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.

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

Xencor Presents Preclinical Data on XmAb®24306, Introduces XmAb® IL15 Bispecific Platform at American Association for Cancer Research (AACR) 2018 Annual Meeting

On April 18, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that preclinical data on XmAb24306, an IL15/IL15-receptor alpha complex fused to a bispecific XmAb Fc domain (IL15/IL15Rα-Fc) for the treatment of multiple oncology indications (Press release, Xencor, APR 18, 2018, View Source [SID1234525514]). Data show that the engineered complex enhanced the duration and magnitude of T and NK cell proliferation in vitro and in vivo. XmAb24306 is designed for reduced potency and extended half-life, and exhibited a steady, tolerable and sustained increase in T-cells in primates.

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Key findings from the study presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting include:

Fusing IL15/IL15Rα with Xencor’s highly stable heterodimer Fc platform and Xtend Fc domain creates a long-acting CD122 agonist, without targeting CD25
Potency reduction of the complex promotes improved exposure and sustained pharmacodynamics
Preserves native CD122/CD132 signaling despite potency reduction
Marked and sustained peripheral NK and T cell expansion at well-tolerated doses
"The plug and play nature of our XmAb technology provides tremendous opportunity to build a suite of tumor microenvironment activators with tunable potency and sustained activity, which have the potential for improved performance over current approaches," said Bassil Dahiyat, president and chief executive officer of Xencor. "With the IL15/IL15Rα-Fc platform, we have an engine to develop these candidates quickly, and are on track to file an IND for XmAb24306 in 2019."

XmAb24306 is the first of a suite of tumor microenvironment activators using the IL15 bispecific platform. Additional IL15 bispecific candidates, which target specific sub-populations of T cells, in preclinical development include:

A PD1 targeted IL15/IL15Rα (PD1 x IL15) candidate to promote selective expansion and activation of exhausted T cells
Additional targeted IL15/IL15Rα candidates
About XmAb IL15 Bispecific Platform

Xencor’s XmAb IL15 bispecific antibody platform provides a more druggable version of IL15 with reduced potency to improve tolerability, slow receptor-mediated clearance, and prolong half-life. IL15 is an extremely potent cytokine that stimulates the proliferation of lymphocytes, however its potential as a therapeutic has been limited by low tolerability and very fast clearance that limits therapeutic window. IL15 naturally targets CD122 without targeting CD25. Xencor has engineered the IL15/IL15Rα-Fc complex to create lead candidate XmAb24306 and to provide a basis for rapid generation of targeted T-cell activators. These Fc-fusions have been tuned for enhanced in vivo lymphocyte proliferation as a result of more sustained exposure.

MabVax Therapeutics Antibody Program Results Featured in Three Presentations at 2018 American Association for Cancer Research (AACR) Annual Meeting

On April 18, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that three poster presentations on the Company’s antibody development programs were made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois at McCormick Place (Press release, MabVax, APR 18, 2018, View Source [SID1234525497]).

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We successfully shared the significant progress we have made through these clinical and preclinical studies that continue to establish our growing body of data supporting the development of MVT-1075 for the treatment of pancreatic cancer and other CA19-9 cancers, MVT-2163 as a immunoPET imaging agent, and our most advanced research program focused on the Tn and sTn cancer antigen targets."

MabVax Poster Presentation Details

Jonah Rainey, Ph.D., Executive Director, Antibody Research at MabVax presented a poster on Sunday April 15th entitled: "A fully human antibody binds Tn and sTn carbohydrate antigens specifically on serine residues, without need for polypeptide interaction."

Dr. Rainey’s presentation included results from the Company’s successful human antibody discovery and engineering efforts that resulted in creating a panel of anti-Tn antibodies with specificity and affinity for the Tn and sTn epitopes. This observation was confirmed by a binding array analysis performed by a well-known independent academic based consortium. These antibodies bind preferentially to a particular presentation of the Tn epitope that exhibits a pharmaceutically useful pattern that is expressed on ovarian and breast cancers, including triple-negative breast cancer.

Paul Maffuid, Ph.D., Executive Vice President, Research & Development MabVax Therapeutics presented a poster on Tuesday April 17th entitled: "Phase 1 dose escalation study of 177Lu-HuMab-5B1 (MVT-1075) in combination with MVT-5873 as radioimmunotherapy (RIT) in subjects with relapsed / refractory pancreatic cancer or other CA19-9+ malignancies."

Dr. Maffuid’s presentation summarized results from the first cohort of three patients treated in the Phase 1 clinical trial of the Company’s MVT-1075 radiopharmaceutical product in late stage pancreatic cancer. These results at the initial dose support a high uptake of the on-target lesions with a prolonged time of residence and accumulation on target lesions. The predominant treatment-related toxicities in the first cohort included expected and manageable (Grade 1-3) changes in hematologic and liver function parameters.

Though the current data set is small, clinical biodistribution studies with the immunoPET imaging agent MVT-2163 in a prior Phase 1 study were used to successfully predict the absorbed organ doses of MVT-1075 and in particular red marrow which is the dose limiting organ. In addition, the studies completed to date were sufficient to establish a fractionated dosing schedule of MVT-1075 combined with image-based dosimetry as a feasible RIT Phase 1 dosing strategy, permitting within cycle patient specific dose adjustments to achieve a selected target red marrow exposure. A fourth patient has been treated in a second cohort at a planned escalated dose.

Jonah Rainey, Ph.D., Executive Director, Antibody Research at MabVax was a co-presenting author of a second poster on Tuesday April 17th entitled: "PEGylated Hyaluronidase Increases Tumor Uptake of 89Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive Hyaluronan-Accumulating Pancreatic Cancer Model"

This poster was the result of a preclinical collaboration with Halozyme Therapeutics, Inc. combining the use of MabVax’s immunoPET imaging agent MVT-2163 with Halozyme’s PEGylated Hyaluronidase, PEGPH20 to determine if the enzymatic degradation of HA could improve the uptake of MVT-2163 on tumor lesions as measured by in vivo PET imaging and ex vivo gamma counting, in a CA19-9-positive, HA-rich human pancreatic tumor xenograft model. PEGPH20 increased both the tumor uptake and the tumor-to-liver ratios of MVT-2163 as well as decreased liver uptake in a CA19-9 positive xenograft mouse model of HA-accumulating pancreatic cancer. The increased tumor uptake and the decreased liver uptake support further investigation into the potential diagnostic utility for the combination of PEGPH20 and MVT-2163.

To access the three full abstracts, please click here.

About MVT-1075

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. MVT-1075 has the potential to deliver a more potent HuMab-5B1-based product, by using small doses of a radioisotope coupled to the Company’s MVT-5873 antibody to target pancreatic cancer cells and kill them.

About the HuMab-Tn Antibody Targeting Tn and sTn

HuMab-Tn is a fully human antibody discovered by MabVax from a patient vaccinated with a pool of cancer glycans, including Tn. The antibody has been affinity-matured and demonstrates highly selective Tn/sTn glycan binding. Further, the antibody recognizes a wide array of cancers, particularly ovarian and breast including approximately 90% of triple negative breast cancers tested.

About MVT-2163

MVT-2163 is an immunoPET imaging agent product that combines the established PET imaging capabilities of 89Zr with HuMab-5B1 tumor specific targeting. It has the potential to aid in identifying the best surgical treatment options for patients with pancreatic cancer and as a potential companion diagnostic with treatment options.