Cell therapy weekly: updates on CAR-T therapy for solid tumors
This week: Dispatch Bio (PA, USA) announced updates on two therapeutics utilizing its Flare platform to address solid tumors, Eureka Therapeutics (CA, USA) received Regenerative Medicine Advanced Therapy (RMAT) designation for its CAR-T therapy targeting the most common form of liver cancer, and SmartCella (Tullinge, Sweden) and Catalent (FL, USA) entered into an agreement to support the research and development of regenerative medicines targeting cardiac disease and Parkinson’s disease
The news highlights:
- Flare platform for solid tumors
- RMAT designation for liver cancer CAR-T
- License agreement for GMP iPSCs
Flare platform for solid tumors
Dispatch Bio announced two significant updates on the investigational therapeutics DISP-10 and DISP-11, both of which leverage the company’s Flare platform. This platform utilizes a tumor-specific virus (DV-10) to deliver a synthetic antigen (Flare) onto tumor cells. This process enables precise recognition by T cells and reshapes the tumor microenvironment to support immune activity.
The company announced that the FDA has cleared an Investigational New Drug (IND) application for DISP-10, an investigational therapy comprising Dispatch Bio’s DV-10, and Bristol Myers Squibb’s autologous BCMA-directed CAR-T therapy ide-cel. This approval enables the initiation of a Phase I clinical study, with patient enrollment is expected to commence in the coming months.
“FDA clearance of the IND for DISP-10 represents an important milestone for Dispatch as we advance our first clinical program for patients with solid tumors of epithelial origin,” said Mauro Avanzi, Chief Medical Officer of Dispatch. “We are beginning our initial clinical evaluation of DISP-10 in gastrointestinal cancers, where there remains a substantial unmet medical need. Because DISP-10 was designed with broad applicability in mind, we plan to leverage early clinical insights to expand into multiple additional solid tumor indications following clinical proof of concept.”
The company also announced a clinical collaboration with CARsgen Therapeutics to initiate a Phase I trial in China to evaluate DISP-11, which comprises CARsgen’s autologous BCMA-targeting CAR-T therapy zevorcabtagene autoleucel, and DV-10.
“We are working to expand the impact of the Flare platform, and this collaboration represents a step forward in a region with infrastructure for efficient and impactful oncology development and significant unmet medical need,” said Sabah Oney, CEO of Dispatch. “CARsgen’s scientific rigor and track record of rapid clinical advancement make them an ideal partner. As our second collaboration with a company that has successfully commercialized a CAR-T therapy, this partnership reinforces the growing confidence in Flare’s potential across a variety of immunotherapies and will help shape our global development strategy.”
RMAT designation for liver cancer CAR-T
The FDA granted RMAT designation to Eureka Therapeutics’ CAR-T therapy ECT204 for the treatment of the most common form of liver cancer, hepatocellular carcinoma (HCC). This designation is based on results from the completed Phase I cohort, along with additional data from the company’s ongoing Phase I/II ARYA-3 trial.
ECT204 is an autologous CAR-T therapy, engineered using Eureka’s proprietary ARTEMIS CAR platform to target Glypican-3 (GPC3), a cell surface protein that is highly expressed in certain solid tumors, particularly HCC.
“This represents an important inflection point for Eureka and for cell therapy in solid tumors,” said Cheng Liu, Founder and CEO of Eureka Therapeutics. “ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy.”
License agreement for GMP iPSCs
SmartCella and Catalent entered into a nonexclusive license agreement granting SmartCella access to Catalent’s proprietary off-the-shelf GMP-compliant iPSCs. This agreement allows SmartCella to utilize these cells for the research, development and clinical translation of novel allogeneic stem cell-based regenerative therapies. Specifically, this partnership aims to support efforts to develop regenerative therapies for cardiac disease and Parkinson’s disease.
“Access to robust, well-characterized iPSC lines is a critical enabler of our Regenerative Medicines technology platforms. It provides a strong foundation for scalable manufacturing of iPSC-derived therapies that de-risk scale-up and future GMP implementation. It also underpins our development efforts and partnerships, with current focus on Parkinson’s disease, cardiac failure and osteoarthritis. We are pleased to partner with a world-renowned CDMO leader such as Catalent as we advance these programs,” said Ricardo Baptista, Chief Technology Officer at SmartCella.