Why IMU is a multi multi bagger, page-20573

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Hi Bluegum

Sorry to hear about your friend. I'm not a Dr, let alone an Oncologist, but I think the answer is potentially "yes." CF33 in preclinical trials was effective against pretty much every solid cancer type. So when they set up the MAST trial they decided to make it open to patients with "Any histologically or cytologically confirmed advanced or metastatic solid tumor."

The idea being - lets see if it is effective in human subjects against a wide range of solid cancer types - and then choose one or more specific types where we have the best chance of FDA support for a "Fast Track" to registration. They have achieved "Fast Track" for Biliary Cancer, but I'm sure that's just the start, because - so far - they do indeed seem be getting good results across a wide range of cancer types.

I haven't seen Endometrial Cancer mentioned yet - but I think it would be a cancer they are happy to include in the study.

The complete set of "Eligibility Criteria" is quite complex though. Here it is:

Eligibility Criteria

Description

Inclusion Criteria:

1. Written informed consent from subject or legally authorized representative.
2. Age ≥ 18 years old on the date of consent.
3. Life expectancy of at least 3 months.
4. Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1 following at least one prior line of treatment. Eligible subjects must have received at least two prior lines of approved therapies, including targeted therapies, for which they are eligible and failed or relapsed on or after that treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. At least one measurable lesion as defined by RECIST v1.1 criteria.
7. Adequate renal function.
8. Adequate hepatic function.
9. Adequate hematologic function.
10. Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Prior treatment with an oncolytic virus or a bispecific CD19-directed CD3 T-cell engager.
2. Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
3. Any radiation within 2 weeks of start of study treatment.
4. Active autoimmune disease.
5. Current or history of severe skin disease with open wounds.
6. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
7. History of pancreatitis.
8. > Grade 2 neuropathy.
9. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
10. History or presence of brain or other central nervous system (CNS) metastases.
11. History of documented congestive heart failure (New York Heart Association [NYHA] class II - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias.
12. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
13. History or presence of clinically relevant CNS pathology, or any other CNS disability judged by the Investigator to be clinically significant and precluding informed consent or participation in the study.
14. Active infection requiring systemic treatment.

Source: https://clinicaltrials.gov/study/NCT06063317?term=%22Imugene%22&rank=1#participation-criteria

I hope your friend makes a full recovery.

Best regards

Dave