Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Japan
  4. Japan Exchange
  5. Astellas Pharma Inc.
  6. News
  7. Summary
    4503   JP3942400007

ASTELLAS PHARMA INC.

(4503)
  Report
SummaryChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Affinivax and Astellas Presents Safety and Immunogenicity Data from Phase 2 Study of ASP3772, a Novel 24 valent MAPS Vaccine for Streptococcus pneumoniae

07/12/2021 | 06:00pm EDT

Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. Developed using Affinivax’s proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated. ASP3772 also exhibited an antibody response to each of the 24 polysaccharides, as well as an additional antibody response to the conserved pneumococcal proteins. The Phase 2 data for ASP3772 were delivered in an oral presentation at the 31stEuropean Congress of Clinical Microbiology & Infectious Diseases (ECCMID), taking place online from 9-12 July 2021. The U.S. Food and Drug Administration (FDA) has also granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. The FDA decision is informed by the results of the Phase 2 data. The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. Designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. The Phase 2 clinical trial1 of ASP3772 was conducted in 503 adults 65 to 85 years of age, and 293 adults received ASP3772, 97 adults received Prevnar13 and 113 adults (who were previously vaccinated with Prevnar13) received Pneumovax23. The primary objective was to evaluate safety/tolerability and reactogenicity of ASP3772 compared to Prevnar13. The secondary objective was to evaluate the immunogenicity of ASP3772, versus Prevnar13 or Pneumovax23. A summary of the results is below: ASP3772 was observed to be well tolerated with mild and self-limited injection site and systemic reactions, similar to those seen in the Prevnar13 group. Frequently reported local reactions were tenderness and pain, occurring within the first 2-3 days with no clear difference across ASP3772 and Prevnar13 cohorts. Neither serious vaccine-related adverse events, nor clinically relevant abnormalities (vital signs, ECGs, laboratory parameters), were observed. No serious adverse events or medically attended adverse events related to immunization and no potentially immune mediated adverse events were observed in subjects through the 180-day safety assessment period post-immunization. At the three dose levels studied, ASP3772 induced a robust immune response to all 24 pneumococcal serotypes in the MAPS vaccine, as measured by both immunoglobulin G (IgG) and opsonophagocytic activity (OPA). When compared to Prevnar13 alone, ASP3772 demonstrated a similar or better IgG and OPA immune response to the 13 shared serotypes included in both ASP3772 and Prevnar13. Of note, ASP3772 demonstrated a statistically higher immune response to serotype 3 at all ASP3772 dose levels, as well as a statistically higher immune response to serotypes 5 and 19F at the highest ASP3772 dose tested. ASP3772 also demonstrated a statistically higher immune responses for all remaining 11 serotypes that are not included in Prevnar13. When compared to Prevnar13 plus Pneumovax23, ASP3772 demonstrated a similar or better IgG and OPA immune response to the 13 shared serotypes with Prevnar13. Of note, ASP3772 demonstrated a statistically higher immune responses for serotypes 3, 4, 5, 6A, 7F, 9V, and 18C at the highest dose tested. ASP3772 also demonstrated a similar, and in most cases statistically higher, immune response for all remaining 11 serotypes. ASP3772 also demonstrated an increase in antibodies (more than 2-fold, as measured by geometric mean fold rise in IgG) response to the conserved proteins included in the MAPS vaccine design .


© S&P Capital IQ 2021
All news about ASTELLAS PHARMA INC.
09/23ASTELLAS PHARMA : Tohoku University and Astellas Establish Second Phase of Comprehensive I..
PU
09/23ASTELLAS PHARMA INC. : will present 12-week results (S-13) from the pivotal Phase 3 SKYLIG..
AQ
09/22Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic..
AQ
09/22Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ Trial in Ora..
CI
09/22ASTELLAS PHARMA : to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ ..
PU
09/21ASTELLAS PHARMA : Science-based Exercise at Home with Fit-eNce HomeTM Pilot Sales Begins T..
PU
09/20ASTELLAS PHARMA : ' and Pfizer's XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Me..
PU
09/20ASTELLAS PHARMA : ' and pfizer's xtandi (enzalutamide) reduced risk of death by 34% in men..
AQ
09/09ASTELLAS PHARMA : Updates “Contact for Potential Acquisition of ' R&D Programs&rdquo..
PU
09/02ASTELLAS PHARMA : Nitto, and M. Heart Partnering for ECG testing service
PU
More news
Financials
Sales 2022 1 325 B 11 964 M 11 964 M
Net income 2022 194 B 1 756 M 1 756 M
Net cash 2022 478 B 4 313 M 4 313 M
P/E ratio 2022 18,0x
Yield 2022 2,63%
Capitalization 3 525 B 31 844 M 31 835 M
EV / Sales 2022 2,30x
EV / Sales 2023 1,94x
Nbr of Employees 15 455
Free-Float 98,9%
Chart ASTELLAS PHARMA INC.
Duration : Period :
Astellas Pharma Inc. Technical Analysis Chart | 4503 | JP3942400007 | MarketScreener
Technical analysis trends ASTELLAS PHARMA INC.
Short TermMid-TermLong Term
TrendsBullishNeutralBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 13
Last Close Price 1 902,50 JPY
Average target price 2 451,54 JPY
Spread / Average Target 28,9%
EPS Revisions
Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Naoki Okamura CFO, Representative Director & Vice President
Yoshihiko Hatanaka Chairman
Yoshitsugu Shitaka Chief Scientific Officer
Fumiaki Sakurai Head-Business Administration & Compliance
Sector and Competitors
1st jan.Capi. (M$)
ASTELLAS PHARMA INC.19.35%31 844
JOHNSON & JOHNSON4.44%432 675
ROCHE HOLDING AG10.16%321 605
PFIZER, INC.20.05%246 358
NOVO NORDISK A/S50.45%231 485
ELI LILLY AND COMPANY37.22%210 037