On April 19, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp. (NEEQ: 430187), a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported they have entered into a license agreement providing ApolloBio with an exclusive license to develop and commercialize Toca 511 & Toca FC within the greater China region, including mainland China, Hong Kong, Macao and Taiwan (Press release, Tocagen, APR 19, 2018, View Source [SID1234525818]).

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Toca 511 & Toca FC is a cancer-selective immunotherapy currently under evaluation in an international Phase 3 trial, called Toca 5, for patients with recurrent high grade glioma (HGG), a type of brain tumor. The product candidate has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).

Under the terms of the agreement, ApolloBio will make an upfront payment of $16 million to Tocagen, plus potential payments of $4 million in near-term development milestones, including completion of enrollment in the Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, low double-digit tiered royalty payments will be made based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China’s recent regulatory changes supporting the development of new medicines," said Marty Duvall, chief executive officer of Tocagen. "ApolloBio brings valuable regional expertise in product development, regulation and healthcare access, positioning our lead product to advance towards patients in the greater China region as quickly and efficiently as possible."

The total number of new diagnoses of HGG expected in 2018 is about 180,000 worldwide and about 47,000 in the greater China region. Standard treatment for newly diagnosed HGG includes safe surgical removal of as much of the tumor as possible, followed by radiation therapy and chemotherapy. However, HGG recurs in most patients even after maximal treatment and there are currently very few treatment options available.

"We are committed to accelerating the availability of novel immuno-oncology treatments to patients with high unmet medical needs in the greater China region," said Dr. Weiping Yang, chief executive officer of ApolloBio. "Toca 511 & Toca FC is a highly promising, best-in-class cancer-selective immunotherapy and we look forward to working with Tocagen to advance this innovative late-stage product towards commercialization."

The license grant to ApolloBio is subject to the satisfaction of customary conditions and is expected to become effective in the second quarter of 2018. For more details, please refer to the corresponding Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

About ApolloBio Corp.

ApolloBio Corp. (NEEQ:430187) is an innovative Chinese biomedical company committed to research and development of innovative new medicines, accessing such new medicines through in-licensing, and additionally providing medical services. ApolloBio is focused on pharmaceutical products with significant market potential in China in the field of oncology; providing efficient access for American biomedical companies to enter into the Chinese market; and aiming to bring the newest and best medicines across the globe to the Chinese people. For more information, visit www.apollobio.com.

On April 18, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Deutsche Bank’s 43rd Annual Health Care Conference on Wednesday, May 9, 2018 (Press release, AbbVie, APR 18, 2018, View Source [SID1234525494]). Bill Chase, executive vice president and chief financial officer, will present at 7 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On April 18, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX), reported preclinical data for TG-1601, the Company’s novel BET inhibitor at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, taking place this week in Chicago, Illinois, at McCormick Place North/South (Press release, TG Therapeutics, APR 18, 2018, View Source [SID1234525512]). The Company’s poster is available for viewing today from 8:00am to 12:00pm CT, during the Experimental and Molecular Therapeutics/ Canonical Targets 2 Session in Exhibit Hall A.

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Highlights from this poster include:

Title: TG-1601 is a novel BET inhibitor with strong binding affinity and long-lasting effect in pre-clinical models (Abstract Number 5790)
— TG-1601 is a novel and potent BET inhibitor that specifically inhibits the binding of the BET sub-family of bromodomain-containing protein family;
— TG-1601 potently inhibits cell growth of various multiple myeloma and lymphoma cell lines in vitro, but does not affect the growth of normal cell lines;
— TG-1601 inhibits MYC and Bcl-2 expression in preclinical models;
— TG-1601 showed combinatorial effects in an in vivo model with anti-PD-1 antibodies. Clinical trials will be focused on a potential synergism between TG-1601 and other drugs in the TG pipeline.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are encouraged by the preclinical data presented today for TG-1601 which we believe to be a potent BET inhibitor that could have activity in a number of hematological malignancies. Importantly, by inhibiting c-Myc and Bcl-2 protein expression, TG-1601 may provide complimentary and/or synergistic effects when combined with our other products under development to potentially create best-in-class combinations. We look forward to continuing our research and advancing this compound into the clinic later this year."

PRESENTATION DETAILS

A copy of the above referenced poster is available on the Company’s website at www.tgtherapeutics.com, located on the Publications Page

On April 18, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that it has expanded its clinical development team with hiring of Vijay Reddy, M.D., Ph.D. as Vice President, Clinical Development, who will focus on Actinium’s clinical programs centered on targeted myeloablation (Press release, Actinium Pharmaceuticals, APR 18, 2018, View Source [SID1234525495]). Actinium is differentiating itself by developing the only multi-disease, multi-target pipeline of drug candidates focused on improving bone marrow transplant access and outcomes through improved myeloablation which includes the Company’s lead program, Iomab-B, that is being studied in the Pivotal Phase 3 SIERRA study and its planned Phase 2 Actimab-MDS trial.

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "I am incredibly excited to welcome Dr. Reddy, Dr. Safavi and Ms. McNamara to Actinium’s clinical development team. Vijay brings extensive clinical experience in the field of bone marrow transplant along with hematology focused drug development experience. His deep domain expertise and knowledge will allow us to capitalize on the many opportunities in myeloablation, for which our drug candidates and Actinium Warhead Enabling technology are ideally suited. Farnoush has a strong background in clinical trial execution and a proven ability to drive clinical trial enrollment, which will be of great benefit as we work to complete the SIERRA trial and launch new trials such as Actimab-MDS. Kathleen possesses a strong clinical nursing background, drug development experience and significant experience in the administration of complex therapies that will be well received by the SIERRA sites she supports. I am confident that collectively and individually, Dr. Reddy, Dr. Safavi and Ms. McNamara will make invaluable contributions that will allow us to continue to build on Actinium’s leadership position in myeloablation."

Dr. Reddy said, "As a transplant physician I am keenly aware of Iomab-B and its value proposition for patients, so it is incredibly exciting to have the opportunity to help bring this important targeted therapy against acute myeloid leukemia to patients with a clear need that can benefit from a BM. Actinium has done a fantastic job in the execution of the SIERRA trial thus far, as evidenced by participation of many of the leading BMT centers. In addition, expansion of the myeloablation programs with the planned Actimab-MDS trial represents a compelling opportunity. I am incredibly excited by the opportunities that lie ahead for Actinium and look forward to working with Dr. Berger and my new colleagues to build the leading myeloablation company."

Sandesh Seth, Actinium’s Chairman and CEO said, "Actinium is committed to being the leading company focused on myeloablation that improves access to and outcomes from potentially lifesaving bone marrow transplants. What started as a single asset in Iomab-B has evolved into a myeloablation franchise with the only multi-disease multitarget pipeline in myeloablation. The addition of Dr. Reddy, Dr. Safavi and Ms. McNamara will allow us to execute on the critical milestones for our pivotal Phase 3 trial for Iomab-B, efficiently launch our planned Phase 2 Actimab-MDS trial and capitalize on other opportunities in the field. We are incredibly excited for the talent we have assembled within Actinium and are motivated to make great advances with our drug candidates and technologies to better outcomes for patients."

Dr. Reddy has specialized in hematologic oncology with a Ph.D. in cancer immunology who focused his clinical practice in the area of bone marrow transplantation. Dr. Reddy was attending physician at Shands Hospital, University of Florida, and the Medical Director for adult BMT program in Orlando, prior to his starting in industry. He has served as inspector for the Foundation of Accreditation of Cellular Therapies (FACT). He is currently an Editorial Board Member for Biology of Blood and Marrow Transplantation and has authored over 50 publications in hematology/oncology and BMT journals.

Dr. Reddy joins Actinium from Pharmacyclics LLC, an Abbvie company, where he was Senior Medical Director, Oncology Medical Affairs. In this role, Dr. Reddy worked on the Ibrutinib program in CLL, MCL and chronic graft versus host disease (GVHD), along with additional indications. Previously, he worked at Medimmune (AstraZeneca) as Medical Director, Early clinical development, Immuno-Oncology R&D. Prior to Medimmune, Dr. Reddy worked at Janssen, a Johnson & Johnson company as Medical Director, Oncology. Prior to his experience in the pharmaceutical industry, Dr. Reddy was Professor of Medicine at the University of Central Florida. As a practicing clinician, Dr. Reddy participated in several clinical trials for BMT as an investigator, physician advisor or advisory board member.

Dr. Reddy received his M.B., B.S. (M.D. equivalent) from the Madras Medical College in India and his Ph.D. in cancer immunology from Memorial University of Newfoundland in Canada. He completed fellowships in hematology at The Princess Margaret Hospital and in Blood and Marrow Transplantation at the University of Toronto. He also was a Research Associate at the Dana Farber Cancer Institute.

Dr. Safavi joined Actinium from Progenics Pharmaceuticals, Inc., where she focused on oncology clinical studies. Prior to Progenics, Dr. Safavi had clinical roles of increasing responsibility at Stealth Bio Therapeutics, Verastem Inc. and New England Research Institute, Inc. Before her work in industry, Dr. Safavi supported academic clinical research at Massachusetts General Hospital, Emory University, Memorial Sloan Kettering Cancer Center, Montefiore Medical Center – Albert Einstein School of Medicine and MD Anderson Cancer Center.

Dr. Safavi received her M.D. from Xavier University School of Medicine, West Indies, Master of Health Services Administration from St. Joseph’s College of Maine and her Bachelor of Science degree in Biology from the University of Houston.

Kathleen McNamara is a Registered Nurse and Oncology Certified Nurse with significant clinical experience in the care of oncology patients. Most recently, Ms. McNamara was the Nurse Manager at a large infusion center where she oversaw patient care and trained the nursing staff in oncology therapy administration. Kathleen gained valuable experience in drug developing where she worked at Celgene Corporation as a Clinical Research Scientist on leukemia focused clinical trials and at Quintiles as an Oncology Nurse Educator. The majority of Kathleen’s career has been focused on the clinical care of oncology patients where she gained valuable experience in the administration of complex oncology therapies including biologics, bone marrow transplants and clinical trials. In addition, Kathleen has successfully managed, led and helped educate nursing staffs in a number of hospitals and infusion centers.

Kathleen earned her Bachelor of Science degree in Nursing from Niagara University and her Master of Arts degree in Education from Long Island University. She is a Registered Nurse with a certificate in Pediatric Nurse Practitioner in Ambulatory Pediatrics from the State University of New York.

On April 18, 2018 Verseon, a technology-based pharmaceutical company employing a computer-driven platform to develop a diverse drug pipeline, reported new preclinical data on its anticancer drug candidates at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting yesterday (Press release, Verseon, APR 18, 2018, View Source [SID1234525513]). Dr. Mohan Sivaraja, Associate Director of Discovery Biology, presented studies showing that Verseon’s drug candidates are potent against a range of cancer cell lines, including those that exhibit multidrug resistance.

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While chemotherapy remains the first line of treatment against most cancers, many tumors develop resistance to chemotherapy agents over time, limiting their efficacy. A common way for cancer cells to render drugs ineffective is by triggering an overproduction of transport proteins (efflux pumps) that expel many chemicals, including chemotherapeutics. In addition, cells can become resistant to tubulin-targeting chemotherapy drugs by overexpression of β-III tubulin.

The preclinical studies presented at the AACR (Free AACR Whitepaper) conference demonstrate that Verseon’s drug candidates target cancer cells by inhibiting the protein tubulin, which leads to cell cycle arrest. While marketed chemotherapies such as doxorubicin, paclitaxel, and vincristine show up to 2,000-fold reduced potency in cell lines overexpressing the major MDR1, MRP1, and BCRP efflux pumps, Verseon’s drug candidates are only weakly affected by these transporters (typically less than 2-fold). The Company’s drug candidates also appear unaffected by the overexpression of β-III tubulin. Dr. Sivaraja also presented pharmacokinetic data for one of Verseon’s tubulin inhibitors, which shows good exposure suitable for infusion. The candidate was also well tolerated in a preclinical repeat-dosing study.

"We are very encouraged by these preclinical results," said Dr. Sivaraja. "Multidrug resistance is one of the main reasons why chemotherapies fail. The insensitivity of our compounds to the major transporters and to the overexpression of β-III tubulin may help us address the need for a more effective, precise therapy."

About Verseon’s oncology program
Verseon plans to use its promising class of tubulin inhibitors to target multidrug resistant cancers. Several drug candidates show potency in functional and cellular assays. Furthermore, Verseon’s inhibitors maintain their efficacy across multiple chemotherapy-resistant cancer cell lines and are either unaffected or only weakly affected by the overexpression of common transporters, a primary source of multidrug resistance.