On July 26, 2021 Allarity Therapeutics A/S ("Allarity") and Lantern Pharma Inc. ("Lantern") reported that they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven ("LP-100") and assume full authority to manage and guide future clinical development and commercialization (Press release, Allarity Therapeutics, JUL 26, 2021, View Source [SID1234585174]).
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Irofulven is a well-studied small molecule that causes bulky single strand DNA adducts that cause DNA damage in cancer cells, which can only be repaired by the transcription coupled nucleotide excision repair (TC-NER) pathway. This DNA modification stalls RNA polymerase II leading to transcription and cell cycle arrest and apoptosis in certain types of cancer cells. The drug was originally developed by MGI Pharma (USA) and Eisai (Japan), through Phase 3 clinical trials. Allarity acquired global exclusive rights to the drug through a license from Lantern in 2015 and initiated a Phase 2 clinical trial in Denmark aimed to benefit late-stage, metastatic, castration-resistant prostate cancer (mCRPC) patients. Lantern plans on pursuing further development and advancement of the drug candidate immediately.
Allarity has previously developed and retrospectively validated a companion diagnostic for Irofulven, using its DRP technology, which was utilized to select and enroll mCRPC patients in its Phase 2 clinical trial at sites in Denmark. Based, in part, upon early results (unpublished) of that trial (NCT03643107) Lantern has decided to reacquire the Irofulven program and will review the potential to advance clinical development of Irofulven in both bladder and prostate cancer patients who have a key mutation in the ERCC2/3 genes (excision repair cross-complementation group 2/3 genes). The genes encode a crucial TC-NER pathway protein (helicase subunit XPB) necessary for DNA damage repair, and it is postulated that patients having tumors harboring the ERCC2/3 gene mutations, and thus lacking the crucial DNA damage repair protein, may be more responsive to treatment with Irofulven.
Under the agreement, Lantern will purchase assets and reacquire global, exclusive rights to further develop and commercialize Irofulven, and Allarity will discontinue further involvement in the Irofulven program. Allarity will provide Lantern with existing, clinical grade drug inventory, manufacturing trade secrets and know-how, and certain data from Allarity’s current Phase 2 clinical study in mCRPC, along with a developed clinical protocol for the intended ERCC2/3 study. Lantern will also receive a license to utilize, in its sole discretion, Allarity’s Irofulven DRP companion diagnostic in future clinical development and commercialization of the drug. Allarity will receive an upfront payment from Lantern, development and regulatory milestone fees, which payments together total, 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. Further financial terms of the agreement were not disclosed.
Steve R. Carchedi, CEO of Allarity Therapeutics, commented "We are pleased to announce this promising agreement with Lantern Pharma, in order to build on our prior efforts to explore the clinical potential of Irofulven and advance the value of this pipeline asset. Providing Irofulven to selected patients with tumors harboring the ERCC2/3 mutations and resulting DNA damage repair defect represents a novel approach to potentially increasing the therapeutic benefit of Irofulven. Our agreement with Lantern on this program enables Allarity to remain focused on its top priority programs, while at the same time leveraging Lantern’s resources, expertise, and commercial position to continue clinically advancing Irofulven."
Panna Sharma, CEO of Lantern Pharma, further commented "Irofulven has the potential to have a key position in helping extend survival in bladder and metastatic prostate cancers, and potentially other cancers that harbor mutations in ERCC2/3 and other related genes. This program is very synergistic with our other drug candidates that are also focused on DNA damage repair and the NER pathway. Most importantly Irofulven has the potential to be an important compound for several challenging cancers that are impacting patients globally. We are looking forward to advancing and expanding the Irofulven program using our data-driven and precision approach aimed at future patient benefit from this therapy."