November Biologics, an immunotherapy company for solid tumors, announced that the FDA has approved its IND application
for TIDAL therapy TIDAL-01 for the treatment of advanced solid tumors.
Turnstone is expected to begin a multicenter Phase 1 clinical trial later this year to evaluate its safety and anti-tumor activity
THE CLINICAL TRIAL, CODENAMED STARLING, WILL INCLUDE PATIENTS WITH ADVANCED SOLID TUMORS, INCLUDING BREAST AND COLORECTAL CANCER
In addition, TIDAL-01 is evaluating other solid tumors, including cutaneous and noncutaneous melanoma
, in a Phase 1 clinical study funded by Moffitt Cancer Center.
TILs, tumor-invasive lymphocytes, are a type of cellular immunotherapy that has a natural homing advantage over solid tumors, which isolates lymphocytes from a patient's tumor, activates and expands or transforms the isolated cells in vitro, and then infuses them back into
TILs have the ability to penetrate, recognize and kill cancer cells, and are one of the effective means to achieve the cure of
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while Turnstone's goal is to improve and expand the clinical efficacy
of TIL cell therapy.
Its next-generation elective TIL therapy has the potential to reap therapeutic benefits
in solid tumors not covered by first-generation TIL therapy.
By identifying, selecting, and expanding the most potent subpopulation of patient-specific tumor-reactive T cells, the limitations of current TILs-based therapies are overcome to achieve positive outcomes
in cancers that are more difficult to treat and have a lower burden of mutations.
After more than ten years of research, there has been scientific evidence to prove its effectiveness and therapeutic potential
Today, Turnstone is establishing a standardized manufacturing process
for the mass production of its elective TIL therapies.
According to Turnstone's website, its method of selecting TILs uses the following basic principles to generate the maximum number and proportion of tumor-reactive T cells in TIL products:
- unbiased screening of patient-specific tumor antigens;
- The T cells with the widest coverage of tumor-specific antigen responses were selected from the TILs extracted from the patient;
- Expand all tumor-reactive T cells and remove all non-tumor-reactive bystander cells
In addition, Turnstone is trying to combine this select TIL therapy with an oncolytic virus to enhance its therapeutic benefits
Viral immunotherapy is a treatment modality with broad potential to drive and modulate the immune response
to solid tumors.
Many viruses have intrinsic oncolytic activity and can be designed with genetic modification to increase potency and safety
These viruses preferentially infect, replicate, and kill malignant cells and can induce a broad immune response
Viral immunotherapy aims to transform immunorestrained "cold" tumors into a more reactive "hot" tumor microenvironment (TME), thereby enhancing the activity
of other immunotherapies.
Turnstone evaluated the combination of its proprietary oncolytic virus immunotherapy with TIDAL-01 product candidate in two ways:
- Patients are treated with oncolytic viruses prior to TIL extraction to optimize TIL benefits and extend application to other tumor types with low immune cell infiltration;
- Patients are treated with oncolytic viruses after treatment with TIDAL-01 to optimize TIL delivery and infiltration into solid tumors and to further deepen the response and persistence
of TIL therapy.
Stewart Abbot, chief scientific officer at Turnstone Biologics, said: "To better fight solid tumors, we are applying a differentiated approach to TILs to overcome what we believe is the biggest obstacle to cell therapies that we believe is more effective: the low number of T cells that recognize and attack tumors.
In identifying, selecting, and expanding these tumor-reactive T cells, our goal is to drive more effective solid tumor killing and improve clinical outcomes
in many different cancer indications.