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Actinium Pharmaceuticals to Host Webinar Showcasing New Pipeline Initiative Focused on the CAR-T Space

On September 18, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company"), reported that it will unveil a new clinical initiative that expands the Company’s pipeline into the CAR-T space (Press release, Actinium Pharmaceuticals, SEP 18, 2018, View Source [SID1234529483]). CAR-T is a type of cellular therapy that genetically alters a patient’s own T cells to target and kill their cancer cells. Currently, there are 2 approved CAR-T therapies for patients with certain B-cell cancers and over 200 CAR-T candidates in preclinical and clinical development for a wide range of hematologic and solid tumor indications. Actinium’s management team along with Dr. Nirav Shah, Assistant Professor of Medicine, Division or Hematology and Oncology at Froedtert & the Medical College of Wisconsin will discuss the Companies latest pipeline initiative, its value proposition as applicable to CAR-T and the expected development pathway.

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Dr. Shah said, "CAR-T is an exciting medical advancement that has demonstrated incredible promise in patients that need better treatment options and outcomes. The Froedtert & the Medical College of Wisconsin was an early adopter of CAR-T becoming one of the first FACT certified medical centers in the nation and commercial CAR-T sites, consistent with its pioneering of other techniques such as stem cell transplantation and immunotherapy. My colleagues and I, at the Froedtert & the Medical College of Wisconsin, are committed to continuing to advance the exciting field of CAR-T to further improve patient outcomes. I am excited by the potential of Actinium’s next generation technology to further advance the field of CAR-T and look forward to providing more details on this potentially disruptive clinical initiative."

In addition to Dr. Shah, Sandesh Seth, Actinium’s Chairman and CEO and Dr. Dale Ludwig, Actinium’s Chief Scientific Officer will be on the call to discuss this new pipeline initiative. Participation details for the conference call and webcast are as follows:

Date: Wednesday, September 26, 2018
Time: 4:15 PM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831

"We are excited to be forging a path into CAR-T and are thrilled to be working with Dr. Shah and his colleagues at the Froedtert & Medical College of Wisconsin who have been pioneers in this field. We look forward to the contributions they will make to our next generation technology that we believe has great potential to advance access to CAR-T and patient outcomes’" said, Sandesh Seth, Actinium’s Chairman and CEO. "I am incredibly motivated by this important pipeline expansion which has been enabled by the efforts of our new team and the potential growth opportunities it can provide for Actinium."

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer

On September 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy (Press release, Johnson & Johnson, SEP 18, 2018, View Source [SID1234529481]). Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.

"Erdafitinib has demonstrated promising results in the treatment of metastatic urothelial cancer, a disease where patients unfortunately have limited treatment options today," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We look forward to working with the FDA in the agency’s review of the application as we believe erdafitinib will provide patients with an important therapeutic option."

The NDA submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations. The primary endpoint of this study was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1* criteria. The study results were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Abstract #4503) and were recognized as a "Best of ASCO (Free ASCO Whitepaper)" selection.

"The erdafitinib FDA submission is an important milestone as we work to bring a new treatment option to patients diagnosed with metastatic urothelial cancer," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "Our organizational focus on areas of high unmet medical need underscores our commitment to advancing transformational science and developing solutions that may prolong and improve patient lives."

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well a cancer patient responds to treatment and is based on whether tumors shrink, stay the same, or get bigger.1

For information about Janssen’s pre-approval access program, visit View Source

About Urothelial Cancer

Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the U.S.2 In 2018, an estimated 81,190 new cases of bladder cancer will be diagnosed in the U.S. and an estimated 17,240 bladder cancer deaths will occur.2 The relative five-year survival rate for patients with Stage IV metastatic bladder cancer is currently five percent.3 Patients with metastatic urothelial cancer, who have FGFR genetic alterations, have poor prognoses and a high unmet need based on low response rates and may be resistant to treatment with immune-checkpoint inhibitors.4

About Erdafitinib

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) inhibitor being studied in Phase 2 and Phase 3 clinical trials for the treatment of patients with locally advanced or metastatic urothelial cancer.5 FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.6 A companion diagnostic to identify patients with FGFR alterations is an integral part of the development program for erdafitinib. In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.

BioClin Therapeutics Announces New Leadership to Advance Late-Stage Bladder Cancer Development Program

On September 18, 2018 BioClin Therapeutics, Inc., a privately-held clinical stage drug development company, reported the appointment of Scott Myers as Chief Executive Officer, and Julie Eastland as Chief Financial Officer and Chief Business Officer (Press release, BioClin Therapeutics, SEP 18, 2018, View Source [SID1234529480]). Mr. Myers will also continue in his role as company Chairman.

"We are excited to announce the appointment of Scott Myers as Chief Executive Officer," said David Kabakoff, Ph.D., Director of BioClin Therapeutics and Executive Partner at Sofinnova Ventures. "Scott’s track record of leadership and shareholder value creation are an excellent fit for our company."

"We are also pleased to announce the appointment of Julie Eastland as our Chief Financial Officer and Chief Business Officer. Scott and Julie previously partnered to successfully transform Cascadian Therapeutics, leading to its acquisition by Seattle Genetics for $614M earlier this year."

"On behalf of the entire board, I would like to thank our founding CEO Stephen Lau, who is stepping down, for his exceptional contribution to the company from inception to its current Phase 2 clinical stage. We are grateful that he will continue to serve as an advisor to the company."

"I have been privileged to lead BioClin over the past 6 years and to have advanced the development of B-701, which is a potential best-in-class therapy for metastatic bladder cancer. I look forward to supporting Scott and team during the transition," said Stephen Lau, founder of BioClin Therapeutics.

"I’m delighted to welcome Julie Eastland to our management team as our Chief Financial Officer and Chief Business Officer," said Scott Myers. "Julie has a strong background in finance, business strategy and licensing, having previously worked at a number of publicly traded and private biotechnology companies. Her fundraising and business development experience will prove invaluable as we execute on our clinical development plans and enter the next phase of growth. Julie, I and the entire management team are focused on advancing vofatamab (B-701) into registration trials, keeping BioClin well-funded, and strengthening the company’s market profile."

Scott Myers was appointed Chairman of BioClin in June 2018. Mr. Myers most recently served as CEO, President and Director of Seattle based, Cascadian Therapeutics (NASDAQ: CASC), an oncology company that was acquired by Seattle Genetics (NASDAQ: SGEN) in March 2018. Prior to Cascadian, Mr. Myers was CEO of Aerocrine AB, a publicly-traded medical device company based in Stockholm, Sweden and Morrisville, NC, that was acquired by Circassia, PLC in 2015. Prior to Aerocrine, Mr. Myers held senior commercial operations, business development, general management and information management positions for UCB SA, a Belgium based biopharmaceutical company, and Johnson & Johnson.

Julie Eastland most recently served as Chief Financial Officer and Chief Business Officer of Cascadian Therapeutics, from September 2010 to May 2018, through the sale and transition of the company to Seattle Genetics. From 2006 to 2010, Ms. Eastland was the Chief Financial Officer and Vice President of Finance and Operations of VLST Corporation, a privately-held biotechnology company. Prior to VLST, Ms. Eastland held various financial and strategic management positions at publicly-traded biotechnology companies including Dendreon and Amgen.

Rapamycin Holdings, Inc. Opens First Human Clinical Trial of its eRapaTM Compound Targeting Early Stage Prostate Cancer

On September 18, 2018 Rapamycin Holdings, Inc. (RHI), a privately-held drug development company based in San Antonio, Texas, reported that it has treated its first human patient with the company’s pharmaceutical formulation of its eRapaTM compound (Press release, Rapamycin Holdings, SEP 18, 2018, View Source [SID1234529479]). This first in human Phase 1b clinical trial of eRapa focuses on men with early stage prostate cancer.

The trial will dose an expected twelve to 24 qualified patients to establish safety and explore the optimal biologic dose of eRapa. The trial is led by Michael Liss, M.D., a urologic oncologist at UT Health San Antonio MD Anderson Cancer Center, where the Phase 1b study is being conducted.

"This trial holds tremendous promise, not only for early stage prostate cancer patients but for many people with age-related diseases," commented RHI President and CEO, Dan Hargrove. "In addition to evaluating the safety and optimal dose of eRapa to potentially prevent the progression of prostate cancer, this trial will explore the ways in which eRapa can rejuvenate the body’s immune system, which is one of the strongest weapons against cancer. The final results will help signal our next clinical trials, as well as identify the various opportunities to explore to move eRapa toward becoming a platform therapy to alleviate a number of age-related diseases."

Dr. Liss, the principal investigator of the trial, said, "Early stage prostate cancer is a good target for eRapa because past research has shown that the compound has inhibited the growth of certain types of cancer cells. In this trial, men will be given eRapa in different doses to find the level that provides the biggest benefit with minimal side effects. The therapy has the potential to change how we manage men with early prostate cancer."

Dr. Ruben Mesa, director of UT Health San Antonio MD Anderson added, "This is a great example of the innovative clinical trials that are taking place here. Our cancer center has a long history of testing cancer breakthrough therapies in our world-renowned, early-phase cancer treatment program, the Institute for Drug Development. I am particularly excited about the potential of this new therapy to make an impact on early stage prostate cancer and possibly decrease the chance of recurrence."

RHI anticipates that the trial will conclude in mid 2019, leading the company closer to collaboration with the US FDA toward the expedited 505(b)(2) regulatory pathway. The company is also looking ahead to future clinical trials in potential indications that may expedite marketing authorization and commercialization of eRapa.

For information about participating in the study, please contact Allison Sherrill at (210) 567-1172.

About eRapaTM

Researchers at UT Health San Antonio discovered that an improved formulation of the well-known drug, Rapamycin, extended life span and health span in rodents by mitigating the effects of age-related diseases. Rapamycin Holdings, as the exclusive licensee of this technology, is capitalizing on this discovery by developing a novel proprietary and patented formulation for the treatment of serious unmet medical needs.

European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma

On September 18, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy (Press release, Bristol-Myers Squibb, SEP 18, 2018, View Source [SID1234529478]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

"Given the need for new treatment options for patients with multiple myeloma, we look forward to working closely with the EMA as they review this application," said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb. "It is our hope that this new Empliciti-based combination will soon become available for patients in the European Union with multiple myeloma, whose disease progressed on lenalidomide and a PI."

The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). Data from this study were presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

The Phase 2 ELOQUENT-3 trial randomized 117 patients with RRMM who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a PI. Patients were randomized 1:1 to receive either EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity. Patients in both the EPd and Pd arms received 4 mg of pomalidomide for days 1-21 of each cycle, and the weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75 years or >75 years, respectively. In the EPd arm, Empliciti was administered at the dose of 10 mg/kg IV weekly for the first 2 cycles and 20 mg/kg monthly starting from cycle 3. Patients randomized to EPd experienced a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) compared with patients randomized to Pd alone, with median PFS, the study’s primary endpoint, of 10.3 months (95% CI: 5.6 to not estimable) compared with 4.7 months (95% CI: 2.8 to 7.2) in Pd patients. The PFS benefit experienced among patients randomized to EPd was consistent among patients who had received two to three prior lines of therapy (HR 0.55; 95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51; CI 95%: 0.24 to 1.08).

Rates of treatment-related hematologic adverse events (AEs) were comparable between EPd and Pd groups (38% and 42%, respectively). The most commonly occurring hematologic AEs among patients receiving EPd were neutropenia (13%), anemia (10%), thrombocytopenia (8%) and lymphopenia (8%). AEs led to discontinuation in 18% of patients in the EPd arm, compared with 24% of patients in the Pd arm.