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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 8, 2023
ICOSAVAX, INC.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-40655 |
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82-3640549 |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
1930 Boren Avenue, Suite 1000
Seattle, Washington 98101
(Address of principal executive offices) (Zip Code)
(206) 737-0085
(Registrant’s telephone number, include area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Common Stock, par value $0.0001 per share |
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ICVX |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 7.01 |
Regulation FD Disclosure. |
The slides attached as Exhibit 99.1 to this Current Report contain certain additional information related to the clinical data results discussed in Item 8.01 below.
The information contained in this Item 7.01, including in Exhibit 99.1 hereto, is being “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
On August 8, 2023, Icosavax, Inc. (the Company or Icosavax) provided a 12-month immunogenicity update from its Phase 1b extension trial of IVX-121 against Respiratory Syncytial Virus (RSV) in older adults. These data demonstrate substantial durability of neutralizing antibody (NAb) response against RSV at twelve months after a single administration of IVX-121. The Company also reported initial evidence for revaccination potential with its VLP-based vaccines, including robust immune responses against RSV-A in Phase 1b extension trial participants who received 75 µg unadjuvanted IVX-121 at one year after their first dose.
IVX-121 (RSV) Phase 1b extension 12-month immunogenicity update
Icosavax has previously reported day 28 and day 180 data from the IVX-121 Ph 1/1b trial, which followed young and older adult subjects through six months after administration of either IVX-121 or placebo. Older adult subjects had the opportunity to participate in a Phase 1b extension trial that allowed continued evaluation through 12 months following their initial dose of vaccine.
IVX-121 continued to be generally well-tolerated with no safety concerns observed in this 12-month follow up. No vaccine related serious adverse events (SAEs) were observed.
Data described below refer to RSV NAb responses to a single administration of IVX-121 at the 75 and 250 µg unadjuvanted dosage levels or placebo in older adults at the designated timepoints. Geometric mean neutralizing antibody titers (GMTs) were measured in international units (IU/mL) using the World Health Organization international reference standard.
GMTs for RSV-A at day 365 were maintained within a range of ~45-50% relative to the GMTs at day 28 for the same group of subjects. RSV-B titers were also durable, persisting at ~65-70% of the GMTs at day 28 for the same dosage groups.
IVX-121 (RSV) Phase 1b extension trial revaccination data
The Phase 1b extension trial also evaluated immune responses one month after revaccination, in older adult participants who received IVX-121 (75 µg without adjuvant) approximately 12 months after their initial dose of vaccine or placebo in the Phase 1b trial. Revaccination with IVX-121 was generally well tolerated.
At one month after revaccination (month 13 overall), IVX-121 induced robust RSV-A immune responses with GMTs for RSV-A NAbs increased to a range of ~70-115% of the GMTs observed one month after the initial dose for the same subset of participants. RSV-B titers did not increase following revaccination but remained at ~40-60% of the GMTs observed 28 days after the initial dose.
Update on IVX-A12 (RSV/hMPV) Phase 2 topline interim data milestone timing
IVX-121 is a component of Icosavax’s lead vaccine candidate IVX-A12, a potential first-in-class bivalent combination in Phase 2 for RSV and hMPV in older adults.
The Company reported that dosing has been completed in its Phase 2 trial of IVX-A12, and the Company now expects to announce topline interim data by the end of 2023 versus the prior guidance of 1Q 2024.
Forward-Looking Statements
Statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the Company’s current beliefs and expectations and include, but are not limited to: the Company’s expectation regarding the opportunities for, and the prophylactic and commercial potential of, its vaccine candidates and technology platform, including the potential for IVX-A12 to be a first-in-class vaccine; and the Company’s planned development activities, including clinical trials and data readouts, and the timing thereof. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the early stage of the Company’s development efforts; the risk that results of a clinical trial at a particular time point may not predict final results and that an outcome may materially change as follow-up of subjects continues and following more comprehensive reviews of the data; the possibility of disappointing results in later clinical trials despite promising results in earlier preclinical research or clinical trials; potential unexpected adverse side effects or inadequate immunogenicity or efficacy of IVX-121 or IVX-A12 that may limit their development, regulatory approval, and/or commercialization; the Company’s approach to the development of vaccine candidates, including its IVX-A12 combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the development process including without limitation in the enrollment, conduct of, and receipt of data from, clinical trials; the Company’s dependence on third parties in connection with manufacturing, research, and clinical testing; the risk that approved third party RSV vaccines may make conducting clinical trials more difficult and costly and otherwise adversely affect the Company’s ability to successfully develop, obtain regulatory approval of and commercialize its vaccine candidates; approved vaccines and competing approaches limiting the commercial value of the Company’s vaccine candidates; regulatory developments in the United States and other countries; and other risks described in the Company’s prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2023 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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Financial Statements and Exhibits. |
(d) Exhibits
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Description |
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Slide Presentation |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ICOSAVAX, INC. |
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| Date: August 8, 2023 |
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By: |
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/s/ Thomas Russo |
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Thomas Russo |
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Chief Financial Officer |
The world needs better vaccines.
We’re striving to create them. IVX-121 Phase 1b extension 12-month durability and revaccination update AUG 8, 2023 Exhibit 99.1
Forward looking statements Statements
contained in this presentation regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company’s current beliefs and expectations and include, but are not limited to: the
company’s expectation regarding the opportunities for, and the prophylactic and commercial potential of, its vaccine candidates and technology platform, including the potential for IVX-A12 to be a first-in-class vaccine; and the
company’s planned development activities, including clinical trials and data readouts, and the timing thereof. Actual results may differ from those set forth in this presentation due to the risks and uncertainties inherent in the
company’s business, including, without limitation: the early stage of the company’s development efforts; the risk that results of a clinical trial at a particular time point may not predict final results and that an outcome may
materially change as follow-up of subjects continues and following more comprehensive reviews of the data; the possibility of disappointing results in later clinical trials despite promising results in earlier preclinical research or clinical
trials; potential unexpected adverse side effects or inadequate immunogenicity or efficacy of IVX-121 or IVX-A12 that may limit their development, regulatory approval, and/or commercialization; the company’s approach to the development of
vaccine candidates, including its IVX-A12 combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the development process including without limitation in the enrollment, conduct of, and
receipt of data from, clinical trials; the company’s dependence on third parties in connection with manufacturing, research, and clinical testing; the risk that approved third party RSV vaccines may make conducting clinical trials more
difficult and costly and otherwise adversely affect the company’s ability to successfully develop, obtain regulatory approval of and commercialize its vaccine candidates; approved vaccines and competing approaches limiting the commercial value
of the company’s vaccine candidates; regulatory developments in the United States and other countries; and other risks described in the company’s prior filings with the Securities and Exchange Commission (SEC), including under the
heading “Risk Factors” in the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2023 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety
by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
IVX-121 is the RSV VLP incorporated
into our potential first-in-class IVX-A12 bivalent vaccine candidate targeting both RSV and hMPV OA: older adults; YA: younger adults MF59®: Seqirus Inc.’s proprietary adjuvant IVX-121 RSV Ph 1 / 1b completed (YA & OA) Ph 1b extension
ongoing (OA) Icosavax clinical development first initiated with RSV monovalent in younger and older adult populations, to assess platform durability and revaccination potential Positive Phase 1/1b day 28 and day 180 immunogenicity data provided an
initial indication of a potentially differentiated durability profile RSV monovalent IVX-A12 RSV / hMPV Ph 1 ongoing (OA) Ph 2 initiated (OA) Only bivalent RSV/hMPV candidate in the clinic Fast Track designation received from the FDA Phase 1 study
in older adults with positive interim Phase 1 readout for safety and immunogenicity Phase 2 initiated assessing two IVX-A12 formulations: 150 µg of IVX-121 (RSV) and 150 µg of IVX-241 (hMPV), with/without MF59® RSV / hMPV bivalent
GMT (95% CI) No Adjuvant + MF59 75
µg IVX-121 150 µg 225 µg 300 µg 150 µg PBO 225 µg GMT (95% CI) No Adjuvant + MF59 75 µg IVX-121 150 µg 225 µg 300 µg 150 µg PBO 225 µg Day 0 and Day 28 Results Day 28 Day 0 RSV-B Recap:
IVX-A12 Phase 1 topline interim data showed robust RSV immune response despite high baseline titers; no evidence of immune interference Per-protocol analysis set. RSV-A LLoQ = 9.4. RSV-B LLoQ = 8.0. MF59®: Seqirus Inc.’s proprietary
adjuvant. 75 µg IVX-121: IVX-121 Ph 1 reference sera panel from OA subjects receiving unadjuvanted 75 μg IVX-121. GMFR: Geometric Mean Fold Rise from Baseline. Assays Conducted by Viroclinics. N= 20 18 20 18 19 19 23 23 20 20 21 20 17 17
GMFR - 2 - 2 - 4 - 3 - 4 - 1 - 4 N= 20 18 20 18 19 19 23 23 20 20 21 20 17 17 GMFR - 1 - 2 - 3 - 3 - 3 - 1 - 3 IVX-A12 induced NAb titers of up to ~16,100 IU/mL for RSV-A and ~8,300 IU/mL for RSV-B; substantially higher than IVX-121 alone
Neutralizing Antibodies; GMT expressed in IU/mL As reported May 2023 Day 0 and Day 28 Results Day 28 Day 0 RSV-A
GMT (95% CI) No Adjuvant + MF59 150
µg 225 µg 300 µg 150 µg PBO 225 µg GMT (95% CI) No Adjuvant + MF59 150 µg 225 µg 300 µg 150 µg PBO 225 µg Recap: IVX-A12 Phase 1 topline interim data provided first demonstration of hMPV vaccine
immunogenicity in older adult population for the field Day 0 and Day 28 Results Day 28 Day 0 hMPV-B Day 0 and Day 28 Results Day 28 Day 0 hMPV-A N= 20 18 20 18 19 19 23 23 20 20 21 21 GMFR - 1 - 3 - 5 - 3 - 3 - 1 N= 20 18 20 18 19 19 23 23 20 20 21
20 GMFR - 2 - 2 - 4 - 3 - 3 - 1 Neutralizing Antibodies; GMT expressed in assay units/mL Same pattern of response as observed with RSV; initial indication of combinability achievable with Icosavax VLP technology As reported May 2023 Per-protocol
analysis set. hMPV-A and hMPV-B LLoQ = 4.0 log 2. MF59®: Seqirus Inc.’s proprietary adjuvant. GMFR: Geometric Mean Fold Rise from Baseline. Assays Conducted by Viroclinics.
August 2023 data update: Positive
IVX-121 Ph 1b 12-month immunogenicity data in older adults, and initial evidence for revaccination potential with VLP-based vaccine Substantial durability of RSV-A and RSV-B neutralizing antibody (NAb) titers up to 12 months (365 days) after initial
vaccination with IVX-121 GMTs against RSV through Day 365 persisted at ~45-70% of the GMTs from Day 28 for unadjuvanted dosage levels 75 and 250 µg1 Others in the field2 have shown Day 365 titers at ~30-40% relative to Day 28 levels New data
provides additional evidence of potential differentiation on durability with company’s VLP platform technology Initial evidence for revaccination potential with Icosavax’s VLP technology Robust immune response against RSV-A in Phase 1b
extension trial participants who received revaccination3 approximately 12 months following their initial dose of IVX-121 or placebo RSV-A NAbs increased following revaccination to a range of ~70-115% of the GMTs observed 28 days after the initial
dose for prior IVX-121 recipients1 RSV-B titers did not increase following revaccination but remained at ~40-60% of the GMTs observed 28 days after the initial dose1 Emerging data for approved RSV vaccines2 show revaccination responses around
~50-55% of the GMTs observed 28 days after the initial dose New IVX-121 data provides additional support for durability and revaccination potential of VLP platform 1Data shown represent unadjuvanted 75 µg and 250 µg dosage levels, which
bracket the 150 µg dose level of RSV VLP taken into Phase 2 for IVX-A12 RSV/hMPV bivalent program; 2Citations for other RSV vaccines provided on slides that follow; data are shown for illustrative purposes only, not a head-to-head comparison
and there could be assay, laboratory and other differences across trials; 3All participants on study at time of revaccination received 75 µg unadjuvanted IVX-121, regardless of initial dose
IVX-121-01 Study Design: Phase 1b,
Phase 1b extension (D365 and Revaccination) alum: 500 µg/mL aluminum hydroxide. AE: adverse event; SAE: serious adverse event; AESI: adverse event of special interest; MAAE: medically-attended adverse event Full analysis set is shown for each
stage above; immunogenicity analysis set shown in subsequent slides is the revaccination cohort for prior 75 and 250 µg IVX-121 unadjuvanted or placebo recipients Topline Data through Day 393 Solicited AEs SAEs, AESIs, MAAEs, Unsolicited AEs
Immunogenicity DAYS 365-372 (7 days after revaccination) DAYS 0-393 DAYS 0, 28, and 180 (Ph 1b); 365 and 393 (Ph1b extension) RSV-A and RSV-B Virus Microneutralization Assay Older Adult Subjects (ages 60-75) n=130 PH1b Older Adult Subjects (ages
60-75) n=90 PH1b Ext. 28 180 7 365 393 Revaccination (Dose 2): IVX-121 75 µg unadjuvanted Phase 1b - Older Adult Subjects (ages 60-75) n=130 Phase 1 - Young Adult Subjects (ages 18-45) n=90 Sera Collected Day 0 Dose 1: IVX-121 25, 75, or 250
µg +/- alum, or PBO Phase 1b EXT - n=108 28 Days n=90
Topline immunogenicity data: RSV-A NAb
through D365 GMT expressed in IU/mL GMT: Geometric mean titer; LLoQ = 9.9; Assays conducted by Viroclinics. Data above reflect all subjects who met the per protocol criteria at the time of this 12-month analysis *Data shown represent unadjuvanted 75
µg and 250 µg dosage levels, which bracket the 150 µg dose level of RSV VLP taken into Phase 2 for IVX-A12 RSV/hMPV bivalent program GMTs for RSV-A at Day 365 were maintained within a range of ~45-50% for relevant dosage range*
relative to GMTs at Day 28 PBO GMT (95% CI) Day 0, 28, 180, and 365 Results Day 0 Day 28 Day 180 Day 365 Older Adult Subjects (ages 60-75), unadjuvanted 75 and 250 µg IVX-121 groups, N=28; Placebo, N=15 PH1b Ext. RSV-B titers were also durable
to Day 365, persisting at ~65-70% of the GMTs from Day 28 No Adjuvant 75 µg 250 µg 52% 46% % retained titers, D365 vs. D28 N= 11 11 10 9 17 17 17 17 15 15 15 15
Kinetics of RSV-A response over time
through D393 (28 days after revaccination at D365) GMT expressed in IU/mL RSV-A LLoQ = 9.4 1All participants were dosed with unadjuvanted 75 µg IVX-121, regardless of previous formulation received GMT (IU/mL) Dose 2 (75 µg IVX-1211) Day 0
to Day 393 (28 days post-revaccination) results RSV-A Days Dose 1 (IVX-121 or PBO) Older Adult Revaccinated Subjects (ages 60-75), unadjuvanted 75 and 250 µg IVX-121 groups, N=28; Placebo, N=15 PH1b Ext. Revaccination with 75 µg IVX-121
increased RSV-A titers to ~70-115% of the GMTs observed 28 days after the initial dose RSV-B titers did not increase following revaccination but remained at ~40-60% of levels seen following the first dose % retained titers vs. D28 Dose 1 D28 D393
(post 75 µg dose 2) 75 µg 100% 116% 250 µg 76% 72% 28 180 365 393 0
Conclusions and next steps NEXT
STEPS: IVX-A12 Phase 2 topline interim data by end 2023; Phase 1 six-month immunogenicity update 1Q 2024 Positive 12-month data on IVX-121 provide additional support for differentiation potential of VLP technology on durability and revaccination
data provides initial evidence for platform’s ability to improve response with revaccination IVX-121 is the RSV VLP incorporated into lead bivalent RSV/hMPV candidate IVX-A12 Data and ACIP recommendation for recently-approved RSV vaccines in
the field highlight opportunity for an improvement in durability and revaccination potential Further potential for differentiation driven by combination with hMPV VLP as well as product format (liquid refrigerator stable formulation with plans for
pre-filled syringes at launch) Lead candidate IVX-A12 (RSV/hMPV) in Phase 2, with topline interim data now expected by end 2023 Positive Phase 1 data included robust immune responses to both RSV and hMPV, higher post-vaccination levels of RSV-A
& RSV-B NAbs than historically seen with IVX-121 alone, and no evidence of immune interference 300 µg total VLP content (150 µg* of IVX-121 (RSV) and 150 µg* of IVX-241 (hMPV)), with/without MF59® We are evaluating potential
to add revaccination into an IVX-A12 clinical trial * 150 µg of IVX-121 VLP and 150 µg of IVX-241 VLP correspond to 84 µg RSV antigen content and 82 µg hMPV antigen content, respectively MF59®: Seqirus Inc.’s
proprietary adjuvant
Appendix
Dose 1 Dose 2 25 µg 75 µg
75 µg 75 µg 250 µg 75 µg PBO 75 µg Older Adult Revaccinated Subjects (ages 60-75) unadjuvanted IVX-121 groups, N=55 PH1b Ext. Solicited adverse events within 7 days of revaccination with unadjuvanted 75 µg IVX-121 Mild
Moderate Severe Mild Moderate Severe Systemic Adverse Events (Tolerability) Local Adverse Events (Reactogenicity) Mild to moderate reactogenicity and tolerability after revaccination in prior IVX-121 and prior placebo recipients N 12 11 17
15
IVX-121 GMT ranges for RSV-A and
RSV-B in older adults GMT expressed in IU/mL IVX-121 immunogenicity data above reflect all subjects who met the per protocol criteria for each stage at the time of this 12-month analysis. Number of participants per group across timepoints included
in dataset: 25 µg: 11-12; 75 µg: 9-11; 250 µg: 17; Placebo: 15. MF59®: Seqirus Inc.’s proprietary adjuvant IVX-121 Day 0 – Day 393 Results (Unadjuvanted) Older Adult Revaccinated Subjects (ages 60-75), unadjuvanted
25, 75 and 250 µg IVX-121 groups, N=40; Placebo, N=15 PH1b Ext. IVX-121 12-month and revaccination data provide evidence for platform potential; IVX-A12 formulations of 150 µg of IVX-121 (RSV) and 150 µg of IVX-241 (hMPV),
with/without MF59® currently being tested in Phase 2 study % retained titers vs. Dose 1 D28 Dose 1 D28 D365 D393 (post 75 µg dose 2) 25 µg 100% 36% 71% 75 µg 100% 52% 116% 250 µg 76% 46% 72% GMT (95% CI) RSV-A Dose 1 Dose 2
PBO 75 µg 250 µg 75 µg 25 µg 75 µg 75 µg 75 µg % retained titers vs. Dose 1 D28 Dose 1 D28 D365 D393 (post 75 µg dose 2) 25 µg 100% 66% 50% 75 µg 100% 71% 59% 250 µg 76% 63% 37% GMT (95% CI)
RSV-B Dose 1 Dose 2 PBO 75 µg 250 µg 75 µg 25 µg 75 µg 75 µg 75 µg
Phase 3 data for a
recently-approved product shows diminished efficacy during a second season - trending similarly with lower NAb titers, and a reduced1 response to revaccination at 12 months 1Relative to initial response following a single dose; 2GSK June 2023 ACIP
presentation, NCT04886596; 3GSK June 2023 ACIP presentation, NCT04732871; 4Data are approximate estimates derived from reported graphs; 5RSV-A and RSV-B, Pfizer Ph 1/2 120 µg, ages 65-85 (VRBPAC presentation Feb ’23); 6Pfizer Ph 1/2, 240
µg revaccination, RSV-B data not presented (Walsh EE presentation, RSV2022 Belfast) GSK Phase 3 pivotal, efficacy2 GSK Phase 3 open label, immunogenicity3 In Phase 3 pivotal efficacy study, efficacy was lower in season 2 relative to season 1,
and revaccination at 12 months did not appear to be clinically beneficial2 In Phase 3 immunogenicity study, RSV-A and RSV-B NAb titers at 12 months dropped to ~30%4 of initial dose D28 values; revaccination increased titers to ~50-55%4 of the
initial dose D28 values Earlier-stage data for the other approved RSV vaccine showed a 12 months drop to ~35-40%5 of initial dose D28 values; revaccination increased RSV-A titers to ~55%6 of initial dose D28 values * LRTD: ≥ 2 lower
respiratory symptoms/signs for ≥ 24 hours including ≥1 lower respiratory sign OR ≥ 3 lower respiratory symptoms for ≥ 24 hours Season 1 Season 2 Season 1 Single dose 2 doses RSV-LRTD* 82.6% 56.1% 55.9% Analysis timing Apr
’22 (End of S1 analysis) Mar ’23 (End of S2 analysis) - Recent ACIP recommendations (adults aged ≥60 years of age may receive a single dose of RSV vaccine, using shared clinical decision making) may leave room for vaccines with
greater durability and greater ability to improve titers with revaccination
Nonclinical studies demonstrate
IVX-A12 achieved proof-of-concept protection against BOTH hMPV and RSV 1Two doses of IVX-121, IVX-241, or IVX-A12 (1 µg of each VLP) formulated with Addavax (oil-in-water adjuvant) were administered on day 0 and day 21, with RSV-A, RSV-B, or
hMPV-A challenge two weeks post 2nd administration; 2Lung tissue samples tested 5 days post challenge Control (challenge) IVX-A12 Control (no challenge) IVX-121 Control (challenge) IVX-A12 Control (no challenge) IVX-241 RSV-A Challenge hMPV-A
Challenge Cotton Rat Lung Viral Titers following RSV/A and hMPV/A Challenge Monovalent (RSV: IVX-121 or hMPV: IVX-241) and bivalent RSV/hMPV (IVX-A12) formulations similarly blocked viral replication post challenge In a live virus challenge model,
cotton rats were administered two doses of adjuvanted IVX-121, IVX-241, or IVX-A12 and subsequently challenged with RSV-A, RSV-B or hMPV-A1 Robust neutralizing titers were induced against RSV-A and RSV-B by IVX-121 and IVX-A12 and against hMPV-A and
hMPV-B by IVX-241 and IVX-A12 (data not shown) In lung tissue, both monovalent (IVX-121, IVX-241) and bivalent (IVX-A12) formulations reduced viral titers post challenge to below the lower limit of quantitation2 In nonclinical studies, IVX-A12
showed potential protection against two causes of viral pneumonia Cotton Rat Lung Viral Titers following RSV/B Challenge
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|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
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