On 2 June 2017, the European Commission withdrew the marketing authorisation for Removab (catumaxomab) in the European Union (EU) (Press release, European Medicines Agency, JUL 10, 2017, View Source [SID1234527268]). The withdrawal was at the request of the marketing authorisation holder, Neovii Biotech GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons*.
Removab was granted marketing authorisation in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2013. The product had not been marketed in the EU since 2014.

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The European Public Assessment Report (EPAR) for Removab will be updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

*Since 2014, Revomab could not be marketed due to the insolvency of the manufacturer of the drug substance.

On July 9, 2017 Laekna reported that it acquired the global rights from Novartis Pharma AG to develop, manufacture and commercialize small molecule candidate LAE001 (previously known as CFG920) for prostate cancer (Press release, Laekna Therapeutics, JUL 9, 2017, View Source;article_id=14 [SID1234530439]). LAE001 has been previously studied in phase II clinical trial in the United States, and demonstrated satisfactory efficacy and safety profile in metastatic castration prostate cancer patients. Laekna are committed to deliver this drug further to regulatory approval in China and the rest of the world

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On July 7, 2017 Oncology Venture AB ("Oncology Venture") and 2X Oncology, Inc. ("2X Oncology"), reported that Oncology Venture has entered into an exclusive global license agreement with Eisai Inc. for Eisai’s Phase 2 PARP inhibitor E7449 – now called 2X-121 (Press release, 2X Oncology, JUL 7, 2017, View Source [SID1234526103]). 2X-121 will be developed by 2X Oncology, a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer.

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2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of cancers, including ovarian and breast. The drug also has potential to treat brain metastases and primary brain tumors based on its ability to pass through the blood-brain barrier.

"We are excited to in-license this promising PARP-inhibitor from Eisai. The cutting-edge science and compelling clinical data behind 2X-121 in combination with our unique Drug Response Predictor (DRP) biomarker technology provide an exceptional risk-reduced opportunity to develop effective treatments for hard to treat cancers," said Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Oncology Venture successfully validated its DRP biomarker for 2X-121 using clinical biopsy materials and blinded patient response data provided by Eisai under a prior agreement between the companies.

The drug will be developed in the pipeline of 2X Oncology, a Cambridge, MA-based spin-out of Oncology Venture focused on developing precision medicines for unmet needs in women’s cancers.

"We plan to initiate a focused Phase 2 trial of 2X-121 for the treatment of metastatic breast cancer later this year, using a DRP biomarker to identify patients who are most likely to respond to and benefit from treatment with this promising therapeutic," said George O. Elston, CEO of 2X Oncology, Inc. "Positive data from this study will position this program for a pivotal Phase 2 study initiation in 2018," Mr. Elston added.

Under the terms of the agreement, Oncology Venture will be responsible for the development and commercialization of 2X-121 in oncology. Oncology Venture will, through 2X Oncology, Inc., execute a mutually agreed upon clinical development plan, which includes an initial Phase 2 clinical study in patients with metastatic breast cancer using the DRP biomarker. Further terms of the agreement were not disclosed.

About 2X-121

2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome PARP inhibitor resistance.

A Phase 2 study (>20 patients) is planned using a DRP biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121. Positive data from this study will position the program for a pivotal Phase 2 study initiation in 2018.

In a prior Phase 1 study conducted without a DRP, two patients had a durable partial response (281 and 208 days, respectively). 2X-121 was well tolerated with no myelotoxicity observed. The planned Phase 2 study using a DRP is expected to significantly improve response rates seen in this initial study.

About the Drug Response Predictor (DRP) Companion Diagnostic

Developed by and in-licensed from Medical Prognosis Institute A/S (MPI.ST), the DRP screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRPs are developed for each pipeline product, which will enable Oncology Venture and its spin-out 2X Oncology to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product. This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight.

About Oncology Venture AB

Oncology Venture AB is engaged in the research and development of anti-cancer drugs through its wholly-owned Danish subsidiary Oncology Venture ApS. Oncology Venture has an exclusive license to use the Drug Response Predictor (DRP) platform in order to significantly increase the probability of success in clinical trials. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients’ tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Focusing on this defined patient group reduces risk and costs are reduced while increasing efficiencies in the development process. The current Oncology Venture product portfolio includes LiPlaCis for breast cancer in collaboration with Cadila Pharmaceuticals; Irofulven for prostate cancer; and APO010, an immuno-oncology product in development for the treatment of multiple myeloma.

In addition to 2X Oncology, of which Oncology Venture currently owns 92%, Oncology Venture has spun out Danish OV-SPV 2, which will test and potentially develop an in-licensed, oral phase 2 Tyrosine Kinase inhibitor.

On July 6, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that the Company has been awarded a ‘Programm für Innovation’ ("PROFI") grant for a period of two years from the Hamburgische Investitions- und Förderbank ("IFB Hamburg"), the central development institution of the Free and Hanseatic city of Hamburg, to identify and develop therapeutic antibodies directed against novel immune-checkpoints on T-cells to improve future cancer treatments (Press release, Evotec, JUL 6, 2017, View Source [SID1234519765]).

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Immuno-oncology has emerged as a particularly promising field to create superior and potentially curative treatment options for many cancer patients. Over the recent years, Evotec’s fully integrated drug discovery and development infrastructure has been adapted to facilitate high-throughput functional screening of monoclonal antibody candidates in complex biological assays. This grant will fund a programme focused on demonstrating pre-clinical activity for at least one first-in-class antibody against novel immune-checkpoints active against patient-derived tumour cells, a hallmark of current immuno-oncological approaches.

This EVT Innovate-anchored programme is designed to utilise synergies between Evotec’s infrastructure for the identification of novel therapeutic antibodies and Evotec’s collaboration partner, the University Medical Center Hamburg-Eppendorf ("UKE"), for the long-term understanding of immunological mechanisms, antibody-based cancer therapies and oncological screening.

The grant funding has been awarded under the IFB’s ‘Programm für Innovation’. The ‘Programm für Innovation’ was created to fund Hamburg-based R&D projects delivering novel or significantly improved products, processes or services across different disciplines. The grant will fund R&D work at Evotec and the UKE for a period of two-years.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are very pleased that the IFB Hamburg has chosen to support Evotec’s antibody based immuno-oncology approach. IFB’s support will accelerate UKE’s and Evotec’s combined efforts to discover and develop new treatment options for cancer patients in a very exciting and promising field."

Benjamin Fischer, Program Advisor Innovation of IFB Hamburg, said: "We are very proud to promote such an innovative and important life sciences project with grants of the Ministry of Economics, Transport and Innovation of the Free and Hanseatic City of Hamburg. We are particularly pleased that our financial support will enable both partners Evotec and UKE in transferring and strengthening important know-how in developing an innovative antibody-based cancer therapy. We expect this R&D funding to help the Hamburg location to achieve major importance within the field of life sciences and innovation.

On July 5, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported an update on its preclinical small molecule programs (Press release, Trillium Therapeutics, JUL 5, 2017, View Source [SID1234519756]).

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Trillium’s small molecule programs are built upon a proprietary fluorine-based chemistry platform. Incorporation of fluorine into small molecules can improve potency, absorption and blood-brain-barrier (BBB) penetration. It can also reduce the formation of toxic metabolites and increase a molecule’s half-life. Trillium has applied its unique medicinal chemistry platform to design proprietary brain-penetrant, selective and potent orally available small molecules, including epidermal growth factor receptor (EGFR) and bromodomain and extraterminal (BET) inhibitors.

TTI-2341:

A combination of molecular design, novel fluorine-based chemical synthesis, and extensive biological testing led to the identification of TTI-2341, a novel brain-penetrant, second generation, covalent EGFR inhibitor. Trillium has benchmarked the compound against a second- and a third-generation EGFR inhibitor (both approved for the treatment of non-small cell lung cancer). This comparison included measurements of BBB penetration, as well as retention and the ratio of free to bound drug in the brain. Based on the results the company has concluded that TTI-2341 appears to be a viable and competitive drug candidate for the treatment of brain cancers and brain metastases. The company plans to continue to pursue internal development of TTI-2341 while undertaking partnering discussions in parallel.

TTI-281:

The company has completed its planned preclinical development program for its bromodomain inhibitor (TTI-281). The company believes that TTI-281 represents a unique opportunity to reduce the expression of c-Myc, a proto-oncogene that contributes to the pathogenesis of many cancers but has proven to be difficult to target pharmacologically. However, with the reprioritization of the EGFR program and the majority of Trillium’s resources focused on the various CD47-targeting clinical trial efforts, the company is now initiating a partnering effort for further development of this program.

Discovery Program:

The major impetus for acquiring the company’s fluorine-based medicinal chemistry platform was to gain an internal discovery engine that can be utilized to rapidly generate drug candidates to promising cancer targets. Trillium has launched a discovery program that is focussed on an undisclosed early-stage immuno-oncology target. The company is also evaluating validated cancer targets, with the goal of producing drug candidates that through novel fluorine chemistry are differentiated from existing approved therapies with respect to potency, oral absorption or BBB penetration.