On July 7, 2017 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that its abstract covering the complete data set from its Phase Ib study of ARGX-111 in patients with advanced cancers over-expressing the MET protein was selected as part of the Best of ASCO (Free ASCO Whitepaper) program at the 3rd Singapore Society of Oncology Annual Scientific Meeting in Singapore (Press release, arGEN-X, JUL 7, 2017, View Source [SID1234519763 Schedule your 30 min Free 1stOncology Demo! The differentiated design of ARGX-111 to enhance killing of advanced tumor cells offers a really exciting approach to treating patients with MET-driven cancers," commented Nicolas Leupin, Chief Medical Officer of argenx. "We are pleased to see preliminary anti-tumor activity and a consistently favorable safety profile, which was the goal of this expansion study. These data offer a compelling path forward to further examine in a Phase 2 study the activity of ARGX-111, which we are looking to strategically partner."
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The new data from the Phase Ib study continue to show evidence of anti-tumor activity with
ARGX-111 at all dose levels and across different indications. Partial response and stable disease were observed, respectively, in one and nine of 24 heavily pretreated patients with MET-positive malignancies, both MET-gene-amplified and with MET overexpression. Treatment-emerging adverse events were reported for all patients, but none of the grade 5 toxicities were related to ARGX-111. The poster presented at Best of ASCO (Free ASCO Whitepaper) can be accessed from the "Downloads" section of the argenx website.
About ARGX-111
ARGX-111 was developed for the treatment of patients with certain solid tumors that overexpress c-Met, a receptor associated with tumor growth and metastasis, or tumors that are mesenchymal-epithelial transition factor, or MET, amplified. ARGX-111 employs the SIMPLE AntibodyTM, NHance and POTELLIGENT technologies to drive tissue penetration in the body and to increase its ability to enhance ADCC. ARGX-111 binds to c-Met with high affinity and does not cause dimerization of the c-Met receptor, which differentiates it from other, earlier attempts to direct antibodies against c-Met. Dimerization is a process which can result in receptor activation, undermining the intended therapeutic effect of antibodies blocking hepatocyte growth factor, or HGF, binding to c-Met. By blocking both HGF-dependent and independent c-Met activation, ARGX-111 is able to block c-Met receptor activation which could trigger survival, proliferation and metastasis of tumor cells. In order to further examine the activity of the product candidate in a Phase 2 study, argenx is actively looking for an appropriate collaboration partner.
Author: [email protected]
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. Schedule your 30 min Free 1stOncology Demo! "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."
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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]).
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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.
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]). Schedule your 30 min Free 1stOncology Demo! 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.
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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. Schedule your 30 min Free 1stOncology Demo! 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.
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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."