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Targeting B-cell lymphoma with Leukothera-phase II

Award Number: R42CA173900
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/27/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2017

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Targeting B-cell lymphoma with Leukothera-phase II - DESCRIPTION (provided by applicant): B-cell lymphoma is cancer of B-lymphocytes and accounts for more than 20,000 deaths in the U.S. each year. While many patients respond to currently available therapy, there is a high rate of cancer relapse and inability for the patients o tolerate chemotherapy. Thus, there is a significant need to make available to these patients newer therapies that are more effective and better tolerated than the drugs that are currently used. Actinobac Biomed, Inc. is developing a natural biologic therapy that seeks out and kills a subset of white blood cells (WBCs). This therapy, Leukothera(R) (LtxA; leukotoxin), is a native protein derived from an oral bacterium. LtxA binds specifically to the active form of lymphocyte function associated antigen- 1 (LFA-1) and causes cell death. LFA-1 is found exclusively on WBCs, and malignant WBCs overexpress the molecule, making them ideal targets for the drug. During the phase I stage of this STTR application, we showed that 1) LtxA kills malignant B-cells using a unique mechanism of action, which involves Fas death receptor and caspase 8; 2) lymph node tissue samples from B-cell lymphoma patients express high levels of LFA-1; 3) LtxA causes complete regression of tumors in a humanized mouse model for B-cell lymphoma and results in long-term survival; 4) the drug is well-tolerated, highly active, and does not cause a neutralizing immune response in healthy dogs or a dog with naturally-occurring lymphoma, and 5) we have initiated expression and production of recombinant LtxA in a cGMP drug manufacturing facility in preparation for Investigational New Drug (IND)-enabling studies and clinical trials. Important pharmaceutical properties of LtxA include: 1) the drug works rapidly in vivo, within minutes or less; 2) doses as low as 0.5 g/kg have been shown to be highly active in animals; 3) neutralizing antibody to LtxA is not generated in healthy or diseased animals, even after repeat dosing; and 4) the high specificity of the drug allows targeting of a subset of WBCs and complete depletion of WBCs has never been observed with LtxA treatment. During this STTR phase II proposal, Actinobac will carry out IND-enabling studies that will be included in the IND application to the FDA.


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: 2018 ( Subtotal = $0 )
2018	2016	ACTINOBAC BIOMED, INC.	15 PELHAM RD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	000	3	2/21/2018	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $140,000 )
2016	2016	ACTINOBAC BIOMED INC	15 PELHAM ROAD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	002	3	9/16/2016	SUPPLEMENT FOR EXPANSION	$140,000
2016	2015	ACTINOBAC BIOMED INC	15 PELHAM ROAD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	000	3	9/14/2016	NON-COMPETING CONTINUATION	$140,000
2016	2015	ACTINOBAC BIOMED INC	15 PELHAM ROAD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	001	3	9/15/2016	NON-COMPETING CONTINUATION	-$140,000
														Subtotal = $140,000

Issue Date FY: 2015 ( Subtotal = $894,222 )
2015	2015	ACTINOBAC BIOMED INC	15 PELHAM ROAD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	000	3	8/24/2015	NON-COMPETING CONTINUATION	$894,222
														Subtotal = $894,222

Issue Date FY: 2014 ( Subtotal = $905,040 )
2014	2014	ACTINOBAC BIOMED INC	15 PELHAM ROAD	KENDALL PARK	NJ	08824	MIDDLESEX	USA	Cancer Treatment Research	000	2	9/26/2014	COMPETING CONTINUATION	$905,040
														Subtotal = $905,040

Grand Total All Awards = $1,939,262

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Targeting B-cell lymphoma with Leukothera-phase II

Award Number: R42CA173900

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/27/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2017

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