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BIND Therapeutics Announces FDA Authorization of First-in-Human Clinical Trial with AstraZeneca’s Aurora B Kinase Inhibitor Accurin AZD2811

On June 23, 2015 BIND Therapeutics reported that the U.S. Food and Drug Administration (FDA) has authorized the use of AstraZeneca’s Accurin AZD2811 in clinical trials under an investigational new drug (IND) application (Press release, BIND Therapeutics, JUN 23, 2015, View Source [SID:1234505791]).

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BIND is collaborating with AstraZeneca on the development of AZD2811, an Aurora B Kinase inhibitor that has been shown to be active in both solid and hematological tumors in preclinical models, and the companies anticipate enrolling patients in a phase 1 clinical trial with AZD2811 in the fourth quarter of this year. BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD2811.

Preclinical data on AZD2811 were presented at the 2015 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2015, including data demonstrating promising in vivo and in vitro tumor growth inhibition as monotherapy in models of diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC). Additional data showed that AZD2811 delivers prolonged exposure to active drug while having the potential to adapt the dosing regimen, potentially achieving an improved therapeutic index. In addition, using mass spectrometric imaging, AZD2811 was shown to accumulate in tumors and achieve prolonged tumor drug exposure. This represents the first time distribution of nanoparticles in tumors has been demonstrated. Previously, preclinical tumor model data were presented showing that AZD2811 minimizes the bone marrow toxicity seen with the parent compound, which has limited the clinical utility of Aurora B kinase inhibitors as a class.

"We have worked diligently with our collaborators at AstraZeneca to quickly advance the Aurora B kinase inhibitor program, AZD2811, through preclinical development," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "The data recently presented at AACR (Free AACR Whitepaper) describing the optimized pharmacological properties of AZD2811 further demonstrate the unique attributes of Accurins as a new treatment modality with the potential to produce therapeutics with best-in-class profiles. With AZD2811 now cleared to begin a phase 1 study, we are positioned to have two Accurins in clinical development, with our lead Accurin BIND-014 currently in phase 2 studies."

BIND and AstraZeneca expect to enroll the first patient in a phase 1 clinical trial with AZD2811 in the fourth quarter of 2015. Under terms of the collaboration, AstraZeneca is responsible for clinical development and commercialization and BIND is responsible for conducting clinical manufacturing through at least the end of phase 2 clinical trials.

About Accurins
Accurins, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of Accurins allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

Accurins can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables Accurins to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 22, 2015 Aptose Biosciences reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will present at the upcoming 10th Annual JMP Securities Life Sciences Conference on Wednesday, June 24th at 10:30 a.m. ET at the St. Regis New York (Filing, 6-K, Aptose Biosciences, JUN 22, 2015, View Source [SID:1234505790]). Dr. Rice will provide a corporate overview of the Company’s recent activities and strategic direction, including the development of Aptose’s lead clinical agent, APTO-253, for acute myeloid leukemia (AML), high risk myelodysplastic syndromes (MDS) and other hematologic malignancies.

A live audio webcast of the Aptose presentation will be accessible by visiting:

View Source

The audio webcast will be archived shortly after the live event and will be available for 90 days through the Aptose website at www.aptose.com.

IMS Health and Foundation Medicine Announce Collaboration to Optimize Targeting of Precision Therapies in Oncology

On June 22, 2015 IMS Health and Foundation Medicine reported a collaboration to advance the understanding and effectiveness of precision medicines for treating cancer (Press release, Foundation Medicine, JUN 22, 2015, View Source [SID:1234505788]). Commercial, medical and outcomes research teams in biopharma and life sciences companies will now be able to leverage an offering that combines IMS Health’s powerful Real-World Evidence (RWE) platform providing clinical and cost-of-care insights with Foundation Medicine’s dynamic knowledgebase of comprehensive cancer genomic profiles, all at the patient-anonymous level.

Through the collaboration, IMS Health’s clients will gain unprecedented insights to rapidly assess health outcomes and effectiveness, and to improve cancer care by better connecting patients to the right targeted therapies at the right time.

"As life sciences companies look to deploy new, targeted therapies that address the unique molecular drivers of specific cancers, it has become increasingly important for them to better understand unmet needs, treatment decisions and outcomes for patient populations living with those cancers," said Jon Resnick, IMS Health vice president and general manager of Real-World Evidence Solutions. "This collaboration with Foundation Medicine extends our Real-World Evidence platform – uniquely linking claims, EMR and biomarker data at the anonymous patient level to drive a complete understanding of the oncology patient journey and improve clinical development and commercialization strategies."

These enhanced oncologic insights will be powered by Evidence 360 and FoundationCORE. Evidence 360 is IMS Health’s scalable and secure RWE platform that helps clients extract, analyze and visualize real-world data to better understand and measure healthcare outcomes. It brings together IMS Health’s vast library of patient-anonymous data with other patient-anonymous sources of health information to help life sciences companies interpret real-world outcomes and better target their commercial efforts. FoundationCORE is a molecular information knowledgebase containing comprehensive cancer genomic information and insights from more than 43,000 clinical cases profiled by Foundation Medicine. FoundationCORE evolves in real-time, informed by every new cancer patient tested with the company’s commercial assays, FoundationOne and FoundationOne Heme.

"There is recognition within the healthcare industry that rich and highly credible information will be the primary catalyst for the broad adoption of precision medicine, particularly in oncology," said Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "As the leader in molecular information solutions, Foundation Medicine’s collaboration with IMS Health expands existing relationships with our biopharma partners, further underscoring the value of FoundationCORE and its impact on informing physicians and patients, and transforming clinical practice."

8-K – Current report

On June 22, 2015 Provectus Biopharmaceuticals reported that it has retained healthcare communications company PharmaHEALTHLabs to coordinate and facilitate an Investigator Advisory Board meeting to be held during 11th Brazilian Melanoma Conference from August 13-15, 2015 in Goiania, Brazil (Filing, 8-K, Provectus Pharmaceuticals, JUN 22, 2015, View Source [SID:1234505787]).

The meeting will target approximately 15 key oncologists who will be attending the conference and who are active in the investigator community in Brazil for the treatment of melanoma. The purpose is to offer insight and feedback into the status of treatment of melanoma in Brazil as well as the feasibility of initiating the PV-10 Trial in Brazil.
Under the terms of the agreement, PharmaHEALTHLabs will provide a dedicated management team to handle numerous functions at which their company excels. This includes, but is not limited to, content development; overall account and project management; participant recruitment, planning and contracting; expense accounting functions; development of meeting materials; venue research and contracting; program coordination and logistics; travel and accommodations; onsite support; and meeting summary and reporting.

Peter Culpepper, CFO and COO, of Provectus said, "The 11th Brazilian Melanoma Conference is a gathering of melanoma experts from all around Brazil, a country where melanoma survival rates are lower than average, that offers us a unique opportunity to explore the possibilities of extending our melanoma research into Brazil.

PharmaHealthLabs’ personnel are highly experienced in melanoma and in managing the kind of meeting we need to have with the leading investigators in the country, and we are confident that their efforts will help us quickly and clearly understand the potential of Brazil in our PV-10 development program."

Jeff Meehan, PharmaHealthLabs Lead Oncology Advisor, said, "PharmaHealthLabs is very happy to be working with Provectus in assessing the potential of Brazil as a place for further research into PV-10 in melanoma. Putting together this kind of high level meeting on an international level requires agility as well as experience, and we believe that Provectus will be highly pleased with the quality of the information they receive."

ImmunoCellular Therapeutics Establishes Agreement with Pure MHC for Novel Quality Control Assay for ICT-107 Phase 3 Registrational Trial

On June 22, 2015 ImmunoCellular Therapeutics reported an agreement with Pure MHC, an Emergent Technologies portfolio company, for development of a novel assay for quality control that will be an important component of ImmunoCellular’s ICT-107 phase 3 registrational clinical program in newly diagnosed glioblastoma, anticipated to begin in the second half of 2015 (Press release, ImmunoCellular Therapeutics, JUN 22, 2015, View Source [SID:1234505785]). Under the terms of the agreement, Pure MHC will develop and validate a new assay specifically created for ICT-107, a dendritic-cell based immunotherapy targeting six antigens found on glioblastoma cells, especially stem cells. The new assay will be used to validate the quality and confirm the activity of ICT-107 and allow it to be released for administration to patients in the phase 3 trial.

ImmunoCellular Therapeutics Logo.
"The agreement with Pure MHC is another important milestone in ImmunoCellular’s progress toward the phase 3 registration trial for ICT-107," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "Designing a new release assay to support the specific requirements of the ICT-107 six-antigen complex requires special skill and expertise, and we are confident in Pure MHC’s ability to deliver a validated release assay. We believe that the knowledge and know-how gained from developing this assay can be applied to our other dendritic cell-based immunotherapy programs, thus representing a meaningful return on investment for our Company. We look forward to continuing to advance toward beginning patient enrollment in the phase 3 trial of ICT-107 in the late third quarter or early fourth quarter of this year."

"Pure MHC has developed a suite of platform technologies in the field of immuno-oncology including the use of TCRm mAb to validate peptide vaccine delivery," said Tommy Harlan, Pure MHC Chief Executive Officer. "Pure MHC looks forward to using its patented TCRm potency assay to support the release of ImmunoCellular’s ICT-107 dendritic cell-based immunotherapy for glioblastoma."