On June 01, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CA-170 (Press release, Curis, JUN 1, 2016, View Source [SID:1234512911]). CA-170 is a first-in-class orally available small molecule that has been designed to target and inhibit the immune checkpoints, Programmed Death Ligand-1 (PD-L1) and V-domain Immunoglobulin Suppressor of T-cell Activation (VISTA). Schedule your 30 min Free 1stOncology Demo! "The acceptance of CA-170’s IND by the FDA marks an important milestone in the advancement of immuno-oncology therapy," said Ali Fattaey, Ph.D., Curis’s president and CEO. "The last few years have seen the successful development and commercial launch of multiple checkpoint inhibitors to treat a broad range of human cancers. However, all checkpoint inhibitors developed thus far have been monoclonal antibodies, with similar pharmacokinetic properties, and can only be administered by IV infusion. Today, the FDA has cleared us to test the first small molecule checkpoint inhibitor, CA-170, that will be taken orally by cancer patients. We envision that the pharmacokinetic properties of a small molecule will likely provide an advantage in dosing flexibility of a checkpoint inhibitor, either as a monotherapy or in combination with other cancer treatment regimens. We believe that, if successful, CA-170 can provide a compelling treatment alternative for patients and physicians."
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!
CA-170 is an orally available, small molecule designed to selectively target and inhibit both PD-L1 and VISTA checkpoint regulators of immune activation. Preclinical data have demonstrated that CA-170 can induce effective proliferation and cytokine production by T cells in culture that are specifically suppressed by PD-L1 or VISTA. In addition, CA-170 demonstrated in vivo anti-tumor activity similar to anti-PD-1 or anti-VISTA antibodies in multiple mouse tumor models and appeared safe to administer based on toxicology studies.
Author: [email protected]
Bayer collaborates with U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) to Investigate Stivarga® (Regorafenib) as Additional Adjuvant Therapy in Colon Cancer (for specialized target groups only)
On June 1, 2016 Bayer and the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP), a leading clinical trials cooperative group, are collaborating on a new Phase III study to investigate Stivarga (regorafenib) as an additional adjuvant therapy in colon cancer (Press release, Bayer, JUN 1, 2016, View Source [SID:1234512910]). The ARGO trial will investigate regorafenib as a single agent for the adjuvant treatment of Stage IIIB and IIIC colon cancer following completion of standard adjuvant chemotherapy. In this stage, the tumor has started to invade the wall of the colon, but not yet spread to other distant organs. Schedule your 30 min Free 1stOncology Demo! "In 2016, more than 134,000 adults in the United States will be diagnosed with colorectal cancer. Two-thirds of these cases, or more than 95,000, will be cancers of the colon," said Norman Wolmark, MD, Chairman of the Foundation. "Despite receiving adjuvant chemotherapy, patients with stage IIIB and IIIC colon cancer have about a 40% risk of developing metastatic disease, meaning that the disease has spread from the colon to distant organs. Given the anti-metastatic effects of regorafenib demonstrated pre-clinically and the treatment benefits in the metastatic setting of colorectal cancer, we are keen to explore if it could also help patients at earlier stages of the disease."
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!
The Phase III study ARGO, a randomized, double-blind, placebo-controlled study, will be conducted by NSABP, with Bayer offering consultation as well as financial support. If positive, Bayer may use the results for submission of marketing authorization of Stivarga in this earlier stage of the disease.
"We are excited to be collaborating with NSABP to further explore the potential of regorafenib in an earlier line of treatment for patients with colon cancer, one of the most common forms of cancer worldwide," said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. "We believe that by partnering with those on the front line of patient care, we will be in a position to deliver additional therapeutic options to treating physicians and their patients."
Regorafenib is approved under the trade name Stivarga in 90 countries worldwide, including the United States, Europe, and Japan for the treatment of metastatic CRC. The approval of regorafenib was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Full results from the CORRECT study were published in January 2013 in The Lancet.
About the ARGO Study
The Phase III study ARGO (A Phase III Randomized Placebo-Controlled Study Evaluating ReGOrafenib Following Completion of Standard Chemotherapy for Patients with Stage III Colon Cancer) will investigate whether providing oral regorafenib monotherapy in the adjuvant setting after standard chemotherapy increases disease-free survival (DFS) in patients with Stage IIIB/IIIC colorectal cancer. The secondary study endpoints include overall survival (OS) and safety. The trial will enroll approximately 1,100 patients from the U.S. who will be randomized in a 1:1 ratio to receive either 120 mg regorafenib or placebo for a planned duration of two years.
About Colon Cancer
The colon is part of the body’s digestive system, which is called the gastrointestinal system. Most colon cancers begin as a growth or a polyp on the inner lining of the colon, a part of the large intestine. Some types of polyps can develop into cancer over the course of several years. The cancer occurs when cells in the body begin to grow out of control.
Colon cancer is often grouped with rectal cancer because the two diseases share many common features. However, treatment approaches may differ for colon and rectal cancers, especially in the earlier stages.
Worldwide, colon and rectal cancers make up the third most common cancer in men and women combined. In 2012, there were an estimated 1.3 million new cases, and that number is expected to increase to 1.6 million by 2020.
About Regorafenib (Stivarga)
Regorafenib is an oral multi-kinase inhibitor that targets various kinases involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, regorafenib inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.
Regorafenib is approved under the brand name Stivarga in 90 countries for the treatment of mCRC and in more than 70 countries for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
About the National Surgical Adjuvant Breast and Bowel Project
The National Surgical Adjuvant Breast and Bowel Project (NSABP) is a clinical trials cooperative group supported since its inception by the National Cancer Institute (NCI).
Since its beginning the NSABP has enrolled more than 110,000 women and men in clinical trials in breast and colorectal cancer. Headquartered in Pittsburgh, Pennsylvania, the NSABP has research sites at nearly 1000 major medical centers, university hospitals, large oncology practice groups, and health maintenance organizations in the United States, Canada, Puerto Rico, Australia, and Ireland. In addition to federally sponsored studies, the NSABP also conducts research supported by other resources.
20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]
(Filing, Annual, BioLineRx, 2015, MAY 31, 2016, View Source [SID:1234512873])
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!
Myriad Acquires Sividon Diagnostics
On May 31, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has acquired Sividon Diagnostics, a leading breast cancer prognostic company, for €35 million upfront with the potential for €15 million in additional performance-based milestones (Press release, Myriad Genetics, MAY 31, 2016, View Source [SID:1234512945]). The transaction closed on May 31, 2016. Myriad expects the deal to be neutral to both revenue and earnings in fiscal year 2017. A discussion on the details and strategy underlying the transaction will be provided on a conference call today at 4:30 pm EDT.
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!
"Sividon brings to Myriad the best-in-class breast cancer prognostic test and strengthens our market leading oncology portfolio of high value personalized medicine products," said Mark C. Capone, president and CEO, Myriad Genetic Laboratories. "The EndoPredict test will be the foundational product of our newly initiated kit-based strategy and allow Myriad to leverage its global oncology distribution to bring this important test to patients worldwide."
"We are excited to be integrated with the global leader and pioneer in personalized medicine," said Christoph Petry, CEO of Sividon Diagnostics. "Myriad has the reimbursement, regulatory, and commercial expertise to make this product very successful, especially as we seek distribution in the United States and broader reimbursement coverage in Europe."
Sividon Diagnostics was spun out of Siemens Healthcare Diagnostics in 2010 as part of a management buyout. Their core EndoPredict product is a kit-based RNA expression test that evaluates 12 genes to assess the aggressiveness of breast cancer on a molecular level. The test is currently CE Marked on the Siemens Versant instrument, however, Myriad is transitioning the product to the Thermo Fisher QuantStudio platform as a key step in the international kit strategy. EndoPredict has been evaluated in 5 major studies incorporating more than 4,000 patients, utilized on a clinical basis in over 13,000 patients worldwide, and is extensively referenced in clinical guidelines across the globe. In a head-to-head study, it has been shown to outperform the prognostic ability of the leading first generation test while providing definitive answers with no intermediate results.
Benefits of the Transaction
Synergistic Product Within the 4in6 Strategy: EndoPredict evaluates the aggressiveness of breast cancer to help patients decide whether to safely forgo chemotherapy and will be added into our existing oncology commercial channel, creating significant opportunities for operating leverage.
Substantial Market Opportunity: Myriad believes the global market opportunity for EndoPredict is greater than $600 million with the majority of that market existing in major European countries, Canada, and the United States. We estimate that this market is less than 25 percent penetrated on a global basis and EndoPredict should benefit from a significant expansion in reimbursement in the coming years.
Best-in-Class Product: EndoPredict has been studied in approximately 4,000 patients and utilized in over 13,000 patients, and has consistently demonstrated the best ability to predict which patients are at low risk for distant metastases in both node negative and node positive patients. Additionally, the kit-based format provides unique advantages in the marketplace and EndoPredict will be the foundational product in Myriad’s global kit-based strategy.
Broadens Comprehensive Product Offering in Oncology: Myriad currently sells market leading tests in oncology for hereditary cancer and companion diagnostics. EndoPredict answers another important clinical question for breast cancer patients by identifying which can safely forgo chemotherapy. Oncology customers can increasingly rely on Myriad as a single source trusted advisor answering questions across the entire continuum of care with unmatched quality.
Financing
Myriad intends to fund the transaction entirely through cash on hand. At the end of the fiscal third quarter Myriad had cash and cash equivalents of $286 million on hand.
Baxalta and Award-winning Photographer Debut Unique Exhibition Showcasing Perspectives of Those Impacted by Rare Cancers
On May 31, 2016 Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported the unveiling of an initiative that illustrates the perspectives of those impacted by rare cancers, created in partnership with photographer Rick Guidotti of Positive Exposure (Press release, Baxalta, MAY 31, 2016, View Source [SID:1234512924]). The photo exhibit, Rare Cancer Illuminated: a View From Within, debuts on June 2 in Chicago as part of The Atlantic’s "The Search for Answers: Fighting Rare Cancers," which Baxalta is underwriting.
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!
"The Search for Answers: Fighting Rare Cancers"
Tweet this
This press release has an accompanying Smart Marketing Page providing further details about the organization, products and services introduced below. You can access the Smart Marketing Page via the following link: View Source
People living with rare and underserved cancers often experience difficulty with disease recognition, late or inaccurate diagnosis,1 limited treatment options, and scarcity of clinical trial availability or registries.2 Through photography, Guidotti and Baxalta aim to raise awareness and understanding of the unique challenges that rare cancer communities face and encourage greater collaboration to achieve more efficient diagnoses, treatment, access, and support.
The exhibit gathers individuals connected by various types of rare adult, pediatric, and adolescent cancers, such as pancreatic cancer, myelodysplastic syndromes (MDS), and acute lymphoblastic leukemia (ALL), and aims to illuminate the passion that drives them daily. While there is no international consensus on the definition of rare cancer, it is defined as fewer than 15 per 100,000 cases per year in the U.S.3 In Europe, rare disease is defined as those with a prevalence of fewer than 50 per 100,000 cases.3 Underserved cancers are typically referred to as those receiving inadequate physical or emotional resources.
"At Baxalta, our mission is to improve the lives of individuals affected by rare cancers through the use of innovative technologies and approaches, such as harnessing the body’s immune system," said David Meek, Executive Vice President and President, Oncology, Baxalta. "Our collaboration with Positive Exposure aims to raise awareness of rare cancers and to unite the community to drive action."
Guidotti founded the not-for-profit organization, Positive Exposure, in 1998, to celebrate and understand human diversity. Using photography, Guidotti aims to change public perception by helping people to see beyond standard definitions of beauty and arrive at their own interpretation. Rare Cancer Illuminated: a View From Within features photographs by Guidotti of rare cancer community members including those who have been diagnosed with cancer, their family and friends, advocacy organizations, and healthcare professionals. The exhibit will travel to Europe later this year.
"Baxalta’s commitment to serving rare cancer communities aligns with my vision to see beyond disease or diagnosis and celebrate our shared humanity," said Guidoitti, Founder, Positive Exposure. "We hope that people who experience this exhibit are able to take away a greater sense of understanding and compassion for communities that are up against these challenges, and feel empowered to learn more and become part of the effort to bring solutions."
The exhibit includes representation from leading advocacy organizations including: American Cancer Society Cancer Action Network; Austrian Childhood Cancer Organization; the Myelodysplastic Syndromes (MDS) Foundation, Inc.; PAN-Austria (Patient Advocacy for Adolescents and Young Adults with Neoplasia); Pancreatic Cancer Action; Stupid Cancer, Inc.; and TEB e.V. Germany (translated to Tumors and Diseases of the Pancreas). Together, their stories focus on the need for improved delivery and access to critical resources and support worldwide.
The Atlantic’s "The Search for Answers: Fighting Rare Cancers," underwritten by Baxalta, will take place on June 2 from 2:00-5:00 p.m. CDT in Chicago ahead of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The event will focus on topics such as the fight against rare cancer, the role of advocacy organizations, the White House’s Moonshot Initiative, patient access, and support networks. Confirmed speakers include: Richard Schilsky, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Chief Medical Officer and co-author of Value Framework; American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld; and Kim Thiboldeaux, President and Chief Executive Officer of the Cancer Support Community.
This event is open to media; please RSVP directly to The Atlantic’s Sydney Simon ([email protected]; 202-266-7338) to attend. A live stream of the afternoon’s conversations will be available beginning at 2:30 p.m. CDT on June 2 on AtlanticLIVE’s website where it will be archived for later viewing.