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Actinium Pharmaceuticals Highlights Data at the American Society of Hematology Annual Meeting Showing CD33 Expression in a Significant Number of Multiple Myeloma Patients Supporting the Rationale for Actimab-M

On December 11, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported results from an analysis performed on a large U.S. library of samples from 865 multiple myeloma patients which showed that twenty-five percent of patients had CD33 expression on their multiple myeloma cells (Press release, Actinium Pharmaceuticals, DEC 11, 2017, View Source [SID1234522539]). Actinium is currently conducting a Phase 1 clinical trial for its Actimab-M drug candidate in patients with refractory multiple myeloma. Actinium is the first and only company thus far to have a CD33 targeted therapy for multiple myeloma and the results from this analysis provide further rationale for the Company’s myeloma initiative.

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This analysis was the first of its kind to analyze such a large, U.S. based patient sample library as previous studies exploring CD33 expression in multiple myeloma looked at significantly smaller sample sizes from established multiple myeloma cell lines. Patient samples at initial diagnosis were assessed for CD33 expression and CD33 expression was stratified with CD33 expression greater than 40% considered high and greater than 60% very high. The analysis showed that 61.6% of patients in the dataset had high CD33 expression and 41% of patients had very high CD33 expression which translates to approximately fifteen percent of the overall multiple myeloma sample population.

The online abstract can accessed through the following link:
View Source

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "It is generally believed that expression of CD33 on multiple myeloma plasmocytes is in line with the low levels of expression in cells of the lymphoid lineage. The results from this study confirm that CD33 is expressed in a significant sub-set of multiple myeloma patients. Given that CD33 expression levels have been found to be high or very high in a large percentage of patients that do express the antigen, we have great confidence that our Actimab-M drug candidate, which uses an anti-CD33 antibody, can have a beneficial impact on these patients. In a disease like multiple myeloma, which remains incurable, we believe it is important to explore new therapeutic modalities and use of our CD33 targeting ARC or Antibody Radio-Conjugate is supported by these results. Additionally, myeloma cells are sensitive to radiation and targeting them using an ARC like Actimab-M may provide further advantages."

Patients that relapsed were also assessed for CD33 expression and 27.1% of relapsed patients were found to have CD33 expression with 58.3% of these patients having very high expression at initial diagnosis and relapse.

About Actimab-M

Actimab-M is being investigated in patients with refractory multiple myeloma. Multiple myeloma is a currently incurable cancer of plasma cells, which are white blood cells that produce antibodies. Actimab-M is currently being studied in a Phase 1 dose escalation study in up to 12 patients that is designed to establish safety, maximum tolerable dose and proof of concept. Actimab-M is an ARC or Antibody Radio-Conjugate that consists of Actinium-225, an alpha-emitting radioisotope coupled to the anti-CD33 monoclonal antibody, lintuzumab. CD33 has been shown to be expressed on myeloma plasmocytes in 25% of multiple myeloma patients and up to 35% of multiple myeloma patients and has also shown to be correlated with poorer outcomes.

IMBRUVICA® (ibrutinib) Data Provide Insights Into Its Potential Treatment Benefits for Previously-Treated Chronic Graft-Versus-Host Disease — A Serious, Possibly Life-Threatening Condition

On December 11, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported new data on the biologic and cellular mechanisms of IMBRUVICA (ibrutinib) in patients with chronic graft-versus-host disease (cGVHD), a potentially life-threatening consequence of an allogeneic stem cell or bone marrow transplant (Press release, AbbVie, DEC 11, 2017, View Source;serious-possibly-life-threatening-condition.htm [SID1234522538]). New results showed ibrutinib selectively inhibited pre-germinal center B cells and follicular helper T cells (Tfh) that are believed to play a critical role in treating cGVHD. In addition, the data also showed that ibrutinib preserved immune memory and Th1 T cells, which suggests the potential for additional treatment benefit. These results were observed in a Phase 1b/2 trial (PCYC-1129).

The data will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Dec. 11 in Atlanta (abstract #4481). IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

"These new data further underscore the potential benefit of IMBRUVICA in chronic graft-versus-host disease, and provide encouraging signs for its mechanism of action in a way that’s meaningful to advancing treatment," said Lori Styles, M.D., Senior Medical Director and GVHD program clinical lead at Pharmacyclics LLC, an AbbVie company. "The full potential of IMBRUVICA continues to unfold."

Patients can develop GVHD, a potentially life-threatening complication, following an allogeneic stem cell or bone marrow transplant.2 The condition occurs when donor immune cells mistakenly attack patient’s normal tissues.2 The effects of GVHD can be seen throughout the body, affecting almost any organ and manifesting through rashes and skin thickening, joint pain and stiffness, eye dryness and irritation, diarrhea, jaundice, mouth sores and ulcers, and severe lung dysfunction.1 The incidence of cGVHD has continued to increase over time,3 with approximately 30 to 70 percent of post-allogeneic transplant patients developing the condition.4

The U.S. Food and Drug Administration (FDA) recently granted approval of IMBRUVICA for the treatment of adult patients with cGVHD after failure of one or more lines of systemic therapy. This approval was based on data recently published in Blood.

To view all IMBRUVICA company-sponsored or investigator-initiated studies being presented at ASH (Free ASH Whitepaper) 2017, which includes 12 oral presentations, please click here.

About the Presentation

Abstract #4481: Ibrutinib Inhibits cGVHD Pathogenic Pre-Germinal Center B-cells and Follicular Helper Cells While Preserving Immune Memory and Th1 T-cells
Poster Presentation: Monday, December 11, 6:00 – 8:00 p.m. ET

Data derived from the use of Nanostring gene expression analysis showed ibrutinib reduced inflammatory genes, including NFkB-1 and chemokines CXCL10, CCL7 and CCL3 (2.6, 2.3, 25, and 1.8-fold decrease, respectively), over the first three months. Additionally, a luminex plasma quantification showed several additional chemotactic, inflammatory, and fibrotic factors (CCL22, CXCL9, CXCL10, IL-8, sCD25, CCL4, and ST2) decreased in 69-80% of patients treated with ibrutinib. A 42-parameter CyTOF single cell analysis also revealed a 10-fold reduction in absolute numbers of cGVHD implicated pre-germinal center B cells (CD19+, CD27+, CD38+, IgD+), and notably diminished Tfh, Th17, and total B cells (2.6, 1.5, and 1.4-fold decrease, respectively) over the first three months following ibrutinib therapy.

The relative numbers of CD4+ and CD8+ T cells remained unchanged, although the total number of CD8+ cells seemed to follow an increasing trend. An analysis of relative numbers of T-cell subsets indicated a trend towards increasing numbers of Th1 and T regulatory cells, while Tfh cells and iNKT cells showed a trend towards decreasing numbers when compared with pretreatment numbers and 343 days of follow up. IgG plasma levels persisted while IgM significantly decreased supporting an ibrutinib germinal center effect that did not deplete long-lived plasma cells. Further, T cell reactivity against influenza increased, and antibodies against EBV and tetanus remained unchanged. However, single cell phosphorylation analysis showed BTK and interleukin-2-inducible T-cell kinase (ITK) signaling decreased following ibrutinib treatment in defined B and T-cell subsets.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.5 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).6

IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
IMBRUVICA was approved for adult patients with WM in January 2015.
In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously treated CLL/SLL.
In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.5 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 90,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood.

IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA.

Monitor complete blood counts monthly.

Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA.

Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%), neutropenia (61%), diarrhea (43%), anemia (41%), musculoskeletal pain (30%), rash (30%), bruising (30%), nausea (29%), fatigue (29%), hemorrhage (22%), and pyrexia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%), thrombocytopenia (16%), and pneumonia (10%).

Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%), muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%), and pneumonia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%), pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

DRUG INTERACTIONS

CYP3A Inducers: Avoid co-administration with strong CYP3A inducers.

CYP3A Inhibitors: Dose adjustment may be recommended.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA dose.

Genmab’s 2017 R&D Update

On December 11, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it will hold a R&D Update on December 11, 2017 at 8:00 PM Eastern Time (2:00 AM CET / 1:00 AM GMT on December 12) (Press release, Genmab, DEC 11, 2017, View Source [SID1234522510]). The event will take place in Atlanta, Georgia and will also be webcast live and archived on the company’s website. The event will include updates on daratumumab, including presentations by key opinion leaders on data from daratumumab studies presented at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). The meeting will also feature a review of tisotumab vedotin, including data previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September and an update on the product pipeline including Genmab’s next IND/CTA candidate, DuoBody-CD40x4.1BB developed jointly with partner BioNTech. Genmab speakers will also discuss the company’s 2017 progress and key goals for 2018.

The following cancer experts and senior Genmab staff will be at the event:
Key Opinion Leaders:
Professor Maria Victoria Mateos, University Hospital of Salamanca
Professor Philippe Moreau, University Hospital of Nantes
Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute
Professor Ignace Vergote, Catholic University of Leuven

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
David Eatwell, Executive Vice President and CFO, Genmab
Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
Dr. Kate Sasser, Corporate Vice President, Clinical Biomarkers, Genmab
The R&D Update is taking place at the Omni Atlanta Hotel at CNN Center, International Ballroom AB, North Tower M2. Those wishing to attend in person may register on site.

The event may also be attended via webcast. To view this webcast, visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.
This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

TRILLIUM THERAPEUTICS PROVIDES UPDATE ON ITS TTI-621 PROGRAM AT THE AMERICAN SOCIETY OF EMATOLOGY 59TH ANNUAL MEETING

On December 11, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that new clinical data from ongoing Phase 1 a/b trials for its CD47-blocking agent, TTI-621 (SIRPa-IgG1 Fc), were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting, December 9-12, in Atlanta (Press release, Trillium Therapeutics, DEC 11, 2017, View Source [SID1234522536]).

Poster Presentation 4076: A Single Direct Intratumoral Injection of TTI-621 (SIRPaFc) Induces Antitumor Activity in Patients with Relapsed/Refractory Mycosis Fungoides and Sézary Syndrome: Preliminary Findings Employing an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal. Presenter: Christiane Querfeld, MD, PhD, City of Hope National Medical Center.

This poster presentation highlighted preliminary safety and anti-tumor activity of intratumoral TTI-621 administration in highly pretreated patients with relapsed or refractory mycosis fungoides or Sézary syndrome. Intratumoral injection was well tolerated, with no dose-limiting toxicity observed. A rapid reduction in CAILS scores, which measures local lesion responses, was observed in 9 out of 10 mycosis fungoides patients and a reduction in circulating leukemic Sézary cells was observed in 3 out of 3 patients. Several patient profiles were presented which demonstrate clinical responses in disfiguring lesions, in some cases after a single dose of TTI-621. Collectively, the data demonstrate that cutaneous T-cell lymphoma (CTCL) appears biologically responsive to intratumoral injections of TTI-621, and enrollment in this trial (NCT02890368) is continuing.

Poster Presentation 4116: TTI-621 (SIRPaFc), an Immune Checkpoint Inhibitor Blocking the CD47 "Do Not Eat" Signal, Induces Objective Responses in Patients with Advanced, Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL). Presenter: Stephen Ansell, MD, PhD, Division of Hematology, Mayo Clinic.

This poster presentation summarized the overall safety profile of intravenous TTI-621 in patients with relapsed/refractory hematologic malignancies and preliminary anti-tumor activity in patients with diffuse large B-cell lymphoma (DLBCL). Weekly infusions of TTI-621 were shown to be well tolerated, and notably, transient thrombocytopenia was attenuated after the first dose. These data, combined with the previously reported results from the dose escalation phase, demonstrate a favorable safety profile of intravenous TTI-621 in over 100 patients. Intravenous administration of TTI-621, particularly in combination with rituximab, resulted in objective responses in 5 out of 18 evaluable patients with heavily pre-treated, relapsed/refractory DLBCL, and several others experienced prolonged progression-free intervals.

"The regression of local tumor lesions observed in most CTCL patients treated with intratumoral TTI-621 monotherapy provides us with a rationale to initiate a sharply focussed effort to characterize efficacy in this largely incurable disease, as well as other forms of T-cell lymphoma. Having completed the dose-escalation phase, we are now pursuing weekly dosing in the intratumoral trial with the goal of inducing systemic responses. In parallel, we continue to enroll a wide variety of T-cell lymphoma patients, including CTCL, into an expanded cohort in the intravenous TTI-621 trial," said Trillium CEO Dr. Niclas Stiernholm. "Notwithstanding the added level of complexity associated with developing combination therapies, the emerging signal in the DLBCL cohort is intriguing, especially since these patients have previously progressed after rituximab therapy." Dr. Stiernholm added, "With growing evidence supporting the tolerability of dose intensification we are now able to assess whether increasing systemic exposure of TTI-621 leads to greater anti-tumor activity in patients, including those with T-cell malignancies."

Copies of both posters will be available on Trillium’s website at the time of the presentations www.trilliumtherapeutics.com

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a type of non-Hodgkin’s lymphoma which is characterized by localization of malignant T lymphocytes to the skin. The two most common types of CTCL are mycosis fungoides and Sézary syndrome. The disease most often involves the skin, may progress to involve lymph nodes, blood, viscera and other organs, and in select cases may become leukemic.

About Diffuse Large B-Cell Lymphoma (DLBCL)

DLBCL is the most common form of non-Hodgkin lymphoma, a cancer of white blood cells responsible for producing antibodies. While effective therapies exist for newly diagnosed DLBCL, cancer that has relapsed after treatment, or whose cancer is treatment resistant, represent an area of high unmet medical need.

TG Therapeutics, Inc. Announces Preclinical & Clinical Data Presentations at the 59th American Society of Hematology Annual Meeting

On December 11, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported the presentation of six posters highlighting preclinical and clinical data sets for TGR-1202 (umbralisib), the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, currently being held at the Georgia World Congress Center in Atlanta, Georgia (Press release, TG Therapeutics, DEC 11, 2017, View Source [SID1234522535]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are very pleased by the data presented yesterday and today during the ASH (Free ASH Whitepaper) annual meeting. The preclinical data help us to better understand the difference between TGR-1202 and other agents in the class and offers a more complete rationale for the differentiated safety profile seen in the clinic. With the updated and expanded integrated safety analysis of TGR-1202 alone and in combination with other agents, we believe we have provided the long-term follow-up sufficient to allay any lingering safety concerns related to TGR-1202 caused by the toxicity profile of first generation PI3K delta inhibitors." Mr. Weiss continued, "In 2018, with registration-directed data expected in CLL and NHL, our focus will turn to showcasing the efficacy of TGR-1202 and our proprietary combination of TG-1101 plus TGR-1202, our U2 combination, ideally leading to NDA/BLA filings in CLL and NHL."

The following summarizes the highlights from each poster presented at the ASH (Free ASH Whitepaper) 2017 meeting.

Clinical Data Presentations:

An Integrated Safety Analysis of the Next Generation PI3K Delta Inhibitor Umbralisib (TGR-1202) in Patients with Relapsed/Refractory Lymphoid Malignancies

This presentation includes data that were pooled from 5 completed or ongoing Phase 1 or 2 studies containing TGR-1202, including a total of 347 patients with relapsed or refractory hematologic malignancies. Patients were heavily pretreated, with 50% of patients having seen 3 or more prior lines of therapy.