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Lantern Pharma Reacquires Irofulven From Allarity Therapeutics; Plans Bladder, Prostate Cancer Trial

NEW YORK – Allarity Therapeutics and Lantern Pharma on Monday announced that Lantern has reacquired global rights to the investigational agent irofulven, which it plans to develop as a treatment for certain cancers, beginning with ERCC2/3-mutated bladder and prostate cancer.

Irofulven, or LP-100, was originally a product of MGI Pharma and Eisai, which Dallas-based Lantern licensed for redevelopment and then licensed out again to Allarity in 2015. Since then, Denmark-based Allarity, previously known as Oncology Venture, has owned global commercialization and development rights to irofulven.

Following the 2015 licensing agreement, Allarity began evaluating irofulven in a Phase II clinical trial involving metastatic castration-resistant prostate cancer patients and stratified them in the study using a response-predicting 86-gene expression signature. To screen mCRPC patients for this signature, Allarity used its proprietary drug response predictor (DRP) technology.

In reacquiring irofulven, Lantern is also garnering the rights to Allarity's DRP technology, inventory, and manufacturing knowledge, as well as the data from the ongoing prostate cancer Phase II trial, which Allarity has not yet publicly disclosed. In addition, Lantern will evaluate irofulven for bladder and prostate cancer patients with ERCC2/3 mutations using a clinical protocol that Allarity developed.

ERCC2/3 genes encode a protein that plays a role in repairing DNA damage. Tumors with mutations in these genes may be more susceptible to irofulven, which is designed to impair cancer cells' DNA damage repair pathways.

Under the terms of the licensing agreement, Allarity will discontinue developing irofulven. Lantern will pay Allarity an undisclosed upfront sum along with development and regulatory milestone fees. Contingent on these milestones, including potential regulatory approval in the US and EU, Lantern could pay Allarity as much as $18 million. If regulators approve irofulven, Allarity would receive tiered royalties on the drug's sales.

According to the two companies, Lantern made the decision to reacquire the agent — which previously failed MGI and Eisai's non-biomarker selected Phase III trials — after reviewing undisclosed data from Allarity's ongoing, biomarker-selected mCRPC trial. Allarity agreed to out-license the agent because it wanted to prioritize other pipeline programs, and indicated that Lantern is well-positioned to advance irofulven.