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GlycoMimetics to Receive European Patent for GMI-1271

On July 6, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that the European Patent Office has issued an "intention to grant" letter for European Patent Application Number EP12813711.1, titled "E-Selectin Antagonist Compounds, Compositions, and Methods of Use (Press release, GlycoMimetics, JUL 6, 2017, View Source [SID1234519766])." This patent is part of GlycoMimetics’ expanding patent portfolio covering the drug candidate GMI-1271 and its uses in a variety of indications, including various cancers. The U.S. Patent and Trademark Office has already issued a patent covering GMI-1271. GlycoMimetics has ongoing efforts to secure additional U.S. and foreign patents. With the issuance of patents in the U.S. and Europe, GlycoMimetics will have claims directed at GMI-1271 extending at least until 2032.

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"The European Patent Office’s issuance of patent rights covering GMI-1271 underscores the progress we’ve made in protecting our intellectual property and innovative pipeline," said Rachel King, Chief Executive Officer, GlycoMimetics. "The release of promising new clinical data in both the newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) patient populations from our ongoing study during the 2017 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings, the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation, and our enhanced patent position provide a strong foundation for defining a pivotal registration program and commercialization strategy for GMI-1271."

Evotec received funding from IFB Hamburg to identify antibody-mediated t-cell immunotherapies

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]).

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.

Puma Biotechnology Completes Targeted Enrollment in Neratinib Phase III Metastatic Breast Cancer Trial

On June 6, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that targeted patient enrollment in the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease has been completed (Press release, Puma Biotechnology, JUL 6, 2017, View Source [SID1234519760]).

The Phase III NALA trial is a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial has enrolled approximately 600 patients who are randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial is being conducted at sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival (PFS) and overall survival (OS). The company reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) has also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.

The primary analyses of PFS and OS are event driven. The Company anticipates that primary analysis of PFS will be available during the first half of 2018.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are very pleased to achieve this important milestone for the Phase III NALA trial of neratinib in HER2-positive metastatic breast cancer. We look forward to reporting initial data from the study, which we anticipate will occur during the first half of 2018. We also look forward to the continued development of neratinib in combination with Kadcyla in HER2-positive metastatic breast cancer (FB-10 trial), in patients with HER2-positive breast cancer that has metastasized to the brain (TBCRC-022 trial) and in patients with HER2 non-amplified tumors that have a HER2 mutation (SUMMIT)."

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that targeted patient enrollment in the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease has been completed. The Phase III NALA trial is a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial has enrolled approximately 600 patients who are randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial is being conducted at sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival (PFS) and overall survival (OS). The company reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) has also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial. The primary analyses of PFS and OS are event driven. The Company anticipates that primary analysis of PFS will be available during the first half of 2018. Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are very pleased to achieve this important milestone for the Phase III NALA trial of neratinib in HER2-positive metastatic breast cancer. We look forward to reporting initial data from the study, which we anticipate will occur during the first half of 2018. We also look forward to the continued development of neratinib in combination with Kadcyla in HER2-positive metastatic breast cancer (FB-10 trial), in patients with HER2-positive breast cancer that has metastasized to the brain (TBCRC-022 trial) and in patients with HER2 non-amplified tumors that have a HER2 mutation (SUMMIT)."

Oxford BioMedica Announces a Major Supply Agreement

On July 6, 2017 Oxford BioMedica plc (LSE:OXB) ("Oxford BioMedica" or "the Group"), a leading gene and cell therapy group, reported that it has signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric Antigen Receptor T cell (CART) products (Press release, Oxford BioMedica, JUL 6, 2017, View Source [SID1234519759]). The agreement builds on the collaboration announced between the Group and Novartis in October 2014 and anticipates the commercial launch of CTL019 later this year.

Under the terms of the agreement which includes minimum offtake requirements, Oxford BioMedica could potentially receive in excess of $100 million from Novartis over the next three years. This amount includes a $10 million upfront payment, various performance incentives and bioprocessing and development services. The supply agreement is for three years, extendable to five years subject to the agreement of both parties.

In addition to this, and as previously announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis’s CAR-T products. On 30 March 2017, Novartis announced that the US Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) filing and granted priority review for CTL019.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "Today’s news demonstrates the value of our LentiVector platform and the quality of work we have delivered to Novartis over the last few years. The new deal with Novartis will strengthen the Group’s balance sheet immediately and will support the Group’s continued growth over the next three years. Oxford BioMedica is recognised as a world leader in the field of lentiviral vectors and we are delighted to be supporting Novartis and patients with commercial supply of the lentiviral vector used to generate CTL019."

USPTO APPROVES AND ISSUES PATENT FOR OXIS-4235 TO TREAT MULTIPLE MYELOMA

On July 5, 2017 Oxis International, Inc. (OTCQB: OXIS and Euronext Paris OXI.PA), parent of Oxis Biotech, reported that the U.S. Patent and Trademark Office has approved and issued Patent No. 9,580,382 for its drug candidate OXIS-4235 for the treatment of myeloma (Press release, OXIS International, JUL 5, 2017, View Source [SID1234539562]).

The USPTO also requires that products made or sold under the patent be marked with the statement "Patent No. 9,580,382."

The patent clears the way for Oxis Biotech to begin the process of pursuing clinical trials for OXIS-4235. The drug is a P62-ZZ chemical inhibitor intended for use as a treatment for multiple myeloma. According to the American Cancer Society, more than 30,000 people are expected to be diagnosed with the disease this year and more than 12,000 are expected to die from it.

Dr. Sean Xie of Pittsburgh, Pa., developed the drug. The drug is intended to stop the growth of multiple myeloma cells without harming healthy cells. In addition to shrinking the tumors, the dual purpose drug is also intended to increase bone density, a second benefit of the technology.

Oxis Biotech, through its licensing agreement with Dr. Xie, holds the exclusive worldwide rights to commercialize this technology.

CEO, Anthony Cataldo, said, "Patents are one of the major build blocks of market cap appreciation. Oxis continues to show progress with it’s oncology product pipeline. The issuance of patents that support the products in our portfolio, allows us to move these assets into commercially driven clinical trials with the market protections that issued patents provide." With the most recent announcement of the Oxis merger with Georgetown Translational Pharmaceuticals, Inc. (GTP), GTP brings in highly successful Executive Management, CEO, Kathleen Clarence-Smith, MD, Ph.D., and her team, are able to advance Oxis’ patented portfolio in oncology.