Cell therapy weekly: Encouraging results from Phase I prostate cancer trial
This week: InDevR (CO, USA) and Sino Biological (Beijing, China) join forces to accelerate the development of multiplexed analytical solutions, and Orca Bio (CA, USA) completes and exceeds patient enrollment for its Phase III trial for the treatment of various hematological malignancies. Plus, City of Hope® (CA, USA) reports encouraging data from its Phase I prostate cancer trial.
The news highlights:
- A strategic alliance forms to accelerate assay development for a range of therapeutic applications
- Patient enrollment exceeds goal for Phase III trial for various hematological malignancies
- Encouraging results from Phase I prostate cancer trial
A strategic alliance forms to accelerate assay development for a range of therapeutic applications
InDevR, a provider of analytical solutions for vaccine in-process and quality-control testing, has joined forces with Sino Biological, a biotechnological company, to accelerate the development of multiplexed analytical solutions for an extensive range of vaccine, mRNA therapies and cell and gene therapy applications.
Sino Biological’s comprehensive range of products can now be used on InDevR’s VaxArray Platform, aiming to deliver solutions for in-process and quality-control testing to address the needs for improved multiparametric analytical tools in the biopharmaceutical industry.
Kathy Rowlen, CEO of InDevR, reflected on the strategic partnership, stating: “Moving forward, our goal is to leverage that expertise to address the urgent need for improved analytical tools for cell and gene therapies and mRNA vaccine testing. Our partnership with Sino Biological, with their extraordinary breadth and depth of offerings and commitment to quality, will drive new product development and empower our customers to design their own multiplex assays with ease.”
Patient enrollment exceeds goal for Phase III trial for various hematological malignancies
Orca Bio has completed patient enrollment for the Precision-T Phase III randomized, open-label multicenter study assessing the safety and efficacy of Orca-T, the company’s lead investigational allogenic T-cell immunotherapy. Orca-T is a donor-derived product intended to treat various hematologic malignancies by replacing a patient’s unhealthy blood and immune system with a new, healthy system using highly purified regulatory T cells.
The study will compare Orca-T with a conventional allogeneic hematopoietic stem cell transplant in patients with certain blood diseases, including acute myeloid leukemia, acute lymphocytic leukemia and high-risk myelodysplastic syndrome.
“Completing enrollment in our multicenter Phase III study of Orca-T is an important milestone toward our ultimate goal of delivering a potentially life-saving product to patients who have long had to settle for a standard of care that carries significant risks,” commented Ivan Dimov, CEO and co-founder of Orca Bio.
The study has surpassed its target of 174 patients by enrolling an additional 13, bringing the total to 187 participants across 19 clinical trial sites in the USA. Results from the trial are forecasted to be available in the first half of 2025.
“We’re immensely grateful to the patients, their families and the trial site investigators who participated in our study and look forward to sharing pivotal data in the near future with the broader blood cancer community,” expressed Dimov.
Encouraging results from Phase I prostate cancer trial
City of Hope® has detailed encouraging findings from its first in-human Phase I trial utilizing CAR-T cell therapy to treat 14 patients with metastatic castration resistant prostate cancer.
In the trial, the patients’ cancer had spread beyond the prostate and hormonal treatments were ineffective. The team at City of Hope programmed CAR-T cells to target prostate stem cell antigens, which are highly expressed on the surface of prostate cancer cells.
Among the study’s findings, one patient exhibited a 95% decrease in prostate-specific antigen levels as well as a decline in his bone and soft tissue cancers; he sustained these positive result for approximately eight months.
“The patient’s results were very encouraging, and we are deeply grateful for his participation in our study as well as other patients and their families,” remarked Tanya Dorff, City of Hope section chief. “We want to continue with this therapy and increase the amount of CAR-T cells, and continue to carefully monitor for any health problems, as we think this can improve the therapy’s effectiveness.”
