On May 23, 2016 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and The University of Texas MD Anderson Cancer Center reported the formation of a strategic alliance to discover and develop novel cancer therapeutics (Press release, Ionis Pharmaceuticals, MAY 23, 2016, View Source [SID:1234512670]). Schedule your 30 min Free 1stOncology Demo! Combining advances made with Ionis’ antisense technology, which provides enhanced potency for effectively engaging targets in solid and liquid tumors, with MD Anderson’s expertise will allow Ionis and MD Anderson to develop novel therapeutic strategies to treat patients with a variety of cancers.
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!
"MD Anderson is dedicated to accelerating the end of cancer. As part of our Moon Shots Program, we identified many new, traditionally undruggable cancer targets, which could offer a potentially fresh approach to treating cancer," said Gordon Mills, M.D., Ph.D., chair, systems biology at MD Anderson. "This collaboration allows our experts to take advantage of a novel technology capable of targeting undruggable targets that we believe will add to our ability to develop therapeutic strategies that will transform patient outcomes."
Mills is co-leader of the Breast and Ovarian Cancer Moon Shot, one of 12 in MD Anderson’s effort to reduce cancer deaths by accelerating conversion of scientific discoveries into new therapies, prevention approaches and early detection.
"MD Anderson has undertaken groundbreaking work in identifying novel cancer targets and building pre-clinical cancer models that will streamline our collective drug discovery efforts. Their genetically defined patient populations should greatly shorten the overall development timelines and enhance our drug discovery efforts as we move our programs forward," said Brett Monia, senior vice president, antisense drug discovery at Ionis Pharmaceuticals. "Our Generation 2.5 chemistry coupled with the expertise of a world leading cancer center, like MD Anderson, will drive our oncology drug development program and pipeline."
In the collaboration, Ionis and MD Anderson will work together to validate novel undruggable cancer targets selected based on human genomic data. Ionis will lead the drug discovery efforts against mutually agreed upon novel targets and MD Anderson will lead development activities through clinical proof of concept. Following clinical proof of concept, Ionis and MD Anderson plan to identify a partner to complete development and to commercialize each drug with Ionis leading business development efforts.
"We are excited to have MD Anderson as a strategic partner for our cancer franchise. This alliance allows Ionis and MD Anderson to combine their collective expertise and resources to identify and ultimately develop novel anti-cancer drugs," said Sarah Boyce, chief business officer at Ionis Pharmaceuticals. "This alliance enables Ionis and MD Anderson to focus on their respective areas of expertise, thereby facilitating rapid progress in moving each drug through the clinic. We believe this collaboration has the opportunity to create novel therapeutic agents that can provide great benefit for cancer patients."
Month: May 2016
TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 21st European Hematology Association Annual Congress
On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Press release, TG Therapeutics, MAY 20, 2016, View Source [SID:1234512627]).
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!
Presentations Include:
Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA
Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY
Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA
A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.
8-K – Current report
On May 20, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark (Filing, 8-K, TNI BioTech, MAY 20, 2016, View Source [SID:1234512626]).
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!
Presentations Include:
Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P207
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA
Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: P315
Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
Location: Poster Hall H
Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY
Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
Abstract Number: E1053
E-poster Presentation
Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA
A copy of the EHA (Free EHA Whitepaper) abstracts were made available yesterday, May 19, 2016 through the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.
Horizon Pharma plc to Acquire Worldwide Rights to Interferon Gamma-1b From Boehringer Ingelheim International GmbH
On May 19, 2016 Horizon Pharma plc (NASDAQ: HZNP) ("Horizon Pharma"), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, reported that its affiliate has entered into a definitive agreement with Boehringer Ingelheim International GmbH ("Boehringer Ingelheim") to acquire the rights to interferon gamma-1b, which Boehringer Ingelheim commercializes under the trade names IMUKIN, IMUKINE, IMMUKIN and IMMUKINE in an estimated 30 countries primarily in Europe and the Middle East (Press release, Horizon Pharma, MAY 19, 2016, View Source [SID:1234514863]).
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!
"Obtaining worldwide rights for interferon gamma-1b solidifies our continued investment in the medicine, and pending the outcome of clinical studies investigating it in Friedreich’s ataxia and advanced solid tumors, such as kidney and bladder cancer, strengthens our ability to expand its potential global use," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.
Under the terms of the agreement, Horizon Pharma paid Boehringer Ingelheim EUR 5 million upon signing and will pay EUR 20 million upon closing for the rights for interferon gamma-1b in all territories outside of the United States, Canada and Japan. Horizon Pharma and Boehringer Ingelheim expect to close the transaction by year-end 2016, subject to the satisfaction of closing conditions.
Under the terms of a separate agreement with an undisclosed third party, Horizon Pharma also licensed the U.S., European and Canadian intellectual property rights for interferon gamma-1b for the treatment of Friedreich’s ataxia. Interferon gamma-1b is currently not indicated or approved for the treatment of Friedreich’s ataxia.
On May 5, 2016, the Company announced that it completed target enrollment of 90 patients in the Phase 3, randomized, double-blind, placebo controlled STEADFAST study evaluating ACTIMMUNE in patients with Friedreich’s ataxia. Top-line results from the trial are expected by the end of 2016.
As a result of the agreement with Boehringer Ingelheim, Horizon Pharma will immediately begin investing in related manufacturing, supply chain, regulatory and commercial activities for interferon gamma-1b. As a result, the Company anticipates a reduction to 2016 adjusted EBITDA of approximately $10 million versus prior guidance.
8-K – Current report
On May 19, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster discussion presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 3-7, 2016 in Chicago, IL (Filing, 8-K, Bio-Path Holdings, MAY 19, 2016, View Source [SID:1234512709]). Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.
Details for the poster presentation are as follows:
Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)
. Dr. Maro Ohanian, Assistant Professor at the University of Texas MD Anderson Cancer Center will present data from the Company’s completed Phase I clinical trial and from the safety segment of the Phase II trial of BP1001 in combination with low-dose cytarabine (LDAC), including initial efficacy results. Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition.
Details for the poster presentation are as follows:
Date: Monday, June 6, 2016
Presentation Time: 8:00 am – 12:45 pm Central Time
Location: Hall A, McCormick Place
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7010
Title: "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies" (Link to abstract)
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!