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MabVax Therapeutics Nominates The Fully Human Antibody HuMab 5B1 As The Company’s Lead Clinical Development Candidate

On October 21, 2014 MabVax Therapeutics reported that it has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer (Press release MabVax, OCT 21, 2014, View Source [SID:1234500854]). The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials to take place simultaneously. One program will be aimed at demonstrating the utility of the radio-labeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer. The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.

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Fidelity Biosciences and Atlas Venture Lead $12 Million Series A Funding to Launch Unum Therapeutics, a New Cellular Immunotherapy Company

On October 21, 2014 Unum Therapeutics reported that it has raised $12 million in Series A funding led by Fidelity Biosciences and Atlas Venture, with participation from Sanofi-Genzyme BioVentures (Press release Unum Therapeutics, OCT 21, 2014, View Source!21oct2014-unum-series-a-funding/cu46 [SID:1234500856]). Unum has built a platform for cancer treatment based upon an antibody-coupled T-cell receptor (ACTR). Genetically programming T-cells with ACTR allows them to efficiently attack and kill tumor cells using targeting antibodies. In contrast to other approaches that are limited to a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigen and may have applications for treating many types of cancers. Unum plans to use capital raised through this financing to advance its lead candidate through initial proof-of-concept clinical studies, further enhance the ACTR technology, and establish partnerships to access tumor-specific antibodies for a pipeline of novel combination therapies.

Industry veteran Charles "Chuck" Wilson, PhD, will serve as President & CEO. Before founding Unum, Dr. Wilson led the team responsible for partnering to support research and early development at Novartis. With many oncology and immuno-oncology deals to his credit, he brings extensive experience to Unum spanning from early drug discovery through Phase II clinical development. Prior to Novartis, Dr. Wilson held both scientific and business management roles in biotech.

"We’ve created Unum to rapidly develop this universal cell therapy platform and to explore its potential in a number of different cancer types," said Dr. Wilson. "With our Series A funding from Fidelity Biosciences, Atlas Venture, and Sanofi-Genzyme BioVentures, we will drive our lead program into Phase I testing and aim to quickly validate the ACTR approach in the clinic."

Dario Campana, MD, PhD, is the company’s Scientific Founder. Dr. Campana is an established leader in the field of cancer cell therapies. At the National University of Singapore (NUS), he developed the ACTR technology that forms the basis for Unum. At St. Jude Children’s Research Hospital (Memphis, TN), he created a chimeric antigen receptor (CAR) approach that is currently being pursued by several pharma and biotech companies. He currently oversees a number of cell therapy clinical trials in oncology.

In addition to Drs. Wilson and Campana, Unum Therapeutics’ management team also includes Chief Scientific Officer Seth Ettenberg, PhD, a cancer biologist and drug development scientist with extensive experience leading teams in biotechnology and large pharmaceutical drug discovery settings. Dr. Ettenberg most recently served as the Cambridge site head for Novartis Oncology Biotherapeutics.

The initial Board of Directors for Unum Therapeutics is comprised of:

Chuck Wilson, PhD, President & CEO, Unum Therapeutics

Ben Auspitz, Partner, Fidelity Biosciences

Bruce Booth, DPhil, Partner, Atlas Venture

"Unum combines a strong, experienced management team, a transformational technology that may revolutionize cancer treatment, and top scientific and business development talent," said Mr. Auspitz. "It has the right combination of resources to carry out its vision of bringing to market a single therapy that can augment the activity of many different antibodies to treat many different cancers."

Agios Pharmaceuticals Announces Initiation of a Phase 1/2 Clinical Trial of AG-221 in Patients with Advanced Solid Tumors with an IDH2 Mutation

On October 21, 2014 Agios Pharmaceuticals reported the initiation of a Phase 1/2 multicenter study of AG-221 in patients with advanced solid tumors, including gliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry an isocitrate dehydrogenase-2 (IDH2) mutation (Press release Agios Pharmaceuticals, OCT 21, 2014, View Source [SID:1234500851]). The study will enroll patients who have recurred or progressed following standard therapy or have not responded to prior standard therapy. This is the second trial to be initiated in patients with cancer as part of AG-221’s clinical development program, which includes the ongoing Phase 1 trial with four expansion cohorts in patients with hematologic malignancies.

Preclinical evidence shows that mutant IDH2 enzyme, the target of AG-221, produces 2-hydroxyglutarate (2HG), which blocks the normal maturation of progenitor cells. In solid tumor cells expressing the IDH2 mutation, AG-221 inhibited the production of 2HG, which has the potential to affect differentiation and cell proliferation in patients with solid tumors. In addition, AG-221 has demonstrated an acceptable safety profile and evidence of antitumor activity in the ongoing Phase I trial of AG-221 in patients with advanced hematologic malignancies that carry an IDH2 mutation.

“Evaluating AG-221 in patients with advanced solid tumors is an important next step in our efforts to understand the potential of this investigational medicine to treat a broad range of cancers with the IDH2 mutation,” said Chris Bowden M.D., chief medical officer at Agios. “The safety, pharmacokinetics, clinical activity, and effect on the biomarker 2HG we have observed from the different dose levels studied in the Phase 1 trial for advanced hematologic malignancies give us insights into the potential to fight cancer in patients with advanced solid tumors. AG-221 will only be evaluated in prospectively defined patients whose cancers carry an IDH2 mutation, and who we believe have the greatest potential to benefit from treatment.”

Cancer Research Technology introduces Ximbio, an online reagents portal

On October 20, 2014 Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK, reported the launch of Ximbio (www.ximbio.com), an online reagents portal for the life science community (Press release, Cancer Research Technology, OCT 20, 2014, View Source [SID1234523221]). Ximbio has been developed to change the way that research reagents are searched, sourced and shared, to broaden the range of tools available to scientists globally and support and advance life science research.

Ximbio provides a portal for the life science community to exchange knowledge and trade reagents. Researchers and technology transfer offices can virtually deposit their reagents to Ximbio. Life science reagents companies can use the portal to easily source new products to augment their portfolios via a straightforward commercialisation process. Ximbio returns a share of product-based revenues to the depositing institution.

For scientists looking for specific reagents to use in their experiments, Ximbio offers a fully searchable database, extensive datasheets, and supplier options, and in future will also feature peer reviews of listed products. Each reagent record can be linked to the originating inventor, enabling scientists and institutions to be credited for their work. Ximbio will operate as a business unit of CRT, and will focus on all areas of biology.

Keith Blundy, Cancer Research Technology’s Chief Executive Officer, commented: "Over the past 25 years CRT has successfully built one of the world’s largest and most well-respected collections of life science reagents. Ximbio now provides us with the opportunity to extend our reach globally to provide an enhanced offering that better meets the needs of researchers, technology transfer offices, and life science companies."

Melanie Hardman, Head of Ximbio, commented: "Through in-depth analysis of our partnerships with technology transfer offices, life science reagents companies, and the research community, we recognised a real need for an easy to use, online reagents portal. This has been validated by the extensive stakeholder research we have undertaken over the past 8 months. We have created Ximbio to be a place where scientists and technology transfer offices can share their research, and reagents companies can source new products, in a streamlined process that saves both time and resource, maximising the visibility and impact of all research reagents. By unifying the reagent community in this way, to make tools more widely and easily available, we hope to accelerate life science research."

Boehringer Ingelheim initiates global Phase III study investigating nintedanib* in patients with colorectal cancer refractory to standard treatments

On October 21, 2014 Boehringer Ingelheim reported the enrollment of the first patient in a new global Phase III study in patients with advanced colorectal cancer (CRC) (Press release Boehringer Ingelheim, OCT 20, 2014, View Source [SID:1234500853]). Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Prognosis is poor for patients with advanced CRC with fewer than 10% surviving for more than five years after diagnosis.

LUME-COLON 1 [ClinicalTrials.gov identifier: NCT02149108] is a double-blind, randomised, placebo-controlled study designed to evaluate the efficacy and safety of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. This new study builds on the early efficacy signs observed with nintedanib in CRC during Phase I/II trials.

“There is a significant need to improve treatment options for patients with advanced colorectal cancer and Boehringer Ingelheim is proud to conduct further research into this disease area. The initiation of LUME-COLON 1 reinforces our ongoing commitment to driving innovation in oncology research,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

LUME-COLON 1 plans to enroll more than 750 patients with CRC, whose disease has progressed on previous treatment and will be conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, amongst others. Patients will receive either nintedanib 200mg twice daily plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. The co-primary endpoints will be progression-free survival (PFS), evaluated by blinded review and overall survival (OS). Secondary endpoints are objective tumour response rate and disease control rate.

In the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of nintedanib in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first line chemotherapy.

Another EU marketing authorisation application (MAA), has been submitted for nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF). In the U.S., the Food and Drug Administration (FDA) has approved nintedanib capsules under the brand name OFEV for oral use for the treatment of IPF.