On July 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS) (Press release, CytRx, JUL 11, 2016, View Source;p=RssLanding&cat=news&id=2184496 [SID:1234513826]).

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In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events. Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed. This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.

For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator’s choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

"While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma," said Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin’s potential in this very challenging disease."

Treatment-related adverse events for aldoxorubicin were consistent with those observed in prior studies. Aldoxorubicin was not associated with clinically significant cardiac, kidney or liver toxicities. The Company plans to present updated results of the study at an upcoming medical meeting.

"The complexity, in terms of tumor diversity and primary location, makes soft tissue sarcoma extremely difficult to treat, especially in the relapsed and refractory setting, resulting in few treatment advances over the last four decades," said Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer of CytRx. "This first-of-its-kind study in STS included a comparator arm with multiple regimens, allowing for treatments to be matched to specific sarcoma subtypes. Despite a requirement for this challenging study design, aldoxorubicin demonstrated markedly greater activity over investigator’s choice therapy. That said, the unforeseen clinical hold that interrupted this study impacted the outcome of the current evaluation, underscoring a need for a subsequent analysis."

"In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of our global Phase 2b trial of aldoxorubicin in small cell lung cancer. We are deeply grateful for the continued support and commitment of the patients, their families, the investigators and clinical support professionals participating in the Phase 3 trial."

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.

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

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

On July 07, 2016 Heat Biologics, Inc. (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that a preclinical study on its next generation ComPACT platform technology, which combines a T cell priming vaccine and T cell co-stimulator in a single product, was published online in the journal "Cancer Immunology Research (Press release, Heat Biologics, JUL 7, 2016, View Source [SID:1234513758])." In the manuscript titled "Gp96-Ig/costimulator (OX40L, ICOSL or 4-1BBL) combination vaccine improves T-cell priming and enhances immunity, memory and tumor elimination," Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection in two cancer tumor types (melanoma and colorectal cancer) compared to OX40 agonist antibody treatment. Heat also reported that ComPACT enhanced antigen-specific T cell infiltration into tumors, improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments. In addition, the findings also showed that the ComPACT platform can be adapted to secrete other costimulatory molecules, including TL1A, 4-1BBL and ICOSL.

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"We are pleased to have our work published in ‘Cancer Immunology Research.’ These data suggest that local vaccine co-stimulation has compelling advantages compared to systemic antibody co-stimulation," said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "This combination platform provides flexibility to deliver multiple costimulatory ligands, which appear to outperform agonist antibodies in terms of immune response and tumor rejection, warranting further study in human clinical trials."