NATCO puts US$24.7 million into pig-organ transplant biotech

NATCO Pharma Limited has invested US$24.7 million in eGenesis, its largest disclosed biotech investment, while eGenesis has FDA-cleared kidney and liver studies, NRC-2694-A is recruiting for a Phase 2 trial, and Cellogen plans first human leukemia dosing in India.

What has NATCO invested in biotech ventures?

NATCO has disclosed US$27.7 million of investments across eGenesis, Cellogen Therapeutics and Stero Therapeutics, with eGenesis accounting for US$24.7 million. The portfolio spans xenotransplantation, which involves organs engineered for human transplantation, cellular engineering and gene-therapy approaches, and metabolic-disease research. NATCO separately identifies NRC-2694-A as an internally discovered and developed oral cancer drug, rather than an investment in an outside company.

The disclosed allocation to eGenesis is US$21.7 million higher than to Cellogen Therapeutics and US$23.7 million higher than to Stero Therapeutics. eGenesis has disclosed US Food and Drug Administration, or FDA, clearances for kidney and liver studies, while Stero is conducting animal studies. The presentation does not disclose ownership stakes, investment dates, valuation terms, revenue expectations or additional funding commitments for the three investments.

How far has eGenesis progressed with pig-organ transplants?

eGenesis has completed three kidney xenotransplants in patients with end-stage kidney disease, and two patients achieved more than eight months of dialysis independence, according to NATCO. eGenesis is developing genetically engineered pig organs intended to be compatible with human transplantation. NATCO says the first human transplant of a genetically engineered pig kidney occurred in March 2024.

The FDA has cleared a Phase 1/2/3 clinical study for kidney xenotransplantation, and registration for a 33-patient trial is due to commence in early 2027. The FDA has also cleared a Phase 1/2 liver xenotransplantation study in patients with acute-on-chronic liver failure, or ACLF. The kidney programme therefore has a disclosed registration-study plan, whereas the liver programme is described as a Phase 1/2 study.

What is NATCO’s home-grown cancer drug NRC-2694-A?

NRC-2694-A is NATCO’s orally administered small-molecule tyrosine kinase inhibitor for head and neck cancer. The FDA has approved a Phase 2 study in recurrent or metastatic head and neck cancer for patients whose disease progressed on Keytruda, identified in the presentation as pembrolizumab manufactured by Merck & Co. The programme is an internal clinical-stage drug project alongside NATCO’s investments in biotechnology companies.

Patient recruitment for the Phase 2 NRC-2694-A study is in progress in the US and India. NATCO specifies the drug’s oral small-molecule mechanism, treatment setting and trial geography, but does not give a patient target, primary endpoint, completion date or efficacy results. Its mechanism differs from Cellogen’s chimeric antigen receptor T-cell, or CAR-T, approach, which uses cellular engineering rather than an oral tyrosine kinase inhibitor.

Which cell and gene therapy projects are nearest human dosing?

Cellogen Therapeutics is the investment with the nearest stated first-in-human milestone, as first human dosing for leukemia is expected to begin shortly in India. NATCO has invested US$2 million in Cellogen, which is developing third- and fourth-generation CAR-T therapies for leukemia and lymphoma. It also lists genetic therapies for beta-thalassemia and sickle cell disease.

Cellogen has received good manufacturing practice, or GMP, manufacturing approvals in India, an operational milestone disclosed before its planned leukemia dosing. In comparison, NATCO’s US$1 million Stero Therapeutics investment is focused on novel metabolic-disease therapies and remains in pre-clinical animal studies. Stero’s initial focus is Cushing’s syndrome, with expansion into non-alcoholic steatohepatitis, or NASH, while Cellogen has disclosed both manufacturing approvals and an intended human-dosing step.

Conclusion

NATCO’s disclosed biotechnology strategy consists of US$27.7 million invested across organ transplantation, cell and gene therapy, and metabolic disease, plus the internally developed NRC-2694-A cancer programme. The US$24.7 million eGenesis investment is materially larger than the US$2 million Cellogen and US$1 million Stero commitments, and eGenesis has disclosed the furthest-defined clinical plan through its proposed 33-patient kidney registration study.

The next disclosed milestones are the planned early-2027 commencement of eGenesis’s 33-patient kidney registration study, Cellogen’s intended first human leukemia dosing in India, and continuing recruitment for NRC-2694-A in the US and India. NATCO also discloses that Stero is conducting animal studies, but provides no clinical-readout timetable, ownership terms or further investment target for any of the projects.