On August 31, 2016 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its RNA-based companion diagnostic, next-generation sequencing (NGS) assay (Trailblaze Pharos) (Press release, Ignyta, AUG 31, 2016, View Source [SID:1234514819]). The Trailblaze Pharos assay is intended for use in identifying patients, including those who are treatment-naïve, who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins, to determine eligibility for enrollment into the global STARTRK-2 trial, a Phase 2 study of entrectinib, a novel, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK gene fusions. Schedule your 30 min Free 1stOncology Demo! "We are pleased to have been granted this IDE approval for our investigational companion diagnostic assay, as it allows us to screen potential patients for STARTRK-2 who might not otherwise have access to tumor profiling for these fusions and therefore may never have been identified," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We look forward to continuing to work with the FDA on developing and providing a robust assay to help physicians identify cancer patients who may be eligible for our clinical studies."
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An IDE allows an investigational device, in this case the Trailblaze Pharos assay, to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application submission to FDA. An IDE application is approved only after direct review by the FDA on many aspects of the device validation and how clinical testing will be performed.
About Trailblaze Pharos
The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next-generation sequencing (NGS) based assay for the qualitative detection of fusions in the NTRK1/2/3, ROS1, or ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE) human solid tumor tissue. The assay is intended to be used as an aid in selecting patients, including those who are treatment-naïve, with solid tumors that harbor a gene rearrangement in NTRK1/2/3, ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be appropriate. A laboratory developed test (LDT) version of the Trailblaze Pharos assay was previously used to identify non-treatment-naïve patients with NTRK1/2/3, ROS1, or ALK gene rearrangements who might be eligible for the STARTRK-2 study.
About Entrectinib
Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against primary and metastatic CNS disease. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.
Author: [email protected]
Genmab Announces U.S. FDA Approval of Arzerra® (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL
On August 31, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, AUG 31, 2016, View Source [SID:1234514818]). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab. Schedule your 30 min Free 1stOncology Demo! Approval for this indication by the FDA is based on results from the Phase III COMPLEMENT 2 study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from COMPLEMENT 2 were reported in April 2015.
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"This is the fourth CLL indication approved in the U.S. for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About CLL
CLL is the most commonly diagnosed adult leukemia in Western countries, and accounts for approximately 1 in 4 cases of leukemia.1 Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.2
About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide (FC) or up to six cycles with fludarabine and cyclophosphamide alone.
The primary endpoint of the study was progression free survival (PFS), which was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines.3 The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032). Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.
Annual report and full year financial results
On August 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2016 (Press release, Starpharma, AUG 30, 2016, View Source [SID:1234514814]).
Financial Results
Net cash burn (cash outflows before new capital) $17.5M[1]
Cash position at end of the year $46.0M
Net proceeds of $32.6M from equity placement and share purchase plan
Total revenue and other income $4.6M including the first US$2M DEP milestone from AstraZeneca
Reported loss $22.7M
Receipt of $3.4M R&D tax incentive
Operational Highlights
VivaGel
EU marketing approval for the VivaGel BV treatment and symptom relief product;
Licensing deal with Aspen for VivaGel BV treatment and symptom relief product in Australia and New Zealand with pre-launch activities well advanced;
Phase 3 clinical trials of VivaGel BV for the prevention of recurrent bacterial vaginosis (BV) more than 90% enrolled;
VivaGel active shows potent antiviral activity against Zika virus;
License for VivaGel condom in China for the Government market; and
Significant progression of commercial and regulatory activities for the VivaGel condom in important markets with approvals anticipated in coming months.
Drug Delivery
Signing of a multiproduct drug delivery license with AstraZeneca for DEP enhanced oncology molecule;
Second DEP candidate nominated by AstraZeneca under the license;
DEP docetaxel phase 1 clinical trial showing promising efficacy signals and advancing to the final expansion phase with no neutropenia or hair loss reported;
Extension of DEP programs with AstraZeneca adding a new DEP candidate from their portfolio;
Impressive preclinical results for both DEP cabazitaxel and Targeted DEP candidates in human cancer models; and
Two new Targeted DEP partnerships signed with world leading antibody-drug conjugate companies.
Agrochemicals
Adama licenses Priostar for the US market to create novel dendrimer-enhanced versions of 2,4-D, a major global agrochemical;
Signing of several new partnerships with leading agrochemical companies including major Japanese agrochemical business; and
Important progress and results for Priostar agrochemical internal programs.
Commenting on the 2016 financial year’s achievements and the outlook, Starpharma CEO, Dr Jackie Fairley, said:
"FY16 has been a significant year in Starpharma’s development as a company, with each of our business areas reaching important commercial milestones and a number of major development and regulatory accomplishments across our VivaGel, drug delivery and agrochemical portfolios".
"The year saw Starpharma sign the multiproduct DEP license with AstraZeneca, starting with a DEP enhanced oncology molecule, and rapidly expanding to a second candidate under that license. The relationship with AstraZeneca was recently further cemented when they added a completely new compound from their portfolio to the DEP collaborative programs. In the wider drug delivery portfolio, the phase 1 clinical trial of our internal candidate, DEP docetaxel, is showing promising efficacy signals and advancing into its final expansion phase with no neutropenia or hair loss reported. Also, we’ve seen impressive preclinical efficacy results for DEP cabazitaxel and our Targeted DEP candidates. The latter, generated a significant amount of industry interest and as a result we have very recently added two new partnerships with world leading antibody-drug conjugate (ADC) companies. It is great to have them working alongside Starpharma to exploit the unique benefits of the DEP technology for the development of the next generation of ADCs" she added.
"In the VivaGel portfolio we achieved a landmark for VivaGel BV this year – EU regulatory approval. This approval has been used to expedite regulatory processes in a number of markets as well as supporting a very active commercialisation and licensing program in preparation for product launch. The VivaGel BV phase 3 clinical trials for the prevention of recurrent BV are more than 90% enrolled. Thirdly, the deal with Sky and Land adds the large Chinese Government sector as a new market opportunity to the existing Ansell and Okamoto licenses for the VivaGel condom. We also anticipate FY17 will be another year of significant regulatory and commercial progress for the VivaGel condom product".
"Finally in our agrochemical portfolio, over the period we secured an important deal with the Adama license of Priostar to create new enhanced versions of a major global agrochemical 2,4-D, for the US market. We have also seen important progress with further promising field trial results for Priostar agrochemicals in our internal programs. In addition to Adama we signed a number of external partnerships including one with a major Japanese agrochemical company" Dr Fairley stated.
Net cash outflows from operating and investing activities for the year were $17.8 million (2015: $14.3 million), with cash reserves at 30 June 2016 of $46.0 million (2015: $30.8 million). The net loss after tax was $22.7 million (2015: $19.0 million), with the increase primarily a result of the VivaGel and DEPTM docetaxel clinical programs in progress, offset by an increase in revenue. Revenue increased for the year largely as a result of the first milestone (signature fee) from AstraZeneca under the multiproduct DEP license.
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Varian Expands Access to Advanced Cancer Care in Bolivia
On August 30, 2016 Varian Medical Systems (NYSE: VAR) reported the installation of a Clinac iX medical linear accelerator at Instituto Oncologico del Oriente Boliviano in Santa Cruz, Bolivia (Press release, Varian Medical Systems, AUG 30, 2016, View Source [SID:1234514797]). First patient treatments were started earlier in August.
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In addition to the installation of the Clinac iX, Varian in conjunction with its distributor in Bolivia, HP Medical, held a two day seminar in Santa Cruz, Bolivia for clinicians and radiation therapists. At the seminar, attendees were able to learn about the latest advances in cancer care treatment, including imaging, and treatment planning and delivery.
The seminar keynote speaker, Dr Beatriz Amendola, radiation oncologist, Innovative Cancer Institute stated, "By partnering with Varian on this successful first seminar in Bolivia, we were able to deliver important cancer care information to clinicians and therapists. I look forward to working with Varian and Dr. Oliver Pinto and Dr. Oscar Javier Urenda from the Oncology hospital and training more staff in in the future."
Designed to deliver a wide range of imaging and patient treatment options, the Clinac iX system offers features to facilitate advanced treatments including intensity- modulated radiation therapy (IMRT), image-guided radiation therapy (IGRT), and stereotactic radiosurgery. Instituto Oncologico del Oriente Boliviano will also be utilizing Varian Eclipse treatment planning software and ARIA information management system to manage, plan and deliver patient treatment.
"With the installation of the Clinac iX and the Varian software, we are now able to quickly deliver much needed cancer care treatment to a greater number of patients in Bolivia," said Dr. Oliver Pinto, head of Radiation Therapy, Instituto Oncologico del Oriente Boliviano.
"As was outlined in the Lancet Oncology Commission report in 2015, a lack of investment in radiotherapy services in the past has severely limited access to radiotherapy treatments worldwide," said Chris Toth, president, Oncology Systems Americas at Varian. "We are proud to be working with Instituto Oncologico del Oriente Boliviano, and making this advanced cancer fighting treatment available to a wider range of patients in Bolivia."
Radius Health Announces Three Presentations on RAD1901 at the San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016
On August 30, 2016 Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported that it will present new data from multiple studies of RAD1901, an oral selective estrogen degrader, in ER-positive breast cancer at the San Antonio Breast Cancer Symposium Meeting December 6-10, 2016 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Radius, AUG 30, 2016, View Source [SID:1234514796]).
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Details for the abstracts related to RAD1901 are below:
Abstract Title: A Phase 1 Study of RAD1901, a Novel, Oral, Selective Estrogen Receptor Degrader (SERD), for the Treatment of ER-Positive Advanced Breast Cancer, Poster # 1454
Poster Session 4
Session Title: Treatment: Advanced Endocrine Therapy
Session Date: 12/8/2016
Session Time: 7:30 AM — 9:00 AM
Location: Hall 1
Abstract Title: A Phase 1 Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, to Determine Changes in the F-FES Uptake and Tumor Responses in ER-Positive, HER-2-Negative, Advanced Breast Cancer Patients, Poster # 1604
Poster Session 4
Session Title: Treatment, Advanced Endocrine Therapy
Session Date: 12/8/2016
Session Time: 7:30 AM — 9:00 AM
Location: Hall1
Abstract Title: RAD1901 Demonstrates Anti-Tumor Activity in Multiple Models of ER+ Breast Cancer Treatment Resistance, Poster # 1378
Poster Session 4
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2016
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1