On August 1, 2023 AVM Biotechnology, a clinical stage company actively enrolling Phase 2 for Relapsed/Refractory Non-Hodgkin’s Lymphoma of all subtypes (partially funded by NCI Ph II FastTrak grant 1R44CA272096), reported that twenty-eight (28) solid tumor and blood cancer patients have been treated with its immunomodulatory drug AVM0703 through Expanded Access (EAP)/Compassionate Use (CUP) programs (Press release, AVM Biotechnology, AUG 1, 2023, View Source [SID1234633614]). Cancers that have been treated include highly relapsed/refractory, some imminently terminal, patients with glioblastoma, metastatic breast cancer (two with advanced bone metastases), metastatic ovarian cancer, metastatic gastric cancer, Hodgkin’s Lymphoma, mixed phenotype acute leukemia, B-ALL, metastatic colon cancer, malignant myxoid spindle cell neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, desmoplastic small round cell tumor, metastatic esophageal adenocarcinoma, prostate cancer, anaplastic T-cell Non-Hodgkin’s Lymphoma and inoperable/chemotherapy ineligible CNS squamous cell carcinoma.
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Immunomodulatory AVM0703’s relatively broad anti-cancer activity is hypothesized to be due to mobilization of a highly active gamma/delta T-cell receptor expressing immune cell, which is programmed to recognize special stress signals produced by most cancer cells but not normal cells. Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting [email protected].
"AVM Biotechnology is committed to providing AVM0703 to patients who cannot participate in our enrolling clinical trial. Based on absence of safety concerns and responses reported to date, we believe AVM0703 may provide benefits to all cancer patients who are desperately searching for options. Our team at AVM Biotechnology is dedicated to providing hope to patients and their loved ones." Theresa Deisher, AVM Biotechnology, Founder and CEO.
Requests for Expanded Access in the US must be made by a US licensed physician. Physicians can learn more about the AVM0703 EAP on clinicaltrials.gov and can request access by sending an email to [email protected].
About AVM0703:
AVM0703 is small molecule immunomodulatory drug enrolling Phase 2 trials in US in relapsed/refractory Non-Hodgkin’s Lymphoma (NHL) which began enrollment Q3 2023 (partially funded by NCI Ph II FastTrak grant 1R44CA272096). AVM0703 mobilizes a novel endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cell with profound antitumor activity. AVM0703 has shown an absence of safety concerns with side-effects limited to grades 1-3. Clinical responses in the enrolling NHL trial and in FDA-approved expanded access/compassionate use include multiple NHL sub-types and diverse solid tumor types. Responses to AVM0703 are quite rapid, reported from 30 minutes to 14 days after infusion. Preclinical data also demonstrates a significant response against autoreactive lymphocytes in the NOD Type 1 diabetes model (Funded by NIDDK SBIR Ph I grant 1R43DK121634 and NIDDK SBIR Ph II grant 2R44DK121634). Gamma delta TCR+ lymphocytes recognize phosphoantigens expressed by stressed, cancer and infected cells and autoreactive lymphocytes, but not normal cells. Adoptive transfer of AVM0703 induced gamma delta TCR+ immune cells has potent activity against preclinical melanoma (funded by NCI SBIR Ph I grant 1R43CA246896). Additionally, AVM0703 has been shown to have potent neo-adjuvant activity before chemotherapy against immune-resistant, aggressive mouse A20 lymphoma (Funded by NCI SBIR Ph I 1R43_CA271951). Based on its ability to penetrate collagen-encased desmoplastic tumors, AVM0703 has promise as a neoadjuvant prior to chemoimmunotherapy to improve outcomes for metastatic advanced pancreatic cancer patients.