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ONCOLOGY VENTURE AND EISAI FORGE EXCLUSIVE GLOBAL LICENSE AGREEMENT FOR CLINICAL STAGE ONCOLOGY DRUG PARP INHIBITOR E7449 / 2X-121

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.

argenx presents full data from ARGX-111 Phase Ib study in patients with advanced cancers over-expressing the MET protein at Best of ASCO Asia 2017 (Singapore)

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

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."

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.

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.

"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)."