Alloplex Biotherapeutics today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,403,186, covering the company’s ENLIST platform. The patent, granted last month, will remain in force until late 2038.
Alloplex’s patent covers an allogeneic tumor cell vaccine comprising genetically modified tumor cell lines that express multiple immunomodulators. In pre-clinical laboratory studies, these cell lines were shown to activate human immune cells and induce responses that cross-react with a patient’s own tumor cells, supporting enhanced anti-tumor immunity compared with unmodified cells.
The new patent provides a foundational advance for applying these principles to novel cellular therapies. In parallel, Alloplex has elected to maintain additional proprietary innovations outside the patent system, providing the company with both patent protection and a portfolio of undisclosed competitive advantages.
“ENLIST started as an allogeneic tumor cell vaccine concept, hence the source of our company name ‘Allo’-plex, but our research evolved into an even more powerful approach based on emerging data which led us to settle on an autologous adoptive cell therapy approach,” said Frank Borriello, M.D., Ph.D., Founder and Chief Executive Officer of Alloplex Biotherapeutics.
“By harnessing ENLIST to prime a patient’s own immune cells outside the body, we created SUPLEXA — a next-generation adoptive cellular therapy comprised of uniquely activated immune cells to specifically attack solid tumors while also priming the host immune system against the released tumor antigen. This patent secures the foundational element of the ENLIST immune cells training platform and supports our ongoing clinical development.”
Building on the original ENLIST concept, Alloplex successfully translated the platform to the clinic. In a first-in-human Phase 1 trial, SUPLEXA cells were prepared from each patient’s peripheral blood mononuclear cells (PBMCs) and administered intravenously without the need for chemotherapeutic preconditioning or cytokine support. The study confirmed a remarkable safety profile and demonstrated meaningful clinical activity, including complete and partial responses as well as durable stable disease across multiple tumor types.
Remarkably, SUPLEXA treated patients showed a change in the composition of their peripheral blood that are expected to enhance an anti-tumor response, thus offering a potential biomarker for monitoring SUPLEXA activity. These results validate the use of the ENLIST immune cell training platform and highlight its broad potential for future applications.
This newly granted patent, in combination with Alloplex’s portfolio of proprietary innovations, reinforces the company’s leadership in next-generation cellular therapies.
Alloplex Biotherapeutics is a privately held biotechnology company developing next-generation cellular therapies for the treatment of solid tumors and autoimmune diseases. The company’s proprietary ENLIST platform trains immune cells to recognize and attack cancer, forming the basis for its lead autologous cellular therapy, SUPLEXA.
Building on compelling clinical validation, Alloplex is actively seeking strategic partnerships with pharmaceutical companies and additional investment to advance Phase 2 clinical testing. The ENLIST platform and SUPLEXA therapeutic cells offer unique opportunities to augment existing cancer therapy programs under development by other companies and to pioneer a novel approach to cancer treatment.
Alloplex employs a dual intellectual property strategy: securing foundational patents while maintaining additional innovations as proprietary innovations not disclosed in the public domain. This approach ensures both long-term protection and unique competitive advantages. The versatile ENLIST platform also holds broad potential for future development, including applications in allogeneic (“off-the-shelf”) therapies and integration with other methods such as CAR and iPSC-derived approaches with relevance across oncology and autoimmunity.
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