Highly personalized (autologous) process: Each batch is made for one patient.
Complex logistics: Requires cell collection, modification, and reinfusion.
Stringent regulatory and quality controls.Expensive reagents, viral vectors, and consumables.
Skilled labor and specialized facilities.High failure rates and batch losses.
How CHM could reduce manufacturing costs ?
In-House Manufacturing (“Vertical Integration”)
Current industry trend:Centers that produce CAR-T cells on-site (hospital or company-owned GMP labs) can cut costs by 30–50% compared to outsourcing to contract manufacturers.
CHM’s opportunity:
Invest in its own GMP suites in Australia or partner with hospitals to create “point-of-care” manufacturing.
Reduces logistics, shipping, and cold-chain costs.Enables faster “vein-to-vein” turnaround, improving outcomes and lowering bridging therapy needs.
Automation and Closed-System Manufacturing
Adopt automated, closed-system bioreactors.
Benefits:Reduces labor costs and human error.Increases batch consistency and yields.
Enables scale-up without linear increases in staff or space.
Move Toward Allogeneic (“Off-the-Shelf”) CAR-T
Long-term strategy: Develop allogeneic CAR-T platforms using donor cells or induced pluripotent stem cells.
Why:
Mass production, batch freezing, and inventory management are possible.Dramatically reduces per-dose cost (potentially to $20,000–$50,000).
CHM’s pipeline:
If not already, invest in allogeneic programs or partner with innovators in this space.Strategic Global Manufacturing PartnershipsLeverage
Lower-cost geographies:Contract manufacturing in China, Turkey, or India where regulatory standards are high but costs are lower. Remember we can't ship living cells into the USA due to biohazard legislation.
China can manufacture CAR-T for $55,000 per dose.
CHM could:
Partner with accredited overseas manufacturers for global trials or compassionate access programs.
Import finished product under TGA/EMA/compassionate or expedited pathways.Process Optimization and Yield Improvement
Invest in R&D to:
Increase transduction efficiency (get more T-cells successfully modified).
More product per run, fewer wasted batches, lower cost per patient.
Bulk Purchasing and Supplier Negotiation
Negotiate better rates for viral vectors, reagents, and disposables by pooling orders with other biotechs or joining purchasing consortia.
Explore local suppliers to avoid import tariffs and supply chain delays.
Regulatory and reimbursement strategy.
Work with Australian and US governments to get CAR-T therapies listed on reimbursement schedules (PBS, Medicare).
Why:
Higher volumes can drive economies of scale.Government support can offset fixed costs and enable price negotiation with suppliers.
Intellectual Property and LicensingLicense enabling technologies (e.g., non-viral gene editing, novel vectors) that reduce royalty burdens and per-batch costs.
Develop proprietary innovations (e.g., CHM’s own manufacturing IP) and license them out to generate revenue and offset costs.
Speculative Example:
What If CHM Implemented these?
Short-term:By shifting to in-house or regional manufacturing, using automation, and optimizing processes, CHM could potentially cut costs by 30–50%—from $400,000+ to $200,000 or less per treatment.
Long-term:If CHM develops or licenses allogeneic CAR-T or leverages global manufacturing, costs could fall below $100,000 per dose, making the therapy accessible to more patients and improving margins.
Could CHM Build Turkey-Like Costs in Australia?
Automation:Invest in closed-system, automated manufacturing.Reduces labor, error, and contamination risk; increases throughput.
Process Optimization:Use whole blood as starting material to simplify cell separation and reduce cost.
Government Support:Seek government incentives or public-private partnerships to subsidize local production.
Bottom line:With the right partnerships and regulatory strategy, CHM could approach—but may not exactly match—Turkey’s low CAR-T prices for CDH17, especially in the short term.
Long-term, local innovation and automation will be key to sustainable cost reduction.
Ok that's more or less it for manufacturing as one can see , its complex and expensive at the moment.
Onto the next important scientific theorem. I am going outside the mostly known contributers to cancer killing regime.
So speculation only.
Combination drugs to benefit the synergy of Cdh17.
As per a previous series we saw how the cancer cells evade the drugs given and regain their stature in the body.
How to overcome that hugely important significant issue.
So along with Cdh17 we use a Checkpoint inhibitors .These drugs (e.g., anti-PD-1/PD-L1) are designed to block immune checkpoints that tumors exploit to evade T cell-mediated killing.
So in laypersons terms.
T Cell Exhaustion in Solid Tumors:CAR-T cells, especially in solid tumors, often become exhausted due to chronic antigen exposure and the immunosuppressive tumor microenvironment (TME).
This limits their persistence and efficacy.
Checkpoint Pathways:Tumors upregulate PD-L1 and other checkpoint ligands, which bind to PD-1 on T cells (including CAR-Ts), dampening their activity.Studies show that combining CAR-T cells with checkpoint inhibitors (e.g., anti-PD-1) enhances CAR-T cell infiltration, persistence, and anti-tumor activity in solid tumor models.
Engineering CAR-T cells to secrete PD-1–blocking antibodies locally at the tumor site further boosts efficacy and reduces systemic toxicity.
Clinical:Early clinical and translational studies in solid tumors (not yet specific to CDH17) suggest improved response rates and Progression free survival ( PFS) with combination approaches.
Checkpoint inhibitors prevent the TME from shutting down these T cells, allowing prolonged and more effective tumor killing.Combination may convert “cold” (non-inflamed) tumors into “hot,” immunologically active tumors, further recruiting the host immune system.
Potential Outcomes:
Higher response rates .Longer PFS and possibly overall survival.
Greater depth and durability of response, especially in patients with high PD-L1 expression or immunosuppressive TME.
Risks and ConsiderationsToxicity:
Combining CAR-T with checkpoint inhibitors could increase immune-related adverse events, including cytokine release syndrome (CRS) and neurotoxicity.
Careful dose escalation and monitoring would be essential.Patient Selection:Best suited for patients with high PD-L1/PD-1 axis activity or those with partial responses to either therapy alone.
Conclusion :
There is strong scientific and early clinical rationale for combining CDH17 CAR-T therapy with checkpoint inhibitors to enhance efficacy and PFS in GI cancers.Preclinical and early clinical data in other CAR-T settings support this synergy, and the approach is likely to be explored as CHM-CDH17 advances.If CHM pursues this, careful patient selection and toxicity management will be key.
Who are our competitors?
Direct CAR-T CompetitorsCurrently, CHM appears to be the only company in the world with a clinical-stage CDH17-targeted CAR-T cell therapy, based on public disclosures and clinical trial registries as of May 2025.Part 6 we will look at the Companies value and it's not 0.005 cents.
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