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.

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!

"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.

On September 18, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $60.00 per share, for total gross proceeds of $180,000,000 (Press release, G1 Therapeutics, SEP 18, 2018, View Source [SID1234529789]). All of the shares in the offering will be sold by G1 Therapeutics. In addition, G1 Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock at the public offering price, less the underwriting discount. The offering is expected to close on September 21, 2018, subject to customary closing conditions.

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!

J.P. Morgan Securities LLC and Cowen and Company, LLC are serving as joint book-running managers for the offering. Needham & Company, LLC and Wedbush Securities Inc. are acting as lead managers for the offering. BTIG, LLC and H.C. Wainwright & Co., LLC are acting as co-managers for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 592-5973.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

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!

"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.

On September 18, 2018 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, reported that the completion of a $2.7M financing effort, which includes an over-subscribed $2M round in venture-backed capital and over $670K in non-dilutive capital (Press release, PhoenixMD, SEP 18, 2018, View Source [SID1234536960]). The venture round is led by Pallasite Ventures and includes new angel investors and existing angel investors from prior funding rounds. PhoenixMD intends to use the proceeds to advance its lead asset PMD-026 through IND-enabling studies and to develop a sophisticated companion diagnostic test to determine which patients have high levels of activated RSK2, the protein that PMD-026 disrupts.

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!

"This financing is a critical step forward in bringing the first disease-modifying therapeutic treatment to women suffering from TNBC. The PhoenixMD team is committed to innovating in the breast cancer field and we are excited to deploy Pallasite’s investment to such an experienced team to solve an unmet medical need," said Chris Bissonnette, Ph.D., Managing Partner of Pallasite Ventures. In connection with the financing, Dr. Bissonnette has joined PhoenixMD’s Board of Directors.

"We are thrilled to close our first venture-backed round with such high-quality investors, which is a major achievement for the company," said Sandra E. Dunn, Ph.D., CEO of PhoenixMD. "The proceeds from this financing, and the non-dilutive capital from recent research grants will advance PMD-026 through critical IND-enabling studies and will begin planning around our upcoming Phase 1 study, which we are very excited to initiate."

About Triple Negative Breast Cancer (TNBC) and RSK Kinases

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are still no targeted therapies available for TNBC.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Currently, there are no approved targeted therapies for TNBC, although several drugs are subject to research studies and clinical trials. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

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.

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!

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."