On May 29, 2018 NeoImmuneTech, Inc. (NeoImmuneTech), an immunotherapy drug development company focused on advanced cancer treatments, reported the initiation of its first U.S. clinical trial (Press release, NeoImmuneTech, MAY 29, 2018, View Source [SID1234526931]). The trial, studying HyLeukin-7, an immunotherapeutic agent for cancer patients being co-developed by NeoImmuneTech and Genexine, Inc. (Genexine), will be conducted under agreement with the Adult Brain Tumor Consortium (ABTC) in the U.S. and supported by the National Cancer Institute (NCI) as a joint study of the Cancer Immunotherapy Trials Network (CITN) for biomarker analysis. The purpose of this study is to determine HyLeukin-7’s effect on lymphocyte counts in patients with brain cancer following radiation. In addition, the safety and efficacy of different doses of this new agent will be explored. The study will enroll up to 75 patients.

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"It is the first time that NeoImmuneTech’s HyLeukin-7 has cleared the U.S. IND for clinical trials and is an important milestone for our global clinical development. We plan to continue expanding HyLeukin-7’s target indications and to initiate several additional research collaborations to study it in combination with global immuno-oncology products", said NeoImmuneTech’s Chief Executive Officer, Se Hwan Yang, Ph.D.

The U.S. Food and Drug Administration (FDA) accepted NeoImmuneTech’s Investigational New Drug (IND) application on March 16, 2018. The study was recently approved by the NCI’s Cancer Therapy Evaluation Program (CTEP) allowing for a Phase 1 and Pilot study of HyLeukin-7 (Registered code name: NT-I7) in brain cancer patients.

About Glioblastoma

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and most malignant type of primary brain tumor. Its standard therapy is surgery and chemotherapy. The average survival rate is about 12 months, relatively shorter than other solid tumors. When glioblastoma patients are treated with standard radiation and chemotherapy, approximately 40% experience a severe reduction in their immune cell counts, especially T cells. Recent data suggest that poor survival rates are associated with very low T cell counts.

About HyLeukin-7

HyLeukin-7 (IL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells, acting on increasing both the number and functionality of T cells. HyLeukin-7 could play a pivotal role in reconstitution and reinvigoration of T cell immunity for treatment of cancer patients, providing unique opportunities for Immuno-oncology (IO) combination strategies. HyLeukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine are collaborating in three Phase 1b/2a clinical trials in advanced solid tumors and glioblastoma in the US and Korea.

On May 29, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, reported that management will present company overviews at the following conferences (Press release, Alnylam, MAY 29, 2018, View Source [SID1234527057]):

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Bernstein 34th Annual Strategic Decisions Conference onFriday, June 1, 2018 at 9:00 am ET at the Grand Hyatt in New York City
Jefferies 2018 Global Healthcare Conference on Wednesday, June 6, 2018 at 4:00 pm ET at the Grand Hyatt in New York City
Goldman Sachs 39th Annual Global Healthcare Conference onThursday, June 14, 2018 at 9:20 am PT (12:20 pm ET) at the Terranea Resort in Rancho Palos Verdes, California

A live audio webcast of each presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after each event.

On May 29, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that the company’s management team will present at the Jefferies Healthcare Conference on Tuesday, June 5th at 3:30 p.m. EDT (Press release, Endocyte, MAY 29, 2018, View Source [SID1234527073]).

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A live audio webcast of the Company’s presentation can be accessed by visiting "Events & Presentations" under the Investors & News section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event, and a replay will be available on the Company’s website for 90 days following the conference.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On May 29, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the Goldman Sachs 39th Annual Global Healthcare Conference on Tuesday, June 12, 2018, in Rancho Palos Verdes, Calif (Press release, Medtronic, MAY 29, 2018, View Source;p=RssLanding&cat=news&id=2351076 [SID1234527091]).

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Omar Ishrak, Medtronic chairman and chief executive officer, and Karen Parkhill, Medtronic executive vice president and chief financial officer, will answer questions about the company beginning at 8:00 a.m. PDT (10:00 a.m. CDT).

A live audio webcast of the session will be available on June 12, 2018, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.

On May 29, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Commission (EC) has authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy (Press release, Clovis Oncology, MAY 29, 2018, View Source [SID1234526932]). Certain confirmatory post-marketing commitments are required as part of this conditional authorization.

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For the full European approved prescribing information, please refer to the Rubraca (rucaparib) Summary of Product Characteristics on the European Medicines Agency website.

"Rucaparib provides a unique opportunity within Europe for women with BRCA mutated ovarian cancer, for whom platinum chemotherapy isn’t an option, to receive an oral non-chemotherapy treatment," said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London, U.K. "In this group of patients with limited treatment options, rucaparib provides a much-needed oral targeted therapy for these women."

The project that led to rucaparib’s discovery was among the first of the Newcastle Cancer Drug Discovery Group that started at Newcastle University, involving the Northern Institute for Cancer Research and a team of Cancer Research U.K.-funded scientists. Rucaparib went into phase 1 trials in 2003, with Ruth Plummer, Clinical Professor of Experimental Cancer Medicine at Newcastle University, leading the administration of rucaparib to the first patient in the world to be treated with the drug and the first ever cancer patient to be treated by a PARP inhibitor.

"Ovarian cancer is one of the most difficult cancers to detect and for this reason most women who develop the disease are often diagnosed in the advanced stages, leaving them with few viable treatment options," said Ruth Plummer, Clinical Professor of Experimental Medicine at the Northern Institute for Cancer Research, Newcastle University. "We are delighted that the culmination of many years of research from the team here in Newcastle has resulted in a new treatment option for women in the EU."

"We are pleased to receive this important authorization, as new options for women with recurrent ovarian cancer are needed," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Importantly, the granting of the license means we are now able to submit a variation to the Marketing Authorization for rucaparib to include the maintenance treatment setting based on ARIEL3 data, where we may soon be able to offer a new option to a larger population of women with recurrent ovarian cancer."

The EC approval was based on data from two multicenter, single-arm, open-label clinical trials, Study 10 (NCT01482715) and ARIEL2 (NCT01891344), in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All patients received Rubraca orally 600 mg twice daily as monotherapy. Treatment continued until disease progression or unacceptable toxicity. The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Based on investigator assessment of response, rucaparib showed an objective response rate (ORR) of 54.7% (95% CI [44.8, 64.4], in the primary efficacy population (N=106) and 64.6% (95% CI [53.0, 75.0], in the platinum sensitive population (N=79). The independent radiology review response rate reported was consistent with the investigator assessed response rate reported.

Adverse reactions occurring in ≥ 20% of patients receiving rucaparib were fatigue/asthenia, nausea, creatinine elevations, ALT elevations, AST elevations, vomiting, anemia, decreased appetite, dysgeusia, diarrhea, and thrombocytopenia. The majority of adverse reactions were mild to moderate (Grade 1 or 2). The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anemia (23%), increased ALT (10%), fatigue/asthenia (9%), neutropenia (9%), and thrombocytopenia (5%). The only serious adverse reaction occurring in >2% of patients was anemia (5%). Adverse reactions that most commonly led to dose reduction or interruption were anemia (22%), fatigue/asthenia (19%), and nausea (15%). Adverse reactions leading to permanent discontinuation occurred in 8% of patients, with asthenia/fatigue being the most frequent adverse reaction leading to permanent discontinuation.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib.

In the United States (U.S.), rucaparib is approved 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. Rucaparib is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA- approved companion diagnostic for rucaparib.

Rucaparib is an unlicensed medical product outside of the U.S. and EU.