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IND-enabling Preclinical Studies on Anti-Tau AD Vaccine for Phase 1 Trial

Award Number: U01AG060965
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2019
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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IND-enabling Preclinical Studies on Anti-Tau AD Vaccine for Phase 1 Trial - Project Summary Data from various Alzheimer’s disease (AD) active vaccine clinical trials targeting Aβ pathology suggest that these trials were unsuccessful because the vaccines: (i) did not induce therapeutically potent titers of anti-Aβ antibodies in immunized elderly people with immunosenescence and (ii) were initiated too late in AD pathogenesis. We suggest that an optimal AD vaccine formulation, adjuvant selection and targeting of the right pathological molecules at the right stage of disease will be crucial to a successful immunotherapeutic approach. We have developed novel, safe and immunogenic vaccines, based on the MultiTEP platform technology, that offer substantial benefits over vaccine platforms presently used in clinical trials. Our MultiTEP-based vaccines are specifically designed for the immunization of humans and our pre-clinical data generated in various Tg mice, rabbits, and monkeys suggest that these vaccines potentially can (i) overcome high polymorphism of MHC class II genes by activating a broad repertoire of naïve and memory Th cells specific to carrier (MultiTEP platform); (ii) induce high titers of antibodies specific to pathological molecules involved in AD (e.g., Aβ/tau), but not to the MultiTEP platform itself; and (iii) generate therapeutically potent immune responses in the vast majority of vaccinated subjects without induction of potentially harmful autoreactive Th cells. Currently, a growing body of evidence suggests that Aβ pathology emerges many years before accumulation of tau pathology and before the first signs of cognitive impairment. Importantly, the accumulation of tau rather than Aβ correlates most strongly with cognitive decline in AD. Hence, we hypothesized that while anti-Aβ vaccination should be initiated as a prophylactic measure in very early AD (prodromal) and/or in non-symptomatic subjects at risk for AD, tau-based immunotherapeutic(s) can be used as a therapeutic measure in patients with mild-moderate AD. Accordingly, in this proposal we suggest to conduct pre-clinical IND-enabling studies on MultiTEP-based therapeutic vaccine targeting N-terminus of pathological Tau (AV-1980R). Importantly, our data showed that the AV-1980R formulated in the novel cGMP grade AdvaxCpG adjuvant (AV-1980R/A) is likely to be safe and effective, since it is inducing therapeutic antibodies that efficiently reduce total and phosphorylated Tau in brains of vaccinated Tg mice without generating potentially harmful autoreactive cellular immune responses. Collectively, published data from different groups including ours and preliminary results on AV-1980R/A provide the strong support for (i) manufacturing of engineering run (aka first run cGMP) recombinant protein that is according to FDA guidance is sufficient for safety/toxicology studies; (ii) completing safety/toxicology studies in diseased mouse model of Tauopathy and healthy rabbits, (iii) manufacturing cGMP AV-1980R/A, and (iv) obtaining all necessary regulatory documents for the IND submission. Getting an FDA-cleared IND for AV-1980R/A will allow us to test for the first time the safety and immunogenicity of an active vaccine targeting the N-terminus of tau in Phase 1 clinical trials and develop an effective vaccination protocol for future Phase 2/3 clinical trials.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	INSTITUTE FOR MOLECULAR MEDICINE INC	16371 GOTHARD ST	HUNTINGTON BEACH, CA	CA	92647		USA	Aging Research	000	4	6/4/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	INSTITUTE FOR MOLECULAR MEDICINE INC	16371 GOTHARD ST	HUNTINGTON BEACH, CA	CA	92647		USA	Aging Research	002	4	12/7/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	INSTITUTE FOR MOLECULAR MEDICINE INC	16371 GOTHARD ST	HUNTINGTON BEACH, CA	CA	92647		USA	Aging Research	001	4	12/7/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	INSTITUTE FOR MOLECULAR MEDICINE INC	16371 GOTHARD ST	HUNTINGTON BEACH, CA	CA	92647		USA	Aging Research	000	4	12/7/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $2,270,000 )
2023	2023	INSTITUTE FOR MOLECULAR MEDICINE INC	16371 GOTHARD ST	HUNTINGTON BEACH, CA	CA	92647		USA	Aging Research	000	4	12/20/2022	SUPPLEMENT FOR EXPANSION	$2,270,000
														Subtotal = $2,270,000

Issue Date FY: 2022 ( Subtotal = $2,535,691 )
2022	2022	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	001	4	3/1/2022	SUPPLEMENT FOR EXPANSION	$297,719
2022	2022	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	002	4	5/5/2022	NON-COMPETING CONTINUATION	$223,798
2022	2022	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	000	4	2/28/2022	NON-COMPETING CONTINUATION	$2,014,174
														Subtotal = $2,535,691

Issue Date FY: 2021 ( Subtotal = $3,438,418 )
2021	2021	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	000	3	3/4/2021	NON-COMPETING CONTINUATION	$1,672,856
2021	2021	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	002	3	9/8/2021	SUPPLEMENT FOR EXPANSION	$419,490
2021	2021	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	001	3	4/23/2021	SUPPLEMENT FOR EXPANSION	$1,346,072
														Subtotal = $3,438,418

Issue Date FY: 2020 ( Subtotal = $1,661,397 )
2020	2020	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	002	2	8/14/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	000	2	3/14/2020	NON-COMPETING CONTINUATION	$1,272,333
2020	2020	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	001	2	8/11/2020	SUPPLEMENT FOR EXPANSION	$389,064
														Subtotal = $1,661,397

Issue Date FY: 2019 ( Subtotal = $1,116,260 )
2019	2019	INSTITUTE FOR MLCULAR MEDICINE	16371 GOTHARD ST. H	HUNTINGTON BEACH	CA	92647	ORANGE	USA	Aging Research	000	1	1/29/2019	NEW	$1,116,260
														Subtotal = $1,116,260

Grand Total All Awards = $11,021,766

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IND-enabling Preclinical Studies on Anti-Tau AD Vaccine for Phase 1 Trial

Award Number: U01AG060965

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2019

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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