1stOncology™: Cancer Intelligence Service – Page 14477 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Constellation Pharmaceuticals Announces Initiation of Phase 1b/2 Study of CPI-1205

On January 16, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research and development in cancer epigenetics, reported it has initiated a Phase 1b/2 clinical trial to evaluate CPI-1205, a small-molecule inhibitor of Enhancer of Zeste Homolog 2 (EZH2), combined with checkpoint inhibitor ipilimumab (marketed as YERVOY by Bristol-Myers Squibb) and potentially other cancer immunotherapies (Press release, Constellation Pharmaceuticals, JAN 16, 2018, View Source [SID1234523138]). The study, named ORIOn-E, is based on translational insights which identified combination approaches using epigenetics-mediated mechanisms aimed at Overcoming Resistance to Immune Oncology therapies by inhibiting EZH2.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"This is the second combination study we’ve initiated evaluating the potential for CPI-1205 to overcome resistance mechanisms to existing cancer therapies," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "Our preclinical results with CPI-1205 demonstrate that epigenetic targets can be utilized by cancers to suppress the immune system and render immunotherapy treatment options less effective. We aim to build on this insight with CPI-1205 in clinical trials and with other epigenetic therapies that we discover and develop in this important area of research."

CPI-1205 is a potent, highly selective, first-generation small-molecule inhibitor of an enzyme called EZH2. In pre-clinical studies, CPI-1205 has shown potential to re-wire T regulatory and T effector cells within tumors to enhance tumor rejection alone and synergistically in combination with immune checkpoint inhibition.

"Since they were first made available in the U.S., checkpoint inhibitor therapies like ipilimumab have provided considerable benefit for patients with many different cancers. However, many patients do not respond to therapy or relapse after initial response," said Adrian Senderowicz, M.D., senior vice president and chief medical officer of Constellation Pharmaceuticals. "CPI-1205 plays a critical role in inhibiting the suppressive function of regulatory T cells and consequently may address resistance mechanisms that limit the benefit of immune checkpoint inhibitors in patients."

The Phase 1b portion is a dose escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and the assessment of potential predictive biomarkers in patients across solid tumors when treated with CPI-1205 in combination with ipilimumab. The Phase 2 portion will be conducted in melanoma patients, among other cancers.

About CPI-1205
CPI-1205 is a therapeutic candidate from Constellation Pharmaceuticals’ EZH2 portfolio and is an inhibitor of Enhancer of Zeste Homolog 2 (EZH2). The function of EZH2 is to selectively suppress gene expression of several pro-cancer pathways that contribute to drug resistance.

Athenex Receives Positive Feedback from FDA on the Design of Phase III Clinical Trial for Oraxol

On January 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the United States Food and Drug Administration ("FDA") has provided positive feedback on the design of the currently ongoing Phase III Clinical Trial for Oraxol, an innovative oral formulation of paclitaxel combined with HM30181A (a novel P-gp inhibitor) (Press release, Athenex, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326701 [SID1234523137]). Specifically, the FDA indicated that if the study meets the primary endpoint with an acceptable Benefit/Risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States.

The Oraxol Phase III clinical study (KX-ORAX-001) is a randomized controlled international clinical trial investigating the superiority of Oraxol over intravenous ("IV") paclitaxel in the treatment of patients with metastatic breast cancer. The primary endpoint is confirmed tumor response rate assessed by a blinded independent radiologic imaging analysis center using the RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. The study has a target sample size of 360 patients. The study has completed the first of two planned interim analyses. The second interim analysis based on 180 evaluable patients is planned for the middle of 2018. The positive US FDA feedback would allow an Oraxol US registration submission upon successful completion of this single Phase III study.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "This positive feedback from the U.S. FDA is an important step in bringing Oraxol closer to the doctors and patients. Our Phase III trial also recently received the unanimous recommendation to continue by an independent Data and Safety Monitoring Board. The recommendation was based on the positive overall response rate of Oraxol and the very low incidence of neuropathy, which is a severe dose-limiting side-effect of IV paclitaxel."

Dr. Johnson Lau, Athenex’s Chief Executive Officer, added, "We are delighted with the positive feedback from the FDA on the Phase III Clinical Study Design for Oraxol, which provides further validation of our regulatory pathway for Oraxol. With the recent allowance of the Oraxol Investigational New Drug application in China and the receipt of the Promising Innovative Medicine designation from the United Kingdom Medicines and Healthcare products Regulatory Agency, we continue to advance towards our goal of improving the lives of cancer patients worldwide."

Athenex previously announced that the Data and Safety Monitoring Board unanimously recommended the continuation of its Phase III clinical trial comparing Oraxol versus IV paclitaxel in the treatment of metastatic breast cancer after the interim analysis of the first 90 patients on October 5, 2017. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018, enabling Athenex to initiate clinical studies in China.

Oncolytics Biotech® Announces Abstract for Poster Presentation at the 2018 Gastrointestinal Cancers Symposium Sponsored by ASCO in Patients with Relapsed
Metastatic Adenocarcinoma of the Pancreas

On January 16, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn "cold" tumors "hot", reported that the abstract relating to the previously announced poster presentation highlighting results from the REO 024 study was published by the 2018 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) (Presentation, Oncolytics Biotech, JAN 16, 2018, View Source [SID1234523193]). The conference takes place January 18 – 20, 2018, in San Francisco.

The poster presentation by Dr. Devalingam Mahalingam, M.D. Ph.D., Associate Professor of Medicine (Hematology and Oncology) at the Feinberg School of Medicine, Northwestern University, will present full details from the study evaluating intravenous administration of pelareorep in combination with pembrolizumab (KEYTRUDA) and chemotherapy in patients with advanced or metastatic pancreatic adenocarcinoma, including safety, efficacy and biomarkers evaluating the inflammatory phenotype.

The abstract outlines five efficacy evaluable patients, including one that had partial response lasting 13.8 months and two with stable disease of 126 days and 277 days. The abstract also demonstrates manageable safety profiles and antitumor activity in previously treated patients with metastatic or advanced pancreatic adenocarcinoma. Furthermore, on-treatment biopsies show reovirus infection in cancer cells and immune infiltrates demonstrating the viruses ability to create a pro-inflammatory phenotype in treated tumors.

Abstract number:
283
Title:
A study of pelareorep in combination with pembrolizumab and chemotherapy in patients (pts) with relapsed metastatic adenocarcinoma of the pancreas (MAP)
Poster Session:
Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time:
January 19, 11:30 a.m. – 1:00 p.m.; 5:30 – 6:30 p.m.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

MediciNova to Present at the 98th Annual Meeting of the Chemical Society of Japan

On January 16, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova has accepted an invitation to present at the 98th Annual Meeting of the Chemical Society of Japan to be held in Funabashi-city, Chiba in Japan (Press release, MediciNova, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326908 [SID1234523151]). The presentation entitled "Drug Repositioning: An Experience at MediciNova" will be presented by Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.

Presentation details are as follows:

Session Date and Time: March 21, 2018, 3:00 – 3:30 pm.

Session Title: Advanced Technology Program

Location: Nihon University, Funabashi City, Chiba, Japan

Innovation Pharmaceuticals Presents at 2018 Biotech Conference; Oral Mucositis Drug Candidate Garners Exceptional Interest After Successful Phase 2 Trial

On January 16, 2018 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported shareholders of a productive appearance by Innovation last week at leading health care meetings held in San Francisco, with an audio file of the Biotech Showcase presentation now available on the Company website (Press release, Innovation Pharmaceuticals, JAN 16, 2018, View Source [SID1234523142]).

Interest in the Brilacidin Franchise—based on the breadth of its treatment potential—was notable. Strong momentum gained as a result of Brilacidin’s recent positive topline findings seen in both Inflammatory Bowel Disease (IBD) and Oral Mucositis (OM), coupled with previously successful results achieved in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), has delivered a complementary cross-indication scientific anchoring for each Brilacidin indication in the Company’s pipeline.

In particular, Brilacidin-OM received an exceptional degree of attention at the San Francisco shows, further adding to an already robust partnering matrix. Innovation is developing Brilacidin-OM under a FDA Fast Track designation as a novel therapeutic and recently met the primary endpoint in a Phase 2 trial for preventing severe OM as well as a key secondary endpoint by delaying the onset of severe OM. Brilacidin has effectively earned a leadership position as an easily-delivered oral rinse drug candidate in OM—what many analysts predict will become a $1 billion market opportunity within the next few years.

"What must be stressed is that Brilacidin is a mature, later-stage drug candidate with platform potential. It took the recent completion of two Phase 2 trials, in IBD and OM, to further validate the exceptional results achieved from our Phase 2b study in ABSSSI. These recent data, taken in aggregate, are what various actively engaged pharmaceutical companies have desired from us for some time—and they are what triggered a newfound flurry of inbound partnership discussions at the San Francisco conferences," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Datasets now in hand, reflecting three successfully completed Phase 2 studies across which multiple endpoints were met, have brought the Company to an important inflection point regarding Brilacidin. In coming weeks, we look forward to advancing these discussions with attractive partnership / licensing scenarios, towards determining the best path forward for the Company and its loyal shareholders."

Biotech Showcase Event Recording

An audio file of the Corporate Overview given at 2018 Biotech Showcase, on January 8, in San Francisco, is now available and accessible on the Events and Presentations section of the Company’s website.

Brilacidin-OM (Phase 2 Trial Completed)

As announced earlier, the Company has completed a Phase 2 randomized, double-blind, placebo-controlled trial (see NCT02324335) evaluating Brilacidin’s ability, administered as an oral rinse, to prevent and attenuate OM in patients with Head and Neck Cancer (HNC) receiving chemoradiation with at least 55 Gy across 7 weeks. The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of severe OM (SOM) (WHO Grade ≥ 3) compared to placebo. A key secondary endpoint in the trial, delaying the onset of SOM, also was met. The Company has begun exploring patient-friendly improvements to drug delivery (the use of sachets) and will be meeting with the FDA to determine next steps in the clinical development of Brilacidin-OM. Patents for Brilacidin-OM have also been granted globally, most recently in Europe. Worldwide, the potential market for OM, largely untapped, is estimated to be in excess of $1 billion, with the Company considered a top contender in this space.