On April 11, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported its presence at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) that is being held April 14 – 18 in Chicago, Illinois (Press release, Actinium Pharmaceuticals, APR 11, 2018, View Source [SID1234525264]). Actinium will feature its AWE Technology Platform at AACR (Free AACR Whitepaper) including additional data from the Company’s efforts focused on creating biobetters and novel antibody radio-conjugates (ARCs). Recently, Actinium announced that it has entered into a collaborative research agreement with Astellas Pharma, Inc. that will leverage the Company’s AWE Technology Platform to conjugate and label select Astellas targeting agents with actinium-225. Actinium submitted additional data that has been accepted for poster presentation at AACR (Free AACR Whitepaper), the details of which are below: Details on the poster are as follows:

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Title: Conjugation of daratumumab with 225actinium greatly increases its antitumor activity against multiple myeloma tumors
Abstract Number: 760
Session Category: Experimental and Molecular Therapeutics
Date: Sunday, April 15, 2018, 1:00 – 5:00 PM

At time of abstract submission, the Ac-225 labelled daratumumab at an equimolar concentration demonstrated superior antitumor activity to naked daratumumab in a highly predictive DAUDI model and provided a survival benefit. Additional details will be presented during the poster session at the Annual Meeting.

To arrange a meeting with Actinium Pharmaceuticals at AARC or to learn more about Actinium’s AWE Technology Platform, please contact Keisha Thomas, Ph.D., Corporate Development at [email protected] or visit View Source

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer said, "We are heading to AACR (Free AACR Whitepaper) with significant momentum around our AWE Technology program following our recently announced collaboration with Astellas and following the exciting preclinical data we published at ASH (Free ASH Whitepaper). At AACR (Free AACR Whitepaper), we will be presenting additional preclinical data further demonstrating the utility and benefits of our AWE Technology platform in enhancing the potency of anti-cancer targeting agents. Collectively, this will showcase our capabilities and we look forward to the interactions we will have with biopharmaceutical companies attending the Annual AACR (Free AACR Whitepaper) meeting."

Recently, Actinium presented data at the American Society of Hematology (ASH) (Free ASH Whitepaper) demonstrating the Company’s ability to utilize AWE Technology to dramatically enhance the potency of daratumumab, CD38 targeted therapy for patients with multiple myeloma which is marketed by Johnson & Johnson as Darzalex, by stably labeling the antibody with the isotope actinium-225. In doing so, tumor cell death in vitro was dramatically enhanced, resulting in potent and selective CD38-dependent cell killing approaching 100% in each of the lines tested.

Sandesh Seth, Actinium’s Chairman and CEO said, "We see great potential for our AWE Technology Platform and are encouraged that it has been validated by our collaboration with Astellas Pharma, Inc., a top twenty global biopharmaceutical company. Having formalized our AWE Technology Program less than 6 months ago, we are incredibly pleased with the progress we have made, the team we have built and the data we have generated. Actinium is committed to leading the field in alpha-particle therapies driven by cutting edge research and development, strong translation into clinical programs and building a robust infrastructure that can support late stage development and commercialization."

About Our Actinium Warhead Enabling Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Even though it exhibits superior cell killing power, actinium-225, when delivered in a targeted manner, is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture Actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of Actinium Radio-Conjugates (ARC’s), management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with Actinium-225. In addition to increased efficacy, these Actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of biobetters or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected]

On April 11, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will webcast presentations from its Investor Day on Friday, May 4, 2018 starting at approximately 8:30 a.m. ET in New York (Press release, Agios Pharmaceuticals, APR 11, 2018, View Source [SID1234525265]).

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Presentations will be given by members of Agios’ leadership team and external speakers including:

David Schenkein, M.D., Chief Executive Officer
Scott Biller, Ph.D., Chief Scientific Officer
Chris Bowden, M.D., Chief Medical Officer
Andrew Hirsch, Chief Financial Officer and Head of Corporate Development
Steve Hoerter, Chief Commercial Officer
Darrin Miles, Vice President, IDH Program Management
Susan Pandya, M.D., Senior Medical Director, Clinical Development
Kevin Marks, Ph.D., Senior Director, Head of Cancer Biology
Maeve Lowery, M.B., B.Ch., B.A.O, Trinity College Dublin
A live webcast of the presentations can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The presentations are scheduled to begin at approximately 8:30 a.m. ET and conclude at 12:00 p.m. ET. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On April 10, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (Press release, Karyopharm, APR 10, 2018, View Source [SID1234525246]). The FDA’s statement, consistent with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of therapy include regimens comprised of an alkylating agent, a glucocorticoid, Velcade (bortezomib), Kyprolis (carfilzomib), Revlimid (lenalidomide), Pomalyst (pomalidomide) and Darzalex (daratumumab). In addition, the patient’s disease must be refractory to at least one proteasome inhibitor (Velcade or Kyprolis), one immunomodulatory agent (Revlimid or Pomalyst), glucocorticoids and to Darzalex, as well as to the most recent therapy. The Company expects to report top-line data from the STORM study at the end of April 2018.

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The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

"The designation of Fast Track for selinexor represents important recognition by the FDA of the potential of this anti-cancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We are fully committed to working closely with the FDA as we continue development of this potential new, orally-administered treatment for patients who currently have no other treatment options of proven benefit."

About the Phase 2b STORM Study

In the multi-center, single-arm Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study, approximately 122 patients with heavily pretreated, penta-refractory myeloma receive 80mg oral selinexor twice weekly in combination with 20mg low-dose dexamethasone, also dosed orally twice weekly. Patients with penta-refractory disease are those who have previously received an alkylating agent, a glucocorticoid, two immunomodulatory drugs (IMiDs) (Revlimid (lenalidomide) and Pomalyst (pomalidomide)), two proteasome inhibitors (PIs) (Velcade (bortezomib) and Kyprolis (carfilzomib)), and the anti-CD38 monoclonal antibody Darzalex (daratumumab), and their disease is refractory to at least one PI, at least one IMiD, Darzalex, glucocorticoids and their most recent anti-myeloma therapy. Overall response rate is the primary endpoint of the study, with duration of response and clinical benefit rate being secondary endpoints. All responses will be adjudicated by an Independent Review Committee (IRC).

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,300 patients have been treated with selinexor, and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On April 10, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, reported that a poster highlighting the effectiveness of pelareorep in combination with Keytruda and/or an anti-CD73 immunotherapy in prostate cancer cell lines was presented at the 11th International Oncolytic Virus Conference (IOVC) (Press release, Oncolytics Biotech, OCT 10, 2018, View Source [SID1234525554]). The conference takes place at Oxford University, April 9-12, 2018, in Oxford, UK.

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"This poster adds to the critical mass of validating data that demonstrates the positive outcomes seen when using pelareorep in combination with other immuno-oncology drugs," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Prostate cancer is generally considered to be a ‘cold’ tumor, and this non-inflamed phenotype is thought to be largely responsible for the lack of sensitivity of these patients to immune checkpoint blockade. We continue to believe that the use of oncolytic viruses can overcome pre-existing mechanisms of resistance to immunotherapy in many cancers by transforming these ‘cold’ tumors into ‘hot,’ immune cell infiltrated tumors."

Data presented in the poster demonstrated that:

treatment of subcutaneous TRAMP-C2 prostate tumors with a combination of pelareorep and anti-PD-1 (Keytruda) or anti-CD73 antibody significantly enhanced survival of mice compared to pelareorep or antibody therapy alone;

immune profiling of pelareorep treated and untreated tumors confirmed the ability of pelareorep to increase tumour immune cell infiltration;

pelareorep infection of tumours is needed before a therapeutic effect of anti-immune inhibitory/suppressive antibodies is seen;

pelareorep-initiated antitumor immunity protects against subsequent tumour challenge; and

after the study of negative regulators, only B and T lymphocyte attenuator (BTLA) and PD-L1 were significantly upregulated in the pelareorep treated TRAMP-C2 tumors compared to untreated tumour.

The poster presentation by Dr. Guy Simpson, Department of Clinical and Experimental Medicine, University of Surrey, is now available on the Posters, Presentations & Publications page of the company’s website: www.oncolyticsbiotech.com/technology/posters-publications.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On April 10, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that updated poziotinib Phase 2 data in MD Anderson’s EGFR Exon 20 Mutant Non-Small Cell Lung Cancer study are available, based on longer follow-up (Press release, Spectrum Pharmaceuticals, APR 10, 2018, View Source [SID1234525373]).

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"I am pleased to observe the preliminary confirmed objective response rate and potential progression-free survival (PFS) benefit in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer patients," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "In the first 11 patients, the confirmed objective response rate was 64%. This is very exciting because we were initially hoping to get response rates between 20% to 30%. I am encouraged to see that in these 11 patients, the median PFS has not been reached after a median follow up of 6.5 months. In addition, the two most common adverse events observed in the study to date are skin rash and diarrhea, which are known EGFR inhibitor-related toxicities. We are looking forward to presenting comprehensive data from this study at a major medical meeting later this year."

"The updated data from MD Anderson provides additional insight into just how meaningful poziotinib may be in this area of high unmet need," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "At each turn, the possibility of this drug as an option for EGFR Exon 20 mutant NSCLC patients is becoming more clear."

"Our study at MD Anderson has far exceeded our enrollment expectations," said Xiuning Le, M.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "At this point, the original cohort of 30 EGFR patients is fully enrolled and the expanded cohort of 20 patients is nearing the completion of enrollment. As enrollment in our study nears completion, we will soon begin enrolling patients in Spectrum’s ongoing multicenter Phase 2 study."

"These early data from MD Anderson suggest poziotinib may have a meaningful impact on outcomes for patients who have limited treatment options," said David Chu, M.D., New York Cancer and Blood Specialists. "As one of the initial sites on the east coast for Spectrum’s ongoing multi-center Phase 2 study, we have patients seeking us out from around the world. I am excited about this potential option for these patients."