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.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
Author: [email protected]
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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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
OncoMed Pharmaceuticals Completes Enrollment of Phase 2 PINNACLE Clinical Trial of Tarextumab in Small Cell Lung Cancer
On August 30, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical development-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported the completion of patient enrollment in the Phase 2 "PINNACLE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of small cell lung cancer (SCLC) (Press release, OncoMed, AUG 30, 2016, View Source [SID:1234514798]). The PINNACLE study enrolled 145 patients with extensive-stage SCLC who had not received prior treatment. Topline data from the Phase 2 trial are expected to be reported at the end of 2016 or in early 2017. Schedule your 30 min Free 1stOncology Demo! "Our PINNACLE Phase 2 trial accrued patients more quickly than anticipated and we would like to thank the patients, their families, caregivers and the participating investigators and study site personnel for their participation. Small cell lung cancer is a difficult to treat cancer and unfortunately most patients survive a year or less. New and improved treatment options are needed for these patients," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "In a Phase 1b dose-escalating trial of tarextumab in small cell lung cancer we observed that patients who received standard-of-care chemotherapy in combination with tarextumab near or at the selected Phase 2 dose appeared to have deeper anti-tumor responses and improved survival outcomes, particularly in tumors that were high in certain Notch pathway genes. We look forward to seeing if these observations are maintained in our Phase 2 trial and anticipate reporting data from PINNACLE at the end of 2016 or in early 2017."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Patients enrolled in the PINNACLE trial were randomized into two study arms and received either 15mg/kg of tarextumab every three weeks in combination with six cycles of etoposide and platinum therapy followed by tarextumab maintenance to progression or six cycles of standard chemotherapy and a placebo. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival and overall response rate, pharmacokinetics, safety and biomarker analyses. Overall survival, progression-free survival and overall response rates will be assessed against elevated tumor expression of certain Notch pathway genes. The protocol for the Phase 2 trial was amended in May 2016 to enable the assessment of efficacy outcomes using Notch pathway genes Hes1, Hes6, Hey1 and Hey2 as a secondary endpoint.
The PINNACLE trial was conducted at 36 sites in the United States. Enrollment in the randomized, double-blinded, multi-center clinical study began in December 2014 and was completed three months ahead of schedule.
In the Phase 1b trial, all 26 patients evaluable for tumor response saw a reduction in target lesion size as measured by RECIST criteria, with an overall response rate of 77% and a 100% clinical benefit rate. Subjects receiving doses of tarextumab at or above 12 mg/kg plus chemotherapy achieved a median progression-free survival of 5.2 months and a median overall survival of 16 months. Results from OncoMed’s Phase 1b trial of tarextumab were most recently presented at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting.
About Small Cell Lung Cancer
According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in men and women and is by far the leading cause of cancer death. Small cell lung cancer is expected to make up about 10%-15% of the 224,390 newly diagnosed lung cancer cases and the 158,080 deaths estimated to occur in the U.S. in 20161. SCLC tends to grow and spread quickly, and is typically not discovered until it has metastasized to other parts of the body (extensive stage). The current standard of care in treating small cell lung cancer is the chemotherapeutic etoposide in combination with either cisplatin or caboplatin. In spite of a high sensitivity to chemotherapy and remission rates of up to 80% following initial treatment, the median overall survival is less than one year for patients with extensive stage disease2.
About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is being studied in the "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer). Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.