On June 15, 2015 Invenra, Inc., a pre-clinical stage bio-pharmaceutical company focused on next-generation therapeutic human antibodies and antibody derivatives, and Oxford BioTherapeutics (OBT), an international, clinical stage biotechnology company developing a range of innovative antibody-based therapeutics for cancer, reported a collaboration to identify and characterize a panel of fully human therapeutic monoclonal antibodies (mAbs) against a novel cancer target that OBT has identified utilizing its OGAP discovery platform (Press release, Invenra, JUN 25, 2015, View Source [SID1234570590]).

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!

Under the terms of the agreement, OBT will make an initial payment to Invenra upon successful delivery of a panel of novel mAbs confirmed to meet mutually agreed design goals and specifications. OBT will be responsible for all further development of the therapeutic product candidates. Assuming successful development, Invenra could receive further milestone payments and royalties on net sales of therapeutic and diagnostic products. In addition, OBT obtains diagnostic product rights from Invenra and will have the option of developing diagnostic products. Further financial details of the deal were not disclosed.

Invenra’s proprietary platform is based on ultra-high throughput technology to synthesize hundreds of thousands of full-length antibodies via cell-free expression and release them into nanowells, where they can be directly and quickly interrogated against cells in a multi-plexed fashion with a diverse set of immunotypic and biologically relevant assays. The Invenra technology allows rapid identification of high affinity mAbs with the broadest epitope coverage possible while simultaneously performing direct phenotypic screening to isolate those mAbs with the most relevant biological activity, thus leading to the selection of the best lead compounds for further development.

OBT’s proprietary target discovery platform, OGAP (Oxford Genome Anatomy Project), incorporates one of the world’s largest proprietary cell-membrane focused proteomic databases, with data on over 5,000 cancer membrane proteins providing unique, highly-qualified oncology targets that are selected for optimal ADC activity.

Keith Wilson, OBT’s chief scientific officer, said, "OBT is passionate about developing targeted cancer therapies for patients, and we are excited to be working with Invenra on a new approach to pursue mAb-based therapies. This collaboration leverages the complementary expertise of our two companies in identifying optimal mAbs against targets differentially expressed in cancer."

Roland Green, CEO and president of Invenra, said, "This collaboration is a major milestone for Invenra as a company and a validation of our innovative technology. We are delighted to be collaborating with Oxford BioTherapeutics to identify best-in-class antibodies against their novel oncology target. In addition, this collaboration with OBT fits well within our business model, whereby we are making our technology available to a select group of companies while continuing to develop our own internal proprietary pipeline of therapeutic product candidates."

On June 24, 2015 Celator Pharmaceuticals reported final induction response rate results (complete remission plus complete remission with incomplete hematologic recovery, or CR+CRi) in the Phase 3 study comparing CPX-351 (cytarabine:daunorubicin) liposome injection to the standard of care regimen, referred to as 7+3 (conventional cytarabine and daunorubicin treatment), in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) (Press release, Celator Pharmaceuticals, JUN 24, 2015, View Source [SID:1234505795]). The results showed that CPX-351 produced a relative improvement in induction response rate of 43.2% (47.7% for CPX-351 vs. 33.3% for the 7+3 regimen).

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!

Data on overall survival, the primary endpoint, are expected in the first quarter of 2016. However, induction response rate is a key secondary endpoint in the study and has been an important surrogate of overall survival and clinical benefit in this patient population. These data validate the induction response rates observed in the Phase 2 study, which was associated with a marked improvement in overall survival.

"The results are encouraging because this is the third randomized study in which CPX-351 outperformed the control arm of cytarabine plus an anthracycline in overall response rate," said Jeffrey Lancet, M.D., Senior Member and Chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and lead investigator on the Phase 3 study. "With induction therapy for AML, response rate has historically served as a surrogate for overall survival, and these data suggest a clinically meaningful benefit for CPX-351 over standard chemotherapy."

Gail Roboz, M.D., Associate Professor of Medicine and Director of the Leukemia Program at the Weill Medical College of Cornell University and the NewYork-Presbyterian Hospital in New York added, "The magnitude of the CR+CRi rate increase is promising and we may be one step closer to having a superior treatment option for patients with this devastating disease. The improvement in response rate portends well for a clinically meaningful survival benefit."

The randomized, controlled, Phase 3 study evaluated 309 patients, aged 60-75 years, from 39 clinical centers in the U.S. and Canada, with untreated high-risk (secondary) AML. Patients were randomized 1:1 to receive either CPX-351 or the 7+3 regimen. In addition to induction response and overall survival, other important information, such as rate of morphologic leukemia-free state, best overall response, response duration, event-free survival, and early mortality, as well as pharmacoeconomic comparisons, will be assessed and available at the conclusion of the study. The Leukemia & Lymphoma Society has partnered with Celator in the development of CPX-351.

"We are very pleased with the induction response rate results. This is one of the largest trials conducted in this specific patient population, and based on the improvement seen with CPX-351, we are optimistic about the opportunity for CPX-351 to improve overall survival in this patient population," said Scott Jackson, Celator’s Chief Executive Officer. "We look forward to the continued follow up of these patients. If approved, CPX-351 will be well-positioned to become the standard of care for high-risk AML patients. Further, we believe that significant opportunities exist for the additional development of CPX-351 as the backbone of treatment for AML and other blood cancers."

Data on the primary endpoint of the study, overall survival, are expected in the first quarter of 2016.

Additional information regarding the study is available at View Source

On June 24, 2015 Provectus Biopharmaceuticals reported that the abstract titled, "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver" to be presented at the ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer is now available online at:

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!

View Source

The abstract concludes "Preliminary efficacy in treatment of liver tumors with PV-10 was observed (Press release, Provectus Pharmaceuticals, JUN 24, 2015, http://www.pvct.com/pressrelease.html?article=20150624.2 [SID:1234505802]). Toxicity was transient, and treatment had acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to assess response in hepatocellular carcinoma and other cancers metastatic to the liver."

Eric Wachter, PhD, Chief Technology Officer of Provectus, will be the presenter, and is scheduled to make the presentation twice during the Congress. Both presentations are scheduled for Thursday, July 2, 2015; the first is from 10:30 to 11:00 a.m. and the second from 4:55 to 5:25 p.m. local time.

Once the poster has been presented at the Congress, Provectus will provide full details of its contents to the public.

About ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer

The ESMO (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumours. It has been endorsed by leading professional societies and organizations. View Source

On June 23, 2015 Onconova reported that it will host a Key Opinion Leader breakfast focused on the treatment landscape for myelodysplastic syndromes (MDS), including the Company’s late-stage drug candidate, rigosertib, a small molecule RAS mimetic that inhibits cellular signaling (Press release, Onconova, JUN 23, 2015, View Source [SID:1234505792]). MDS is a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis and increased risk of developing acute myeloid leukemia (AML). The event and live webcast will take place on Tuesday, June 30 from 8:00-9:30 AM Eastern Time in New York City.

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 meeting will feature presentations by Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research, Co-Director of the DNA Methylation Core, and Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and Lewis R. Silverman, M.D., Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai. The Onconova management team will also provide an overview of the Company’s clinical development work with rigosertib, including a discussion of the design of a planned global Phase 3 trial in higher-risk myelodysplastic syndromes (HR-MDS) and ongoing Phase 2 trials utilizing combination therapy with rigosertib and azacitidine. A Q&A session with the featured experts and management will follow the presentations.

This event is intended for institutional investors and sell-side analysts. To reserve a place, please contact Mac MacDonald at 212-915-2567 or via e-mail at [email protected]. A live webcast and subsequent replay of the event will be available at View Source

Guillermo Garcia-Manero, M.D., serves as Chief of the Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research, Co-Director of the DNA Methylation Core, and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. He is also on the faculty of The University of Texas Graduate School of Biomedical Sciences at Houston. Dr. Garcia-Manero previously served as Co-Chair of the MDS Clinical Research Consortium. The focus of his academic and clinical efforts have been to improve outcomes for patients with MDS.

Lewis R. Silverman, M.D., is Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai (ISMMS). He leads the Myelodysplastic Syndrome and Myeloproliferative Disease Program at ISMMS, where he has served as the Principal Investigator for several national clinical trials exploring treatments for patients with MDS. Dr. Silverman played an important role in the completion of the AZA-001 trial, which led to the approval of the first drug for the treatment of MDS, azacitidine (VIDAZA).

On June 23, 2015 SRI International reported cancer drug discovery firm Sareum has received a £140,000 government grant to help the development of a molecule that could be used to treat leukaemia (Press release, SRI International, JUN 23, 2015, View Source [SID:1234505797]).

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!

Sareum has been given the cash by the UK’s innovation agency, Innovate UK, through its Biomedical Catalyst fund.

The award will allow Sareum to investigate the potential of lead molecules from its TYK2 autoimmune disease programme to treat a strain of leukaemia known as T-ALL, a rare form of the disease that most often occurs in late childhood and early adolescence.

"We are delighted to have won this award from the Biomedical Catalyst, which will give us the opportunity to demonstrate the potential of our TYK2 inhibitors in leukaemia," said Dr Tim Mitchell, CEO of Sareum.