On March 20, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that preclinical data for the Company’s anti-PD-L1 monoclonal antibody, has been selected for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held April 1-5, 2017, at the Walter E. Washington Convention Center in Washington, D.C (Press release, TG Therapeutics, MAR 20, 2017, View Source [SID1234518216]). Schedule your 30 min Free 1stOncology Demo! The presentation details are as follows:
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• Title: Preclinical characterization of a novel fully human IgG1 anti-PD-L1 mAb CK-301
Abstract Number: 4606
Date and Time: Tuesday, April 4, 2017, 1:00 PM – 5:00 PM ET
Session: Immunoconjugates and Antibodies
Location: Halls A-C, Poster Section 26
Poster Number: 21
A copy of the above referenced abstract can be viewed online through the AACR (Free AACR Whitepaper) meeting website at www.aacr.org. Following the presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com.
Month: March 2017
Dynavax Announces Upcoming Data Presentations for Three TLR9 Agonist Programs at the 2017 American Association for Cancer Research Annual Meeting
On March 20, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will be presenting data on three programs based on stimulation of the immune response using Toll-Like Receptor 9 (TLR9) agonists at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, D.C. from April 1-5, 2017 (Press release, Dynavax Technologies, MAR 20, 2017, View Source [SID1234518213]). Schedule your 30 min Free 1stOncology Demo! Dynavax is presenting data which summarizes the clinical responses and biomarker assessments from an ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada). The results provide insight into the immune mechanisms underpinning the activity of SD-101 and its effect on the tumor microenvironment.
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Dynavax is also presenting preclinical data demonstrating significant anti-tumor activity of an inhaled TLR9 agonist in mice bearing lung tumors. This treatment highlights the synergy of the TLR9 agonist with anti-PD-1 leading to further reduction of both lung tumor burden and metastases in other organs along with long-term survival of treated mice. These studies provide the rationale for the development of DV281, a TLR9 agonist optimized for aerosol delivery. DV281, in combination with anti-PD-1 therapy, will enter clinical studies in non-small cell lung carcinoma patients later this year.
A third presentation shows that intratumoral vaccination with nanoparticles incorporating tumor antigen peptides and a TLR9 agonist provides anti-tumor immunity superior to conventional subcutaneous vaccination. Direct intratumoral vaccination using this novel vaccine platform and mode of administration significantly increases both the magnitude and functional activity of vaccine-primed cytotoxic T lymphocytes (CTL) and enhances control of metastatic disease.
The details of the poster presentations are as follows:
Pharmacodynamic changes confirm the mechanism of action mediating SD-101 efficacy, in combination with pembrolizumab, in a phase 1b/2 study in metastatic melanoma (MEL-01)
Abstract: LB-239
Category: Late-Breaking Research: Clinical Research 2 / Endocrinology
Date/Time: Tuesday, Apr 4, 1:00 p.m. to 5:00 p.m. ET
Location: Poster section 34; Board number 5
Development of an inhaled TLR9 agonist for the immunotherapy of lung cancer
Abstract: 5741
Category: Clinical Research
Date/Time: Tuesday, Apr 4, 1:00 p.m. to 5:00 p.m. ET
Location: Poster section 30; Board number 12
Intratumoral administration of a TLR9-adjuvanted nanoparticle cancer vaccine stimulates more effective immunity in both injected and un-injected tumor sites compared to subcutaneous administration
Abstract: 6000
Category: Immunology
Date/Time: Wednesday, Apr 5, 8:00 a.m. to 12:00 p.m.
Location: Poster section 24; Board number 28
About SD-101
SD-101 is Dynavax’s proprietary, second-generation, TLR9 agonist CpG-C class oligodeoxynucleotide. SD-101 is being studied for its multiple anti-tumor activities in innate immune cells and activation of plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.
For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.
Bristol-Myers Squibb and CytomX Therapeutics Extend Worldwide Collaboration to Discover Probody™ Therapeutics for the Treatment of Cancer and Other Diseases
On March 20, 2016 Bristol-Myers Squibb Company (NYSE:BMY) and CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported an expansion of their 2014 strategic collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform (Press release, Bristol-Myers Squibb, MAR 20, 2017, View Source [SID1234518212]). Schedule your 30 min Free 1stOncology Demo! Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. By remaining inactive until they are activated by proteases in the tumor microenvironment, Probody therapeutics bind selectively to cells within tumor tissue with reduced binding to healthy tissue, potentially improving or creating a therapeutic window. Probody therapeutics may also have application in other diseases where proteases are dysregulated in affected tissues.
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As part of the original collaboration signed in May 2014 to discover, develop and commercialize Probody therapeutics, Bristol-Myers Squibb selected four oncology targets, including CTLA-4. In the collaboration to date, Bristol-Myers Squibb has progressed the CTLA-4 Probody therapeutic to Investigational New Drug-enabling studies and the three other programs are in the lead discovery and optimization phase.
"CytomX’s Probody platform has enhanced our discovery research as we seek to direct the therapeutic effects of immunotherapy in a more targeted approach against tumors," said Carl Decicco, Ph.D., Head of Discovery, Bristol-Myers Squibb. "We look forward to working more extensively with CytomX on this innovative and potentially disruptive approach in oncology as well as other disease areas."
"This expanded collaboration with Bristol-Myers Squibb gives CytomX the opportunity to further the reach of our potentially transformational Probody technology and provides us with additional financial and strategic flexibility to build our company," said Sean McCarthy, D. Phil., President and Chief Executive Officer. "With CX-072 in Phase 1/2, and CX-2009 approaching clinical studies, our broad wholly-owned pipeline is poised for initial proof of concept as we aim to reinvent therapeutic antibodies."
Under the terms of the agreement, CytomX will grant Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probody therapeutics for up to six additional oncology targets and two non-oncology targets. Bristol-Myers Squibb will make an upfront payment of $200 million to CytomX and, in addition, will provide research funding over the course of the research term. CytomX will also be eligible to receive up to $448 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered royalties from the mid-single digits to low-double digits on net sales of each product commercialized by Bristol-Myers Squibb.
Closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Corvus Pharmaceuticals to Present Data That Advances the Understanding of the Adenosine Pathway in Immuno-Oncology, including New Clinical Data on CPI-444 at AACR 2017
On March 20, 2017 Corvus Pharmaceuticals, Inc. (Nasdaq:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present interim data from its ongoing Phase 1/1b study of CPI-444 as a single agent and in combination with Genentech’s Tecentriq (atezolizumab) in an oral plenary session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017, which is taking place April 1-5 in Washington, D.C (Press release, Corvus Pharmaceuticals, MAR 20, 2017, View Source [SID1234518211]). Schedule your 30 min Free 1stOncology Demo! The Company will also present preclinical and clinical data on CPI-444, as well as preclinical data on its investigational humanized monoclonal anti-CD73 antibody, in poster presentations. In a separate invited oral presentation, CPI-444 will be featured as a novel oral checkpoint inhibitor of adenosine mediated suppression of tumor immunity. The following are details for the six oral and poster presentations. The abstract for the oral plenary session will be available on the AACR (Free AACR Whitepaper) website on March 31 at 4:30 p.m. ET.
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ORAL PRESENTATIONS
ABSTRACT #: CT119
TITLE: CPI-444, an oral adenosine A2a receptor (A2AR) antagonist, demonstrates clinical activity in patients with advanced solid tumors
PRESENTER: Leisha Emens, M.D., Ph.D., associate professor of oncology, John Hopkins Sidney Kimmel Comprehensive Cancer Center
SESSION TYPE: Oral Plenary
PRESENTATION DATE AND TIME: Tuesday, April 4, 10:30 a.m.-12:45 p.m. ET
LOCATION: Ballroom C, Level 3, Washington Convention Center
TITLE: CPI-444 – A Novel Oral Checkpoint Inhibitor of Adenosine Mediated Suppression of Tumor Immunity
PRESENTER: Ian McCaffery, Ph.D., Corvus Pharmaceuticals
SESSION TYPE: Invited Oral
PRESENTATION DATE AND TIME: Saturday, April 1, 3:15-5:15 p.m. ET
LOCATION: Ballroom A-B, Level 3, Washington Convention Center
POSTER PRESENTATIONS
ABSTRACT #: 5593/POSTER #: 25
TITLE: Inhibition of A2AR induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical and clinical studies
PRESENTER: Stephen Willingham, Ph.D., Corvus Pharmaceuticals
PRESENTATION DATE AND TIME: Wednesday, April 5, 8:00 a.m-12:00 p.m. ET
LOCATION: Convention Center, Halls A-C, Poster Section 24
ABSTRACT #: 5598/POSTER #: 30
TITLE: Adenosine signaling through A2AR limits the efficacy of anti-CTLA4 and chemotherapy in preclinical models
PRESENTER: Po Y. Ho, Corvus Pharmaceuticals
PRESENTATION DATE AND TIME: Wednesday, April 5, 8:00 a.m-12:00 p.m. ET
LOCATION: Convention Center, Halls A-C, Poster Section 24
ABSTRACT #: 5579/POSTER #: 11
TITLE: Strategic inhibition of adenosine A2A receptor (A2AR) by CPI-444 improves CD8+:Treg ratios and enhances T-cell killing of a HER-2/neu expressing murine tumor
PRESENTER: Blake A. Scott, Johns Hopkins University School of Medicine
PRESENTATION DATE AND TIME: Wednesday, April 5, 8:00 a.m-12:00 p.m. ET
LOCATION: Convention Center, Halls A-C, Poster Section 24
ABSTRACT #: 5577/POSTER #: 9
TITLE: A novel CD73-blocking antibody reduces production of immunosuppressive adenosine and restores T-cell function
PRESENTING AUTHOR: Emily Piccione, Ph.D., Corvus Pharmaceuticals
PRESENTATION DATE AND TIME: Wednesday, April 5, 8:00 a.m.-12:00 p.m. ET
LOCATION: Convention Center, Halls A-C, Poster Section 24
NantKwest Announces FDA Grant of Orphan Drug Designation for the Company’s aNK Natural Killer Cell Therapy in Merkel Cell Carcinoma
On March 20, 2017 NantKwest, Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported that the FDA has granted Orphan Drug Designation to the company’s activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma (Press release, NantKwest, MAR 20, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2255088 [SID1234518189]).
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NantKwest’s aNK cell therapy is currently in Phase II clinical trials at clinical sites in the United States treating subjects with metastatic or locally advanced Merkel cell carcinoma. This protocol was recently amended to include ALT-803, an IL-15 superagonist therapy that has been shown in preclinical clinical studies to improve the activity of NK cells and will synergistically improve the activity of both NantKwest’s infused aNK cells together with the subject’s own NK cells. The Phase II clinical trial will continue based on this novel drug combination.
The application for Orphan Drug Designation was based in part on data presented at the Annual Society of Immunotherapy (SITC) (Free SITC Whitepaper) meeting in November 2016. At the SITC (Free SITC Whitepaper) meeting, Dr. Shailender Bhatia from the University of Washington, Fred Hutchinson Cancer Research Center in Seattle, WA presented interim data showing that in a heavily pretreated patient population, many previously having been treated with a number of other therapies including checkpoint inhibitors, aNK natural killer cell therapy demonstrated activity in patients who failed multiple lines of therapy including check point inhibitors.
In commenting on the FDA’s grant of Orphan Drug Designation, Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest, said: "We believe the FDA’s award of Orphan Drug Designation together with additional data coming out of our ongoing Merkel cell carcinoma Phase II clinical trial will provide us a solid position to submit to the FDA our plans to transition this study to a pivotal study."
Dr. Soon-Shiong added, "Patients with metastatic or locally advanced Merkel cell carcinoma have an extremely poor prognosis, with less than 20% of patients surviving longer than five years. We are encouraged to see, even in a heavily pretreated patient population, that our aNK natural killer cell therapy has been shown to exhibit encouraging antitumor activity and we look forward to the rapid development of this clinical program as we strive to bring the potential for long-term, durable responses to a broad range of cancer patients in multiple cancer indications."