PIERIS PHARMACEUTICALS ANNOUNCES PRESENTATION OF DATA FOR ITS LEAD IO BISPECIFIC PROGRAM, PRS-343, AT THE 2016 CRI-CIMT-EATI-AACR INTERNATIONAL CANCER IMMUNOTHERAPY CONFERENCE

On July 9, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer and other diseases reported that it will be presenting a poster at the 2016 CRI-CIMT-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) -Translating Science into Survival, taking place in New York City, September 25-26, 2016 (Press release, Pieris Pharmaceuticals, JUL 9, 2016, View Source [SID:1234515005]).

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The poster entitled "Costimulatory T-cell engagement by PRS-343, a CD137 (4-1BB)/HER2 bispecific, leads to tumor growth inhibition and TIL expansion in humanized mouse model," will be presented on September 26, 2016.

Session Title: Poster Session
Session Subtitle: New Agents and Their Mode of Action in Animals and Humans
Poster Number: B016
Session Date: Monday, September 26, 2016
Presentation Time: 5:15 p.m. to 7:45 p.m. ET
Session Location: New York Hilton Midtown – Grand America Hall I

About PRS-343
PRS-343 is a bispecific monoclonal antibody/Anticalin fusion protein comprised of a HER2 tumor-targeting mAb genetically linked to a potent anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the Tumor Micro-Environment (TME). 4-1BB is an established marker for tumor-specific infiltrating T lymphocytes (TILs) and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.

ENGOT and TESARO Partnership Generates Positive Data From ENGOT-OV16/NOVA Phase 3 Trial

On July 08, 2016 ENGOT (European Network of Gynaecological Oncology Trial Groups), reported that the Phase 3 ENGOT-OV16/NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS) (Press release, TESARO, JUL 8, 2016, View Source [SID:1234513775]). This trial is led by NSGO (Nordic Society of Gynaecological Oncology) in partnership with TESARO, Inc. and is the first successful Phase 3 trial of a PARP inhibitor to be completed in ovarian cancer. More than 500 patients with recurrent disease who were in response to their most recent platinum-based chemotherapy regimen enrolled in the trial.

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As previously reported, this trial demonstrated that niraparib significantly prolonged PFS compared to control among patients who are germline BRCA mutation (gBRCAmut) carriers, among patients who are not germline BRCA mutation (non-gBRCAmut) carriers but who have homologous recombination deficient (HRD) tumors as determined by the Myriad myChoiceHRD test, and overall in patients who are not germline BRCA mutation carriers.

"The data suggest that niraparib, if approved, will be a step forward in the management of our patients and a potential new treatment option for ovarian cancer patients," said Mansoor Raza Mirza, M.D., Study Chair and Medical Director of NSGO.

"ENGOT with their collaborative clinical trial groups has put a lot of effort to bring this trial to success and this is a great example how today international collaboration between academic groups and industry can benefit patients," said Christian Marth, President of ENGOT.

"We are extremely grateful to the patients, caregivers, and investigators, including our partners at ENGOT, who participated in this trial. The results of this study demonstrate that a single, daily, oral dose of niraparib is superior to control in prolonging PFS in women with recurrent ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "In keeping with our mission of responsible drug development, ENGOT-OV16/NOVA was designed to define those patients most likely to benefit from niraparib treatment and, in so doing, optimize the benefit/risk profile for patients. We believe we have achieved that goal and look forward to our presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress in October."

About the Phase 3 ENGOT-OV16/NOVA Clinical Trial
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that planned to enroll 490 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut). The non-gBRCAmut cohort included patients with HRD-positive tumors, including those with somatic BRCA mutations and other HR defects, and patients with HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS2, overall survival, and other measures of safety and tolerability.

The most common (≥10%) treatment-emergent grade 3/4 adverse events among all patients treated with niraparib were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). Adverse events were generally managed via dose modifications. The discontinuation rate was 14.7% for niraparib treated patients and 2.2% for control.

More information about this trial is available at View Source

Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA or any other regulatory agencies.

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes the Phase 3 trial in patients with ovarian cancer (the NOVA trial) as described above; a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial); and a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial). Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan

Alligator contracts BioInvent for process development and cGMP manufacturing of the immuno-oncology drug candidate ADC-1015

On July 8, 2016 Alligator Bioscience AB is a privately held Swedish biotech company developing immuno-oncology antibodies for tumor-directed immunotherapy (Press release, Alligator Bioscience, JUL 8, 2016, View Source [SID1234538692]). Alligator reported has contracted BioInvent for process development and cGMP manufacturing of the immuno-oncology drug candidate ADC-1015. The agreement will supply Alligator with ADC-1015 Drug Product for early clinical trials.

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Alligator has a strong pipeline consisting of 5 drug candidates. ADC-1013 is an immune activating antibody directed against CD40, developed for treatment of metastatic cancer. Clinical trials in cancer patients were initiated early 2015, and ADC-1013 was later the same year out-licensed to Janssen Biotech, a Johnson & Johnson oncology company. ADC-1015 is a bispecific immune activating antibody that targets OX40 and CTLA-4. Since both OX40 and CTLA-4 are expressed on T cells in the tumor area, ADC-1015 is expected to induce strong tumor-directed immune activation. ADC-1015 has the potential to become first-in-class in this category of immune activating bispecific antibodies. In addition to ADC-1013 and ADC-1015, Alligator has three drug candidates in research phase.

For further information, please contact:

Per Norlén, CEO Alligator Bioscience AB, Office number: +46 46 2864280

PharmaCyte Biotech Uses "Artificial Liver" to Treat Advanced Pancreatic Cancer

On July 7, 2016 PharmaCyte Biotech, Inc. (OTCQB: PMCB) reported that its signature live-cell encapsulation technology, Cell-in-a-Box, is being used in treatments for both cancer and diabetes (Press release, PharmaCyte Biotech, JUL 7, 2016, View Source [SID:1234513760]). For diabetes, the company’s therapy, which is made up of pinhead-sized, porous capsules filled with insulin producing cells, will create an "artificial pancreas" for type 1 diabetics and insulin-dependent type 2 diabetics that no longer produce their own insulin. Meanwhile, for cancer, the company’s therapy is made up of those same pinhead-sized, porous capsules; however, for advanced pancreatic cancer, they’re filled with genetically modified cells that act as a type of "artificial liver."

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First things first, PharmaCyte’s Cell-in-a-Box is not a drug delivery system. There are no drugs encapsulated inside the porous capsules for any of its treatments. Instead, for pancreatic cancer, which we will focus on today, the capsules are filled with about 10,000 live cells that are capable of converting an inactive chemotherapy drug (ifosfamide) into its active cancer-killing form — just as the enzyme system in a patient’s liver would normally do.

Keep in mind that because the chemotherapy drug ifosfamide is a prodrug or an inactive drug, it can travel all over the body and have no effect whatsoever until it is activated in the liver. Knowing that, PharmaCyte is, in a way, moving the "normal" conversion site (the patient’s liver) of that inactive drug closer to the cancerous tumor by using Cell-in-a-Box capsules and the live cells inside them to do the job of the patient’s liver or to act as an "artificial liver."

So how does the treatment work and why is it important to move the conversion site closer to the pancreatic tumor?

First, we will tackle how PharmaCyte’s therapy works.

The encapsulated live cells (Cell-in-a-Box capsules) are placed as close to the patient’s cancerous tumor as possible. Once implanted, ifosfamide, the aforementioned chemotherapy drug that needs to be activated in the body, is given to the patient intravenously at one-third the normal dose. The ifosfamide is then carried by the circulatory system to where the encapsulated cells have been placed. When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells in the Cell-in-a-Box capsules, the chemotherapy drug is activated into its cancer-killing form right at the site of the cancer.

This is "targeted chemotherapy" in the truest sense, and the company’s therapy has proven effective and safe to use in past clinical trials. This is how PharmaCyte will use its therapy in an upcoming Phase 2b clinical trial, so now let’s discuss why it’s important to move the drug activation site closer to the pancreatic tumor in the first place.

There are actually a number of reasons to move the activation site closer to the tumor. We’ll start with the chemotherapy drug itself. Ifosfamide, when activated, has a very short half-life (time before it decays and no longer offers any effect), so by using the cells inside the Cell-in-a-Box capsules to activate the drug at the site of the tumor, ifosfamide can immediately be the most effective when it’s the most potent before dying off minutes later.

Without a treatment like PharmaCyte’s, ifosfamide would be given to the patient intravenously and then activated "normally" in the liver, the activated drug would then affect tissues and organs other than the pancreas, and by the time it reached the pancreas, it undoubtedly would have lost much of its effectiveness. So, this, of course, means to be effective against a pancreatic tumor when the Cell-in-a-Box capsules are not used, a large dose of the drug has to be administered.

Using ifosfamide in such large doses has proven to be damaging for tissues and organs including the patient’s liver, and because the activated drug would come in contact with such other organs and good cells throughout the body on its way to the pancreas, the side effects would be intolerable; in fact, this is known to be the case.

By moving the conversion site as close to the tumor as possible, PharmaCyte is able to give a much smaller dose of the chemotherapy drug (one-third the normal dose), which patients are able to tolerate, and because of the smaller dose, the treatment can be administered without any side effects from the chemotherapy.

That’s right — chemotherapy without any side effects!

Accurexa Files Patent Application for its ACX-31 Brain Cancer Program

On July 7, 2016 Accurexa Inc. (the "Company") (ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain,reported that it filed a new patent application related to its proprietary formulation used in its ACX-31 program (Press release, Accurexa, JUL 7, 2016, View Source [SID1234516519]). Accurexa is developing its ACX-31 program for the local delivery of temozolomide as adjunctive therapy to BCNU, both chemotherapeutics, in the treatment of brain tumors.

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"We are proud that we as an emerging company have the intellectual capability in-house to create new technologies for our brain cancer program. This is our first patent application that we believe has the potential to further protect our brain cancer program in addition to the patent that we licensed from Prof. Brem and his co-inventors at Johns Hopkins University last year. This is our first step of adding internally created technologies to our model of in-licensing of assets and growing our company’s capabilities and assets," said Dr. George Yu, Accurexa’s President & CEO.