– TTX-810 is designed for rapid clearance to circumvent mechanism-based risks of MCL1 inhibition

– High potency affords robust anti-tumor effects whilst preserving cardiomyocyte viability

– Trueline Therapeutics on track to initiate clinical development of TTX-810

CAMBRIDGE, MA, USA & BERLIN, Germany I May 16, 2023 ITrueline Therapeutics Inc., an oncology-focused subsidiary of Anji Pharmaceuticals, today announced the successful completion of IND-enabling studies with MCL1 inhibitor TTX-810, a highly potent and selective macrocyclic compound to treat patients with solid tumor or hematological cancers. A distinguishing feature of TTX-810 is a rapid clearance profile to minimize the potential risks of sustained MCL1 inhibition in non-cancerous tissues.

“The completion of IND-enabling studies marks the culmination of over a decade’s work to truly understand the safest and most effective way to approach MCL1 inhibition,” said Ulla Rauh, Ph.D., CEO/CSO of Trueline Therapeutics. “With our rapid-clearance strategy further de-risked, we are excited to progress TTX-810 into cancer patients and finally unlock the therapeutic potential of MCL1 inhibition.”

TTX-810 was discovered by a partnership between the Broad Institute of Harvard and MIT and Bayer Pharmaceuticals. The exquisite potency of TTX-810 was achieved by structure-guided design and comprehensive profiling versus over 500 cancer cell lines to define the optimal cellular context for rapid and selective induction of cell death. Following candidate selection, Trueline Therapeutics scientists designed and executed the IND-enabling program in preparation for first-in-human testing.

“When we first saw the TTX-810 data package, our key questions were ‘Will it work?’ and ‘Will it be safe?’ given the challenges other therapeutic candidates with more traditional clearance profiles are encountering,” said Michael Serrano-Wu, Ph.D., Chief Scientific Officer of Anji Pharmaceuticals. “This approach benefits from the rapid and irreversible effects of MCL1 inhibition, which we believe offers a therapeutic window not attainable with longer-acting compounds. We customized our IND-enabling program to address these questions, and now it is full steam ahead to demonstrate the clinical advantages of this unique profile.”

About Trueline Therapeutics Inc.

Trueline Therapeutics is an oncology-focused subsidiary of Anji Pharmaceuticals. In addition to the MCL1 inhibitor TTX-810, TruelineTx is developing a CD3/CD33 bi-specific called TTX-564 which has been shown to be safe in cancer patients and induce strong depletion of immunosuppressive cells called myeloid-derived suppressor cells (MDSCs). A dual HCK/BTK inhibitor, TTX-114 is in preclinical development. For more information visit www.truelinetx.com.

About Anji Pharmaceuticals Inc.

Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji’s asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with “hub-and-spoke” efficiency. Since its founding in 2018, Anji Pharma has launched clinical trials for two late-stage development programs: ANJ900 for glucose management in T2D and CKD and ANJ908 as a new mechanism for chronic constipation. For more information, visit www.anjipharma.com.

SOURCE: Trueline Therapeutics