Dynavax to Present Data on Toll-like Receptor 9 Agonist SD-101 at the ASCO Annual Meeting 2019

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.

Adaptimmune Announces Oral Presentation of Allogeneic SPEAR T-cell Program at 2019 ASGCT Meeting

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)

Luminex Corporation First Quarter Earnings Release Scheduled for May 6, 2019

On April 18, 2019 Luminex Corporation (NASDAQ: LMNX) reported that it plans to report results for the first quarter ended March 31, 2019 on Monday, May 6, 2019 (Press release, Luminex, APR 18, 2019, View Source [SID1234535214]). A press release announcing the results is scheduled for release after the close of trading on that date.

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Management will hold a conference call to discuss the operating highlights and financial results for the first quarter ended March 31, 2019 on May 6, 2019, at 4:30 p.m. Eastern time.

The conference call will be webcast live and may be accessed at Luminex Corporation’s website at View Source Simply log on to the website, go to the About Luminex section and access the Investor Relations link. If you are unable to participate during the live webcast, the call will be archived for six months on the website using the ‘replay’ link.

Vanda Pharmaceuticals to Announce First Quarter 2019 Financial Results on May 1, 2019

On April 18, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported it will release results for the first quarter 2019 on Wednesday, May 1, 2019, after the market closes (Press release, Vanda Pharmaceuticals, APR 18, 2019, View Source [SID1234535212]).

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Vanda will host a conference call at 4:30 PM ET on Wednesday, May 1, 2019, during which management will discuss the first quarter 2019 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 6195579.

The conference call will be broadcast simultaneously and archived on Vanda’s website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Wednesday, May 1, 2019, beginning at 7:30 PM ET and will be accessible until Wednesday, May 8, 2019, at 11:59 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 6195579.

AqVida and Phyton Biotech Receive Approval from European Directorate of Quality Medicines for AqVida’s Cancer-fighting Paclitaxel Injectable Finished Dosage Formulation

On April 18, 2019 Phyton Biotech, a German/North American Plant Cell Fermentation (PCF) technology company, and AqVida, a German oncology Finished Dosage Formulation (FDF) manufacturer, reported that they have received European approval from the EDQM (European Directorate of Quality Medicines) for AqVida’s paclitaxel injectable FDF (Press release, Phyton Biotech, APR 18, 2019, View Source [SID1234535211]).

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Phyton Biotech is the world’s leading manufacturer of paclitaxel active pharmaceutical ingredient (API), utilizing its prorprietary PCF technology process. Under the strategic partnership with AqVida, Phyton Biotech will be the exclusive supplier of paclitaxel API for AqVida’s Taxol generic formulation, which is produced in AqVida’s new state-of-the-art injectable manufacturing facility located in Dassow, Germany. AqVida’s ultramodern robotic manufacturing line, designed for filling cytotoxic injectables, will be utilized to produce AqVida’s generic oncology medicines to treat common types of cancer.

"We chose to work with Phyton because of the company’s superior quality fermentation-produced API, in comparison to naturally extracted or semi-synthetically produced alternatives," says Wolfgang Heinze, who is the Chief Executive Officer (CEO) of AqVida. "Approval of ourpaclitaxel injectable FDF by the European Directorate of Quality Medicines is a major milestone for our company."

Recognized for its innovative and broad portfolio of generic oncology medicines, AqVida is a leading German oncology medication supplier that distributes its products globally.

"We are proud to partner with AqVida and assist with the expansion of its oncology product line," says Colin Marr, president of Phyton Biotech. "Phyton is committed to working with trusted pharmaceutical partners who seek to improve the quality of oncology medicines."