On May 22, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it has completed the dose escalation part of its ongoing Phase I trial evaluating IPH4102 in patients with relapsed/refractory cutaneous T cell lymphomas (Press release, Innate Pharma, MAY 22, 2017, View Source [SID1234519247]). No dose-limiting toxicity was reported and the maximum tolerated dose (MTD) was not reached. Schedule your 30 min Free 1stOncology Demo! Full dose-escalation safety results, as well as updated clinical activity data, will be disclosed in an oral presentation at the upcoming International Conference on Malignant Lymphoma (ICML), in Lugano, Switzerland on June 14 at 5:30 pm.
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The abstract entitled "Phase I study of IPH4102, anti-KIR3DL2 mab, in relapsed/refractory cutaneous t-cell lymphomas (CTCL): dose-escalation safety, biomarker and clinical activity results" will be available on the ICML online abstract book on June 7.
The cohort expansion part of the trial in patients with transformed mycosis fungoides and Sézary syndrome, with two cohorts of 15 patients, each receiving IPH4102 at the recommended Phase II dose (RP2D) until progression, will start in the upcoming weeks.
Pierre Dodion, Chief Medical Officer of Innate Pharma, commented: "Although CTCL is an orphan disease, the trial has progressed quickly. We are excited by the promising safety profile and efficacy signals of our antibody in this particularly difficult to treat disease. We look forward to the feedback of regulatory authorities on those data and meanwhile are working on the cohort expansion part of the trial which will start shortly."
About IPH4102 Phase I trial:
The Phase I trial (NCT02593045) is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands and United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Leiden, Netherlands), and the Guy’s and St Thomas’ Hospital (London, United Kingdom). 55 patients with advanced CTCL having received at least two prior lines of systemic therapy have been and will be enrolled in two sequential study parts:
The dose-escalation part has accrued 25 KIR3DL2-positive CTCL patients in 10 dose levels. The objective was to characterize IPH4102 safety profile, identify the MTD and/or the RP2D; the dose-escalation followed an accelerated 3+3 design. Preliminary safety and clinical activity results for the first seven dose levels from the dose-escalation part were presented at the 3WCCL and ASH (Free ASH Whitepaper) in 2016;
The cohort expansion part will have 2 cohorts of 15 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression.
Author: [email protected]
LION BIOTECHNOLOGIES ANNOUNCES FIRST PATIENT DOSED IN SECOND COHORT OF LN-144 PHASE 2 TRIAL FOR METASTATIC MELANOMA
On May 19, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the first patient was dosed in the second cohort of its ongoing Phase 2 trial of LN-144 for the treatment of patients with metastatic melanoma (Press release, Lion Biotechnologies, MAY 19, 2017, View Source [SID1234519274]). This cohort utilizes the company’s generation 2 manufacturing process which includes cryopreservation of the outbound products.
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"We are pleased to be able to offer a shorter manufacturing process for TIL to the melanoma patients enrolling in Cohort 2 of LN-144 trial. This process reduces the time from excision to infusion from approximately six weeks to just over three weeks and includes cryopreservation for the outbound product," said Maria Fardis, PhD, MBA, Lion Biotechnologies President and Chief Executive Officer. "Reducing the time from excision to infusion is critical for treatment of advanced melanoma patients. This process provides greater flexibility for physicians and patients in scheduling the time of the infusion due to the cryopreserved nature of the TIL product. Further, the shorter process increases the manufacturing flexibility for Lion leading to lower production costs."
This Phase 2, multicenter, three-cohort study will assess the safety and efficacy of LN-144 for treatment of patients with metastatic melanoma. Cohorts one and two will enroll 20 patients each and cohort three is a re-treatment cohort for a second LN-144 infusion in ten patients. Lion Biotechnologies will be releasing interim data from the first cohort of this study at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6 in Chicago, IL. For additional information on this study please go click on the link below:
View Source;rank=1
AVEO Oncology Announces Completion of a CHMP Oral Explanation for Tivozanib as a Treatment of First-Line Renal Cell Carcinoma
On May 19, 2017 AVEO Oncology (NASDAQ:AVEO) reported its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC) (Press release, AVEO, MAY 19, 2017, View Source;p=RssLanding&cat=news&id=2274241 [SID1234519231]). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting.
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"We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for tivozanib," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib’s unique tolerability profile, together with the longest progression free survival from a Phase 3 first line RCC study, demonstrates its potential to enhance treatment options for RCC patients."
RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the gold standard treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
Cellular Biomedicine Group (CBMG) Announces Publication Titled “Target cell killing effects of CD20 targeting chimeric antigen receptor T cells derived from the type II anti-CD20 antibody” in Conjunction with 2017 ASCO Annual Meeting
On May 19, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the publication of an abstract exploring the application of B-cell antigen, CD20, for targeted Chimeric Antigen Receptor T cells (CAR-T) therapy . The abstract has been published in conjunction with the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2 – 6, 2017. Schedule your 30 min Free 1stOncology Demo!
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Abstract e14548, J Clin Oncol 35, 2017 – Target cell killing effects of CD20 targeting chimeric antigen receptor T cells derived from the type II anti-CD20 antibody.
The complete text of the abstract can be found at View Source
TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 14th International Conference on Malignant Lymphoma
On May 19, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 14th International Conference on Malignant Lymphoma (ICML), to be held from June 14 – 17, 2017, in Lugano, Switzerland (Press release, TG Therapeutics, MAY 19, 2017, View Source [SID1234519241]). Schedule your 30 min Free 1stOncology Demo! Details of the data presentations are outlined below.
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Oral Presentations:
Title: Updated results of a multicenter phase I/Ib study of TGR-1202 in combination with ibrutinib in patients with relapsed or refractory MCL or CLL
Abstract Number: 040
Presentation Date & Time: Wednesday, June 14, 2017 17:50 CEST
Session Title: Chemotherapy-Free Combinations
Presenter: Matthew S. Davids, MD, Dana-Farber Cancer Institute
Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
Abstract Number: 101
Presentation Date & Time: Friday, June 16, 2017 11:20 CEST
Session Title: Session 7 – Advances in CLL
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Abramson Cancer Center
Title: Chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib is well tolerated and highly active in patients with advanced CLL and NHL
Abstract Number: 102
Presentation Date & Time: Friday, June 16, 2017 11:35 CEST
Session Title: Session 7 – Advances in CLL
Presenter: Loretta J. Nastoupil, MD, MD Anderson Cancer Center
In addition to the above oral presentations, a poster titled "Combination of TGR-1202, Ublituximab, and Bendamustine is safe and highly active in patients with advanced DLBCL and Follicular Lymphoma" has been accepted for poster presentation during the conference. Additional details on this presentation will be available in June.
The above abstracts will be included in the Abstract Book available online on Wednesday, June 7, 2017 through the ICML meeting website at www.lymphcon.ch. 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.