Pregene Enters into Innovative Partnership with CellPoint to Develop anti-BCMA CAR-T Cell Therapy in Europe and the US

SHENZHEN, China and LEIDEN, The Netherlands I April 6, 2022 I Shenzhen Pregene Biopharma, a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and commercializes innovative medicines and CellPoint, a cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), today announce an exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the United States.

PRG-1801 is a single domain antibody anti-BCMA CAR-T cell therapy in development for the treatment of relapsed/refractory multiple myeloma that has demonstrated strong signs of efficacy and an excellent safety profile in its initial investigator-initiated trial and Phase I/II clinical trials.

Under the terms of the collaboration, Pregene will receive over €20 million of upfront and near-term consideration, and is eligible to receive additional development, commercial milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US. As part of this partnership, Pregene will also provide translational and lentivirus manufacturing services to be reimbursed by Cellpoint.

"We are excited to partner with Cellpoint to develop CAR-T cell therapies via a POC platform," said Jishuai Zhang, Chief Technology Officer and Co-founder of Pregene. "The potential of our single domain antibody fully human BCMA CAR-T to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR-T product candidate. We expect the POC modality to enable faster treatment for broader patients using our differentiated CAR-T therapy, and we look forward to working with the team at CellPoint as they seek to develop and commercialize PRG-1801."

Tol Trimborn, Chief Executive Officer of CellPoint, said: "We are very pleased to add Pregene's novel anti-BCMA CAR-T therapy to our CAR-T portfolio and look forward to develop it using our decentralised, POC manufacturing model. This is our second clinical stage program and we have demonstrated we can provide cell therapy to cancer patients in only 6 days vein-to-vein, from apheresis to infusion. We are excited to work closely alongside Pregene to bring this to patients with a convenient, readily available treatment alternative."

About PRG-1801 (anti-BCMA CAR-T)

PRG-1801 is an anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in an investigator initiated trial and Phase I/II clinical trials. In addition to multiple myeloma, Pregene is investigating PRG-1801 in patients with autoimmune diseases. In May of 2021, Pregene and Dr. Reddy's Laboratories announced a license agreement whereby Dr Reddy's acquired the exclusive rights in India for PRG-1801. 

Clinical trials of PRG-1801 include:

  • Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma. Available clinical data showed overall response rate (ORR) of 100%. A Phase II clinical trial is now ongoing.
  • Investigator-initiated trial in China to evaluate the safety and efficacy of PRG-1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.

About Pregene

Pregene is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies with industry-leading cell and lentivirus manufacturing processes and technology. Leveraging its proprietary fully human single domain antibody discovery platform, high-throughput CAR-T drug priority platform, and proprietary cell and lentivirus manufacturing processes, Pregene is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T, CAR-NK, TCR-T, stem cell and biologics product candidates, including Pregene's leading asset, PRG-1801, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (RRMM)., has obtained NMPA IND clearance as the Class I new drug, and Phase I/II clinical trials are now ongoing. Find more at www.pregene.com.

About CellPoint

CellPoint B.V. is a Dutch (EU) company founded to provide affordable and readily available CAR-T therapies for all patients in need. CellPoint has initiated 2 clinical trials with CD19 CAR in NHL and CLL. The CellPoint CAR-T treatment workflow is designed for quality and patient safety, while driving down the time-to-treatment and costs by automation at the POC. Clinical centers of excellence have been selected that have experienced hematology teams and a local cell processing facility. These centers are equipped with a device, Cocoon (by Lonza), that allows automated manufacturing and receive full training and support to manufacture CAR-T therapies and to treat patients. Clinicians are enabled to schedule and perform CAR-T treatments within 1 week, without complex logistics. CellPoint's secure online xCellit platform is used to facilitate scheduling and monitoring of the CAR-T treatment workflow for the various stakeholders. In 2020, CellPoint raised series A funding from +ND Capital, the Dutch government (RVO) and has an exclusive license from Lonza to use the Cocoon at the point of care. Find out more at www.cellpoint.bio.

SOURCE: Shenzhen Pregene Biopharma

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