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Advaxis Provides Additional Information on Clinical Hold

On November 02, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported additional information about the clinical hold issued by the U.S. Food and Drug Administration (FDA) on the Company’s Investigational New Drug (IND) application for axalimogene filolisbac (Press release, Advaxis, NOV 2, 2015, View Source [SID:1234507885]). Since announcing the verbal notification of the clinical hold of axalimogene filolisbac, Advaxis has received written notification from the FDA of the clinical hold.

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Since early October, Advaxis has been in an ongoing dialogue with the FDA. Over the course of these discussions, the FDA has identified certain risk mitigation measures for implementation once the hold is lifted. The Agency requested proposals from the Company regarding such measures. The Company promptly provided its recommendations, including appropriate patient inclusion / exclusion criteria, as well as certain patient surveillance and monitoring measures.

Further, the FDA has concurred with the Investigator’s assessment that the patient’s cause of death, in the safety report triggering the clinical hold, was due to cervical cancer progression. While no additional safety concerns have been identified by the Agency, it also verbally notified the Company that the clinical hold included the INDs for ADXS-PSA and ADXS-HER2 so that their evaluation, and any mitigation measures, could be simultaneously applied to all product candidates.

Advaxis is continuing to work with the FDA to facilitate review and resolution of this matter. The Company expects that the clinical hold will be resolved without significant interruption to its clinical development programs.

About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.

About ADXS-PSA
ADXS-PSA is an Lm Technology immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

About ADXS-HER2
ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

SRI International Receives $9 Million Contract to Support National Cancer Institute PREVENT Cancer Program

On November 2, 2015 SRI International reported that it has been awarded a contract of up to $9 million to provide preclinical development services to the National Cancer Institute (NCI) PREVENT Cancer Program (PCP) (Press release, SRI International, NOV 2, 2015, View Source [SID:1234507884]). Under the contract, SRI will provide scientific expertise, modern testing and support facilities, and analytical instrumentation to conduct a wide variety of preclinical pharmacology and toxicology studies to evaluate potential cancer prevention drugs.

The PREVENT Cancer Drug Development Program is an NCI-supported pipeline to bring new cancer preventing interventions and biomarkers through preclinical development towards clinical trials. PREVENT enables milestone-driven progression of novel cancer preventive chemical or biological agents and biomarkers from the laboratory bench towards proof-of-principle clinical testing and registration or validation.

"We welcome the opportunity to provide preclinical toxicology and pharmacology services to support the NCI’s PREVENT program," said Toufan Parman, Ph.D., D.A.B.T, director, General Toxicology, SRI Biosciences, and principal investigator for the NCI contract. "We’ve provided such services to the NCI for the past 23 years, and look forward to continue applying our expertise to this important work."

The current contract calls for SRI to deliver high-quality laboratory data to support NCI-PCP’s efforts to develop promising therapeutic candidates such as vaccines and cancer chemopreventive agents that will inhibit, delay or reverse manifestations of cancer. SRI will be responsible for managing therapeutic candidates from conception to submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. SRI has broad experience with similar studies for NCI and for many other divisions of the National Institutes of Health, as well as for private sponsors.

Merck and Selvita Announce Drug Discovery Collaboration

On November 2, 2015 Merck, a leading science and technology company, reported that it has entered into a three-year collaboration to validate new therapeutic concepts in the field of oncology with Selvita, headquartered in Krakow, Poland (Press release, Merck KGaA, NOV 2, 2015, View Source [SID:1234507882]). Financial details were not disclosed.

The aim of the collaboration is to deliver potential first-in-class small molecules as lead candidate drugs for multiple oncology indications. Both companies will contribute funding and resources to support the collaboration, as well as bring their
expertise in target validation, bioinformatics, medicinal chemistry, in vitro and in vivo biology, and toxicology.

"We are excited about our new collaboration with Selvita, which will afford us the opportunity to build upon our collective efforts of the last two years," said Andree Blaukat, Head of the Translational Innovation Platform Oncology at Merck. "Our shared success from our previous collaboration has led to strong progress in the area of cancer metabolism. Together, we remain focused on bringing innovative new therapeutic options to patients that have the potential to make a substantial difference in their lives."

This collaboration will steer a joined portfolio of discovery projects in a risk/reward sharing model and builds on the framework that the two companies have developed during a two-year partnership in cancer metabolism, which began in 2013.

Under the terms of the new agreement, Merck will have an exclusive license to the joint intellectual property and Selvita will receive milestone payments and royalties upon successful development and commercialization of products by Merck. The
collaboration consists of a joint research phase up to lead identification, after which Merck will further research and develop the projects on its own.

Krzysztof Brzozka, Selvita Chief Scientific Officer, added: "Collaboration between Merck and Selvita is an excellent example of a successful joint drug discovery platform where both parties contribute their expertise to identify and validate novel therapeutic targets, in parallel developing new compounds and advancing them towards clinical development. This sort of deep and intensive type of collaboration is at the core of Selvita’s vision of modern drug discovery."

Kite Pharma Initiates ZUMA-1 Phase 2 in Patients With Aggressive, Refractory Non-Hodgkin’s Lymphoma (NHL) to Support Registration of KTE-C19

On November 2, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported that it has opened enrollment for the Phase 2 portion of its ongoing Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory, aggressive NHL (Press release, Kite Pharma, NOV 2, 2015, View Source [SID:1234507879]). KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

"Kite has achieved a pivotal milestone with the initiation of our Phase 2 KTE-C19 multi-center clinical trial in DLBCL. We are deeply grateful to the patients and clinical researchers who have participated in our program. We look forward to presenting top-line data from the Phase 1 portion of the trial at ASH (Free ASH Whitepaper) and anticipate reporting interim results from the study next year," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer.

Dr. Belldegrun continued, "With inputs from regulatory agencies, we designed ZUMA-1 to enable market registration of KTE-C19 for refractory, aggressive NHL. Based on our progress and current timelines, Kite remains on track towards potential launch and commercialization of KTE-C19 in 2017."

Kite’s ZUMA-1 trial of KTE-C19 is a single arm, open-label, multi-center study, designed to determine the safety and efficacy of KTE-C19 in patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Kite expects that the Phase 2 portion of the trial will include a total of approximately 112 patients. Additional information about Kite’s Phase 1/2 study may be found at ClinicalTrials.gov, using Identifier NCT: 02348216.

Stemline Therapeutics Announces SL-401 Receives EU Orphan Drug Designation for Treatment of BPDCN

On November 2, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that the European Medicines Agency (EMA) has granted Orphan Drug designation to SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, NOV 2, 2015, View Source [SID:1234507876]). Recently, SL-401 received Orphan Drug designation from the EMA for acute myeloid leukemia (AML), and from the U.S. Food and Drug Administration (FDA) for the treatment of AML and BPDCN.

SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. Stemline is evaluating SL-401 in multiple clinical programs, including an ongoing pivotal trial in BPDCN as well as trials in additional hematological cancers.

Ivan Bergstein, M.D., Stemline’s CEO, commented, "We are pleased with the EMA’s decision to grant Orphan Drug designation to SL-401 for BPDCN, an aggressive and deadly disease with few effective treatment options." Dr. Bergstein continued, "SL-401 now has Orphan Drug status in the U.S. and Europe for both AML and BPDCN, which underscores the unmet medical need in these disorders, and provides us with options for potential accelerated clinical development."

About Orphan Drug Designation

Orphan Drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.