TCBP Awarded Non-Dilutive Funding, ScaleReady's G-Rex® Grant

Rhea-AI Summary

TC BioPharm has been awarded a $250,000 non-dilutive grant from ScaleReady's G-Rex® Grant Program to support TCB008 manufacturing process optimizations over the next 18 months. The company aims to increase yields while reducing manufacturing costs by over 80%. The grant will help expedite process optimizations, allowing for expanded yields with a shortened manufacturing process in the first half of 2025, which is 12 months ahead of schedule. The optimizations will increase TCB008 production rate at the existing Maxim Park facility without increasing overhead costs.

Positive

• Secured $250,000 in non-dilutive funding
• Expected 80% reduction in manufacturing costs
• Production process optimization timeline accelerated by 12 months
• Increased production capacity without additional overhead costs

Negative

• None.

Insights

Biotech Manufacturing Analyst

This $250,000 non-dilutive grant represents a significant opportunity for TC BioPharm's manufacturing optimization efforts. The planned process improvements target an impressive 80% cost reduction while substantially increasing production yields for TCB008. The accelerated timeline, now 12 months ahead of schedule, positions the company to potentially achieve these optimizations by H1 2025.

The implementation strategy appears solid, focusing on maximizing existing facility capacity without increasing overhead costs. This approach to manufacturing efficiency could significantly improve TCBP's market position, especially considering the current challenges in cell therapy manufacturing costs. The partnership with ScaleReady and access to their consortium's expertise adds valuable technical support beyond the monetary grant.

Financial Analyst

The non-dilutive funding, while modest at $250,000, is strategically important for a micro-cap company with a market cap of $620,757. The key value lies not just in the capital but in the potential cost savings and efficiency improvements. If successful, the 80% cost reduction in manufacturing could dramatically improve the company's financial metrics and market competitiveness.

The accelerated timeline for implementation could positively impact the company's cash runway and time to market. The focus on making TCB008 more economical could enhance market adoption and commercial viability, particularly important in the cost-sensitive healthcare market.

EDINBURGH, Scotland, Nov. 12, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP), a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that it has been awarded non-dilutive funding of $250,000 from the G-Rex^® Grant Program. 

The G-Rex^® Grant Program, launched by ScaleReady alongside Wilson Wolf Manufacturing and the Bio-Techne Corporation, is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing. Grant recipients also access exclusive support from ScaleReady's growing consortium of G-Rex^® Grant Partners, who bring best-in-class tools and technologies and unparalleled knowledge and expertise in cGMP-compliant manufacturing, quality, regulatory affairs, business operations, and more.

The $250,000 grant will support TCB008 manufacturing process optimizations over the next 18 months. Dr. Lauren Bor and her team, who lead process development and commercialization efforts at TC BioPharm, will drive process optimizations.

"It's fantastic to see grants offered in support of cell therapy products using the G-Rex^® platform, and we're excited to reveal the benefits of our program work over the next 18 months," said Dr. Lauren Bor. "We announced earlier in 2024 that we were developing the TCB008 manufacturing process to increase yields while reducing costs with the target of increasing our yield by a large scale and decreasing our costs by over 80%. The awarded ScaleReady G-Rex^® Grant will expedite and expand these optimizations, allowing us to deliver expanded process yields with a shortened manufacturing process in the first half of 2025; 12 months ahead of schedule."

Joseph Mullen, Head of Production, who will work with Dr. Lauren Bor's team to implement the developed process optimizations in the latter half of 2025, said, "We look forward to implementing the G-Rex^® platform optimizations, developed using the awarded grant. These developments will increase the rate of TCB008 manufacture within the existing Maxim Park facility without the need to increase overhead costs."

"We appreciate ScaleReady's G-Rex^® Grant Program and ScaleReady's commitment to innovation in the cell therapy manufacturing space," said Bryan Kobel, CEO of TC BioPharm. "This non-dilutive grant will continue to support product development and manufacture as we advance our Phase 2B clinical trial for the treatment of patients with acute myeloid leukemia. The work being done to further advance scaling production of TCB008 to commercial levels will be accelerated by this funding and bring increased cost savings, making TCB008 affordable for all patients and potentially one of the most economical cell therapy options."

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Press Release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the Company's intent or ability to affect any budget savings or execute any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees but involve known and unknown risks, uncertainties, and other important factors that may cause the Company's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Press Release, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Press Release. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.

About ScaleReady
ScaleReady is a joint venture between Bio-Techne, Fresenius Kabi, and Wilson Wolf bringing together proven tools and technologies for cell culture, cell activation, gene editing, and cell processing. ScaleReady provides leading therapeutic developers with the most simple, scalable, and versatile manufacturing platform in the industry.

About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T cell therapies for cancer treatment with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.

TC BioPharm is the leader in developing gamma-delta T cell therapies and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial in treating acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

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SOURCE TC BioPharm

FAQ

What is the value of the G-Rex Grant awarded to TC BioPharm (TCBP)?

TC BioPharm (TCBP) was awarded $250,000 in non-dilutive funding from the ScaleReady G-Rex® Grant Program.

When will TC BioPharm (TCBP) implement the new TCB008 manufacturing process?

TC BioPharm plans to implement the optimized manufacturing process in the first half of 2025, which is 12 months ahead of the original schedule.

How much cost reduction does TC BioPharm (TCBP) expect from the TCB008 manufacturing optimization?

TC BioPharm expects to decrease manufacturing costs by over 80% through the TCB008 process optimization.