Actinium Pharmaceuticals Announces Treatment of First Patient in Novel Combination Trial of Actimab-A Plus CLAG-M

On June 13, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that the Medical College of Wisconsin has treated its first patient in a Phase 1 trial studying Actinium’s Actimab-A in combination with CLAG-M for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) (Press release, Actinium Pharmaceuticals, JUN 13, 2018, View Source [SID1234527311]). This Phase 1 dose-escalation trial will study a single administration of Actimab-A following treatment of CLAG-M and will evaluate safety and tolerability, response rates, rates of bone marrow transplant (BMT), progression-free survival (PFS), and overall survival (OS).

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "We are grateful for all of the hard work that the team at MCW has put in to get to this important milestone. Actimab-A has demonstrated promising activity as a single agent in difficult to treat patient populations that we attribute to its targeting ability, potency and tolerability. We are excited to be leveraging these strengths of Actimab in a combination regimen to bring this potentially important therapy to a greater number of patients in indications that need improved outcomes. We are confident that the addition of Actimab to a salvage chemotherapy regimen has the potential to improve outcomes through improved response rates and by increasing the number of patients that can receive a bone marrow transplant."

Actimab-A is an ARC or Antibody Radio-Conjugate comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the radioisotope actinium-225. CD33 is a marker expressed on AML cells of virtually all AML patients. Actinium’s CD33 ARC has been studied in over 100 patients to date and is the only CD33 targeting agent being studied in a broad range of diseases in which the CD33 antigen is expressed including AML, myelodysplastic syndrome (MDS) and multiple myeloma. CLAG-M is a salvage chemotherapy regimen commonly used to treat patients with AML that consists of cladribine, cytarabine, filgrastim, and mitoxantrone.

Sandesh Seth, Actinium’s Chairman and CEO said, "Through the utilization of targeted radioisotopes we are able to add a new modality of treatment to a salvage cytotoxic chemotherapy regimen with the aim of improving efficacy. Further, we can apply our ARC technology to targeted conditioning to enable a bone marrow transplant that we will explore in this trial as well as our anticipated Actimab-MDS trial. In short time, our team has leveraged our capabilities to create the broadest CD33 program in terms of indications and addressable patient population. We believe our approach for this program which is supported by the strong hypothesis that combinations of targeted internalized radiation using ARC’s with chemotherapeutics is underpinned by a strong biologic rationale that can yield the best in class CD33 program".

About Our CD33 Program

We are developing a potentially best in class CD33 program using our ARC comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle emitter Actinium-225 (Ac225-lintuzumab). Our CD33 program was originally developed in conjunction with Memorial Sloan Kettering Cancer Center and has been studied in over 100 patients to date. CD33 is a marker shown to be expressed on cancerous blast cells of virtually all patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and approximately 25%- 35% of patients with multiple myeloma. Actinium-225 is highly differentiated radioisotope that emits high amounts of energy through the release of four alpha-particles that can cause double-stranded breaks in DNA with known resistance mechanisms to Actinium-225. Given the limited distance of its energy in the body, it is potentially sparing of non-targeted cells leading to better tolerability and less toxicities.

Our CD33 program includes a Phase 2 clinical trial of for patients advanced over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy an indication we have been granted Orphan Drug designation for in the US and EU. We are conducting a Phase 1 trial for patients with refractory multiple myeloma and planning to start a clinical trial for targeted conditioning prior to a bone marrow transplant for patients with high-risk MDS. We are studying Ac225-lintuzumab in combination with the chemotherapy regimen CLAG-M. We intend to continue to develop our CD33 program as a targeted therapy and for targeted conditioning of the bone marrow with Ac225-lintuzumab as a single agent and with novel combinations.

CYTOKINETICS TO PRESENT AT THE JMP SECURITIES LIFE SCIENCES CONFERENCE

On June 13, 2018 Cytokinetics, Inc. (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the JMP Securities Life Sciences Conference on Wednesday, June 20, 2018 at 11:00 AM EDT at the St. Regis Hotel in New York (Press release, Cytokinetics, JUN 13, 2018, View Source [SID1234527303]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

FDA APPROVES GENENTECH’S AVASTIN (BEVACIZUMAB) PLUS CHEMOTHERAPY AS A TREATMENT FOR WOMEN WITH ADVANCED OVARIAN CANCER FOLLOWING INITIAL SURGERY

On June 13, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection (Press release, Genentech, JUN 13, 2018, View Source [SID1234527302]).

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"Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death."

"This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery," said Melissa Aucoin, chief executive officer, National Ovarian Cancer Coalition (NOCC). "Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers."

The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal Phase III GOG-0218 trial. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 – 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total). Avastin has boxed warnings for GI perforation, surgery and wound healing complications and hemorrhage.

Avastin is now approved for ten distinct uses across six different types of cancer in the United States. This indication represents Avastin’s fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed PFS and secondary endpoints included overall survival (OS). The study was conducted by the Gynecologic Oncology Group (GOG) and initial results were previously published in the New England Journal of Medicine.

Grade 3-4 adverse events occurring more often (≥2%) in the Avastin with chemotherapy followed by Avastin alone arm or the Avastin with chemotherapy arm versus the chemotherapy alone arm were fatigue (9%, 6%, 6%, respectively), high blood pressure (10%, 6%, 2%), decreased platelet count (21%, 20%, 15%) and decreased white blood cell count (51%, 53%, 50%).

1 Relative to the control arm; stratified hazard ratio

2 Two-sided p-value based on re-randomization test

3 Final overall survival analysis

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2018, more than 22,000 women will be diagnosed with ovarian cancer in the U.S. and about 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly and/or frequent urination, are present, they can be associated with other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

EY Announces Kevin Hrusovsky, President, Chairman and Chief Executive Officer of Quanterix and Founder of Powering Precision Health as an Entrepreneur Of The Year® 2018 Award Finalist in the New England Region

On June 13, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that Kevin Hrusovsky, President, Chairman and CEO of Quanterix, and Founder of Powering Precision Health (PPH), has been named by EY as a finalist for the Entrepreneur Of The Year 2018 Award in the New England program (Press release, Quanterix, JUN 13, 2018, View Source [SID1234527301]). The recognition acknowledges Hrusovsky’s achievements in healthcare technology innovation, Quanterix’ outstanding financial performance, and his personal commitment to improving precision medicine and human health.

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"We are honored to be recognized by EY for this award," said Hrusovsky. "For me, this recognition represents the many people and institutions that we’ve been working with who are driving a precision health vision to eradicate and prevent some of today’s most lethal diseases, namely cancer, Alzheimer’s and infectious disease forward. It’s a privilege for us to be recognized alongside other entrepreneurs and business leaders who are all pioneers in their respective fields."

Hrusovsky has a more than 25 year-long track record commercializing disruptive technologies in the life science industry. His impressive career has been propelled by a unique leadership style marked by transparency, passion, and purpose. Since joining Quanterix less than four years ago, Hrusovsky has transformed the company from one that lacked mission and direction into a successful public entity with industry-leading technology that has the power to transform the way we diagnose and treat disease. The key is his focus on putting science first. With Hrusovsky at the helm, Quanterix now has over 200 peer-reviewed publications backing the abilities of its Simoa technology, a significant industry accomplishment. He’s also expanded the applications for Simoa in the drug development industry, with 18 out of the top 20 pharmaceutical companies having used the technology to date in over 700 clinical trials.

Two years ago, Hrusovsky realized that more needed to be done to drive a true transformation in our healthcare system. As such, he launched PPH as a forum where all key stakeholders, from the world’s leading medical professionals and innovators to patients and patient advocates, could come together to share their latest research and truly revolutionize medicine. Now in its third year, PPH has sparked a true movement, one that puts science before profits and closely examines how we can prevent diseases, not just treat them. Today PPH has more than doubled in size and is considered the leading industry conference focused on advancing precision health.

Hrusovsky also serves on the Board of Directors of several companies shaping the future of precision health, including Quanterix, BioreclamationIVT, Cell Signaling Technology, 908 Devices, SynapDx and Solect Energy. He also serves on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston.

Hrusovsky was selected as a finalist by a panel of independent judges. Award winners will be announced at a special gala event on June 28, 2018 at the Westin Boston Waterfront. Now in its 32nd year, the program has expanded to recognize business leaders in more than 145 cities in more than 60 countries throughout the world.

Regional award winners are eligible for consideration for the Entrepreneur Of The Year National competition. Award winners in several national categories, as well as the Entrepreneur Of The Year National Overall Award winner, will be announced at the Entrepreneur Of The Year National Awards gala in Palm Springs, California, on November 10, 2018. The awards are the culminating event of the Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

Sponsors

Founded and produced by EY, the Entrepreneur Of The Year Awards are nationally sponsored in the US by SAP America, the Kauffman Foundation and Merrill Corporation.

In the New England region, gold sponsors also include Boston Private Bank, fama PR, the Isenberg School of Management at the University of Massachusetts Amherst, Nixon Peabody, True Search, and Woodruff Sawyer. New England silver sponsors include Chatham Financial, Empire Valuation Consultants, Morgan Lewis, Sullivan & Worcester, and T3 Advisors.

TRACON Announces Presentation of Preclinical Data from Studies of TRC105 in Combination with a PD-1 Antibody in Murine Models of Colorectal Cancer

On June 13, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that positive preclinical data from TRC105, TRACON’s endoglin antibody, in combination with a PD-1 antibody, were discussed in an oral presentation at the 2018 International Cancer Microenvironment Society meeting (Press release, Tracon Pharmaceuticals, JUN 13, 2018, View Source [SID1234527300]).

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Dr. Mark Schoonderwoerd of Leiden University presented data from multiple murine models assessing the activity of TRC105 in combination with a PD-1 antibody. The individual antibodies as well as the combination were studied in two separate models. In the first, immunocompetent mice were implanted with a syngeneic colorectal cancer subcutaneously to mimic metastatic colorectal cancer. In the second, immunocompetent mice were implanted orthotopically to mimic advanced colorectal cancer.

In both models, treatment with either TRC105 or a PD-1 antibody alone decreased tumor volume compared to IgG control antibody to a similar degree. However, combined treatment with TRC105 and the PD-1 antibody significantly reduced tumor volume compared to treatment with TRC105 or PD-1 treatment alone.

Treatment with either TRC105 or a PD-1 antibody improved survival to a similar degree compared to control antibody. However, survival was significantly improved with combination treatment versus the individual therapies, with long-term survival demonstrated in 30% to 60% of animals. Combination treatment also increased tumor specific T cells, indicating stimulation of an immune response.

The activity of TRC105 given as a single agent or combined with a PD-1 antibody was diminished following CD8+ T cell depletion, indicating that TRC105 activity was mediated through an immunologic mechanism.
In a separately reported third preclinical study, an endoglin antibody specific for mouse endoglin that mimics TRC105 activity in mice, M1043, was studied in a chemically induced colorectal cancer model of early-stage colorectal cancer.

Combined treatment with M1043 and a PD-1 antibody significantly reduced tumor volume compared to treatment with M1043 or PD-1 treatment alone. Combination treatment also significantly reduced the number of tumors that formed in response to the chemically induced carcinogenesis.
TRC105 is currently being studied in the ongoing pivotal randomized Phase 3 TAPPAS trial in angiosarcoma (NCT02979899), the randomized Phase 2 TRAXAR trial in renal cell carcinoma (NCT01806064), a Phase 1/2 trial in patients with hepatocellular carcinoma (NCT02560779), and a Phase 1 trial studying the combination of TRC105 and nivolumab (Opdivo) in patients with non-small cell lung cancer (NCT03181308).