On July 9, 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 that ClinicalTrials.gov has updated its website to now include OncBioMune’s Phase 2 clinical trial evaluating ProscaVax as the first ever therapeutic vaccine for prostate cancer patients in the active surveillance group (Press release, Oncbiomune, JUL 9, 2018, View Source [SID1234527803]). The trial is being hosted at Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA, and includes the Dana-Farber Cancer Institute.

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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).

The study will evaluate the safety and efficacy of ProscaVax in patients with localized prostate cancer. The goal of the study is to determine if ProscaVax administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is 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.

Details on the trials can be viewed at: View Source

"The initiation of this study represents a milestone moment for our company, shareholders and the more than 160,000 men that will learn they have prostate cancer this year," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "For the first time ever, prostate cancer patients in the trial will have a therapeutic vaccine as an option rather than waiting for disease progression or jumping into more invasive treatments options that frequently are accompanied by very unpleasant side effects, such as urinary incontinence and impotence. We look forward to the commencement of enrollment and to the future where we will learn more about the efficacy of ProscaVax as a front-line treatment for prostate cancer."

Sign up for OncBioMune email alerts at: View Source

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 9, 2018 Andarix Pharmaceuticals, a clinical stage company aimed at developing targeted peptide therapies for hard to treat cancers, reported that its Chief Executive Officer, Chris Adams, will present at the Chinese Biopharmaceutical Association (CBA) USA conference. The CBA conference will take place on June 9, 2018 in Gaithersburg, MD.

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"The CBA conference offers Andarix the opportunity to present its findings and share its clinical message on a global stage in front of audience with extensive connections in the Chinese market", say Chris Adams, CEO of Andarix

About Tozaride
Tozaride is a novel, best-in-class therapeutic for lung and other cancers, which is based on a radio-labeled somatostatin peptide. Early clinical studies demonstrated that Tozaride is well tolerated and that treatment can promote disease stabilization and improve overall survival in heavily pre-treated advanced lung cancer patients. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefits for both small cell lung cancer (SCLC), and non-small cell lung cancer (NSCLC) patients. This therapeutic stands to provide an additional treatment option for patients who are not eligible for, or who have not responded to
current therapies.

On July 9, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company, announced today the initiation of a research collaboration and licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop novel multi-specific antibodies for undisclosed oncology targets (Press release, TeneoBio, JUL 9, 2018, View Source [SID1234527703]). Under the terms of the agreement, Teneobio will generate product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. For resulting therapeutic candidates, Janssen would have exclusive global licensing rights to the antibodies for clinical development and commercialization. The deal was facilitated by Johnson & Johnson Innovation LLC through its California Innovation Center.

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Teneobio Inc. will receive an upfront payment and is eligible to receive future research, development and commercial milestone payments per potential candidate. Teneobio would also receive royalties on world–wide net sales of each multi-specific product. Financial terms of the agreement were not disclosed.

Roland Buelow, CEO of Teneobio, added, "We are excited to collaborate with Janssen and its oncology scientists to develop the next generation of therapeutic multispecific antibodies. Our UniRat-derived modular human variable heavy-chain antibody domains (UniDabs) enable the assembly of robust, optimized, multispecifics for T-cell redirection, as antibody drug-conjugates, and as extracellular domains of CAR T-cells to target cancers. Through Teneobio’s state-of-the-art discovery platforms, we look to discover and advance differentiated biotherapeutics to the clinic. Janssen‘s deep oncology expertise complements our interests and goals to address unmet medical needs with novel breakthrough therapeutics."

On July 9, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that it will host a webcast on July 10, 2018 at 8:00 AM ET (Press release, Actinium Pharmaceuticals, JUL 9, 2018, View Source [SID1234527628]). The webcast will discuss the Company’s previously announced Actimab-A MRD clinical trial for patients with AML who are in remission but have detectable minimal residual disease (MRD). Dr. Joseph Jurcic, Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center and Dr. Mark Berger, Chief Medical Officer and Sandesh Seth, Chairman and CEO of Actinium Pharmaceuticals, Inc. will lead the webcast.

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Participation and registration information is as follows:

Date: July 10,2018
Time: 8:00 AM ET
Registration Link: View Source
Telephone participation: U.S./Canada Toll Free: (855) 698-6739 or (646) 402-9440
Conference ID:2540
PIN Number: A Pin will be provided in the confirmation email received upon registration.

The Actimab-A MRD trial will study the safety/tolerability of Actinium’s Actimab-A in the postremission consolidation setting and include a dose finding analyses. The trial will also study the impact of Actimab-A on minimal residual disease (MRD) as well as progression-free (PFS) and overall survival (OS) rates. The investigational new drug (IND) application for this trial has been cleared by the FDA.

About Actimab-A
Actimab-A is an antibody radio-conjugate (ARC) comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the radioisotope actinium-225. CD33 is a marker expressed on AML cells of virtually all affected patients. Actimab-A has been studied in over 100 patients to date and is the only CD33 targeting agent being studied in a broad range of diseases in which the CD33 antigen is expressed, including AML, myelodysplastic syndrome (MDS) and multiple myeloma.

Actinium-225 is highly differentiated radioisotope that emits high amounts of energy through the release of four alpha-particles that can cause double-stranded breaks in DNA with known resistance mechanisms to Actinium-225. Given the limited distance of its energy in the body, it is potentially sparing of non-targeted cells leading to better tolerability and less toxicities.

Actimab-A has been granted Orphan Drug Designation from both the U.S. Food and Drug Administration and the European Medicines Agency for newly diagnosed AML in patients age 60 and above.

On July 9, 2018 CTI BioPharma Corp. and Servier reported that the pivotal Phase III study (PIX306) evaluating PIXUVRI (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS) (Press release, CTI BioPharma, JUL 9, 2018, View Source [SID1234527625]).

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"We are disappointed with the outcome of the PIX306 study and will proceed to conduct a thorough review of the clinical data to assess the next steps for the PIXUVRI program," commented Adam Craig, MD, PhD, CEO of CTI BioPharma. "We would like to express our appreciation to the patients, families and investigators who participated in the study."

Results will be submitted for presentation at a major scientific meeting by the end of the year and for publication in a peer-reviewed journal.

About PIX306

The PIX306 study is a randomized, multicenter study comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL).

The PIX306 study enrolled 312 patients who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint was progression-free survival (PFS) while overall survival (OS), complete response rate (CR), overall response rate (ORR) and safety were secondary endpoints.

For more information about the PIX306 study, please visit
View Source

The ClinicalTrials.gov identifier is NCT01321541.

About Non-Hodgkin Lymphoma (NHL)
NHL is a blood cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.1 The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.2

NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.3 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.

About PIXUVRI (pixantrone)
PIXUVRI is the only treatment in the European Union indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).4 PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.5

PIXUVRI has not been approved by the U.S. Food and Drug Administration in the United States (US).

PIXUVRI has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.6 Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product’s immediate availability on the market outweighs the risks due to need for further data.7 The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.

PIXUVRI is mentioned in the ESMO (Free ESMO Whitepaper) guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.8

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.ema.europa.eu

CTI granted Servier rights to commercialize the drug globally in all markets except the US. The two companies continue to work closely to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.