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Advaxis Announces Licensing Agreement With Knight Therapeutics and Raises $25 Million Through Direct Investments From Knight and Sectoral Asset Management

On August 26, 2015 Advaxis, Inc. (NASDAQ:ADXS) ("Advaxis" or the "Company"), a clinical-stage biotechnology company developing cancer immunotherapies, reported that the Company has entered into a licensing agreement with Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, to commercialize in Canada Advaxis’s product portfolio including its three lead drug candidates: axalimogene filolisbac (ADXS-HPV) for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors (Press release, Advaxis, AUG 26, 2015, View Source [SID:1234507339]).

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In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7 percent premium to the price of Advaxis’s common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million.

"We are extremely gratified to, in one transaction, monetize a non-core market with a well-established local partner, while simultaneously increasing our cash balance under very favorable terms," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We have added both a key strategic partner in Knight and a top-tier healthcare institutional investor in Sectoral Asset Management. The license agreement with Knight is consistent with our strategy of focusing our resources in our core geographies."

Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones.

"We believe Advaxis’s technology has significant potential to treat a multitude of cancers," said Jonathan Ross Goodman, President and Chief Executive Officer of Knight. "This agreement, as well as our investment in the Company, are representative of our confidence in Advaxis’s future prospects. Upon approval, Knight looks forward to leveraging our local market expertise to maximize the commercial value of axalimogene filolisbac, ADXS-PSA and ADXS-HER2 in Canada."

"Sectoral Asset Management is pleased to make this significant investment in Advaxis on behalf of our clients," said Stephan Patten, Deputy Chief Investment Officer of Sectoral Asset Management. "We believe the Company’s promising Lm Technology cancer immunotherapy platform, robust clinical pipeline and strong management team with a track record of execution combine to establish a compelling value proposition for Advaxis, and look forward to tracking the Company’s progress going forward."

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 designed to target 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 being developed for the targeted treatment of HER2 expressing cancers. ADXS-HER2 has received orphan drug designation from 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 licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

DelMar Pharmaceuticals to Present at the 17th Annual Rodman & Renshaw Global Investment Conference on September 9, 2015

On August 25, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will be presenting at the 17th Annual Rodman & Renshaw Global Investment Conference being held September 9-10, 2015, at the St. Regis Hotel in New York, New York (Press release, DelMar Pharmaceuticals, AUG 25, 2015, http://ir.delmarpharma.com/news/detail/775/delmar-pharmaceuticals-to-present-at-the-17th-annual-rodman-renshaw-global-investment-conference-on-september-9-2015 [SID:1234507331]).

Jeffrey Bacha, DelMar’s president and CEO, will present on Wednesday, September 9, 2015 at 3:50 p.m. Eastern Time. As part of his presentation, Mr. Bacha will present a corporate overview, including recent progress of DelMar’s Phase II clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme (GBM) and future plans to initiate clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and other solid tumors in collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

The Company presented interim data from its ongoing study in GBM at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting confirming the completion of the Phase I dose-escalation portion of the VAL-083 trial and a promising dose-response trend in patients with recurrent GBM: Patients receiving a dose greater than or equal to 30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses less than 10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar recently announced that the Company will present the next formal update of its clinical trial in GBM at the 2nd International Symposium on Clinical and Basic Research in Glioblastoma, being held September 9-12, 2015 in Toledo, Spain.

A live webcast of the presentation will be available by accessing the DelMar’s IR Calendar in the Investors section of the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).

MorphoSys and Immatics Biotechnologies Enter Strategic Alliance in Immuno-oncology

On August 25, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Immatics Biotechnologies GmbH reported a strategic alliance to generate novel antibody-based therapeutics against multiple proprietary cancer antigens recognized by T cells (Press release, MorphoSys, AUG 25, 2015, View Source [SID:1234507332]).

The collaboration agreement provides MorphoSys with access to several proprietary tumor-associated peptides (TUMAPs) discovered using Immatics’ XPRESIDENT platform to develop novel antibody-based therapeutics against these targets in a number of solid and hematological cancers. XPRESIDENT enables access to novel antibody targets associated with proteins that are present inside cancer cells. In return, Immatics will be provided with MorphoSys’ Ylanthia antibodies against a number of its TUMAPs, with proprietary development rights. The companies will pay each other milestones based on their respective development progress as well as royalties on marketed products. Financial details of the agreement were not disclosed.

Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG, commented: "We are delighted to join forces with Immatics, a world leader in discovering truly novel cancer targets that would be otherwise inaccessible for antibody-based therapies. This alliance opens up the intracellular target space for us and thus complements the therapeutic approaches we use in other oncology programs. We believe this collaboration will create several unique product opportunities for us based on truly differentiated compounds."

Dr. Harpreet Singh, Chief Scientific Officer of Immatics Biotechnologies GmbH, added: "The alliance with MorphoSys marks an important strategic milestone for Immatics. We are now entering the field of antibody-based therapeutics complementing our existing cancer immunotherapy pipeline. The combination of MorphoSys’ outstanding capabilities to create antibodies and the unique access to intracellular targets through our XPRESIDENT discovery engine provides both partners the opportunity to jointly deliver the next generation of transforming antibody drugs for cancer patients with high unmet medical need."

Tumor cells differ from healthy cells in the expression of tumor-associated proteins. These proteins are degraded inside living cells into shorter fragments, called peptides, which are then shuttled to the cell surface. Specialized receptors on the cell surfaces, so-called major histocompatibility complex (MHC) receptors, display these peptides to the external environment thereby providing a snapshot of the cell’s interior. The therapeutic programs now being pursued by Immatics and MorphoSys aim to discover Ylanthia antibodies against these MHC-bound peptide targets in order to kill the tumor cells. Immatics’ XPRESIDENT discovery platform is the only known high-throughput research technology to directly identify, quantify, and prioritize these cancer-related peptides.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Nuvilex, AUG 24, 2015, View Source [SID:1234507333])

8-K – Current report

On August 24, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of its VistaSeq Hereditary Cancer Panel, a novel, 27-gene panel designed to identify patients with increased risk of breast, ovarian, melanoma, pancreatic, colorectal, endometrial, gastric, prostate, and other cancers (Filing, 8-K, LabCorp, AUG 24, 2015, View Source [SID:1234507327]). These cancers are projected to result in approximately 900,000 new diagnoses of cancer, and almost 200,000 deaths, annually in the U.S.

"This innovative new offering enhances our industry-leading portfolio of genetic and genomic testing, which we seamlessly integrate with the largest cohort of board-certified genetic counselors in the industry," said David P. King, Chairman and Chief Executive Officer. "VistaSeq is an important advancement in precision medicine, and represents the latest example of our strategic focus on delivering world-class diagnostics and using the resulting information to change the way care is provided."

The VistaSeq Hereditary Cancer Panel provides an assessment of genetic mutations within a panel of 27 genes known to be associated with hereditary cancer syndromes. The information provided is used to determine an increased cancer risk in patients with an associated personal or family history. Mutations in different genes may cause the same type of cancer; conversely, one gene may be associated with multiple hereditary cancer syndromes. VistaSeq will give healthcare providers and patients additional information to assist in understanding further monitoring and appropriate medical management options.

NCCN Guidelines and The Society of Gynecologic Oncology (SGO) note that hereditary multi-gene panels may be an efficient and cost-effective approach to genetic cancer testing when used in appropriate clinical settings.

"LabCorp’s VistaSeq testing capabilities and services provide physicians and patients with powerful tools for the assessment of hereditary cancers," stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer. "VistaSeq was developed based on our strong in-house expertise in genomics and the latest advancements in science. LabCorp is a leader in genetic testing and counseling services, and we continue to expand our innovative menu of focused genetic tests."

The VistaSeq test is available nationwide through any LabCorp account, and will be performed by Integrated Genetics, a member of LabCorp’s Specialty Testing Group. In addition, LabCorp offers a complete range of complementary services to the testing for patients and physicians, including insurance pre-authorization support and access to genetic counselors, who are professionally trained to analyze, assess, and interpret genetic test results.