Impilo Therapeutics, Inc. (referred to as "Impilo"), a privately-owned enterprise specializing in drug discovery and development, has officially launched its operations with a core mission to facilitate the effective utilization of nucleic acid-based medicines for the treatment of solid tumor cancers. This initiative is underpinned by Impilo's technology, derived from a partnership with Lisata Therapeutics, Inc. (NASDAQ: LSTA), which revolves around the targeted delivery of nucleic acid-based drugs. Impilo is actively advancing its Tumor-Penetrating Nanocomplex, or TPN Platform™, as a method for precise delivery across a diverse spectrum of nucleic acid treatment approaches, including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), messenger RNAs (mRNAs), and in vivo gene editing. Additionally, Impilo is progressing an internal portfolio of programs dedicated to addressing solid tumor cancer indications.

While nucleic acid-based medicines have gained regulatory approval for various medical conditions, their use in cancer treatment remains uncharted. Despite their potential to provide personalized therapies by targeting the genetic underpinnings of diseases, early enthusiasm for this drug category during preclinical and early clinical phases has not translated into commercial success. The major barrier to effective drug delivery for solid tumor cancers is the tumor stroma, which comprises non-cancerous cells and the extracellular matrix encircling cancer cells. Overcoming this challenge is particularly critical for the successful deployment of nucleic acid-based drugs.

David Slack, CEO of Impilo, stated, "Our collective understanding as we initiate Impilo is that the potential of nucleic acid-based drugs in combating cancer is immense. We have assembled the right team and technology to swiftly advance promising product opportunities enabled by the TPN Platform, ultimately benefiting cancer patients. Our platform employs a targeted strategy to enable nucleic acid-based drugs to penetrate the layers of the stroma, yielding promising outcomes in animal models for various types of solid tumors. Notably, the central tissue-penetrating technology element of the Platform, geared towards targeting tumors, has exhibited promising activity and a favorable safety profile in clinical trials undertaken by our partners at Lisata, particularly in combination with a variety of agents across diverse solid tumor types."

Impilo's leadership is helmed by CEO David Slack, an industry veteran with three decades of experience in leading biotech companies and overseeing numerous financial transactions, strategic collaborations, mergers, and acquisitions. Prior to this role, David served as CEO at Cend Therapeutics, a predecessor of Lisata. He has held senior positions at entities such as Viracta Therapeutics, Ionis Pharmaceuticals, Aventis Pharma (now Sanofi), Rhone-Poulenc Rorer, and RPR Gencell. Supporting David is an esteemed team of executives and scientists, possessing extensive expertise in various RNA modalities. Chief Development Officer John S. Grundy, Ph.D., joins after co-founding and serving on the board of DTx Pharma, and boasts a rich background in preclinical development and clinical pharmacology at Ionis, Regulus Therapeutics, and Arena Pharmaceuticals.

Impilo's scientific founder, Erkki Ruoslahti, MD, PhD, expressed his enthusiasm for the initiative, stating, "I am excited about the team and focus that David has brought together to establish Impilo. With backgrounds rooted in companies that originated multiple nucleic acid drug technologies, they possess a profound understanding of the challenges associated with applying this drug class to anti-cancer applications. Their comprehensive plan to leverage the extensive potential of the TPN Platform to address these challenges is highly promising."

The TPN Platform is distinguished by a proprietary tumor-targeted tissue penetrating peptide, developed by Dr. Ruoslahti and colleagues. This internalizing RGD or iRGD peptide specifically targets tumors through its affinity for integrins that are selectively present on tumor vasculature and crucial cell types within the tumor stroma, including cancer cells themselves. Once bound to these integrins within the tumor, the peptide is cleaved to release a cryptic peptide fragment that initiates an active transport pathway. This enables the peptide, peptide fragment, and attached nucleic acid-based drugs to penetrate the stromal layers effectively, thereby enhancing the treatment of solid tumor cancers. The Platform encompasses peptides targeting various cell types, such as tumor-associated macrophages, and incorporates an array of carrier formats and additional technologies to optimize the application of diverse nucleic acid-based treatment modalities.

Regarding the Impilo-Lisata transaction, Lisata granted Impilo exclusive rights to iRGD for nucleic acid-based drug applications and relinquished rights to other technologies in exchange for equity in Impilo. Lisata also secured the right of first negotiation for an Impilo-originated TPN drug development candidate. Dr. David Mazzo, CEO of Lisata, will join Impilo's Board of Directors alongside Dr. Ruoslahti and David Slack.

Impilo Therapeutics, as a private entity, is dedicated to the advancement of nucleic acid-based medicines for the effective treatment of solid tumor cancers. The company was established by professionals and executives with profound experience and commitment to enabling cancer patients to benefit from this emerging class of drugs. The TPN Platform serves as a cornerstone, enhancing nucleic acid drug delivery to tumors through targeted tissue penetration. Impilo is actively pursuing internal programs and collaborative efforts aimed at bringing these advancements to clinical fruition, thereby addressing unmet needs for patients battling solid tumor cancers.

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