On February 22, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported a strategic research collaboration with TESARO and Merck, known as MSD outside the U.S. and Canada, to help identify potential responders to an investigational combination drug therapy using TESARO’s PARP inhibitor (niraparib) plus KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Myriad Genetics, FEB 22, 2016, View Source [SID:1234509126]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, the companies will use Myriad’s myChoice HRD test and new tumor tests to evaluate treatment response in a clinical trial evaluating the combination of niraparib plus pembrolizumab in patients with triple negative breast cancer (TNBC) or ovarian cancer. Other terms of the deal were not disclosed.
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"The combination of a PARP inhibitor and anti-PD-1 antibody may offer a novel way to treat women with triple negative breast cancer or ovarian cancer," said Mary Lynne Hedley, Ph.D., president and COO of TESARO. "Our goal is to use Myriad’s assays to help enrich for those patients who will respond to the treatment and have the best chance for success."
"Treatment options for patients with triple negative breast cancer are extremely limited," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics, Inc. "We are very excited to expand our collaboration with TESARO and Merck to determine if our novel companion diagnostic assays can optimize the potential for this experimental combination therapy."
The new agreement builds upon a collaboration with TESARO that began in March 2014. Since then, Myriad has been working with TESARO to use the myChoice HRD test to identify ovarian cancer patients who may respond to niraparib, which is in Phase 3 clinical development.
About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.
Year: 2016
AVEO Announces Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation
On February 22, 2016 AVEO Oncology (NASDAQ:AVEO) reported that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced renal cell carcinoma ("RCC") has been accepted by the Ministry of Health ("MoH") of the Russian Federation (Press release, AVEO, FEB 22, 2016, View Source [SID:1234509125]). The dossier was submitted in December 2015 by Pharmstandard Group, the largest Russian pharmaceutical group ("Pharmstandard"). Schedule your 30 min Free 1stOncology Demo! In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications other than non-oncologic diseases or conditions of the eye.
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Marketing authorization is being sought by Pharmstandard based upon results from TIVO-1, AVEO’s global, randomized, controlled Phase 3 trial evaluating tivozanib compared to sorafenib in patients with advanced RCC. AVEO is eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia, provided that Russian regulatory authorities grant marketing approval based on the results from TIVO-1. If Russian regulatory authorities require additional studies to be performed prior to approval, the amount potentially payable to AVEO upon approval would be $3.0 million. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
"Acceptance of a registration dossier marks an important step toward potential approval of tivozanib in RCC in territories outside the United States," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to MoH review of the dossier as we work toward submitting a marketing authorization application to the European Medicines Agency with our partner EUSA Pharma. In parallel, we continue to work toward the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor. Both studies may provide important strategic datasets in a rapidly evolving treatment landscape in RCC."
About Tivozanib
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.
Celldex Presents Preliminary Cohort Data from Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Harvest at the 2016 BMT Tandem Meeting
On February 20, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported new clinical data on CDX-301 (recombinant human Flt3 ligand), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells (Press release, Celldex Therapeutics, FEB 20, 2016, View Source [SID:1234509111]). An open label, pilot study of CDX-301, alone and in combination with Mozobil (plerixafor), in sibling-matched donors for allogeneic hematopoietic stem cell transplantation (HSCT) recipients who have certain hematologic malignancies is currently enrolling donor/patient pairs. Early data were presented in a poster entitled "Preliminary Safety and Efficacy Data using CDX-301 (Flt3 ligand) as a Sole Agent to Mobilize Hematopoietic Cells Prior to HLA-matched Sibling Donor Transplantation" at the 2016 BMT Tandem Meeting, the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The poster is available on the "Publications" page of the "Science" section of the Celldex website.
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Three donor/patient pairs showed that CDX-301 given as a single agent for 5 days was well tolerated and effective at mobilizing hematopoietic stem cells in healthy donors. The stem cell graft contained notable increases in naïve lymphocytes and plasmacytoid dendritic cells compared to administration of G-CSF (granulocyte colony-stimulating factor) and is consistent with preclinical data suggesting a possible better outcome for recipients. Notably, no donors required rescue with either G-CSF or Mozobil in this arm of the study, and none experienced any grade 3 or 4 adverse events. Recipients experienced successful engraftment in an expected time frame. Additional donor/patient pairs are being accrued to a second, planned cohort in order to assess the potential synergies and feasibility of combining CDX-301 with Mozobil in this setting.
"From these data and preclinical studies, CDX-301 appears to be an effective, targeted approach to mobilization comparable to G-CSF. With a relatively short course of treatment, we are observing specificity for mobilized stem cells and a lack of toxicity, instead of broad cellular mobilization and side effects," said Steven Devine, M.D., Professor of Internal Medicine, Division of Hematology, Department of Internal Medicine, and Program Director, Blood and Marrow Transplant Program at The Ohio State Comprehensive Cancer Center.
"CDX-301 shows a favorable safety profile and effectively mobilizes early stem cells when used alone, and we expect even greater yields in the next cohort where we combine with Mozobil," said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex Therapeutics . "CDX-301 could potentially provide good engraftment, less graft-versus-host disease and mitigated side effects, which would be a breakthrough for these patients undergoing HSCT. We are also looking forward to receiving data from investigators who are using CDX-301 in other drug combination studies designed to assess its potential in immunotherapy for cancer and other indications."
In addition, CDX-301 has shown impressive results in models of cancer, infectious diseases, inflammatory/autoimmune diseases and immune suppression. Celldex believes CDX-301 may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company’s portfolio and in external development. CDX-301 is in clinical development for cancers in combination with vaccines, adjuvants, and other treatments that result in release of tumor antigens to enhance tumor immunogenicity.
OV in-licensed LiPlaCis™ as third drug in OV pipeline
On February 19, 2016 Oncology Venture Sweden AB (OV:ST) reported that it has in-licensed LiPlaCis from LiPlasome Pharma ApS, Denmark (Press release, Oncology Venture, FEB 19, 2016, View Source;as-third-drug-in-ov-pipeline,c9919954 [SID1234532173]). LiPlaCis is the third drug in OV’s pipeline and will be the first prospective trial using the Drug Response Predictor – DRP. LiPlaCis is the lead product in LiPlasome Pharma – mainly owned by Vecata Invest A/S an investment company managing the Bagger-Sorensen Group’s investments in the venture segment. LiPlaCis – a liposomal formulation of cisplatin – is just finalizing the dose escalation part of a phase 1 study in solid tumors and is on the verge of moving into the extension phase where screened breast cancer patients with metastatic disease will be treated. Using analysis of patients own biopsies by the DRP patients are screened beforehand for high likelihood of effect of the LiPlaCis drug. The DRP should thereby enable a high response rate and give breast cancer patients a new effective treatment opportunity. There is no sign on fee and no up-front payment to LiPlasome. The License agreement is based on a revenue split between the parties once the LiPlaCis product is commercialized. It is anticipated that more capital will be needed to take LiPlaCis the whole way to outlicensing/exit. OV will raise money when it is needed and as previously announced each product including LiPlaCis is budgeted to cost approximately 2 mUSD on average.
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"This is a key step for OV – the team in OV has the last three years worked with MPI and LiPlasome on LiPlaCis and the fact that OV can now take over the responsibility for this promising project is indeed a major step forward for OV", Said Adjunct professor Peter Buhl Jensen, MD, PhD and CEO of Oncology Venture. "We know the project well and we are proud that Vecata Invest as the major owner has let us include LiPlaCis in the OV portfolio. We trust we can develop LiPlaCis into a new effective treatment opportunity for breast cancer patients", Dr. Buhl Jensen further commented."
"We are very happy to out-license the lead product LiPlaCis to Oncology Venture which we believe is a better home for a product progressing into a more advanced level in clinical development", Said Hans-Henrik Eriksen CEO of Vecata Invest. "Oncology Venture has a proven team and in our joined advisory board we look forward to a continued collaboration bringing LiPlaCis to cancer patients."
LiPlaCis is a liposomal formulation of cisplatin. LiPlaCis is finalizing a promising clinical phase 1-studie with early responses in non-screened patients with solid tumors (one patient with esophageal cancer and one patient with skin cancer) and is on the verge of entering an extension phase 2 design study in which 12 breast cancer patients will be treated based on screening using the DRP and where efficacy will be measured. LiPlaCis is thereby the most advanced drug in the Oncology Venture pipeline. The team responsible for running the phase 1 trial is the OV team which is an advantage as OV is therefore very familiar with the product manufacturing, regulatory communication as well as the conduct of the study at the clinical site. Thus, there will be no time wasted in the takeover period.
In a collaboration with the Danish Breast Cancer Cooperative Group (DBCG) including nine Danish breast cancer sites more than 900 patients with metastatic breast cancer have participated in the screening for high likelihood responders to LiPlaCis. Biopsies from the patients have been analyzed by the LiPlaCis DRP and the project is very soon to start include patients. The LiPlaCis active ingredient is cisplatin and the Cisplatin DRP has been previously validated retrospectively in a lung cancer study and now also in a prospective lung cancer study (Abstract submitted to ASCO (Free ASCO Whitepaper)). OV therefore prioritize this proof of concept study with LiPlaCis in breast cancer patients. This is the fastest possible first prospective trial using the DRP method.
The LiPlaCis deal
There is no sign on fee and no up-front payment to LiPlasome. The License agreement is based on a revenue split between the parties once the LiPlaCis product is commercialized. It is anticipated that more capital will be needed to take LiPlaCis the whole way to outlicensing/exit. OV will raise money when it is needed and as previously announced each product including LiPlaCis is budgeted to cost approximately 2 mUSD on average.
About LiPlaCis
Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumour types. Cisplatin is used in the treatment of large indications as lung cancer EU+US ≈ 480,000 new cases annually), head and neck cancer (500,000 cases annually worldwide) bladder cancer (EU+US ≈ 170,000 annually) and ovarian cancer (EU+US ≈ 71,000 annually). The lipid formulation from LiPlasome is the answer to a well-established need for improving cisplatin therapy and improving the formulation of the drug, so that a more selective up-take of cisplatin administered takes place at the tumour sites. LiPlasome Pharma ApS has identified and incorporated a mechanism into their liposomes – called LiPlasomes – designed to trigger the release of an encapsulated drug specifically in the tumour tissue. An enzyme especially present on tumors called secretory phospholipase A2 (sPLA2), is utilised to break down the LiPlaCis once it has accumulated in the cancer tissue. The lipid composition of the LiPlasomes is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated drug. The technology behind LiPlaCis was originally developed by scientists from Danish Technical University -DTU.
More about LiPlaCis and the clinical testing
The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours is running at a Phase 1 Unit at a University Hospital in Copenhagen and has included 18 patients in the dose escalation part of a phase 1 study in solid tumors. The LiPlaCis program is now on the verge of moving into the extension phase 2 designed trial (part of the phase 1 application where patients with a specific disease – here metastatic breast cancer – are included to investigate early Proof of Concept – i.e. effect of the drug. LiPlaCis is administered intravenously in cycles weekly on day 1, day 8 Upon the investigator’s judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug.
About the Drug Response Predictor -DRP – screening tool
Oncology Venture uses the MPI DRP to select those patients that by the gene signature in their cancer is found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients and by screening patients before treatment the response rate can be significantly increased.
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. The DRP based on microRNA is used on certain products where the DRP based on messenger RNA is more broadly useable and more validated.
10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
(Filing, 10-K, Eli Lilly, FEB 19, 2016, View Source [SID:1234509112])
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