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A microbial engineering platform for sustainable, scalable, and cost-effective production of pharmaceutical grade cannabinoids and related compounds

Award Number: R44AT012710
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/16/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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A microbial engineering platform for sustainable, scalable, and cost-effective production of pharmaceutical grade cannabinoids and related compounds - Abstract Cannabinoids and compounds made from Cannabis have a diverse range of therapeutic potentials, including novel treatments for pain, seizure disorders, neurodegenerative diseases, addiction, and cancer. The Cannabis plant itself produces over 400 unique compounds, 100 of which are bioactive cannabinoids that can activate the endocannabinoid system through activating the G-protein-coupled receptors CB1 and CB2. The interest in developing effective cannabinoid-based pharmaceuticals has only grown in recent years, with four FDA- approved drugs on the market, and 200 trials in progress for a variety of therapeutic applications. Despite their high therapeutic promise, critical issues in cannabinoid production have strained the commercial supply chain. Cannibis plant cultivation uses large amounts of water and energy, and the realities of agricultural production result in variable year-to-year yields and pesticide impurities. Adding to the issue, the purification process of a specific cannabinoid from the many compounds produced by Cannibis plants are extremely labor and manufacturing intensive, leading to prohibitively expensive final products. To overcome these challenges, Cellibre is developing a fermentation-based microbial engineering and biofactory platform to produce high-quality, cost-effective cannabinoids. This method has the potential to reduce the costs of cannabinoid manufacturing by 5-10x and establish Cellibre as cost-effective, environmentally friendly leader in cannabinoid manufacturing. By selecting bacterial and yest strains that naturally produce high concentrations of cannabinoid precursors, then bioengineering them to encourage cannabinoid synthesis, Cellibre has yielded fermentations of THCVA (2.7 g/L), CBGA (3.9 g/L) and other minor cannabinoids (i.e CBCA ~1.5 g/L) of high interest to drug development. To accelerate these breakthroughs from proof of concept to scalable commercial platforms, this Direct to Phase II project has the following two specific aims: 1) De-bottleneck metabolic pathways to achieve >5 g/L of CBGA and THCVA, 2) Establish a process ready for technology transfer with an overall COGS <$500/kg. These aims will result in the development of a pipeline capable of producing therapeutically relevant cannabinoids at commercially viable titers, paving the way for the development and effective production of cannabinoid-based treatments for a wide range of devastating diseases.


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 = $999,954 )
2025	2025	CELLIBRE, INC.	6825 FLANDERS DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	000	2	4/16/2025	NON-COMPETING CONTINUATION	$999,954
														Subtotal = $999,954

Issue Date FY: 2024 ( Subtotal = $999,954 )
2024	2024	CELLIBRE, INC.	6825 FLANDERS DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	000	1	5/16/2024	NEW	$999,954
														Subtotal = $999,954

Grand Total All Awards = $1,999,908

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A microbial engineering platform for sustainable, scalable, and cost-effective production of pharmaceutical grade cannabinoids and related compounds

Award Number: R44AT012710

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/16/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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