On April 18, 2019 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Apr. 25, 2019, to discuss the company’s first quarter 2019 financial results (Press release, Alkermes, APR 18, 2019, View Source;p=RssLanding&cat=news&id=2395048 [SID1234535197]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Apr. 25, 2019, through Thursday, May 2, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13690081.

On April 18, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported an oral presentation by Dr. Jo Brewer, VP of Platform Sciences, summarizing data from Adaptimmune’s off‑the‑shelf SPEAR T-cell program at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting that will be held from April 29 to May 2, 2019 in Washington, DC (Press release, Adaptimmune, APR 18, 2019, View Source;p=RssLanding&cat=news&id=2395049 [SID1234535216]). Details on date and time of the presentation can be found below.

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Oral presentation details:
Title: Differentiating T-Cells from Human induced pluripotent stem cells (hiPSCs) to Create Off-The-Shelf SPEAR T-Cell Therapies
Session title: Immunotherapy II
Session Date/Time: Thursday May 2, 2019 10:15 AM – 12:15 PM (EDT)
Presentation Time: 11:30am – 11:45am
Room: Heights Courtyard 1
Final abstract: #990, p. 460 (https://bit.ly/2PeMtDZ)

On April 18 2019 Bexion Pharmaceuticals, Inc., a clinical stage oncology company, reported the initiation of an open-label Phase 1 Safety Study of BXQ-350 (Press release, Bexion, APR 18, 2019, View Source [SID1234535542]). The first US site is Cincinnati Children’s Hospital Medical Center. This clinical trial will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in the pediatric population with recurrent solid tumors, brain tumors and diffuse intrinsic pontine gliomas (DIPG).

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Phase 1 Adult Dose Ranging Study
In a Phase 1 Part 1 Adult Dose Ranging Study, BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and no serious adverse events attributed to the therapy. Preliminary data in Part 2 of the Phase 1 support a safe and tolerable drug profile. Information about the Phase 1 Study of BXQ-350 in Adult Patients with Advanced Solid Tumors trial can be found at View Source

Phase I Pediatric Protocol
In December 2018, the FDA cleared a Phase I Pediatric Protocol as part of Bexion’s current IND to move BXQ-350 into the pediatric population.

"With this initiation of Pediatric Phase 1 studies, we are confirming our commitment to the pediatric patient community," stated Dr. Ray Takigiku, Founder and CEO of Bexion. "It is our goal to develop BXQ-350 as quickly as possible for both adult and pediatric cancer patients, particularly those with difficult to treat tumors including high grade gliomas and other brain tumors. We are very grateful to the patients, participating clinical trial sites, and our partners for their engagement and their support."

Technology supporting BXQ-350 was discovered over 15 years ago
The technology supporting BXQ-350 was discovered over 15 years ago by Dr. Xiaoyang Qi, a then faculty member at Cincinnati Children’s. CancerFree KIDS, a non-profit focused on eradicating cancer a life-threatening disease in children, provided the first grant that supported this discovery. Cincinnati Children’s licensed the technology to Bexion to continue development and ultimately commercialize the discovery.

"The very first research grant CancerFree KIDS ever awarded was to Dr. Qi in 2004", explained Ellen Flannery, Founder and Executive Director of CancerFree KIDS. "It was for the study that eventually led to the formation of Bexion Pharmaceuticals. We have followed this research and Bexion since that time, waiting for this pivotal moment of the initiation of a Pediatric Phase I trial. It is rare for a pediatric trial to happen so early in the development of a new treatment. CancerFree KIDS is grateful to Bexion, Cincinnati Children’s and CTI Clinical Trial and Consulting Services, Bexion’s Clinical Research Organization for initiating this trial as quickly as feasibly possible. This means we have an opportunity to get this extremely promising new treatment approved for the children who need it as quickly as possible."

Additional Sites Are Planned
Additional sites are planned, including Nationwide Children’s Hospital in Columbus, Ohio and several children’s hospitals in the western United States.

On April 18, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported plans to report first quarter 2019 financial results on May 2, 2019 (Press release, Ligand, APR 18, 2019, View Source [SID1234535198]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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First Quarter 2019 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates
When: Thursday, May 2, 2019
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 6375579

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On April 18, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present data from a Phase 1b/2 combination study of SD-101 and pembrolizumab for patients with advanced melanoma and for patients with recurrent or metastatic head and neck squamous cell carcinoma, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Dynavax Technologies, APR 18, 2019, View Source [SID1234535220]).

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Abstract Number and Title: #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"
Poster Session Title: Head and Neck Cancer
Session Date and Time:Sat, Jun 01, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #28

Abstract Number and Title: #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #105

Abstract Number and Title: #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #126

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.