#USA #Princeton #Made Scientific #Sentinel BioTherapeutics #ePP Encapsulated Cell

Strategic Manufacturing Partnership

In a significant development within the biotechnology sector, Made Scientific, a prominent cell therapy contract development and manufacturing organization (CDMO), has announced a strategic partnership with Sentinel BioTherapeutics, a clinical-stage biotech firm focused on advancing encapsulated cell-based immunotherapies. This collaboration aims to enhance the Phase I/II clinical development of SENT-001, a groundbreaking allogeneic encapsulated cell therapy.

SENT-001 utilizes genetically engineered ARPE-19 cells to facilitate localized delivery of native human IL-2 (interleukin-2) directly to the peritoneal or pleural cavities. This innovative therapy has previously been assessed in a multicenter, open-label Phase I clinical trial focused on patients suffering from high-grade serous adenocarcinoma of the ovary, fallopian tube, or primary peritoneum, under the trial identifier NCT05538624. This clinical advancement represents a promising step in the fight against difficult-to-treat solid tumors.

Advancements in Clinical Development

As part of this partnership, Made Scientific will establish a new GMP (Good Manufacturing Practice) Master Cell Bank while also playing a pivotal role in process optimization and clinical GMP drug product manufacturing for SENT-001. Importantly, this will allow the therapy to be administered as an off-the-shelf product, enabling Sentinel's phase I/II trials to incorporate re-dosing and combinations with targeted immunotherapy agents. Made Scientific's innovative drug manufacturing strategy aims to introduce a closed, scalable production model intended to enhance efficiency, increase throughput, and ultimately reduce the manufacturing time as well as overall cost of goods (COGs).

This well-thought-out approach not only supports clinical scalability but also strengthens the economic sustainability of the therapy in the long term. By automating manufacturing workflows, decreasing resource requirements, and maximizing drug product yield, both companies are setting the stage for more accessible treatment options for cancer patients.

Comments from Leadership

Syed T. Husain, the Chairman and CEO of Made Scientific, remarked on the partnership: "This collaboration builds on our mutual history of innovation and reliability. It also leverages our newly established site in Princeton, NJ, which has been purposefully designed to support partners like Sentinel through the entirety of clinical development and commercial manufacturing."

Conversely, Rima Chakrabarti, MD, the CEO of Sentinel BioTherapeutics, noted that, "This partnership marks a substantial step forward in our mission to bring localized immunotherapies to patients with challenging solid tumors. The expertise in cell therapy that MADE brings, coupled with their agile GMP capabilities, will be crucial in accelerating our progress through the Phase I/II development stages. As the first spinout from RBL LLC, we’re showcasing how the right strategic alliances can expedite the transition of landmark medical technologies from concept to clinic, ultimately delivering innovative treatments to patients who need them the most."

About Made Scientific and Sentinel BioTherapeutics

Made Scientific has established itself as a key player within the cell therapy landscape since its inception in 2019, specializing in the development and manufacturing of both autologous and allogeneic cell therapies for early to mid-stage clinical trials. Over time, it has transitioned into a comprehensive clinical-to-commercial service provider, operating from two state-of-the-art facilities in New Jersey.

Sentinel BioTherapeutics stands at the frontier of clinical-stage biotechnology, creating localized immune-modulating therapies specifically designed to tackle tumors that currently resist standard treatments. Their flagship platform administers potent cytokines, like IL-2, via encapsulated allogeneic cell-based protein producers (ePPs), promoting an effective systemic immune response while minimizing side effects.

As this partnership unfolds, industry experts and stakeholders alike will be watching closely to see how this collaboration can set a new standard in the immunotherapy space, advancing options for cancer patients and improving outcomes across the board.