-Selectin Dampens NF-Kb Activation. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #3519—Dual E-Selectin/CXCR4 Antagonist GMI-1359 Exerts Efficient Anti-Leukemia Effects in a FLT3 ITD Mutated Acute Myeloid Leukemia Patient-Derived Xenograph Murine Model. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2826—Administration of the Dual E-Selectin/CXCR4 Antagonist, GMI-1359, Results in a Unique Profile of Tumor Mobilization from the Bone Marrow and Facilitation of Chemotherapy in a Murine Model of FLT3 ITD AML. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2509–Rivipansel (GMI-1070) Inhibits E-Selectin Recognition of Sialyl LewisX Activation and Arrest of Human Neutrophils Expressed on CD62L (L-selectin) and Blocks Integrin. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

The meeting abstracts are available at ASH (Free ASH Whitepaper)’s website.