On March 21, 2019 Novocure (NASDAQ: NVCR) reported 48 presentations on Tumor Treating Fields at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, March 29 through April 3, in Atlanta (Press release, NovoCure, MAR 21, 2019, View Source [SID1234534534]). For the first time at this conference, a symposium session on Tumor Treating Fields also will be held.

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The symposium session titled, "Tumor Treating Fields: A Fourth Modality in Cancer Treatment," will be chaired by Dr. Roger Stupp, Director of Strategic Initiatives at Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago. Presentation topics include "Identification of a new mechanism for how Tumor Treating Fields affect tumor cells" and "TTFields: From bench to bedside." Presentation topics will be followed by multiple discussion sessions.

The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference. Highlights include an oral presentation on using transducer array layouts to optimize the treatment of multiple brain metastases with Tumor Treating Fields and results from a pilot study of Tumor Treating Fields combined with radiotherapy for newly diagnosed glioblastoma.

"The presence of Tumor Treating Fields at the AACR (Free AACR Whitepaper) Annual Meeting has grown substantially over the last five years," said Dr. Uri Weinberg, Novocure’s Vice President of Clinical Development. "The AACR (Free AACR Whitepaper) Annual Meeting is one of the most important gatherings of cancer researchers and clinicians throughout the world. We are honored to be a part of this invaluable exchange of scientific information and proud of the increasing focus on Tumor Treating Fields at this meeting."

Symposium Session

Tumor Treating Fields: A Fourth Modality in Cancer Treatment

1 to 2:45 p.m. EDT April 2

Oral presentation

(Abstract #: 4450) Novel transducer array layouts to optimize the treatment of multiple brain metastases with tumor treating fields. O. Yesharim. 3 to 5 p.m. EDT April 2.

Poster presentations

(Abstract #: 688) Safety and efficacy of TTFields delivery to the lungs: A computational study. H. Hershkovich. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 21)

(Abstract #: 691) Simulating TTFields-induced temperature changes within a patient’s brain – a proof of concept study. A. Naveh. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 24)

(Abstract #: 692) Treating spinal cord metastases with tumor treating fields. O. Yesharim. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #:25)

(Abstract #: 689) Heating of head tissues during TTFields therapy: a computational study. N. Gentilal. 1 to 5 p.m. EDT March 31. (Session: Bioinformatics and Systems Biology; Convergence Science for Therapeutics and Precision Medicine; poster board #: 22)

(Abstract #: 4430) Simulating delivery of TTFields to the infratentorium in patients with brainstem gliomas. 1 to 5 p.m. EDT March 31. (Session: Molecular and Cellular Biology / Genetics; Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets; poster board #: 24)

(Abstract #: 4430) Numerical simulation of tumor treating fields effects on cell structures: Mechanism and signaling pathway candidates. 1 to 5 p.m. EDT April 2. (Session: Tumor Biology; Radiation Tissue Tolerance, Immunity, and in Vivo Effects of Radiation; poster board #: 2)

(Abstract #: 3724) Molecular mechanisms of TTField action determined by measurements and modelling of electro-conductive properties of microtubules. A. Kalra. 1 to 5 p.m. EDT April 2. (Session: Tumor Biology; Radiation Tissue Tolerance, Immunity, and in Vivo Effects of Radiation; poster board #: 1)

(Abstract #:4871) Comparative analysis of tumor treating fields using conventional versus alternative array placement for posterior fossa Glioblastoma. E. Lok. 8 a.m. to 12 p.m. EDT April 3. (Session: Clinical Research; Advances in Radiation Therapy / Surgical Oncology; poster board #: 15)

(Abstract #: 252) Tumor treating fields (TTFields) affect blood brain barrier (BBB) integrity in vitro and in vivo. A. Kessler. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 15)

(Abstract #: 250) Tumor treating fields increases membrane permeability in glioblastoma cells. E. Chang. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 13)

(Abstract #: 239) Aurora kinase inhibition to enhance Tumor Treating Fields efficacy in glioblastoma treatment. P. Bartmann. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #: 2)

(Abstract #: 307) The combined treatment of 150 kHz Tumor Treating Fields (TTFields) and cisplatin or pemetrexed inhibit mesothelioma cells in vitro. M. Munster. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #28)

(Abstract #: 306) The efficacy of the combined treatment of 150 KHz tumor treating fields (TTFields) and Sorafenib in hepatocellular carcinoma in vitro and in vivo. T. Voloshin. 1 to 5 p.m. EDT March 31. (Session: Experimental and Molecular Therapeutics; Brain Cancers and Neuroblastoma; poster board #27)

(Abstract #: 303) The efficacy of the combined treatment of 150 kHz Tumor Treating Fields (TTFields) and FOLFOX in gastric cancer in vitro. 1 to 5 p.m. EDT March 31. (Session: Combination Approaches to Novel Therapies; poster board #: 24)

(Abstract #: 1258) Pooled-analysis of response markers in cancer cell lines treated with tumor treating fields. G. Shahaf. 8 a.m. to 12 p.m. April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 19)

(Abstract #: 2168) Testing the electrical properties of different cell lines using 3DEP reader and compare to TTFields response. M. Giladi. 1 to 5 p.m. April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 19)

(Abstract #: 2191) Reduced clonogenic potential of patient-derived lung adenocarcinoma brain metastasis cells after in vitro application of Tumor Treating Fields (TTFields). S. Michelhaugh. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 13)

(Abstract #: 2192) Concurrent Tumor Treating Fields (TTFields) and dexamethasone decrease proliferation and clonogenicity of patient-derived glioblastoma cells in vitro. S. Michelhaugh. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Credentialing of Molecular Targets; poster board #: 14)

(Abstract #: 2094) Prostaglandin E receptor 3 mediates resistance to tumor treating fields in glioblastoma cells. D. Chen. 1 to 5 p.m. EDT April 1. (Session: Experimental and Molecular Therapeutics; Drug Resistance 3; poster board #: 1)

(Abstract #: 3280) TTFields induces immunogenic cell death and STING pathway activation through cytoplasmic double-stranded DNA in glioblastoma cells. D. Chen. 8 a.m. to 12 p.m. EDT April 2. (Session: Immunology; Novel Immunomodulatory Agents 1; poster board #: 30)

(Abstract #: 3493) Tumor treating fields (TTFields) significantly alters how tumor cells repair double stranded breaks using homeologous Alu sequences. M. Morales. 8 a.m. to 12 p.m. EDT April 2. (Session: DNA Damage and Repair 3; Molecular and Cellular Biology / Genetics; poster board #: 4)

(Abstract #: 3939) Exploiting tumor treating fields induced downregulation of BRCA1 pathway for novel combination therapies. N. Karanam. 1 to 5 p.m. EDT April 2. (Session: Experimental and Molecular Therapeutics; Preclinical Radiotherapeutics; poster board #: 20)

(Abstract #: 3954) Evaluating the compatibility of tumor treating electric fields with key anti-tumoral immune functions. G. Diamant. 1 to 5 p.m. EDT April 2. (Session: Clinical Research; Immunomodulation by Chemotherapy and Targeted Agents; poster board #: 10)

(Abstract #: 3961) Alternating electric fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy. T. Voloshin. (Session: Clinical Research; Immunomodulation by Chemotherapy and Targeted Agents; poster board #: 17)

(Abstract #: 4031) The dielectric properties of brain tumor tissue. M. Proescholdt. 1 to 5 p.m. EDT April 2. (Session: Clinical Research; Tumor Markers to Assess the Biology and Clinical Course of Cancer 2; poster board #: 24)

(Abstract #: 4419) Cell cycle analysis during TTF to exploit novel targets for increasing treatment efficacy. P. Slangen. 1 to 5 p.m. EDT April 2. (Session: Molecular and Cellular Biology / Genetics; Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets; poster board #: 13)

(Abstract #: 3942) Animal studies evaluating the safety of Tumor Treating Fields (TTFields) in the torso. S. Davidi. 1 to 5 p.m. EDT April 2. (Session: Experimental and Molecular Therapeutics; Preclinical Radiotherapeutics; poster board #: 23)

(Abstract #: 5271) Molecular imaging of pyruvate kinase M2 (PKM2) with [18F]DASA-23 detects temozolomide- and tumor treating fields (TTFields)-induced changes in glycolysis in glioblastoma. C. Patel. 8 a.m. to 12 p.m. EDT April 3. (Session: Molecular and Cellular Biology / Genetics; Tracking Metabolic Profiles and Subtype-specific Metabolic Interventions; poster board #: 14)

(Abstract #: 5156) In vitro application of tumor-treating fields to suppress tunneling nanotubes in mesothelioma. A. Sarkari. 8 a.m. to 12 p.m. EDT April 3. (Session: Molecular and Cellular Biology / Genetics; Cellular and Stromal Interactions of Tumor Cells; poster board #: 8)

(Abstract #: CT008) Tumor Treating Fields combined with radiotherapy and temozolomide for newly diagnosed glioblastoma: Final results from a pilot study. A. Hormigo. 8 a.m. to 12 p.m. EDT April 1. (Session: Phase I Clinical Trials: Part 1; poster board #: 3)

(Abstract #: CT062) A Phase I study of the safety and immunogenicity of personalized mutation-derived tumor vaccine and treatment fields in patients with newly diagnosed glioblastoma. A. Hormigo. 8 a.m. to 12 p.m. EDT April 1. (Session: Phase I Clinical Trials: Part 2; poster board #: 19)

(Abstract #: 1413) Using conventional imaging to predict water content and electrical properties at 200 kHz in brain and GBM tumor tissues: a feasibility study in three TTFields patients. C. Wenger. 8 a.m. to 12 p.m. April 1. (Session: Deep Learning; Clinical Research; poster board #: 22)

(Abstract #: CT172) Phase III METIS study: Tumor Treating Fields (150 kHz) and radiosurgery for supra- and/or infratentorial brain metastases (1-10) from non-small cell lung cancer (NSCLC). M. Mehta. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 16)

(Abstract #: CT175) HEPANOVA Phase 2 study design for advanced hepatocellular carcinoma: tumor treating fields concomitant with sorafenib. A. Grosu. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 19)

(Abstract #: CT174) Phase III INNOVATE study of tumor treating fields (200 kHz) concomitant with weekly paclitaxel for platinum-resistant ovarian cancer (ENGOT-ov50/BGOG study groups). I. Vergote. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 18)

(Abstract #: CT173) Tumor Treating Fields (150 kHz) concurrent with standard of care treatment for stage 4 non-small cell lung cancer (NSCLC) following platinum failure: The Phase III LUNAR study. U. Weinberg. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 17)

(Abstract #: CT176) Phase III PANOVA study of tumor treating fields (150 kHz) in combination with nab-paclitaxel and gemcitabine for front-line treatment of locally-advanced pancreatic adenocarcinoma (LAPC). U. Weinberg. 8 a.m. to 12 p.m. EDT April 2. (Session: Phase I-III Trials in Progress: Part 2; poster board #: 20)

(Abstract #: CT202) Safety of Tumor Treating Fields delivery to the torso: Pooled analysis from TTFields clinical trials. G. Ceresoli. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 16)

(Abstract #: CT204) Increasing Tumor Treating Fields dose at the tumor bed improves survival: Setting a framework for TTFields dosimetry based on analysis of the EF-14 Phase III trial in newly diagnosed glioblastoma. M. Ballo. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 18)

(Abstract #: CT201) Final results of Phase II STELLAR trial: TTFields with chemotherapy in unresectable malignant pleural mesothelioma. G. Ceresoli. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 15)

(Abstract #: CT203) Randomized Phase II trial of Tumor Treating Fields plus radiation therapy plus temozolamide compared to radiation therapy plus temozolomide in patients with newly diagnosed glioblastoma. R. Grossman. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 17)

(Abstract #: CT205) Tumor Treating Fields alters progression patterns in glioblastoma: An imaging analysis of the EF-14 Phase III trial. S. Jeyapalan. 1 to 5 p.m. EDT April 2. (Session: Phase II-III Clinical Trials: Part 2; poster board #: 19)

(Abstract #: LB-155) Adherence to tumor treating fields (TTFields) in high-grade glioma patients – a single center experience. C. Hagemann. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 13)

(Abstract #: LB-160) Glioblastoma and mesothelioma: Do estimates of health state utilities compare in rare cancers treatable with tumor treating fields? C. Proescholdt. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #:18)

(Abstract #: LB-162) Treating elderly glioblastoma patients > 65 years with TTFields – a cost-effectiveness perspective. G. Guzauskas. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 20)

(Abstract #: LB-163 ) Comparing clinical value scores (NCCN, ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper)) for TTFields treatment in glioblastoma. J. Kelly. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 21)

(Abstract #: LB-161): Application of the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) frameworks to TTFields treatment of mesothelioma. J. Kelly. 8 a.m. to 12 p.m. EDT April 2. (Session: Science and Health Policy 2/Regulatory Science and Policy; poster board #: 18)

On March 21, 2019 FORMA Therapeutics reported the appointment of Frank D. Lee as Chief Executive Officer, starting on March 27, 2019 (Press release, Forma Therapeutics, MAR 21, 2019, View Source [SID1234534533]). Frank succeeds Steve Tregay, Ph.D., who after more than a decade as Founder and CEO, will transition to the role of Senior Advisor to the CEO. Frank, an industry veteran and champion for patients, joins FORMA with over 25 years of global experience in product development and commercial leadership across a wide range of therapeutic areas within the biotech and pharmaceutical industry. Most recently, Frank served as Senior Vice President, Global Product Strategy and Therapeutic Area Head for the Immunology, Ophthalmology and Infectious Diseases at Genentech, a member of the Roche Group.

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"Steve and the Board collaborated to execute a thoughtful succession plan and I’m pleased to welcome Frank as FORMA’s next CEO. Frank’s passion for understanding the patient perspective, focused commitment to offer profoundly meaningful therapeutic solutions, and proven commercial leadership in building innovative product strategies will undoubtedly provide FORMA with the critical expertise to advance our pipeline toward commercialization," said Peter Wirth, Chairman, Board of Directors, FORMA Therapeutics. "Throughout his career, Frank has proven to be an accomplished leader significantly impacting human health through building highly productive teams, fostering a patient-centric culture, and opening of new markets to advance ground-breaking medicines. With several candidates now in ongoing Phase I and Phase II studies, Frank has a tremendous opportunity to accelerate FORMA’s R&D activities to provide sustained impact."

"FORMA’s ten-year foundation of excellence in discovery research and development, the depth of scientific talent and mission driven culture, as well as the multiple potentially transformative medicines now in the clinic, provide a unique opportunity to dramatically improve the lives of patients with serious diseases," said Frank D. Lee, incoming CEO, FORMA Therapeutics. "I’m excited to lead such a remarkable organization through the next growth phase including product approval and launch, while continuing to sustain an innovative pipeline for the long-term. It’s an honor to continue the legacy of building an innovative research company committed to patients, transformative science and company culture."

Peter Wirth added, "The FORMA Board of Directors extends deep gratitude to Steve for his contributions as founder and years of service as CEO and we wish him the best for his next endeavor. Steve’s entrepreneurial talent and interests reside in reinventing the way potential new drugs are identified, explored and developed, and he grew FORMA with disruptive innovation as part of its core DNA. During Steve’s time at FORMA, he championed the company’s evolution from a chemistry platform focused organization, toward a premiere research partner delivering high quality drug candidates, and recently to a fully integrated R&D company with a robust proprietary pipeline of clinical and preclinical assets in oncology, hematology and inflammatory diseases."

"After leading the company for over 10 years, I believe now is the ideal time for a transition," said Steve Tregay, Ph.D. "With an incoming CEO who has the ideal background to propel the pipeline towards commercialization and realize the company’s vision to change lives for patients, I am truly excited about FORMA’s future. I plan to work with the Board, Frank and FORMA’s leadership team to ensure a smooth transition and equally look forward to my next journey in continuing to transform the paradigm of drug discovery." Steve is founder and Chairman of the Board of Compass Therapeutics and a founding Board member of LabCentral.

Frank’s thirteen-year career at Genentech included leadership positions of increasing scope and responsibility for delivering transformative medicines to patients. Most recently, as Senior Vice President, Global Product Strategy, he was responsible for driving development and commercial strategy for a broad portfolio of molecules in development and for global in-line product sales of more than $11 Billion. Previously, as Vice President of the HER2/Breast Cancer Franchise, Frank was responsible for the US P&L for Herceptin, Perjeta and Kadcyla, driving revenues over $4 Billion and launching the first HER2 neoadjuvant indication shaping a new market and treatment paradigm for early HER2 breast cancer patients. As Vice President of Oral Oncolytics, Frank held P&L responsibility for Tarceva, Zelboraf, Erivedge and Xeloda, advancing personalized medicine for cancer patients with EGFR+ NSCLC and BRAF+ melanoma, and establishing a new treatment option for patients with advanced basal cell carcinoma. Other roles at Genentech included Franchise Head, Transplant and Tamiflu as well as Director of Marketing for Ophthalmology and Respiratory. Prior to joining Genentech, Frank spent approximately 13 years across Novartis, Janssen and Eli Lilly in engineering, manufacturing, sales/marketing and business development.

Frank received a bachelor’s degree in chemical engineering from Vanderbilt University, Nashville, TN., and an M.B.A. in Marketing and Finance from the Wharton Graduate School of Business, Philadelphia, PA. He previously served on the Board of the Genentech Foundation.

On March 21, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles (Press release, Aura Biosciences, MAR 21, 2019, View Source [SID1234534532]).

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"These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk," said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.

"Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients," commented Cadmus Rich, M.D., Chief Medical Officer of Aura. "It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year."

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma. The details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location: The Ritz-Carlton Marina del Rey

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On March 21, 2019 Modra Pharmaceuticals B.V. ("Modra") reported that the first patients have been treated in its Phase IIa study in patients with recurrent or metastatic HER-2 negative breast cancer (Press release, Modra Pharmaceuticals, MAR 21, 2019, View Source [SID1234534531]). The trial will evaluate the efficacy and safety of Modra’s lead product, ModraDoc006/r, a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In addition to enabling patients to take their chemotherapy at home, the novel approach has, in prior pre-clinical and clinical testing, demonstrated the potential to reduce toxicity and increase the efficacy of the treatment. As the lead program in the Company’s pipeline, ModraDoc006/r has successfully completed Phase I clinical trials in patients with solid tumors and specifically in patients with prostate cancer.

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"Chemotherapy remains a fundamental component of many modern cancer treatment regimens, including for patients with breast or prostate cancer, and ModraDoc006/r has been designed to improve the therapeutic outcomes and quality-of-life of patients as it offers a potentially safer and more efficacious solution that can be taken at home," commented Colin Freund, CEO of Modra Pharmaceuticals. "The swift start of this trial represents an important development milestone for Modra, and, together with our planned Phase IIb clinical trial in metastatic castration resistant prostate cancer, which recently received IND approval from the FDA, builds momentum for our global clinical development strategy."

The Phase IIa international multi-center study will determine the efficacy and tolerability of ModraDoc006/r in patients with recurrent or metastatic HER-2 negative breast cancer. For this trial, up to 24 evaluable patients will be treated. All patients will be given tablets of ModraDoc006/r twice daily, one day per week. The primary endpoint is objective response rate according to response evaluation criteria in solid tumors (RECIST). The secondary endpoints include progression-free survival and safety assessments. An additional exploratory objective is to determine whether ModraDoc006/r can be utilized safely in frail patients.

About Metastatic Breast Cancer

Breast cancer is the most common type of cancer in women. Once breast cancer becomes metastatic it is rarely curable, and it is widely accepted that women with metastatic disease should receive a form of systemic chemotherapy at some time during the course of their disease. Docetaxel has proven to be clinically effective in multiple tumor types including breast cancer.

About ModraDoc006/r

ModraDoc006 is a proprietary tablet form of the taxane chemotherapy drug, docetaxel. ModraDoc006 is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard intravenously-administered docetaxel.

On March 21, 2019 Samsung Bioepis Co., Ltd. reported findings of a three-year follow-up study comparing biosimilar ONTRUZANT (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer (Press release, Samsung Bioepis, MAR 21, 2019, View Source [SID1234534530]). The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

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"With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

[P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]
ONTRUZANT (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT.iii With the adoption of CHMP’s positive opinion for ONTRUZANT 420 mg vial presentation, ONTRUZANT will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.