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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.

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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."

Kite Pharma and bluebird bio Announce Strategic Collaboration to Advance Second Generation TCR Cell Therapy Products to Treat HPV-Associated Cancers

On June 22, 2015 Kite Pharma and bluebird bio reported that they have entered into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor (TCR) product candidates directed against the human papillomavirus type 16 E6 (HPV-16 E6) oncoprotein incorporating gene editing and lentiviral technologies (Press release, bluebird bio, JUN 22, 2015, View Source [SID:1234505789]).

Bluebird bio has a platform comprised of lentiviral gene delivery and gene editing capabilities, with a focus on rare diseases and cancer immunotherapies. Kite has a broad existing pipeline of TCR product candidates and will continue to develop its existing and wholly-owned TCR programs directed against high-risk HPV, which are unaffected by this collaboration, including HPV-16 E6 TCR, currently in a Phase I study, and HPV-16 E7 TCR. The collaboration brings together the powerful technologies and capabilities of these two leading immunotherapy companies.

Under the terms of the agreement, both companies will jointly develop and commercialize second generation TCR product candidates directed against the HPV-16 E6 oncoprotein, incorporating gene editing to efficiently modify certain genes to enhance T cell function. In addition, the companies will explore using lentiviral vectors to optimize delivery of HPV-16 E6 TCRs into patient T cells.

Kite will lead the program in the U.S., and bluebird bio will have the option to lead the program in the European Union. Both companies will share overall costs, including research and development and sales and marketing expenses, and profits will be equally split between the companies. Additionally, Kite will have a co-promotion option in the European Union, and bluebird will have a co-promotion option in the U.S.

"As we continue to build a differentiated immuno-oncology portfolio, we are delighted to partner with Kite in a collaboration that combines their leadership in T cell-based immunotherapies with our expertise in gene editing and industry-leading lentiviral vector platform," said Nick Leschly, chief bluebird. "We believe partnering with Kite will allow us to deliver game-changing T cell therapies to patients through great science and great capabilities."

"This partnership is a natural fit with our mission to develop and deliver novel immunotherapies for cancer patients, and collaborating globally with bluebird bio will allow us to benefit from the strengths and capabilities of both companies in immuno-oncology. Through this collaboration, we will have access to our partner’s strong science expertise and enabling technologies to further enhance one of our key TCR programs and to evaluate gene editing technology in the context of T cell therapy," said Arie Belldegrun, M.D., FACS, Kite’s Chairman, President and Chief Executive Officer.

Kite will discuss further details of this collaboration at its upcoming Investor Day event on June 23rd that will be webcast at www.kitepharma.com.

About HPV-Associated Cancers
Human papillomavirus (HPV) is the most common viral infection of the reproductive tract, with two viral strains, HPV type 16 and type 18, believed to cause 70% of cervical cancers and precancerous cervical lesions, as well as other urogenital cancers.1 There were over 500,000 new cases and about 270,000 deaths attributable to cervical cancer worldwide in 2012.2

Additionally, HPV infection has become established as an etiologic risk factor for oropharyngeal head and neck cancers. The incidence of HPV-associated oropharyngeal cancers has been increasing for at least the past decade, and recent studies show that about 70 percent of oropharyngeal cancers may be linked to HPV3,4. According to the CDC, there are over 12,000 new cases of oropharyngeal cancers in the US, of which an estimated 7,500 new cases are attributable to HPV-16.4