On June 20, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that updated data for patients with diffuse intrinsic pontine glioma (DIPG) from NLG2105, a Phase 1 study evaluating indoximod in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors, will be presented at the International Symposium on Pediatric Neuro-Oncology (ISPNO) in Denver, Colorado (Press release, NewLink Genetics, JUN 20, 2018, View Source [SID1234527407]). The presentation session and time are noted below.

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Poster Session 1: IMMU-25 – Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG, to be presented by Theodore S. Johnson, M.D., Ph.D., Georgia Cancer Center, Augusta University, Sunday, July 1, 5:00PM – 6:30PM MT, Hyatt Regency Denver

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

On June 20, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported to inform shareholders that all requisite approvals have been granted to commence a Phase 2 clinical trial of ProscaVax for early-stage prostate cancer to be hosted at Beth Israel Deaconess Medical Center a teaching hospital of Harvard University Medical School in Boston, MA (Press release, Oncbiomune, JUN 20, 2018, View Source [SID1234527408]).

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

Per the study protocol, patients to be enrolled will be in what is termed "active surveillance," a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.

"We are making the final preparations to initiate enrollment, including planned site visits," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Underscored by the compelling data derived from the successfully completed Phase 1a clinical trial and our other research, we are eager to proceed with this study. Our goal is simple: to provide a safe, nontoxic. front-line therapy for prostate cancer patients that are otherwise left with either no therapy or with much more invasive options that typically have very unpleasant side effects, such as impotence or urinary incontinence. I’d like to express my gratitude for all the shareholders that have supported us throughout the process to advance our company to this next stage of ProscaVax development. I believe there is a bright future ahead of us."

Concurrent with the Phase 2 trial of patients in active surveillance, the Company is undergoing the approval process to initiate a Phase 2 trial of ProscaVax in hormone-naïve recurrent prostate cancer patients with increasing PSA at theUrology Clinics of North Texas. More updates on the status of this study are expected soon.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On June 20, 2018 AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, reported the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase II clinical trial investigating the Company’s ROOT OF CANCER technology in patients with glioblastoma multiforme (Press release, AIVITA Biomedical, JUN 20, 2018, View Source [SID1234527425]). This will be the third investigation of AIVITA’s platform cancer immunotherapy, which is currently the subject of a Phase II clinical trial in ovarian cancer in the USA, and a commercialization effort in melanoma in Japan.

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AIVITA’s single-arm, open-label trial calls for approximately 55 patients with newly diagnosed glioblastoma multiforme to be enrolled with the intent to receive the Company’s ROOT OF CANCER treatment. The treatment consists of the patient’s own dendritic cells loaded with tumor antigens from the patient’s own tumor-initiating cells. The treatment will be administered in a series of injections along with standard care, which may include surgery, chemotherapy and radiation, as well as checkpoint inhibitors should they eventually be approved as standard care.

"We are delighted with this opportunity to help glioblastoma multiforme patients, who face the most aggressive form of brain cancer," said Dr. Hans Keirstead, AIVITA’s Chief Executive Officer. "This approval reflects the platform nature, the safety and the manufacturing efficiency of our novel technology."

The University of California, Irvine will be the study’s first site, with additional sites to follow.

About Glioblastoma Multiforme

Glioblastoma Multiforme is the most aggressive and most common form of malignant brain tumor. Median survival is only nine months, rising to 15–16 months for those receiving standard of care surgery and adjuvant chemoradiation.1 The cause of most cases is unclear. The National Cancer Institute estimates there will be 23,880 new cases of brain and nervous system cancer in 2018.

[1] Bi, Wenya Linda, and Rameen Beroukhim. "Beating the Odds: Extreme Long-Term Survival with Glioblastoma." Neuro-Oncology 16.9 (2014): 1159–1160. PMC. Web. 18 June 2018.
About the ROOT OF CANCER GBM trial

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: View Source

On June 19, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today provided an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy (Press release, Can-Fite BioPharma, JUN 19, 2018, View Source [SID1234527389]). Can-Fite anticipates analyzing the results of this important trial before the end of the current year.

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The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

The trial first opened to enrollment in December 2014 and enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled, 19 completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which three completed at least 24 cycles. The longest-treated subject has been receiving study medication for approximately 3 years.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

Michael Silverman, MD, FACP, Can-Fite’s Medical Director says, "While the final analysis of this trial, based on survival, has been delayed past our original projections, we are very happy that the reason for this is the unexpected longevity of patients enrolled into this trial. Historically, HCC patients who have failed treatment with sorafenib and are Child Pugh B, have very limited life expectancy. Although the trial data are still blinded, we are encouraged by the unexpectedly long survival for some patients and hope that this will translate into a survival advantage for the Namodenoson group over the placebo group, and a critical advance for treating patients with HCC."

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On June 19, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present at the JMP Securities Life Sciences Conference on Thursday, June 21, 2018, at 10:30 a.m. ET at the St. Regis Hotel in New York (Press release, VBI Vaccines, JUN 19, 2018, View Source [SID1234527390]).

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Event: JMP Securities Life Sciences Conference
Date: Thursday, June 21, 2018
Time: 10:30 – 10:55 AM ET
Event Website: View Source