d******l
发帖数: 1952 | 1 二楼可拍砖
DVAX
$21.70
+1.45 (+7.16%) HEPLISAV-B
Hepatitis B
PDUFA 11/10/2017
CRL February 25, 2013 and November 14, 2016. Original PDUFA date set for
August 10, 2017 but noted August 3, 2017 a 3-month extension to August 10.
Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of
recommending approval. | I*******a
发帖数: 1124 | 2 凡事皆有可能啊，今年唯一犹豫错过上车机会的就是DVAX了，7刀的时候犹豫了好久没
上，然后再也上不去了...
【在 d******l 的大作中提到】
: 二楼可拍砖
: DVAX
: $21.70
: +1.45 (+7.16%) HEPLISAV-B
: Hepatitis B
: PDUFA 11/10/2017
: CRL February 25, 2013 and November 14, 2016. Original PDUFA date set for
: August 10, 2017 but noted August 3, 2017 a 3-month extension to August 10.
: Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of
: recommending approval.
| P********6
发帖数: 709 | | d******l
发帖数: 1952 | | P********6
发帖数: 709 | 5 Dynavax Announces Acceptance of Two Data Abstracts for SD-101 in Combination
with KEYTRUDA® for Presentation at the 2018 Ameri
2018-03-15 10:30:02.354 GMT
Dynavax Announces Acceptance of Two Data Abstracts for SD-101 in Combination
with KEYTRUDA® for Presentation at the 2018 American Association for
Cancer Research (AACR) Annual Meeting
Data from Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
(HNSCC)
Durability Data in Advanced Metastatic Melanoma
BERKELEY, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies
Corporation (NASDAQ:DVAX) announced today that data from an ongoing Phase 1b
/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in
combination with KEYTRUDA^® (pembrolizumab), an anti-PD-1 therapy
developed by Merck (known as MSD outside the United States and Canada), will
be presented in two posters at the 2018 American Association for Cancer
Research (AACR) Annual Meeting in Chicago, IL to be held April 14-18, 2018.
The details of the poster presentations are as follows:
Phase Ib/II, open label, multicenter study of intratumoral SD-101 in
combination with pembrolizumab in anti-PD-1 treatment naïve patients
with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Session Title: Phase II-III Clinical Trials
Abstract: CT098
Poster Board Number: 19
Date/Time: Monday Apr 16, 2018 1:00 PM - 5:00 PM CDT
Location: McCormick Place South, Hall A, Poster Section 42
Durability of responses to the combination of SD-101 and pembrolizumab in
advanced metastatic melanoma: Results of a phase Ib, multicenter study
Session Title: Phase I Trials in Progress
Abstract: CT139
Poster Board Number: 22
Date/Time: Tuesday Apr 17, 2018 8:00 AM - 12:00 PM CDT
Location: McCormick Place South, Hall A, Poster Section 42
About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with
KEYTRUDA includes patients with histologically or cytologically confirmed
unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are
MTD and evaluation of the safety of intratumoral SD-101 in combination with
KEYTRUDA.
In addition, the trial is investigating response as assessed by the
investigator according to RECIST v1.1, biomarker assessments and duration of
response. Patients previously treated with anti-PD-1 and other
immunotherapies are included.
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
2 study in combination with Keytruda^® (pembrolizumab), an anti-PD-1
therapy, in patients with metastatic 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.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on
leveraging the power of the body's innate and adaptive immune responses
through toll-like receptor (TLR) stimulation. Dynavax discovers and develops
novel vaccines and immuno-oncology therapeutics. The Company’s first
commercial product, HEPLISAV-B^® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], a hepatitis B vaccine for adults, is approved in the United
States. Dynavax's lead immunotherapy product, SD-101, is an investigational
cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and
its second cancer immunotherapeutic, DV281, is in Phase 1 development. For
more information, visit www.dynavax.com.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc.
Contact:
David Burke
Director, Investor Relations & Corporate Communications
510.665.7269
[email protected]
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