Pipeline: Additional Programs
Allarity is also to bring these additional promising clinical programs through development.
LiPlaCis®, a target controlled liposome formulation of one of the world’s most widely used chemotherapeutic agents, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly to the tumor site where is it needed. Allarity completed the initial Phase 2, DRP-guided proof-of-concept trial in metastatic breast cancer that showed promising results. LiPlaCis had been out licensed to Smerud Medical Research International AS. Smerud will advance the development of LiPlaCis® in late stage metastatic breast cancer in an expanded phase 2 trial. Allarity holds an approved Investigational Device Exemption (IDE) from the U.S. FDA to use the LiPlaCis® DRP® in future pivotal trials for LiPlaCis®
2X-111 (Glutathione-enhanced, PEGylated Liposomal Doxorubicin), a novel drug candidate that is designed for the liposomal delivery of the anti-cancer drug doxorubicin directly to a tumor, with a glutathione coating added to exploit active endogenous transporters, allowing the drug to cross the blood-brain barrier. 2X-111 has also previously demonstrated clinical activity against brain metastasis in breast cancer, which remains a second priority indication for this asset. Allarity has out-licensed 2X-111 to Smerud Research International AS to progress late stage development in for the treatment of glioblastoma multiform (GBM) (primary brain cancer) and potentially brain metastases of breast cancer (mBC).
Irofulven, a DNA damaging agent, has previously undergone Phase 2 and 3 clinical trials where the compound proved safe and showed promising efficacy in a number of cancer types, including metastatic prostate cancer. The Company has previously conducted a small-enrollment, DRP®-guided Phase 2 trial of Irofulven in late-stage prostate cancer patients.
In 2021, Lantern Pharma Inc. reacquired the global rights to Irofulven from Allarity Therapeutics (Irofulven is also referred to as “LP-100” by Lantern Pharma), including an exclusive license to utilize, in its sole discretion, Allarity’s Irofulven DRP® companion diagnostic in future clinical development and commercialization of the drug. Under the terms of the reacquisition, Allarity received an upfront payment and may receive additional payments totaling, if all milestones (including regulatory marketing approval in the U.S. and EU) are met, up to approximately U.S. $18 million, and tiered royalties on future sales of Irofulven.