TG Therapeutics, Inc. Announces Preclinical Data Presentation on the Company’s BET Inhibitor, TG-1601, at the 2018 American Association for Cancer Research (AACR) Annual Meeting

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

Actinium Pharmaceuticals Strengthens Targeted Myeloablation Focused Clinical Development Team with New Hires Including Experienced Bone Marrow Transplant Physician and Drug Developer Vijay Reddy, M.D., Ph.D. as Vice President, Clinical Development

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.

Verseon presents anticancer agents at AACR 2018

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.

Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 in Combination with Cabozantinib for Treatment of Patients with Advanced Renal Cell Carcinoma

On April 18, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab (Press release, Calithera Biosciences, APR 18, 2018, View Source [SID1234535241]). CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The trial is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression free survival and the global study is open for enrollment.

"Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among advanced patients who have received prior treatment," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with advanced or metastatic renal cell carcinoma who have failed prior systemic therapy."

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The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

Heat Biologics Announces Upcoming Milestones Following Positive Interim Phase 2 Results for HS-110

On April 18, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported an upcoming clinical milestones for HS-110 in non-small cell lung cancer (NSCLC), its ComPACT platform, as well its Pelican subsidiary’s co-stimulator antibody, PTX-35 (Press release, Heat Biologics, APR 18, 2018, View Source [SID1234525496]).

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Anticipated Phase 2 NSCLC milestones include an interim data readout in Q4 2018 and a final Phase 2 data readout in Q2 2019, followed by a Phase 3-ready NSCLC program in Q3 2019. Expected PTX-35 milestones include receipt of $6.9 million in CPRIT grant funds to support the enrollment of the first patient in a Phase 1 clinical trial in Q1 2019 and an interim data readout in Q3 2019. Additionally, Heat plans on enrolling its first patient in its ComPACT trial in Q4 2018 and anticipates an interim data readout in Q2 2019.

Jeff Wolf, Heat’s CEO, commented, "The next four quarters are shaping up to be very exciting, with events that we believe will be transformational for our company. Earlier this year we reported positive interim results from the Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced NSCLC. We observed some potentially very exciting data with this combination that points to the opportunity to use this combined therapy in a very underserved population of NSCLC patients."

"Given all the recent progress, I am pleased to announce these upcoming milestones for the next 4 quarters. Importantly, we believe each of these milestones will help drive shareholder value. At the same time, we are witnessing advancements in the immuno-oncology landscape that are resulting in a growing interest in our technology across the industry, and, hence, we strongly believe our assets will play an important role in the future of combination immunotherapies."

Anticipated milestones:

Q3 2018:

Receive $6.9M in CPRIT (Cancer Prevention Research Institute of Texas) grant funds
Q4 2018:

Interim Phase 2 NSCLC data readout
IND filing for first ComPACT trial
Enroll first patient in ComPACT trial
Q1 2019:

PTX-35 IND filing
Enroll first patient in PTX-35 trial
Q2 2019:

Complete enrollment in Phase 2 NSCLC trial
Phase 2 NSCLC data readout
Interim ComPACT data readout
Q3 2019:

Interim PTX-35 data readout