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Onconova Announces Data Presentation From Phase 2 Combination Trial of Oral Rigosertib and Azacitidine at the 2015 ASH Annual Meeting

On November 05, 2015 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that an abstract relating to the Company’s Phase 2 clinical trial of oral rigosertib and azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) and acute myeloid leukemia (AML) has been selected for oral presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, which takes place December 5-8, 2015 (Press release, Onconova, NOV 5, 2015, View Source [SID:1234508013]).

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Details for the presentation are listed below.

Abstract Number: 910
Title: A Phase II Study of the Combination of Oral Rigosertib and Azacitidine in Patients with Myelodysplastic Syndromes (MDS)
Session Name: 637. Myelodysplastic Syndromes — Clinical Studies I
Date: Monday, December 7, 2015
Presentation Time: 7:00 PM EST
Location: Orange County Convention Center, W311ABCD
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

MEI Pharma Highlights New Data from Phase II Clinical Studies of Pracinostat in Acute Myeloid Leukemia and Myelodysplastic Syndrome

On November 5, 2015 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported the publication of new data from the Company’s Phase II clinical studies of the investigational drug Pracinostat in patients with previously untreated myelodysplastic syndrome (MDS) and elderly patients with acute myeloid leukemia (AML) (Press release, MEI Pharma, NOV 5, 2015, View Source [SID:1234508012]). Results from these studies were recently selected for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando on December 7, 2015. The abstracts are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

(Logo – http: /photos.prnewswire.com/prnh/20140805/133834)

"The data contained within the abstracts released this morning point to certain trends worth highlighting," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Since the unblinding of our randomized study in front-line MDS, we have learned that the combination of Pracinostat and azacitidine resulted in a high rate of discontinuations due to adverse events compared to azacitidine alone. These discontinuations occurred predominantly within the first two cycles of treatment and often before a response assessment could be performed, leading to a higher complete response (CR) rate overall with azacitidine alone. However, exploratory sensitivity analyses among patients who were able to tolerate treatment for at least four cycles (n=54) suggest that patients treated with Pracinostat plus azacitidine appear to derive benefit compared to azacitidine alone, with hazard ratios for progression progression-free survival (0.37), event-free survival (0.33) and overall survival (0.59) all favoring the Pracinostat plus azacitidine arm.

"The data from our open-label study in elderly patients with newly diagnosed AML," continued Dr. Gold, "demonstrate that many patients are achieving responses within the first two cycles and continue to improve with ongoing therapy, with fewer discontinuations due to adverse events than in our MDS study. Overall, 54% of patients (27 of 50) have achieved a clinical response with 42% (21 of 50) achieving a CR. The 60-day mortality rate in the study is 10% (5 of 50) and the one-year survival rate is estimated at 60%. All of these data points compare favorably to a recent study of azacitidine alone in this population1. Median overall survival, the most important measure in determining the development path forward for this combination, still has not been reached. We will continue to follow these patients and look forward to the presentation of updated overall survival data at ASH (Free ASH Whitepaper) next month."

The data contained within the abstracts listed below are as of the ASH (Free ASH Whitepaper) submission deadline on August 4, 2015. In accordance with ASH (Free ASH Whitepaper) policies, information that goes beyond that which is contained within these abstracts is embargoed until their presentation on December 7, 2015.

Title: Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (Abstract #453)
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Advances in Therapy
Session Date: Monday, December 7, 2015
Session Time: 7:00 AM – 8:30 AM
Presentation Time: 7:30 AM

Title: A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine in Patients with Previously Untreated Myelodysplastic Syndrome (Abstract #911)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies I
Session Date: Monday, December 7, 2015
Session Time: 6:15 PM – 7:45 PM
Presentation Time: 7:15 PM

About Pracinostat

Pracinostat is an orally available inhibitor of a group of enzymes called histone deacetylases, or HDACs. HDACs belong to a larger set of proteins collectively known as epigenetic regulators that can alter gene expression by chemically modifying DNA or its associated chromosomal proteins. Abnormal activity of these regulators is believed to play an important role in cancer and other diseases. Pracinostat has been tested in multiple Phase I and Phase II clinical studies in advanced hematologic diseases and solid tumor indications. The results of these studies suggest that Pracinostat has potential best-in-class pharmacokinetic properties when compared to other oral HDAC inhibitors, with side effects often associated with drugs of this class, including fatigue and myelofibrosis. Pracinostat has not been approved for commercial distribution in the U.S.

Idera Pharmaceuticals to Present Phase 1/2 IMO-8400 Clinical Data in Waldenstrom’s Macroglobulinemia at the 2015 American Society of Hematology Annual Meeting

On November 05, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, reported that new data from the Phase 1/2 clinical trial for IMO-8400, a TLR 7,8 and 9 antagonist, being evaluated for the treatment of relapsed, refractory patients suffering from Waldenström’s Macroglobulinemia, will be presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, FL, December 5-8, 2015 (Press release, Idera Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107366 [SID:1234508011]).

The open-label, dose-ranging clinical trial included three dose-escalating cohorts on IMO-8400 and enrolled 19 patients, who were relapsed or refractory to prior therapies. Data from these 19 patients will be presented at the ASH (Free ASH Whitepaper) Meeting.

"The presentation of the clinical safety and efficacy data from our IMO-8400 study in Waldenström’s Macroglobulinemia is a positive step forward for our company, for our clinical aspirations in cancer care and for the role of Toll-Like Receptors as a therapeutic option for patients suffering from B-cell Lymphomas," stated Vincent Milano, Idera’s Chief Executive Officer. "We look forward to presenting the data next month at the ASH (Free ASH Whitepaper) conference and beginning to elucidate the path forward for IMO-8400 beyond this first clinical study."

Poster Presentation

Date: Saturday, December 5, 2015, Presentation Time: 5:30 PM ET – 7:30 PM ET
Session Title: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Publication Number: 1540
Presentation Title: Preliminary Results from a Phase 1/2 Open-Label, Dose-Escalation Clinical Trial of IMO-8400 in Patients with Relapsed or Refractory Waldenström’s Macrogloblulinemia
Location: Orange County Convention Center, Hall A

Idera Pharmaceuticals Presents Preclinical Data Demonstrating Potent Anti-Tumor Response From Combination Treatment With Intra-Tumoral IMO-2125 and Anti-PD-1 Monoclonal Antibody at AACR-NCI-EORTC International Conference

On November 5, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, reported new preclinical data demonstrating potent and systemic anti-tumor activity in preclinical cancer models with intra-tumoral administration of IMO-2125 in combination with an anti-PD-1 monoclonal antibody (mAb) (Press release, Idera Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107416 [SID:1234508010]). IMO-2125 is a synthetic oligonucleotide-based agonist of Toll-like receptor 9 discovered and developed by Idera. There are currently two anti-PD-1 antibodies that have been recently approved for the treatment of melanoma and non-small lung cancer. These data are being presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, beginning today.

"The emerging data on preclinical studies with IMO-2125 is continuing to expand the potential of IMO-2125 in immunotherapy of cancer. This data is helping guide our strategic direction for the clinical development of the program in terms of understanding the right combinations and tumor targets," stated Sudhir Agrawal, D.Phil., President of Research at Idera Pharmaceuticals. "The data we have assembled to date both in-house and through our academic collaboration clearly demonstrates the impact that intra-tumoral administration of IMO-2125 is having on the tumor microenvironment and the resulting anti-tumor activity both in treated and distant tumors."

In the presentation, entitled "Intra-tumoral administration of IMO-2125, a novel TLR9 agonist, modulates tumor microenvironment and potentiates antitumor activity of anti-PD-1 (mAb) in a murine colon carcinoma model," Idera scientists presented data providing evidence that intra-tumoral IMO-2125 administration changes the tumor microenvironment by increasing infiltration of tumor-infiltrating lymphocytes (TILs) and by modulating gene expression of multiple checkpoints, including PD-L1. In the study, treatment with a combination of intra-tumoral IMO-2125 with anti-PD-1 antibody showed more potent anti-tumor activity than either agent alone, with potent anti-tumor activity observed on treated as well as distant tumors. Additionally, increased infiltration levels of TILs and increased PD-L1 and other checkpoint expression was observed in both treated and distant tumors.

Idera expects to initiate the first clinical study of intra-tumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma in the fourth quarter of this year as part of the previously announced clinical research alliance with MD Anderson Cancer Center.

The presentation is currently available on Idera’s website at View Source

About Toll-like Receptors and Idera’s Immuno-Oncology Research Program

Toll-like receptors (TLRs) are key components of the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. To further potentiate the efficacy of checkpoint inhibitor therapy, intra-tumoral administration of a TLR9 agonist may create a beneficial tumor microenvironment by increasing the tumor-infiltrating lymphocytes (TILs) in both the injected tumor and distant tumors.

Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company’s proprietary chemistry-based discovery platform. IMO-2125 has been shown to activate dendritic cells and induce interferon and other cytokines. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. In preclinical studies in cancer models, IMO-2125 has shown dose-dependent anti-tumor activity in the injected tumor as well as in distant tumors. Anti-tumor activity is associated with changes in the tumor microenvironment, increased T-cell infiltration, and modulation of various checkpoints. In combination with anti-CTLA4 and anti-PD1, IMO-2125 has shown greater anti-tumor activity than with either agent alone.

First Patient Dosed in Clinical Trial of Halozyme Investigational Drug PEGPH20 in Combination With Merck Immuno-oncology Drug KEYTRUDA

On November 5, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the first patient has received its investigational new drug, PEGPH20 in combination with Merck’s KEYTRUDA (pembrolizumab) in a clinical trial to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies (Press release, Halozyme, NOV 5, 2015, View Source [SID:1234508009]).

The Halozyme sponsored Phase 1b study is being conducted at a number of leading sites in the U.S., and is evaluating patients with advanced non-small cell lung and gastric cancers.

Following an initial dose escalation portion to determine the maximum tolerated dose of PEGPH20 in combination with KEYTRUDA, the study will be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents, like KEYTRUDA. PEGPH20 degrades HA, reducing tumor pressure and increasing blood flow to treat the tumor.

During the expansion portion, the study seeks to enroll approximately 50 patients with high HA tumors who have relapsed or refractory stage IIIB/IV non-small cell lung cancer treated with at least one platinum-based regimen, or who have recurrent locally advanced/metastatic gastric adenocarcinoma who are also PDL-1 positive and have failed at least one chemotherapy regimen.

"Our goal is to make a difference in the lives of patients, and that starts by studying the safety, tolerability and efficacy of PEGPH20 in a broad range of tumor types and in combination with a broad range of therapeutic agents," said Dr. Helen Torley, president and CEO of Halozyme. "With this study, we see an opportunity to expand the potential benefits of immunotherapy through the novel combination of KEYTRUDA and PEGPH20, targeting two of the most difficult to treat cancers."

For information on Keytruda, please go to keytruda.com.

About PEGPH20

PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.