Actinium Pharmaceuticals to Showcase Capabilities of its AWE Technology Platform in Developing Biobetters at Upcoming AACR Annual Meeting

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:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]

Agios to Webcast Investor Day and First Quarter 2018 Financial Results on Friday, May 4, 2018

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Exelixis to Release First Quarter 2018 Financial Results on Wednesday, May 2, 2018

On April 11, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that its first quarter 2018 financial results will be released on Wednesday, May 2, 2018 after the markets close (Press release, Exelixis, APR 11, 2018, View Source;p=RssLanding&cat=news&id=2342154 [SID1234525268]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 7895176 to join by phone.

A telephone replay will be available until 8:30 p.m. EDT on May 4, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7895176. A webcast replay will also be archived on www.exelixis.com for one year.

TESARO and Medison Enter Into Exclusive Distribution Agreement to Commercialize ZEJULA® in Israel

On April 11, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Medison Pharma Ltd., Israel’s leading commercial partner for innovative pharmaceuticals, reported an exclusive distribution agreement to commercialize ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, in Israel (Press release, TESARO, APR 11, 2018, View Source [SID1234525269]). ZEJULA is currently approved in the United States and Europe as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA mutation or biomarker status.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under terms of the agreement, Medison will have the exclusive right to commercialize ZEJULA in all indications, excluding prostate cancer, in Israel. Medison will also be responsible for any potential patient access programs prior to regulatory approval. Further terms of the agreement were not disclosed.

"TESARO is committed to globalizing our mission, bringing transformative therapies to those facing cancer. This is an important step forward for us and the many patients in Israel who may benefit from ZEJULA," said Orlando Oliveira, Senior Vice President and General Manager, TESARO International. "We are proud to enter this agreement with Medison which, alongside a track record of bringing important therapies to patients across a number of oncology indications, offers a tremendous potential for collaboration as a source for innovation."

"We are excited about the opportunity to provide ZEJULA to cancer patients in our region. We plan to expedite access to ZEJULA via an early patient access program and will work closely with regulators to bring ZEJULA to patients here as quickly as possible," said Meir Jakobsohn, Founder and CEO, Medison Pharma. "Through our corporate venture arm with a dedicated research team, Medison partners with innovative biopharmaceutical companies, providing us access to best-in-class assets across a number of disease areas. We are happy to find in TESARO a partner that understands the mutual value which can be achieved through strategic collaboration."

ZEJULA is not currently approved for use in Israel.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA is the most utilized PARP inhibitor among women with ovarian cancer in the U.S., with more than 4,000 patients treated in 2017. Following European Commission approval in November 2017, ZEJULA is the first and only PARP inhibitor in Europe authorized for marketing for the maintenance treatment of patients with recurrent ovarian cancer, regardless of BRCA mutation status. TESARO’s clinical development program for ZEJULA incorporates monotherapy and combination approaches for multiple tumor types including ovarian, breast, and lung cancer.

Janssen Biotech has licensed rights to develop and commercialize ZEJULA specifically for patients with prostate cancer worldwide, except in Japan. Takeda Pharmaceutical Company Limited has licensed rights for all potential indications for ZEJULA in Japan, as well as rights in South Korea, Taiwan, Russia and Australia, excluding prostate cancer. TESARO has an agreement with Zai Lab for the clinical development and co-marketing of ZEJULA in China.

ZEJULA Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

H3 Biomedicine to Present at 2018 American Association for Cancer Research Annual Meeting

On April 10, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine, reported that two presentations at the upcoming 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14–18, 2018 in Chicago (Press release, H3 Biomedicine, APR 10, 2018, View Source [SID1234525249]). Both presentations underscore the Company’s scientific leadership in RNA splicing, including the identification of somatic mutations in cancer for the discovery and development of novel therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Presentation / Education Session – Saturday, April 14; 2:00 – 2:25 p.m. (CDT)
Discovery of H3B-8800: A novel, orally bioavailable, small molecule SF3b modulator
Location: Room S103 – McCormick Place South (Level 1)
Presenter: Dominic Reynolds, Ph.D., Vice President of Chemistry, H3 Biomedicine Inc.

Poster Presentation – Tuesday, April 17; 8:00 a.m. to 12:00 p.m. (CDT)
Comprehensive genomic profiling of hematologic malignancies identifies recurrent somatic splicing factor mutations in non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM)
Abstract 3406, Location: Main Exhibit Hall, Section 17, Poster Board 18

This poster presentation is related to a multi-year, ongoing collaboration between H3 Biomedicine and Foundation Medicine, Inc. (NASDAQ:FMI) for the discovery and development of precision medicines in oncology.

About H3B-8800
Splicing modulation is one of several research focus areas of H3 Biomedicine. A Phase 1 trial is underway in patients with hematologic malignancies for H3B-8800, the company’s first spliceosome pathway-targeting cancer therapeutic. H3B-8800 is a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complex, a splicing factor gene. The study is evaluating the safety and preliminary efficacy of H3B-8800 in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) who carry mutations in splicing factor genes. In February 2018, H3 published preclinical data in Nature Medicine demonstrating that H3B-8800 modulates RNA splicing and shows preferential antitumor activity in a range of spliceosome-mutant cancer models.