Boehringer Ingelheim will invest 11 billion euros in Research and Development in the next five years to accelerate the discovery of next generation medical breakthroughs

On November 11, 2015 Boehringer Ingelheim reported that it is launching a new research and development (R&D) strategy and a five-year R&D investment programme (Press release, Boehringer Ingelheim, NOV 11, 2015, View Source [SID:1234508201]). This new plan was announced today at its R&D press conference in Berlin. The company pledges to invest a total of 11 billion euros in its new R&D programme over the next five years. Of the total investment, 5 billion euros will go to preclinical R&D with 1.5 billion euro thereof planned for collaborations with external partners. The company is aiming to develop the next generation of medical breakthroughs and maintain its excellent competitive position. The new R&D strategy embraces open innovation in the form of external collaborations to better leverage emerging science and Boehringer Ingelheim’s experience and capabilities for the discovery of new medicines.

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!

"With eleven new launches in 2014 and 2015, our R&D organisation is an example of Boehringer Ingelheim’s outstanding capability in this field," said Professor Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim. "The new programme and strategy reflect our corporate philosophy of long-term, sustainable growth. They will enable us to continue our excellent track record of bringing therapeutic innovations with high value for patients to the market."

A New R&D Strategy

A key element of the new strategy is an increased focus on collaborations with external partners, while maintaining strong internal R&D capabilities. This approach will enable the company to build on its long-term experience and strength in its core therapeutic areas while expanding its efforts to access the vast creative pool of global biomedical research through open innovation.

"Our new strategy embraces the trend towards more extensive open-innovation approaches between academia and industry in biomedical research. Our partners benefit by accessing our broad experience and capabilities and through establishment of long-term personal interactions with our R&D teams," explained Dr Michel Pairet, senior corporate vice president research and non-clinical development at Boehringer Ingelheim and designated Member of the Board of Managing Directors from January 2016 onwards. "The new strategy will foster our external collaboration efforts by enabling us to be faster and more flexible. This is of essence for research beyond the borders of our current focus areas, where we explore emerging science, new indications and new technology to expand opportunities."

Cooperation with Partners along the entire R&D value chain

Open innovation has become a fundamental part of drug discovery. The R&D organisation of Boehringer Ingelheim is working with the wider scientific world to embed a range of innovative opportunities in its R&D endeavours.

Firstly, bilateral collaboration agreements with academic investigators and biotechnology companies provide important starting points for drug discovery projects. Boehringer Ingelheim has entered into several new research collaborations in exciting areas of science with partners that are worldwide leaders in their fields.

Boehringer Ingelheim just announced new collaborations with four major scientific partners to enrich R&D with novel therapeutic approaches for patients suffering from inflammatory bowel disease (IBD), namely the Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, Scripps Research Institute and Weill Cornell Medicine. These four collaborations aim to identify and validate potential new therapeutic targets as well as identify biomarkers that offer the potential to address the significant unmet medical needs of patients suffering from IBD such as Crohn’s disease and ulcerative colitis. Boehringer Ingelheim has also recently signed exclusive agreements with Hanmi Pharmaceuticals in Korea to develop a third generation EGFR-targeted therapy for lung cancer and with Circuit Therapeutics, California to apply the technique of optogenetics to find new treatments for psychiatric disorders and cardiometabolic diseases.

Secondly, public-private partnerships, such as the Structural Genomics Consortium (SGC), Innovative Medicines Initiative (IMI) and the G-protein coupled receptor (GPCR) Consortium, are playing an increasingly important role in medicines discovery because of their ability to bring together the best academic and industrial scientists in an unrestricted precompetitive field. Boehringer Ingelheim is an active participant in all two of these successful public-private partnerships and recently joined the GPCR Consortium.

Thirdly, crowdsourcing initiatives with organisations such as InnoCentive and the BioMed X Innovation Center can be used to seek scientists with bright ideas to address important medical challenges. Boehringer Ingelheim and the BioMed X Innovation Center recently announced that they are bringing together outstanding scientists at an academic centre of excellence in Heidelberg and providing them with appropriate infrastructure and mentorship to work on new epigenetic approaches to chronic obstructive pulmonary disease.

In addition, Boehringer Ingelheim invests in the Institute for Molecular Pathology (IMP) in Vienna to support basic research, and a global network of scientists as essential elements of the creative endeavour. Finally, the Boehringer Ingelheim Venture Fund, founded in 2010 with an initial financial commitment of 100 million euro, is currently investing in a portfolio of 13 different start-up companies with exciting new therapeutic ideas.

The new R&D strategy is an important building block of Boehringer Ingelheim’s global strategy to be prepared for chances and challenges in the pharmaceutical market. "This is another decisive step to position Boehringer Ingelheim for long-term growth," said Professor Barner. "We are looking forward to addressing unresolved challenges in immunology, respiratory and cardiometabolic medicine, as well as in oncology, in diseases of the central nervous system and beyond."

New combination trial with lirilumab in hemato-oncology

On November 12, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that a new trial performed by the MD Anderson cancer center started, testing a combination of nivolumab, lirilumab and 5-azacytidine for the treatment of patients with Myelodysplastic Syndrome (MDS) (Press release, Innate Pharma, NOV 11, 2015, View Source [SID:1234508207]).

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!

This is the third trial with lirilumab supported by Bristol-Myers Squibb and performed by the MD Anderson cancer center in 2015, after the opening of one trial testing the combination of lirilumab and 5-azacytidine in relapsed/ refractory AML and another trial testing the combination of lirilumab and rituximab in relapsed/ refractory or high-risk untreated CLL.

These new trials bring to 8 the number of trials performed with lirilumab, testing a broad range of solid and hematological cancer indications, multiple rationales and combinations with cytotoxic antibodies, checkpoint inhibitors and chemotherapy.

Immune Design Announces Start of Randomized Phase 2 Cancer Immunotherapy Combination Trial in Patients With Soft Tissue Sarcoma

On November 11, 2015 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported the start of a randomized Phase 2 trial of CMB305, the company’s "prime boost" cancer immunotherapy product candidate, combined with Genentech’s investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1) in patients with soft tissue sarcoma (Press release, Immune Design, NOV 11, 2015, View Source [SID:1234508204]).

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 open label trial is designed to evaluate the safety and efficacy of CMB305 in combination with atezolizumab versus atezolizumab alone in up to 80 patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid/round-cell liposarcoma expressing the NY-ESO-1 cancer testis antigen. The trial is being conducted pursuant to a clinical collaboration with Genentech, a member of the Roche Group, which will provide atezolizumab for the trial.

CMB305 is a "prime-boost" cancer immunotherapy product designed to synergistically induce and expand in vivo cytotoxic T lymphocytes (CTLs) targeting NY-ESO-1 which is found in a broad set of tumors. Specifically, synovial sarcoma and myxoid/round-cell liposarcoma tend to express NY-ESO-1 broadly, which should make them good indications for clinical studies of this antigen-specific immune therapy. Atezolizumab is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells..

"This trial provides our first opportunity to validate the fundamental hypothesis that combining cutting-edge technologies designed to trigger in vivo anti-tumor CTLs with antagonists of the PD-1/PD-L1 axis should be additive, if not synergistic, and thus could enhance the potential therapeutic benefit to patients," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We are excited to work with leading sarcoma investigators to advance CMB305 into its first randomized Phase 2 trial and to explore the potential of these two approaches."

About CMB305

CMB305 is a cancer immunotherapy product candidate combining two potentially synergistic agents, LV305 and G305. LV305 is a hybrid vector from the ZVex discovery platform that specifically targets dendritic cells (DCs) in vivo and delivers the RNA for NY-ESO-1, enabling the DCs to express the entire tumor antigen and potentially induce a diverse set of CTLs targeting NY-ESO-1 in tumors. G305, in contrast, is designed to boost the CTL response via the induction of antigen-specific CD4 "helper" T cells. G305 consists of recombinant NY-ESO-1 protein formulated with a proprietary synthetic small molecule called glucopyranosyl lipid A (GLA), the novel TLR4 agonist at the core of the GLAAS platform. CMB305 is intended to be an "off-the shelf" therapy that does not require patient-specific manufacturing or ex vivo manipulation of patient samples. Having established the safety and individual immunologic activity of LV305 and G305 in prior studies, Immune Design initiated a new Phase 1B study of the product candidate CMB305 earlier this year.

About Soft Tissue Sarcoma

Soft Tissue Sarcomas (STS) are malignancies that arise from the soft tissues of the body, such as tissues that connect, support and surround other body structures including muscle, fat, blood vessels, nerves, tendons and the lining of joints.1 In the United States, nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of STS in 2015.2 There are approximately 50 different types of STS including Liposarcomas and Synovial Sarcomas, which are subtypes affecting fat tissue and tissue around the joints, respectively.3 Myxoid/round cell is a type of liposarcoma that accounts for approximately 30% of all liposarcoma cases.4 Myxoid and round cell liposarcoma and synovial sarcomas have been shown to have high expression of NY-ESO-1, approximately 90% and approximately 60%, respectively.5

Five Prime Therapeutics Receives Early HSR Clearance for FPA008 License and Collaboration Agreement With Bristol-Myers Squibb

On November 11, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 (HSR Act) in connection with the exclusive worldwide license and collaboration agreement with Bristol-Myers Squibb (BMS) for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008 (Press release, Five Prime Therapeutics, NOV 11, 2015, View Source [SID:1234508192]). With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with BMS is effective as of November 10, 2015, and the related $350 million upfront payment by BMS to Five Prime is due within 30 days of the effective date.

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!

Additional details regarding the collaboration can be found in Five Prime’s Form 8-K filed with the Securities and Exchange Commission on October 15, 2015.

About FPA008

FPA008 is an investigational antibody that inhibits CSF1R and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. FPA008 is currently in phase 1 clinical trials in several immunology and oncology indications.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Exelixis, NOV 10, 2015, View Source [SID:1234508198])

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!