On June 8, 2017 AVEO Oncology (NASDAQ:AVEO) reported that its Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in subjects with advanced renal cell carcinoma (RCC) has progressed to the Phase 2 portion of the trial (Press release, AVEO, JUN 8, 2017, View Source [SID1234519472]). Schedule your 30 min Free 1stOncology Demo! Advancement of the study into the Phase 2 expansion follows the successful completion of the Phase 1 dose escalation portion of the trial, where tivozanib was administered in two escalating dose cohorts in combination with nivolumab at a constant 240 mg every 2 weeks (n=6). The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The full dose tivozanib regimen of 1.5 mg daily for 21 days, followed by a 7 day rest period, is the recommended Phase 2 dose (RP2D) for the expansion portion of the trial, which is expected to enroll up to an additional 20 subjects. The TiNivo study is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. Phase 1 results from the ongoing study will be submitted for presentation at an upcoming scientific meeting.
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"The promise of delivering synergistic activity by combining VEGF TKIs and PD-1s in renal cell carcinoma hinges on the tolerability of the combination," said Dr. Escudier. "Tivozanib has a uniquely favorable tolerability profile as demonstrated in past single agent and combination studies. These initial results are very promising in that we see both evidence of a uniquely tolerable combination as well as early and meaningful activity. I look forward to enrolling the expansion cohort and to establishing a broader understanding for the potential of this compelling combination."
"Together with the longest progression free survival from a Phase 3 first line RCC study, tivozanib’s tolerability is distinct from other VEGF TKIs, which we believe better position it for use in combination with immunotherapy and other agents," said Michael Bailey, president and chief executive officer of AVEO. "As our registration strategy for single agent tivozanib reaches key inflection points, with a European regulatory decision expected in the near-term and readout of our US registration-directed TIVO-3 study expected in the first quarter of 2018, our attention is increasing on tivozanib immuno-oncology combinations that have the potential to deliver significantly improved outcomes and tolerability to patients. The TiNivo trial is an important first step in this effort, and we share Dr. Escudier’s enthusiasm for the completion of this trial."
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.a
Month: June 2017
Midatech signs global license agreement to investigate panobinostat for treatment of brain cancers
On June 7, 2017 Midatech Pharma (AIM: MTPH; Nasdaq: MTP), the international specialty pharmaceutical company focused on commercialising and developing products in oncology, reported that it has signed a global licensing agreement with Novartis for the oncology compound panobinostat. Panobinostat will be developed by Midatech for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG) as a continuation of its existing MTX110 program, and potentially for Glioblastoma (GBM) (Press release, Midatech Pharma, JUN 7, 2017, View Source [SID1234519676]).
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In pre-clinical test models, panobinostat, which is a pan-HDAC inhibitor, demonstrated very high potency against DIPG tumour cell lines. In one such study panobinostat was the most effective of more than 80 anti-cancer agents tested.
Midatech’s MTX110 program is focused on the treatment of DIPG, a childhood brain cancer that is nearly always fatal, with a median survival of approximately 9 months. Using a technique called Convection Enhanced Delivery, MTX110 is infused directly into the brain tumour, and diffuses through and around it. This technique allows for elevated drug concentrations to be delivered to the tumour, while at the same time minimizing systemic toxicity and peripheral side-effects. MTX110 has been used to treat 5 patients to date in the USA and UK under its compassionate use program. In these patients MTX110 has been well tolerated thus far. We believe it holds promise as a potential therapeutic treatment for DIPG, for which there are currently no approved or effective therapies. Clinical studies in patients are planned to commence during 2017. Financial terms have not been disclosed.
Jim Phillips, CEO of Midatech Pharma, said: "In line with our strategy to focus on oncology and expand our product mix, we are pleased that Novartis recognises our unique capability to use their product panobinostat alongside our technology to treat orphan cancers. We look forward to driving it through development for treatment of DIPG, and make a real difference to the children suffering from this devastating and terminal disease."
MabVax Therapeutics ImmunoPET Imaging Agent MVT-2163 to be Featured in Two Presentations at the 2017 SNMMI Annual Meeting
On June 7, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported that the Society of Nuclear Medicine and Molecular Imaging (SNMMI) has chosen MabVax’s immunoPET imaging agent, MVT-2163, for a podium presentation and a poster presentation at the upcoming annual meeting to be held in Denver, CO on June 10-14, 2017 (Press release, MabVax, JUN 7, 2017, View Source [SID1234519470]). Schedule your 30 min Free 1stOncology Demo! MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)
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The poster will be presented by Joseph O’Donoghue, Ph.D., Associate Attending Physicist, Department of Medical Physics at Memorial Sloan Kettering Cancer Center.
Poster Title: Biodistribution and radiation dose estimates for 89Zr-DFO-HuMab-5B1 (MVT-2163) in CA19-9 positive cancer: first-in-man results
Location: Hall C in the Colorado Convention Center, Denver Colorado
Session Date: Sunday, June 11, 2017
Time: 7:00 PM to 8:30 PM (CDT)
The podium presentation will be given by Lars Guenter Christian Lohrmann, M.D., Assistant Member and Assistant Attending Radiologist at Memorial Sloan Kettering Cancer Center, and lead investigator in the MVT-2163 Phase 1 clinical trial.
Title of Presentation: First-in-Human Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) PET/CT imaging with and without HuMab-5B1 (MVT-5873) in patients with pancreatic cancer and other CA 19-9 positive malignancies
Location: Room 601 in the Colorado Convention Center, Denver Colorado
Session Date: Tuesday, June 13, 2017
Time: 8:10 AM (CDT)
These presentations will discuss the results of the Company’s Phase 1a dose-escalation and safety trial conducted in 12 patients with advanced pancreatic cancer. Both presentations will include PET scan images illustrating the utility of this novel immunoPET imaging agent and its potential role in preoperative staging of patients with pancreatic cancer.
BeiGene to Present Data on BGB-3111 at the 14th International Conference on Malignant Lymphoma and to Host Conference Call
On June 7, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present updates on its BTK inhibitor BGB-3111 in three oral presentations and a poster at the upcoming 14th International Conference on Malignant Lymphoma (14-ICML) (Press release, BeiGene, JUN 7, 2017, View Source [SID1234519469]). 14-ICML will take place June 14-17, 2017, in Lugano, Switzerland. Following its presentations, BeiGene will host an investor call and webcast to discuss the presented data and development program. Schedule your 30 min Free 1stOncology Demo! Oral Presentation, Abstract # 059
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Title: Bruton’s Tyrosine Kinase (BTK) Inhibitor BGB-3111 Demonstrates High Very Good Partial Response (VGPR) Rate in Patients with Waldenström Macroglobulinemia (WM)
Presenter: Dr. Judith Trotman
Session: Session 4 – Targeting the BCR Pathways
Date & Time: Thursday, June 15, 2017, 4:00 PM CEST
Location: Room A, Cinema Corso and Aula Magna (Lugano University)
Oral Presentation, Abstract # OT06
Title: A Head-to-Head Phase 3 Study Comparing BGB-3111 and Ibrutinib in Patients with Waldenström Macroglobulinemia
Presenter: Dr. Christian Buske
Session: Ongoing Trials
Date & Time: Thursday, June 15, 2017, 6:05 PM CEST
Location: Auditorium (Lugano University)
Oral Presentation, Abstract # 103
Title: Safety and Activity of the Highly Specific BTK Inhibitor, BGB-3111 Plus Obinutuzumab in Patients (Pts) with Follicular Lymphoma (FL) and Chronic Lymphocytic Leukemia (CLL)
Presenter: Dr. Constantine Tam
Session: Session 7 – Advances in CLL
Date & Time: Friday, June 16, 2017, 11:50 AM CEST
Location: Room A, B, Marquee, Cinema Corso and Aula Magna (Lugano University)
Poster, Abstract # 237
Title: High Overall Response Rate with the BTK Inhibitor BGB-3111 in Patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma: An Update on Safety and Activity
Presenter: Dr. John Seymour
Session Dates & Times: Wednesday, June 14, 12:30-6:30 PM CEST; Thursday, June 15, 8:30-6:30 PM CEST; Friday, June 16, 8:30-6:30 PM CEST
Location: Marquee
Investor Conference Call
Date & Time: Friday, June 16, 2017, 2:00 PM CEST (8:00 AM EDT, 8:00 PM China Standard Time)
Dial-in Numbers: 1-845-675-0437 or 1-866-519-4004 (US), 400-620-8038 or 800-819-0121 (China), +852 30186771 (Hong Kong), or +65 67135090 (International)
Conference ID Number: 33044427
A live webcast and replay will be available on BeiGene’s investor website, View Source The dial-in replay will be available approximately two hours after the conference and will be available for two days following the event. It can be accessed by dialing 1-646-254-3697 (US), 400-632-2162 (China), +852 30512780 (Hong Kong), or +61 2 8199 0299 (International).
About BGB-3111
BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.
Eureka Therapeutics And City Of Hope Announce Agreement To Conduct Phase 1 Clinical Trial Of Investigational ET1402L1 CAR-T Therapy In Liver Cancer
On June 7, 2017 Eureka Therapeutics Inc., a biotechnology company focused on developing novel T-cell immunotherapies for the treatment of solid tumors, and City of Hope, a world-renowned independent research and cancer and diabetes treatment center, reported that they have reached agreement to conduct an open-label, dose-escalating Phase 1 clinical trial of ET1402L1-CAR, a potential CAR-T therapy for the treatment of hepatocellular carcinoma, the predominant type of liver cancer (Press release, Eureka Therapeutics, JUN 7, 2017, View Source [SID1234519468]). ET1402L1 is a human antibody, identified from Eureka’s proprietary E-ALPHA phage library, which selectively targets liver cancer cells overexpressing alpha-fetoprotein (AFP). Schedule your 30 min Free 1stOncology Demo! "We are pleased to be working with Eureka Therapeutics on this unique approach to treating liver cancer with CAR-T therapy" Tweet this
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"The clinical trial agreement represents an important milestone for Eureka, as it provides a pathway for treating patients with liver cancer, and it supports our business objectives to develop ET1402L1-CAR in areas of significant unmet medical need," said Cheng Liu, Ph.D., President and Chief Executive Officer of Eureka Therapeutics. "This is a significant step in demonstrating that CAR-T cell therapy can be successfully used to target a major histocompatibility complex (MHC) presented antigen in solid tumors."
Intracellular antigens, which account for the most tumor-specific antigens, are inaccessible by conventional CAR-T therapy. Such antigens which include AFP, however, are processed into peptides and presented by the class I MHC on the surface of tumor cells. A 2017 study (DOI: 10.1158/1078-0432.CCR-16-1203), published by Eureka and City of Hope in Clinical Cancer Research, showed that ET1402L1-CAR T cells can recognize the AFP-MHC complex and launch a potent anti-tumor response, offering a promising new avenue for T cell therapy against solid malignancies.
"We are pleased to be working with Eureka Therapeutics on this unique approach to treating liver cancer with CAR-T therapy," said principal investigator Yuman Fong, M.D., The Sangiacomo Family Chair in Surgical Oncology and chair and professor of the Department of Surgery at City of Hope. "CAR-T therapy has shown remarkable success with liquid tumors. However, the lack of cancer specific cell surface antigens has limited the use of CAR-T therapy to other cancers. The results of this study could have a wide range of applications in other difficult-to-treat solid cancers such as lung and prostate cancer, which have few cell surface markers that are tumor-specific."
"City of Hope has accepted the challenge to bring leading-edge treatments to patients with liver cancer," said investigator Stephen J. Forman, M.D., Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation and director of City of Hope’s T Cell Immunotherapy Research Laboratory. "We are optimistic that CAR-T therapy can be an important component in treating patients with solid tumors, including liver cancer."
The Phase 1 clinical trial will be led by Fong and Forman. Other collaborating investigators include Christine Brown, Ph.D., Heritage Provider Network Professor in Immunotherapy, John Kessler, M.D., John Park, M.D., Ph.D., Saul Priceman Ph.D., Shirong Wang, M.D., M.P.H., and Susanne Warner, M.D., all of City of Hope in Duarte, California.
About Liver Cancer
Liver cancer is the fifth most prevalent and third most lethal cancer worldwide, with incidence rates on the rise and limited treatment options. Hepatocellular carcinoma is the predominant type of liver cancer, affecting over 700,000 people each year worldwide. Alpha-fetoprotein (AFP) is overexpressed, specifically in liver cancer, making it an ideal target for chimeric antigen receptor (CAR) T cell immunotherapy. However, AFP is intracellularly expressed and secreted, and therefore, not targetable by conventional antibody-based therapies.