On December 14, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported that the NeuVax (nelipepimut-S) Phase 2 clinical trial entitled VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast is now open for enrollment and screening patients (Press release, Galena Biopharma, DEC 14, 2016, View Source [SID1234517077]). The trial is being run in collaboration with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center Phase I and II Chemoprevention Consortium.

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Ductal Carcinoma in Situ (DCIS) is a noninvasive cancer in which abnormal cells are found in the lining of the breast duct and have not spread outside the milk duct to invade other parts of the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently it is extremely challenging to identify which lesions may convert to invasive cancer.1 DCIS is the most common type of breast cancer and the rate at which DCIS is diagnosed has increased dramatically in recent years as a result of increased cancer screening.1

"The Phase 2 VADIS trial will broaden the development footprint for NeuVax into this new indication as we assess its safety and immunologic efficacy in patients with DCIS," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The challenge with DCIS is that the exact course of the disease cannot be determined and consequently the outcomes for patients may be undefined. This study will evaluate NeuVax in its capacity to generate the immune response, including tumor-infiltrating lymphocytes (TILs), that could potentially prevent the progression of the disease. Positive study results from the VADIS trial could provide potential evidence for NeuVax as a first of its kind treatment for the primary prevention of invasive breast cancer, thereby sparing significant numbers of women from disfiguring surgery and radiation treatments. We are grateful to be working on this innovative initiative with the NCI and the MD Anderson Cancer Center, two of the finest oncology institutions in the country."

Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the VADIS trial, added, "We are pleased to collaborate with the NCI and Galena on the development of NeuVax in DCIS which affects more than 60,000 women a year. In breast cancer, DCIS may be a precursor to invasive disease, and it is possible that vaccination before tumor cells become genetically unstable and begin dividing rapidly could prevent evolution to malignancy. NeuVax is currently the most advanced breast cancer vaccine in the clinic and we think its broad immune response not only to the specific antigen targeted by the drug, but also to other antigens, speaks to why NeuVax could be an ideal therapeutic candidate in this indication. By vaccinating patients in early-phase disease, we may be giving them long-lasting immunity to protect them down the line."

The MD Anderson Consortium is funded through the Division of Cancer Prevention at the NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as some financial and administrative support.

Source: 1Pang, J-MB, et al, Histopathology 2016.

About VADIS

VADIS (Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast) is a Phase 2 trial to evaluate women diagnosed with DCIS who are HLA-A2 positive, who express HER2 at IHC 1+, 2+, or 3+ levels, and who are pre or post menopausal. Patients will be randomized to one of two arms (n=48): NeuVax plus GM-CSF (n=32 randomized / 27 evaluable) or GM-CSF alone (n=16 randomized / 13 evaluable). The primary endpoint is immunologic and will evaluate the effect of the NeuVax vaccine on NeuVax -specific cytotoxic T lymphocytes to determine whether long-lasting immunity is induced. Secondary endpoints include evaluation of toxicity, In vivo immune response (delayed type hypersensitivity reaction (DTH)), epitope spreading, T-cell functional capacity, and histologic response measured by degree of lymphocyte infiltration, proliferation, and apoptosis.

The trial design via poster presentation is available on the Company’s website here. Additional information on the trial can be found on the ClinicalTrials.gov site here (identifier: NCT02636582).

About Ductal Carcinoma in Situ

Ductal Carcinoma in Situ (DUK-tul KAR-sih-NOH-muh in SY-too), or DCIS, is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2015 there were over 60,000 diagnoses of ductal carcinoma in situ.

About NeuVax (nelipepimut-S)

NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APCs). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is also currently in two breast cancer studies in combination with trastuzumab (Herceptin; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). A Phase 2 clinical trial is planned in patients with gastric cancer.

On December 14, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for United States Patent Application Serial No. 13/933,844 entitled, "Improved Analytical Methods for Analyzing and Determining Impurities in Dianhydrogalactitol (Press release, DelMar Pharmaceuticals, DEC 14, 2016, View Source [SID1234517069])."

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The patent has also been granted in Australia and is being prosecuted in other international jurisdictions as part of more than 100 patent filings from thirteen patent families representing claims covering VAL-083 until 2036.

"This patent provides DelMar with ownership of essential manufacturing controls required under good manufacturing practice (GMP) guidelines," said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. "This is an important component of our strategy to establish a strong international patent portfolio as the foundation to support the global development of VAL-083 in multiple cancer indications."

DelMar is preparing to advance VAL-083 into a pivotal Phase III clinical trial in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

The Company has also recently presented data and outlined plans for expansion of VAL-083 into new indications, including newly diagnosed GBM, ovarian and lung cancer. DelMar’s most recent abstract entitled "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer" was presented at the 17th World Congress on Lung Cancer in Vienna, Austria on December 7, 2016.

Further details regarding DelMar’s scientific presentations can be found at View Source

The USPTO issues a Notice of Allowance after it makes a determination that a claimed invention is novel and nonobvious in light of all known technology in existence, and that a patent should be granted from such an application. Based on the timing of this Notice of Allowance, DelMar Pharmaceuticals expects the forthcoming US patent to be issued in early 2017.

On December 14, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer (Press release, CytomX Therapeutics, DEC 14, 2016, View Source [SID1234517068]). The company plans to immediately initiate the study and open clinical sites to support patient enrollment.

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"Initiating the first clinical program emerging from the Probody platform is a major milestone for CytomX," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "CX-072 has the potential to become a differentiated centerpiece of combination cancer therapy by targeting the tumor microenvironment, while sparing healthy tissues. We are partnering with clinical trial sites to bring this innovative treatment option to patients as quickly as possible."

About PROCLAIM
PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module to be initiated is the PROCLAIM-072 clinical study, an open-label, dose-finding phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients.
Clinical data from PROCLAIM-072 is expected to begin to emerge in late 2017 and throughout 2018.

On December 14, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that it has entered into a strategic research agreement with Personalis, Inc., a precision medicine company, focused on genomics solutions for immuno-oncology, cancer, and genetic disease (Press release, Argos Therapeutics, DEC 14, 2016, View Source [SID1234517066]).

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Personalis will serve as the primary genomic analysis service provider to support ongoing research efforts to demonstrate that Argos’ lead product candidate, rocapuldencel-T, specifically targets patient-specific neoantigens without the need to identify them first. Argos will utilize the Personalis ACE ImmunoID next-generation sequencing (NGS) platform to evaluate tumor samples collected during clinical development of Argos’ tumor-specific dendritic cell technology to treat renal cell carcinoma. The analytically validated ACE ImmunoID platform offers the unmatched accuracy through whole exome and transcriptome sequencing for tumor/normal evaluation coupled with leading edge bioinformatics and sample tracking to ensure timely delivery of results including neoantigen identification and tumor mutational burden.

"We are pleased to work with Argos and to offer the Personalis ACE ImmunoID platform to support the mechanism of action of its precision immunotherapy clinical trials and research," said John West, CEO of Personalis. "As precision medicine continues to gain momentum, we recognize the importance of work done by companies such as Argos to bring truly personalized medicine into reality and we are delighted to be their partners in transforming cancer treatment."

"The Personalis technology is a key component to our efforts to further understand the mechanism of action of our lead product, rocapuldencel-T for the treatment of advanced renal cell cancer. We hope to demonstrate that rocapuldencel-T specifically targets neoantigens found only in the patients’ tumors to explain why we observe tumor regression without autoimmunity to the unaffected contralateral kidney," said Dr. Charles Nicolette, chief scientific officer and vice president of research and development for Argos.