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.

On March 21, 2019 Provectus (OTCQB: PVCT) reported that updates on the Company’s metastatic uveal melanoma drug development program for its lead investigational cancer agent PV-10 (Press release, Provectus Biopharmaceuticals, MAR 21, 2019, View Source [SID1234534529]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells1-4, which may lead to a functional recruitment of the immune system.

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Update #1. Presentations about PV-10 treatment of metastatic uveal melanoma will be given by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center at:

The International Society of Ocular Oncology (ISOO) Biennial Conference in Los Angeles, California from March 22-26, entitled "Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastasis." ISOO is a non-profit corporation with the specific and primary purpose to advance and promote the practice of ocular oncology, and

The spring meeting of the Ophthalmic Oncology Group (OOG) in London, England from April 11-13, entitled "A Phase 1 Study of Percutaneous Oncolytic Rose Bengal Disodium (PV10) for Metastatic Uveal Melanoma to the Liver." OOG is an independent scientific group devoted to clinical ophthalmic oncology and related basic-science research.
Update #2. The Company will host a round table involving metastatic uveal melanoma patients at CURE OM’s Eyes on a Cure: Patient & Caregiver Symposium in Raleigh, North Carolina from April 5-7. The Community United for Research and Education of Ocular Melanoma (CURE OM) is the Melanoma Research Foundation’s initiative to increase awareness, education, and research funding for ocular melanoma, while improving the lives of people affected by this disease.

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.5,6 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.5,6,7 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.8

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers. In February 2019, orphan drug designation status was granted to PV-10 by the U.S. Food and Drug Administration for the treatment of ocular melanoma.