On June 16, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported preliminary findings from OMS-I130, a Phase II clinical trial of ImmunoPulse IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC) (Press release, OncoSec Medical, JUN 16, 2016, View Source [SID:1234513411]). These preliminary findings, indicating that ImmunoPulse IL-12 may lead to an increase in CD8+ T-cells and ‘adaptive immune resistance’ in HNSCC patients, are consistent with preclinical and clinical data previously reported in other indications. Together, the data from these multiple studies support a rationale for combining ImmunoPulse IL-12 with anti-PD-1 blockade therapies.

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Robert H. Pierce, MD, Chief Scientific Officer at OncoSec, presented the findings in an oral presentation entitled: "Intratumoral IL-12 Therapy in HNSCC: Can In-Situ Vaccination Solve the Problem of Anti-PD-1 Non-Response?" at the EUROGIN 2016 Conference in Salzburg, Austria. The oral presentation is part of the conference session entitled: "Updates on Immunotherapy Trials in HPV-HNSCC," chaired by Sara I. Pai, MD, PhD, a faculty member at Massachusetts General Hospital and Harvard Medical School and co-author of the abstract.

Dr. Pierce described a role for intratumoral immunotherapy in driving anti-tumor CD8+ responses and altering the immune environment to enable tumors to become responsive to anti-PD-1 blockade. Specifically, Dr. Pierce described new cases from the single-agent ImmunoPulse IL-12 Phase II HNSCC trial, in which intratumoral electroporation of DNA-based IL-12 drove a CD8+ T-cell response and associated increase in interferon-gamma-related genes in some patients. Moreover, one patient, who went on to receive anti-PD-1 therapy in combination with ImmunoPulse IL-12, experienced a significant tumor regression and has an ongoing partial response.

"Although we have treated only four patients to date, these data in patients with head and neck cancer are entirely consistent with our previous studies in melanoma and Merkel cell carcinoma as well as our preclinical models—namely, that in-situ vaccination with plasmid IL-12 can convert low-TIL, poorly-inflamed tumors into high-TIL inflamed tumors. That conversion may augment responses to T-cell checkpoint therapy, such as anti-PD-1 antibodies," said Dr. Pierce.

The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and Alain Algazi, MD, from the University of California, San Francisco. OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumor activity of ImmunoPulse IL-12 in patients with treatment-refractory metastatic and unresectable HNSCC. The trial (NCT02345330) is open, but currently not recruiting patients.

"We have paused enrollment in the HNSCC trial for two main reasons. First, we are currently focusing our internal resources on moving toward a registration trial in melanoma. Additionally, our strategy is aimed at demonstrating that ImmunoPulse IL-12 is a rational choice for combination therapy with anti-PD-1/PD-L1 and that ImmunoPulse IL-12 will increase the number of patients who will benefit from these treatments," said Punit Dhillon, President and CEO. "As approval of one or more of the PD-1/PD-L1 antibodies in HNSCC seems likely in the near term, we will explore a combination of our technology with the approved agent at that time."

On June 16, 2016 Varian Medical Systems (NYSE: VAR), reported it has been selected by the Icon Group to provide 10 TrueBeam medical linear accelerators for cancer centers Icon operates across Australia (Press release, InfiMed, JUN 16, 2016, View Source [SID:1234513413]). Varian will install the TrueBeam systems in the Icon centers over the next two years and continue to service them under a multi-year agreement.

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Varian’s TrueBeam family of medical linear accelerators incorporate numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery during a radiotherapy or radiosurgery procedure. In addition to the TrueBeam systems, Icon is also ordering Varian’s software suite including the Eclipse treatment planning system and ARIA oncology information management system.

"This agreement is reflective of the strong relationship between our two companies and the high quality cancer treatment equipment and service Varian delivers," said Mark Middleton, CEO of Icon Group. "These ten new TrueBeam systems mean we can provide advanced cancer treatment to more patients across Australia, in addition to the five systems ordered last year and the nine currently in place. Varian technology and services make it possible to deliver quality care rapidly and efficiently so that we can serve more patients."

"We are honored Icon selected Varian systems and software to increase its ability to deliver precise treatments to a greater number of cancer patients across Australia," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "We will continue to work closely with Icon on the deployment of these systems and increasing patient access to high quality cancer care."

On June 16, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported results from three investigator-initiated studies that demonstrate beneficial performance characteristics of Lymphoseek (technetium Tc 99m tilmanocept) injection and positive comparative results versus commonly-used, non-receptor-targeted imaging agents (Press release, Navidea Biopharmaceuticals, JUN 16, 2016, View Source;p=irol-newsArticle&ID=2178174 [SID:1234513414]). The data were presented by the investigators this week at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in San Diego, CA.

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"These data further reinforce the beneficial clinical performance attributes of Lymphoseek (technetium Tc 99m tilmanocept) Injection. And, in addition, they support Lymphoseek’s rapid adoption in sentinel lymph node biopsy procedures and its pre-surgical imaging utility for other solid tumors," commented Michael Blue, M.D., Senior Medical Director of Navidea. "We believe results from these and other performance-based studies will encourage surgeon’s to use Lymphoseek as they look to optimize outcome for their patients and improve patient experience."

Experimental Results

In the presentation entitled, "Performance of Tc-99m tilmanocept when used alone is as or more effective in localizing sentinel nodes than sulfur colloid plus blue dye," Jonathan Unkart and Anne Wallace, M.D., Department of Surgery at the University of California San Diego (UCSD), described a retrospective evaluation of the rate of localization of Lymphoseek when used alone compared to sulfur colloid (SC), blue dye (BD) and SC plus BD. The study included results from 148 breast cancer patients evaluated in two, prospective Phase 3 Lymphoseek clinical trials (data published in Annuls of Surgical Oncology 2013). SC and BD data was derived from a literature search presented at SNMMI 2013 Annual Meeting including treatment groups of 17,814 SC alone, 12,821 BD alone and 19,627 SC+BD patients. Results show the following localization rates: Lymphoseek alone: 0.9865, SC alone: 0.9249, BD alone: 0.8294 and SC+BD: 0.9636. The author’s analysis suggests that Lymphoseek provided superior sentinel lymph node localization in breast cancer patients compared to the other non-targeting agents alone or in combination providing surgeons the option to use just a single agent.

The presentation, "Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy (SLNB) in breast cancer," also presented by Dr. Unkart shows data from a retrospective review evaluating whether there is a difference in the number of nodes removed using Lymphoseek during SLNB in patients who had a pre-operative imaging procedure called lymphoscintigraphy prior to SLNB versus those who only had intra-operative Sentinel Node (SN) identification. The results indicate that in Breast Cancer, identification and removal of SNs using lymphoscintigraphy (3.0 SNs) did not significantly alter the number of SLNs removed during a SLNB procedure with no imaging (2.7 SNs). Lymphoseek’s selective-targeting performance characteristic enables the utilization of only a single dose of Lymphoseek per patient irrespective of whether both lymphoscintigraphy and SLNB are performed. The authors concluded that by using Lymphoseek, lymphoscintigraphy imaging procedures may be eliminated in this patient population and may reduce health care cost without impacting patient outcomes.

The presentation entitled, "Rate of sentinel lymph node visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m filtered sulfur colloid," describes results from a study at Emory University School of Medicine using Lymphoseek in patients with fatty breast tissue a population that is known to be more difficult to localize nodes when doing SLNB. The results suggest that Lymphoseek more effectively visualized sentinel lymph nodes (SLN) both on lymphoscintigraphy and during surgery compared to filtered sulfur colloids (Tc-SC) with 100% localization using Lymphoseek intraoperatively. Dr. Maryam Shahrzad, M.D. presented retrospective data compiled from 29 consecutive patients with early stage breast cancer where lymphoscintigraphy was performed using Tc-SC and 28 patients where lymphoscintigraphy was performed using Lymphoseek. Multiple patient variables were recorded. The Tc-SC cohort included 96% of patients with fatty breasts versus 89% in the Lymphoseek group. Statistically significant findings included:

In lymphoscintigraphy, SLN visualization occurred in 86% of the Lymphoseek group compared to 59% of the TC-SC group. (p-value: 0.02)
At surgery, 100% of patients in the Lymphoseek group showed a "hot" SLN compared to only 79% of patients in the Tc-SC group. (p-value: 0.01)
About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM

On June 15, 2016 Rgenix, a cancer therapeutics company developing first-in-class drugs targeting novel cancer pathways, reported a $33 million Series B financing led by Novo A/S and Sofinnova Partners, with participation from existing investors including Partnership Fund for New York City, Alexandria Venture Investments, and Conegliano Ventures LP (Press release, Rgenix, JUN 15, 2016, View Source [SID1234523088]). The financing will support clinical development of Rgenix’s lead drug candidates, RGX-104 and RGX-202, as well as further development of its therapeutics pipeline.

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"We are thrilled to have attracted top-tier investors to advance development of our novel cancer therapeutics"

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"We are thrilled to have attracted top-tier investors to advance development of our novel cancer therapeutics," said Masoud Tavazoie, M.D. Ph.D., Chief Executive Officer and co-founder of Rgenix. "This financing validates the potential of our lead immunotherapy RGX-104, which will be entering clinical trials this fall, and also demonstrates the strength of our discovery platform, developed in the laboratory of Rgenix co-founder Dr. Sohail Tavazoie at The Rockefeller University. The funding will enable our team to deliver an innovative therapy to cancer patients while simultaneously pushing forward our pipeline of other novel drug candidates."

Antoine Papiernik, Managing Partner at Sofinnova Partners, commented: "We are very excited to back such a high quality team at Rgenix. We also believe that RGX-104 could revolutionize treatment to cancer patients that today lack effective therapies."

Despite recent advances in cancer therapy, most patients will eventually succumb to their disease due to drug resistance and immune evasion. RGX-104 is a small molecule that reverses immune evasion and drug resistance by targeting immunosuppressive cells in the tumor microenvironment via a novel pathway, resulting in strong anti-tumor activity in several drug-resistant cancer types in pre-clinical models, both as a single agent and in combination with approved immunotherapies such as PD-1 inhibitors. The target of RGX-104 was discovered using Rgenix’s miRNA platform that has yielded several new cancer targets across multiple prevalent cancer types.

"We are excited to support Rgenix’s novel approach to treating cancers of high unmet need," said Nilesh Kumar, Senior Principal of Novo Ventures*. "Rgenix has an exciting platform founded on strong science from The Rockefeller University; the lead program is a first in class opportunity addressing a key mechanism in tumor immunosuppression in various cancer types."

In connection with the financing, Nilesh Kumar of Novo Ventures and Antoine Papiernik of Sofinnova Partners will join the Rgenix Board of Directors together with existing members, including Executive Chairman Eric Rowinsky, M.D., Masoud Tavazoie, M.D. Ph.D., Nancy Chang, Ph.D., and Saeed Tavazoie, Ph.D.

On June 15, 2016 Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, reported final topline results from a Phase I trial evaluating APG101 in low to intermediate-1 risk transfusion-dependent patients with myelodysplastic syndromes (MDS) (Press release, Apogenix, JUN 15, 2016, View Source [SID1234524579]). The study showed that APG101 was well tolerated. In addition, the trial showed that APG101 efficiently stimulates erythropoiesis in these patients.

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The single arm Phase I trial enrolled twenty patients with low to intermediate-1 risk MDS who were transfusion dependent. Patients had to be refractory to erythropoietin-stimulating agents (ESAs). The patients were treated with APG101 over a period of three months and followed for an additional six months. An extension of treatment was not intended. The primary objectives of the study were safety and tolerability. Secondary objectives included changes in transfusion frequency and changes in parameters involved in erythropoiesis.

In the study, treatment with APG101 led to a significant decrease in transfusion frequency for more than six months (end of follow up period) in 44% of the patients. In addition, measurements of parameters involved in erythropoiesis (i.e., number and function of progenitor cells) further supported the activity of APG101 in this patient population. This evidence of in vivo activity of APG101 confirms in vitro data recently published (Oncotarget Vol. 7 No. 12, 2016). More details from the final results of the study are being submitted for presentation at a major medical meeting later this year.

"The topline data from this Phase I trial continue to support the activity of APG101 in MDS patients," said Harald Fricke, M.D., Chief Medical Officer. "We were particularly excited to see that APG101 appeared to decrease the number of transfusions required by this very sick patient population. Our next step will be to initiate a Phase II trial in MDS to evaluate APG101 in various doses in combination with an erythropoietin-stimulating agent, and we are currently soliciting input from key opinion leaders on the design of that trial."

About Myelodysplastic Syndromes (MDS)
MDS is a bone marrow disorder that is characterized by ineffective hematopoiesis and can lead to severe anemia. In most cases, the anemia is treated with blood transfusions that eventually result in an iron overload, which can damage the liver and other organs. At the same time, the number of thrombocytes that are responsible for coagulation and the number of leucocytes that are responsible for immune defense significantly decrease in patients with this disorder. As a result, MDS patients frequently suffer from sudden bleeding and life-threatening infections. In addition, they are at risk of developing acute myeloid leukemia, a type of blood cancer.

About APG101
Apogenix’s lead immuno-oncology candidate APG101 is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. APG101 is being developed for the treatment of solid tumors and malignant hematological diseases. By blocking the CD95 ligand, which negatively regulates erythrocyte production in MDS patients, APG101 directly addresses the cause of the disorder and could thus potentially provide a cure for MDS.