December 2023, Research Report
Many promising advances have been made this year at Project Stella.
Project Stella’s FOLR-1 CAR T is nearing the finish line. The Vector has been completed and is undergoing rigorous screening and testing to meet FDA clearance for clinical trial. We are on track to launch a clinical trial in mid 2024. This CAR T will provide a potentially curative treatment AML RAM/CBFGLIS; once considered an incurable diagnosis.
The scope of Project Stella is expanding to include two new targets, PRAME & WT1. These targets are expressed in 30-40% of all pediatric AML subtypes, capturing a much larger set of children impacted by aggressive forms of AML, as well as other pediatric cancers. Development of therapies addressing these targets will be done in collaboration with Dr. Franco Locatelli, Head of the Department of Pediatric Hematology and Oncology, IRCCS Bambino Gesù Children’s Hospital in Rome.
STRO-002 has now been administered successfully (and safely) in 25-30 patients, with more children waiting to receive it. Historically, the survival rate of this AML subtype was less than 10%. With the discovery of STRO-002, overall survival rate has increased to 50%, reaching as high as 90% in those with low disease burden. Most importantly, it is delivered in the outpatient setting with virtually no toxicity. Though it has served a vital role in bridging treatment plans and mitigating the life-threatening toxicities of chemotherapy, some children can become resistant to it and stop responding. This is all the more reason we need multiple options to address the treatment needs of these children.
Thanks to parent advocacy, Elucida has recently opened a pediatric compassionate use program of ELU001, a drug option which targets FOLR1 and FOLR2, and which has demonstrated compelling preclinical potency.
Research Update: December 5, 2023
Dr Meshinchi gives an update on Project Stella; specifically, the use of SUTRO in the treatment of patients with AML, the status of the CAR-T development, and the need to increase the scope of Project Stella to include two new targets that could ultimately lead to the treatment of 30 to 40% of patients with AML vs 2% for children with the rare form AML-RAM/CBF-GLIS.
To see the video with all participants click on this link.
USA Treatment Centers Using STRO-001 Feb 4, 2024
Dear all, wanted to share with you this graphic of all the centers who have treated 40 patients with STRO-001.
Sutro clinical trial development is proceeding thru the Children's Oncology Group.
Our CART is nearing end of process engineering and is on track for submission to FDA as planned.
Best,
Soheil Meshinchi, MD, Ph.D. , Fred Hutchinson Cancer Research Center
Treatment Centers Outside the USA Using STRO-001
Drug is now available in Israel as soon as a patient needs it.
Research Update: October 2021
Dr Meshinchi gives a frank summary of why Project Stella has achieved major milestones in such a short time and why the next phase of CAR T cell therapy is critical to finding a cure for this devastating form of AML.
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5th Edition December 16, 2023
4th Edition December 21, 2022
3rd Edition March 1, 2022
2nd Edition Oct 13th, 2021
1st Edition May 11th, 2021
We need an additional $500,000 in funding to support ongoing work in advancing and supporting the upcoming clinical trial and the pursuit of two additional targets, PRAME & WT1. Dr. Meshinchi and his team have found that these targets are present in 30 to 40% of all pediatric AML patients.
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