The Opportunity
Significant Investment To Date, Extensive Market Opportunities to create myeloid disorder franchise
Prior Investment
In early 2024, Taran acquired the assets of Humanigen, a NASDAQ-listed company, through a 363 sale, and acquired these assets for cash 'free and clear'. The assets included LENZ, which had already been developed in several potential indications, including CMML, at a cost of more than $500 million across these indications and manufacturing optimization., as well as IFAB.
Those past investments provide an unusual opportunity for Taran as a new company with established assets in late-stage clinical trials: completed studies establish the safety and efficacy profile of LENZ, extensive CMC work has been completed, and extensive product inventory is on hand.
A Phase 2/3 trial for LENZ in CMML is almost fully enrolled. Prior studies have been completed in CMML, asthma, rheumatoid arthritis, COVID and as a companion therapy to CAR-T.
Regulatory Opportunity
Taran is pursuing treatments and potential cures for diseases of high unmet medical need such as CMML, AML, MDS which number patients in the many tens of thousands each in major markets. But Taran is also interested in tackling conditions for which there are no or inadequate treatment options for many sufferers, including those with relatively small patient numbers, such as JMML, a potentially lethal disease in children that is newly diagnosed in about 100 children a year in the US.
Our commitment to these rare and orphan diseases makes us eligible for regulatory benefits intended to encourage work in these areas. For example, if priority review is granted by the U.S. Food and Drug Administration for JMML and LENZ is first approved in the US in that indication, the approval may include issuance of a transferable Priority Review Voucher, currently changing hands for $100-125MM.
In addition, while the number of patients with CMML, AML and MDS is now thought to be more substantial than previously, they would still be technically regarded as 'orphan' conditions and multiple country regulatory agencies offer financial, review and other incentives to products that treat orphan conditions.
Our Partners
The University of Adelaide and the South Australian Health and Medical Research Institute, with the assistance of an Australian government grant, are pursuing the PREACH-M Phase 2/3 study for life-threatening Chronic MyeloMonocytic Leukemia (CMML). Encouraging data has also been generated in other myeloid disorders, including AML and MDS. Further conditions are being studied.
The Mayo Clinic is planning to study LENZ to potentially increase the safety and effectiveness of CAR-T cancer therapy, supported by positive Phase 1b results. Taran plans to contribute LENZ for the study, which is expected to involve 160 patients over four years, with the majority of funding contributed by Mayo and commercial payers.
The Olivia Newton John Cancer Research Institute in Melbourne, Australia, a leading research center and world leader in design, construction and development of ADCs is partnering with Taran on its IFAB ADC program in solid tumors. Multiple ADCs have been constructed and tested in animal models, with the most promising now ready to enter a Phase 1 study in multiple types of cancer.
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