1stOncology™: Cancer Intelligence Service – Page 16127 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BioInvent enters into third research collaboration with University of Southampton

On June 1, 2015 BioInvent International (OMXS: BINV) reported a three-year research collaboration with the University of Southampton (UoS), one of the world’s leading antibody research groups, under the direction of Professor Mark Cragg, BSc, PhD, Professor of Experimental Cancer Research and Director of the Cancer Pathway Integrated Postgraduate Programme (Press release, BioInvent, JUN 1, 2015, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=0E5DCBBC28836A0F [SID:1234506557]).

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!

The collaboration, also involving Professor Martin Glennie and Dr Stephen Beers is aimed at developing new immunotherapy treatments for cancer by targeting regulatory T cells (T regs). The program builds on the clinical successes of antibodies to so called T cell checkpoint inhibitors. The collaboration aims to develop novel antibodies and targets that are more specific for the cancer-associated T regs.

This collaboration is separate from two existing research programs in place between the University of Southampton and BioInvent.

Terms of the collaboration are not disclosed, noting that BioInvent will have the option to license any promising results for further development and commercialization. Under the agreement, both parties will contribute to intellectual property generation.

BioInvent has the capacity, through the F.I.R.S.T. platform, to generate a large number of T cell depleting antibodies. UoS has unique capabilities to test and evaluate potential lead candidates in several advanced in vitro and in vivo models. The collaboration between BioInvent and UoS around n-CoDeR antibodies targeting human T regs for cancer therapy utilizes the strengths from both groups.

Professor Cragg commented, "We look forward to building on the strength of our collaborative relationship with BioInvent, which should allow us to remain at the cutting edge of antibody immunotherapy for the benefit of cancer patients worldwide. Both clinical and preclinical data suggests that depletion of T regs can result in efficient anti-tumor T cell responses and tumor eradication. However, current T cell targeting therapeutic antibodies and checkpoint inhibitors were developed based on their abilities to block inhibitory signals. Novel, as yet unidentified targets with broad expression on regulatory T cells in different cancers, such as melanoma, lung cancer etc. and antibody formats with superior T reg depleting activity may have greater activity. We look forward to working with BioInvent’s extensive antibody library and its novel targeting platform to establish several lead candidates for clinical development in this very important area of cancer research."

"We are especially pleased to be undertaking this additional research collaboration with the team at the University of Southampton. This esteemed research center and its renowned clinicians are experts in the fields of immunology and oncology and are at the forefront of unlocking the potential of therapeutic antibodies," said Björn Frendéus, PhD, Chief Scientific Officer of BioInvent and honorary Professor at the University of Southampton. "BioInvent’s phenotypic target and mAb discovery platform, F.I.R.S.T., are ideally suited to identify a great diversity of human mAb with cancer T reg depleting or modulating activity. In collaboration with our colleagues in Southampton, we aim to generate more efficacious and safer immune modulatory antibodies for cancer treatments."

CEL-SCI REPORTS MAY PATIENT ENROLLMENT IN ITS PHASE 3 HEAD AND NECK CANCER TRIAL

On June 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM)("CEL SCI" or the "Company") reported that in May it has enrolled 26 patients in its ongoing Phase III trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer (Press release, Cel-Sci, JUN 1, 2015, View Source [SID:1234506551]). Over 463 patients have been enrolled as of May 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

"With over half of patients enrolled, we have reached a milestone, as we look forward to completing enrollment by the first quarter of 2016," stated CEL-SCI Chief Executive Officer Geert Kersten. "We are now cleared to enroll patients in 23 countries and a number of additional clinical sites are expected to become active soon."

A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line (right after diagnosis, before surgery) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Baxter Ventures, Mayo Clinic and Velocity Pharmaceutical Development announce the formation of Vitesse Biologics, LLC, a company structured to accelerate therapeutic innovation.

On June 1, 2015 Baxter Ventures, the venture arm of Baxter International Inc. (NYSE:BAX), the Mayo Clinic and Velocity Pharmaceutical Development, LLC ("VPD") reported the formation of Vitesse Biologics, LLC, ("Vitesse") (Press release, Velocity Pharmaceutical Development, JUN 1, 2015, View Source [SID:1234506532]). Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology. Following the spin-off of Baxter BioScience as Baxalta Incorporated, anticipated to take place by mid-2015, the Vitesse relationship will be managed by the planned venture arm, Baxalta Ventures, for the new company.

The collaboration model, which represents a new method of drug development, was designed to incent each partner to advance promising therapies quickly through the development process. Each partner will provide its recognized expertise to enhance the target selection, target optimization, expression and product development process. Baxter BioScience will provide global commercialization, antibody and protein development and manufacturing capabilities; Mayo Clinic researchers will execute the Phase I clinical trials; VPD will be responsible for target identification, selection of early stage drug candidates and will lead the design and execution of pre-clinical and clinical protocols.

"Delivering innovative treatments to address unmet patient needs is at the very core of everything we do and drives our ongoing R&D focus," said Ludwig N. Hantson, Ph.D., president of Baxter BioScience. "By creating Vitesse, our business is executing on a new concept in early stage R&D by leveraging the expertise of industry-leading partners to accelerate the identification and development of novel biologic treatments that could eventually contribute to unmet patient needs while enhancing the Baxalta commercial portfolio."

Vitesse will develop treatments in the fields of hematology, oncology and immunology, which aligns strongly with Baxter BioScience’s therapeutic focus. This innovative model enables Baxter to serve as a hands-on partner in the pursuit of innovative treatments, as Baxter BioScience will be involved in the early-stages of development for all products identified by Vitesse and has an exclusive option to acquire each such product following the completion of the applicable Phase I trials.

"We are excited about the possibilities for this new collaboration, and particularly for this new model for early stage drug development," said Greg Gores, M.D., executive dean for research at Mayo Clinic. "Our goal is to identify new, useful therapeutics to address the unmet needs of our patients."

David Collier, M.D., CEO of VPD, said, "We are fortunate to have world-class partners in this project. We believe that the combination of the development and manufacturing expertise offered by Baxter BioScience and the clinical capabilities of the Mayo Clinic, working in conjunction with our team at VPD, will produce a series of very promising new therapeutics developed in a more rapid and cost-efficient manner."

With research as a key priority of the Destination Medical Center (DMC) initiative, Mayo Clinic is building upon the clinical and research infrastructure further accelerating Mayo Clinic’s ability to conduct some of the most important medical research, eventually to translate these discoveries into therapies for patients from across the globe.

ABOUT VITESSE BIOLOGICS, LLC Vitesse Biologics, LLC, a Delaware Corporation based in South San Francisco, CA, develops antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology.

Baxter Ventures, Mayo Clinic and Velocity Pharmaceutical Development Announce the Formation of Vitesse Biologics, LLC, A Company Structured to Accelerate Therapeutic Innovation

On June 1, 2015 Baxter Ventures, the Mayo Clinic and Velocity Pharmaceutical Development reported the formation of Vitesse Biologics, LLC, ("Vitesse") (Press release, Baxter International, JUN 1, 2015, View Source [SID:1234505234]). Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology. Following the spin-off of Baxter BioScience as Baxalta Incorporated, anticipated to take place by mid-2015, the Vitesse relationship will be managed by the planned venture arm, Baxalta Ventures, for the new company.

Trabectedin Improves Disease Control in Patients with Advanced Soft Tissue Sarcoma

On June 1, 2015 Janssen Research & Development reported data from the Phase 3 multicenter study SAR3007, which demonstrated a significant improvement in progression-free survival (PFS) with trabectedin (YONDELIS) compared to dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen (Press release, Johnson & Johnson, JUN 1, 2015, View Source [SID:1234505209]). SAR3007 is the largest randomized Phase 3 study ever conducted in this patient population. These data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

Soft tissue sarcoma (STS) is a type of cancer originating in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints.[1],[2] LPS and LMS are among the most common types of STS in adults and represent approximately 40-50% of all STS cases.[3],[4]

"Advanced soft tissue sarcomas represent a complex set of rare diseases which, when advanced, are life threatening. Our patients need new treatment options that are effective and reasonably well tolerated, as the treatment landscape has been relatively stagnant for decades," said George Demetri, M.D., Director, Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute and Professor at Harvard Medical School. "In soft tissue sarcomas, disease stabilization is an important metric for evaluating treatment success in patients with advanced disease. The safety data from this trial were consistent with the well-defined adverse events observed in previous clinical trials of trabectedin and in clinical use outside the United States where trabectedin has been approved to treat these aggressive diseases."

Trabectedin is approved in 77 countries in North America, Europe, South America and Asia under the trade name YONDELIS for the treatment of advanced STS as a single agent. Janssen submitted a New Drug Application for YONDELISto the U.S. Food and Drug Administration on November 24, 2014, which was granted Priority Review on February 3, 2015.

"The data presented at ASCO (Free ASCO Whitepaper) underscore the value of trabectedin as a potentially important treatment option for patients with LPS and LMS subtypes of soft tissue sarcoma," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen. "This latest research underlines our long-standing commitment to patients with advanced soft tissue sarcoma. To date, more than 50,000 patients worldwide have been treated with YONDELIS, including approximately 3,000 patients in our Expanded Access Program in the United States."

In this randomized, active-controlled Phase 3 study in patients with advanced LPS or LMS, trabectedin significantly reduced the risk of disease progression or death by 45% compared with those who received dacarbazine (hazard ratio [HR] = 0.550; P< 0.0001; median [M] 4.2 vs. 1.5 months, respectively), with results validated through an audit by independent radiologists. The improved PFS benefit with trabectedin treatment was consistently observed across all clinically relevant subgroups and was further supported by an increased objective response rate (ORR), a longer duration of response (DOR), and a higher clinical benefit response rate as compared to dacarbazine. At the interim analysis for overall survival (OS), the trial had not met the primary endpoint of OS. The study is ongoing to determine the final OS results, which will be presented at a future meeting. The results for the secondary efficacy endpoints are mature.

Safety findings were consistent with the well-characterized safety profiles of both agents, with the most common Grade 3-4 toxicities in the trabectedin versus the dacarbazine groups being decreased absolute neutrophil count (40% vs. 25%), decreased platelets (19% vs. 20%), and transient increases in liver transaminases, including alanine transaminase (ALT) (29% vs. 1%). Drug-related deaths occurred in 2.1% of patients in the trabectedin group versus 0% of patients in the dacarbazine group.

About SAR3007

The Phase 3 multicenter study SAR3007 compared trabectedin with dacarbazine in patients with advanced LPS or LMS previously treated with an anthracycline and at least one additional chemotherapy regimen. The primary endpoint is OS and secondary endpoints included PFS, time to progression (TTP), ORR, DOR, symptom severity and safety. Both treatments were administered via an IV infusion every three weeks with the trabectedin dose of 1.5 mg/m2 given over 24 hours versus dacarbazine dose of 1 g/m2 given over 20-120 minutes. Ninety-four percent of study participants were in the United States.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a type of cancer originating in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints.1,2 In the United States, nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of soft tissue sarcomas in 2015.[5] Leiomyosarcoma is an aggressive type of soft tissue sarcoma that occurs in smooth muscles, such as those in the uterus, gastrointestinal tract or lining of blood vessels.[6] Liposarcoma originates in fat cells and most commonly occurs in the thigh and abdominal cavity, though it can occur in fat cells in any part of the body.[7],[8]

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying and is approved in 77 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcoma as a single agent, and in 70 countries for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection).

Under a licensing agreement with PharmaMar, a wholly owned member of the Zeltia Group, Janssen Products, LP has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co., Ltd. If approved in the United States, YONDELIS would be commercialized by Janssen Biotech, Inc.