62 replies to this topic

[Logic]

I can't help thinking that anti CD47 therapy may be a very good adjunct to Cg-MAF:

http://www.longecity...therapy-target/

 

The CD47 antibodies would eliminate the''don't eat me'' signal from cancer cells, while Cg-MAF would kick said macrophages into high gear.

 

Nagalase: Friend and Foe?
http://gcmaf.timsmit...ook/chapter/52/

[jondoeuk]

Some info from LinkedIn and a patent that they have shared. It seems the lead compound (EF-022) is a lectin-receptor activator that modulates suppressor macrophages and tolerogenic dendritic cells.

 

In 25% of patients (n=24) with refractory tumours then it lead to stabilized disease. This was the fourth line of treatment for over a third of them. To be eligible they had to have failed standard of care (chemo, PD-1 inhibitor and/or a EGFR inhibitor). In patients whose disease progressed after treatment with PD-1 inhibitors then 40% (2 out of 5) showed stable disease (SD) after treatment with EF-022.

 

EF-022 has also shown encouraging results in a compassionate use case. A patient with pulmonary metastatic sarcoma received weekly injections (100 ng/each injection) intramuscularly (IM) for one year. As a result, disease stabilization was achieved for 6 months. Thereafter, relapse accompanied with new lesions in the lungs occurred. At that stage, the patient received a combination therapy of it and the anti-PD-1 drug Keytruda which was administered by intravenous (IV) injection every three weeks. The combination was continued for an additional 6 months. This resulted in disease stabilization and complete disappearance of one of the lung metastases (FIGs. IB and 1C). Thus, the combination therapy was found to be more efficacious than either treatment alone.

 

 

Then a patient with oral cavity squamous cell carcinoma (SCC) who after failing SOC (chemotherapy and Keytruda) showed stable disease (SD) after treatment with EF-022. It was shown that it unexpectedly increased the number of cytotoxic T cells and macrophages in the tumour site, leading to disease stabilization despite the extremely high increase in PD-L1 expression on the tumour cells and/or adjacent cells during the EF-022 treatment course.

 

This shows the number of cells expressing PD-L1 from tumour biopsies collected from the patient prior to treatment (baseline) and after 57 days

 

It should be noted that high expression of PD-L1 on tumour cells and/or adjacent cells is typically linked with immune suppression and poor prognosis. Yet, treating this patient for four months resulted in disease stabilization and then tumour shrinkage. This result indicates that in spite of the high expression of PD-L1 EF-022 was capable of arresting tumour growth.

 

This shows staining of CD8+ T cells in biopsies collected from the same patient. They show a significant increase (115% compared to baseline) in the level of these

[jondoeuk]

FDA Orphan Drug Designation for EF-022 for RRP

The U.S. Food and Drug Administration (FDA) has granted Efranat Orphan Drug Designation for EF-022, currently being developed for the treatment of Recurrent Respiratory Papillomatosis (RRP). "This is a very important regulatory milestone for Efranat, and we are pleased that EF-022 for RRP has been granted this status," said Uri Yogev, Efranat’s CEO. "Recurrent Respiratory Papillomatosis is a rare disease caused by human papillomavirus (HPV) infection of the oral mucosa that manifests as wart-like growths in the respiratory tract. RRP affects both adults and children, and may be life threatening in the latter. Currently there is no cure for this disease which requires repeat surgical interventions, and there is a highly unmet medical need for new potential therapies.'' The Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval. FDA has also granted Efranat a Rare Pediatric Disease (RPD) designation for EF-022 in RRP which makes Efranat eligible for a Priority Review Voucher upon approval of EF-022 by the FDA.