On May 19, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that Paul Maffuid, PhD, Executive Vice President of Research and Development, will discuss MabVax’s unique approach to the discovery of fully human antibodies to cancer antigens and the resulting lead HuMab-5B1 clinical projects in a presentation at America’s Antibody Congress in San Diego on May 19-20, 2016 (Press release, MabVax, MAY 19, 2016, View Source [SID:1234512575]).

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Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company’s lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. MVT-2163 (89Zr-DFO-HuMab-5B) is the company’s lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company’s radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.

The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.

Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.

The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.

MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.

On May 19, 2016 (GLOBE Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), reported the publication of an abstract selected for an oral presentation on Phase 1 data of an orally administered, combination regimen of seliciclib and sapacitabine in 67 patients with advanced solid tumors at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Cyclacel, MAY 19, 2016, View Source [SID:1234512573]).

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Abstract: 2503
Title: Phase I study of sapacitabine and seliciclib in patients with advanced solid tumors
Date/Time: Monday, June 6, 2016 9:00 a.m. to 9:12 a.m. CDT
Location: E354b
Session Title: Developmental Therapeutics — Clinical Pharmacology and Experimental Therapeutics
Authors: SM Tolaney1, J Hilton1, JM Cleary1, L Gandhi1, EL Kwak1, JW Clark1, A Wolanski1, T Bell1, SJ Rodig3, JH Chiao2, D Blake2, G Shapiro1
1Dana-Farber Cancer Institute, Boston, MA; Massachusetts General Hospital Cancer Center, Boston, MA; 2 Cyclacel Ltd, Dundee, United Kingdom; 3 Brigham and Women’s Hospital, Boston, MA.

The abstract can be accessed through the ASCO (Free ASCO Whitepaper) website, www.asco.org.

On May 19, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) which will be held June 3 -7 in Chicago, IL (USA) (Press release, Chugai, MAY 19, 2016, View Source [SID:1234512571]). Results from the J-ALEX study will be presented at the oral abstract sessions scheduled for June 6 (CDT).

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Abstract #9008
Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+NSCLC): primary results from the J-ALEX study

The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to either the Alecensa arm or the crizotinib arm of the study in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety, and other endpoints.

The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (36%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (59%), visual disturbance (55%), dysgeusia (52%), constipation (46%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 27% of the Alecensa arm and in 51% of the crizotinib arm, there were no treatment-related deaths in either arm.

In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the J-ALEX study.

"It was found in Japan earlier than in any other country in the world that ALK fusion gene serves as a powerful carcinogenic factor for some types of lung cancer. Alecensa was created by Chugai as a drug selectively inhibiting the activity of ALK fusion gene, and it was first approved in Japan in 2014 based on the Japanese clinical study data. The J-ALEX study, comparing Alecensa therapy directly with standard therapy, demonstrated superiority of Alecensa over standard therapy for the first time in the world. This finding not only greatly encourages the patients suffering from ALK fusion gene positive NSCLC but also illustrates the high level of drug development progression from basic research to clinical studies in Japan," said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. "Chugai is extremely proud of having developed Alecensa which has been shown to provide benefit to patients."

As a top pharmaceutical company in the field of oncology in Japan, Chugai believes that early treatment using Alecensa in ALK fusion gene positive NSCLC is expected to prolong these patients’ PFS and enable them to face their disease with hope for the future.

About Alecensa
Alecensa is a highly selective ALK inhibitor discovered by Chugai. It has been reported that 2 to 5 percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumor cells and transforming the cells into tumor cells.2, 3) Alecensa exerts its anti-tumor effect by selectively inhibiting ALK kinase activity to inhibit tumor cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the transporter proteins in the blood brain barrier that actively pump molecules out of the brain. Alecensa is active in the central nervous system and has proven activity against brain metastases.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. In the US, Alecensa was approved in December 2015 for the indication of "anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or those who are intolerant to crizotinib." In September 2015, Roche filed the MAA in Europe to the European Medicines Agency for the approval of "ALK fusion gene positive unresectable, recurrent/advanced NSCLC."

On May 19, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX) reported that BL-8040, its lead platform for the treatment of multiple cancer and hematological indications, will be presented at two upcoming scientific conferences (Press release, BioLineRx, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169697 [SID:1234512569]).

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An abstract titled "Clinical response in relapsed/refractory AML patients correlates with leukemic blast mobilization and differentiation induced by BL-8040, a potent CXCR4 antagonist; results of a Phase 2a study" was accepted for a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Congress, to be held June 9-12, 2016 in Copenhagen, Denmark. Full detailed results from this Phase 2a study will be presented at an upcoming US-based scientific conference.

An abstract titled "CXCR4 Controls BCL-2 Expression and Function by Regulating miR-15a/16-1 Expression in Tumor Cells," illustrating BL-8040’s mechanism of action, was accepted for an oral presentation at Chemotactic Cytokines Gordon Research Conference, to be held between May 29 – June 3, 2016, in Girona, Spain.

On May 19, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company was selected for a poster presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 3 – 7 in Chicago, IL (Press release, Bellicum Pharmaceuticals, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169692 [SID:1234512568]).

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Also in June, data from the ongoing BP-004 clinical trial of BPX-501, the Company’s adjunct T cell therapy for allogeneic hematopoietic stem cell transplantation, will be discussed by Dr. Alice Bertaina, Head of Stem Cell Transplant at Ospedale Pediatrico Bambino Gesù in an oral presentation at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held from June 9 – 12 in Copenhagen, Denmark.

ASCO Presentation Details:

Presentation Title: "Enhanced efficacy and safety of Her2-targeted chimeric antigen receptor (CAR) T cells using MyD88/CD40 costimulation and iCaspase-9 suicide switch"
Abstract Number: 3050
Poster Board: #372
Session Name: Developmental Therapeutics – Immunotherapy
Date: Sunday, June 5, 2016
Presentation Time: 8:00 AM – 11:30 AM CDT (9:00 AM – 12:30 PM EDT)

EHA Oral Presentation Details:

Presentation Title: "Infusion of BPX-501 (donor T cells transduced with the iC9 suicide gene) after α/β T-cell depleted haplo-HSCT in children with acute leukemia: Preliminary results of a Phase I-II trial"
Abstract Number: S523
Session Name: Stem cell transplantation – Clinical 1
Date: Saturday, June 11, 2016
Presentation Time: 4:30 PM – 4:45 PM CEST (10:30 AM – 10:45 AM EDT)