On April 11, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that it will host a conference call and webcast to report its first quarter 2018 financial results on Wednesday, May 2 at 8:30 a.m. ET (Press release, Acorda Therapeutics, APR 11, 2018, View Source [SID1234525262]).

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To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 2477088. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on May 2, 2018 until 11:59 p.m. ET on June 2, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2477088. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On April 11, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S (Press release, Bellicum Pharmaceuticals, APR 11, 2018, View Source [SID1234525332]). The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.

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About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

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 10, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the first quarter 2018 on Thurs., May 10 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, APR 10, 2018, View Source [SID1234525245]). On the same date, Halozyme will release financial results for the first quarter ended March 31, 2018 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 68917761.

On April 10, 2018 Loxo Oncology (Nasdaq:LOXO) and Illumina, Inc. (Nasdaq:ILMN) reported a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication (Press release, Loxo Oncology, APR 10, 2018, View Source [SID1234525372]). The co-development partnership will seek approval for a version of the Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for Loxo Oncology’s larotrectinib, which targets NTRK gene fusions, and LOXO-292, which targets RET gene alterations, across tumor types.

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TruSight Tumor 170 is a comprehensive, state-of-the-art, next-generation sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumors. The CDx version of TruSight Tumor 170 will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options. This version of TruSight Tumor 170 will run on the NextSeq 550Dx platform.

"We are leveraging our leadership in next-generation sequencing to deliver in-vitro diagnostic solutions to improve the management of cancer patients in the clinic," said Garret Hampton, Ph.D., executive vice president of clinical genomics at Illumina. "To this end, we are partnering with leading biotechnology companies, such as Loxo Oncology, to develop companion diagnostics for best-in-class therapeutics. Distributable diagnostic solutions, such as a CDx version of TruSight Tumor 170, in combination with the NextSeq 550Dx platform, will enable labs to perform precision medicine testing in-house."

Under the partnership, the companies will collaborate to validate a CDx version of TruSight Tumor 170 for NTRK fusions and RET fusions/mutations as a Class III FDA-approved diagnostic in conjunction with larotrectinib and LOXO-292, respectively. The companies are also planning to broaden the clinical utility of the full panel by obtaining regulatory approval for the other assay content, to be marketed as a tumor profiling test. Illumina will lead regulatory activities related to the Class III plans for NTRK and RET, the Class II plans for the tumor profiling content, and CE marking.

"We are very excited to announce this collaboration with Illumina, the world’s leader in NGS technology," said Jacob Van Naarden, chief business officer of Loxo Oncology. "We have piloted numerous NGS assays, and the Illumina TruSight Tumor 170 assay has consistently demonstrated robust performance with its assessment of both DNA and RNA, including highly sensitive gene fusion detection. The broad 170-gene assay content has the potential to deliver meaningful insights from a single tumor specimen, identifying patients with NTRK fusions, RET fusions, RET mutations, and many other actionable tumor alterations. Furthermore, we believe that this collaboration will improve patient access to high-quality NGS testing because pathologists will be able to run TruSight Tumor 170 locally and receive reimbursement."

About TruSight Tumor 170
TruSight Tumor 170 currently serves as the foundation for a comprehensive research use oncology menu, including:
170 unique genes informed by partnering pharmaceutical companies, academic community leaders, and industry guidance enable broad tumor profiling
Integrated workflow allowing more comprehensive testing while preserving precious samples by evaluating DNA and RNA in one integrated protocol with only 40ng from FFPE samples
Underlying assay method to serve as a standard for oncology testing and will be deployed across a variety of applications including Immuno-Oncology and liquid biopsy

About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and highly selective tropomyosin receptor kinase (TRK) inhibitor. The investigational new drug is in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated marked and durable anti-tumor activity in TRK fusion cancer regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated an 80 percent investigator-assessed confirmed overall response rate (ORR) and a 75 percent centrally-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib was well tolerated; the majority of all adverse events were grade 1 or 2. There were no treatment-related grade 4 or 5 events, and no treatment-related grade 3 adverse events occurred in more than 5% of patients.
Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.