Results of AMUN-003, an investigational, first-in-class, immuno-oncologic adenovirus being developed by AmunBio for the treatment of multiple solid tumors, including aggressive, metastasized, triple-negative breast cancer (TNBC), will be presented on Tuesday, December 6, 2022 at the 45th annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Tx.

Breast cancer remains the most common diagnosed cancer in women and the second most common cancer overall. [1][2][3] Over 2.3 million new cases and 685,000 deaths from breast cancer occurred in 2020 and experts predict that by 2040 the burden of breast cancer will increase to over 3 million new cases and 1 million deaths every year because of population growth and aging alone.[4]

Triple-negative breast cancer (TNBC), the most aggressive subtype of breast cancer, accounts for approximately 15% of all cases of breast cancers diagnosed worldwide. This subtype of breast cancer is associated with poor prognosis, as defined by low a five-year survival and high recurrence rates after adjuvant therapy. [5] TNBC, which lacks expression of the estrogen receptor (ER) and progesterone receptor (PR) and has only limited or no human epidermal growth factor receptor 2 (HER2) expression, is, unlike other subtypes of breast cancer (i.e., ER+, HER2+), more commonly diagnosed in women younger than 40 years, and disproportionately affects black women. [6]

Because TNBC is not sensitive to endocrine therapy or HER2 treatment, effective standard treatment options are extremely limited. Since there are no approved targeted treatments available for the TNBC today, there is an urgent medical need to develop new treatment strategies. [7]

Oncolytic Viral Therapies
The development of oncolytic viral therapies, which represents a unique therapeutic paradigm within Immuno-Oncology, promises a new approach for the treatment of human cancers. AmunBio has developed a proprietary platform technology that has the potential to generate a strong pipeline of patient-centric next-generation engineered immunotherapeutic oncolytic viruses for the treatment of cancer, including triple-negative breast cancer (TNBC) and hematological malignancies.

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AMUN-003 is an investigational, first-in-class, Immuno-Oncologic adenovirus being developed for the treatment of multiple solid tumors, including aggressive, metastasized, triple-negative breast cancer (TNBC), melanoma, and other solid tumors. AMUN-003 blocks suppression of the immune response inside the tumor, stimulates the recruitment of cancer-killing immune cells and avoids non-specific inflammation. Preclinical studies with AMUN-003 in breast cancer alone, compared to prior oncolytic virus constructs, have demonstrated near-complete breast cancer inhibition.

V.K. Gadi, MD, Ph.D., Deputy Director of University of Illinois Cancer Center, and a lead scientific advisor to AmunBio.

In preclinical studies, a single dose of AMUN-003 delayed the progression of TNBC, while a single dose of the investigational drug, in combination with Checkpoint Inhibitors, demonstrated significant inhibition of subcutaneous tumor growth and a more durable anti-cancer response. Based on these preclinical findings, treatment with AMUN-003 may lead to long-term protection from cancer recurrence.

Following a planned Investigational New Drug (IND) application, which is expected in early 2023, AmunBio is planning multiple Phase 1 clinical trials of AMUN-003, alone or in combination with Checkpoint Inhibitors, in triple-negative breast cancer (TNBC), Melanoma, Non-Small Cell Lung Cancer (NSCLC), Bladder cancer and Head & Neck Cancer, to start in late 2023/early 2024.

“I believe that AmunBio’s platform technology will result in a fundamental shift of the treatment of human cancers, augmenting existing and novel treatment modalities, compared to what is possible today,” said V.K. Gadi, MD, Ph.D., Deputy Director of University of Illinois Cancer Center, and a lead scientific advisor to AmunBio.

“Inside their microenvironment, many advanced solid cancers, including TNBC are hostile to the immune system and greatly minimize the effectiveness of immunotherapy. AMUN-003 is an advanced generation oncolytic adenovirus that selectively enters cancer cells followed by viral reproduction and destruction of the cancer cell on exit,” Gadi added.

“During cellular infection, AMUN-003 has been engineered to produce two proteins that stimulate the immune response (GM-CSF) and sequesters an inhibitor of the immune response (TGF-ß). Our data, which will be presented at SABCS this year, shows that in a highly aggressive TNBC model AMUN-003 demonstrates single agent safety and efficacy. Moreover, in the same TNBC model, combination therapy with immune Checkpoint Inhibitors synergizes with the AMUN-003, resulting in significant inhibition of further metastatic spread. Additional pre-clinical studies are underway to advance this technology into clinical trials,” Gadi concluded.

Presentation details
Poster ID: PD2-03
Poster Title: Targeting TGF-ß and over-expressing GM-CSF in the Tumor Microenvironment (TME) with AMUN-003 Inhibits Tumor Growth and Metastases and Augments Immune Checkpoint Inhibitor (ICI) Response in triple-negative breast cancer (TNBC)
Date/Time: December 6, 2022, 5:00 PM – 6:15 PM CST

[1] World Cancer Research Fund (WCRF)/Statistics
[2] Arnold M, Morgan E, Rumgay H, Mafra A, Singh D, Laversanne M, Vignat J, Gralow JR, Cardoso F, Siesling S, Soerjomataram I. Current and future burden of breast cancer: Global statistics for 2020 and 2040. Breast. 2022 Sep 2;66:15-23. doi: 10.1016/j.breast.2022.08.010. Epub ahead of print. PMID: 36084384; PMCID: PMC9465273.
[3] Pfeiffer RM, Webb-Vargas Y, Wheeler W, Gail MH. Proportion of U.S. Trends in Breast Cancer Incidence Attributable to Long-term Changes in Risk Factor Distributions. Cancer Epidemiol Biomarkers Prev. 2018 Oct;27(10):1214-1222. doi: 10.1158/1055-9965.EPI-18-0098. Epub 2018 Aug 1. PMID: 30068516; PMCID: PMC8423092.
[4] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338.
[5] de Ruijter TC, Veeck J, de Hoon JP, van Engeland M, Tjan-Heijnen VC. Characteristics of triple-negative breast cancer. J Cancer Res Clin Oncol. 2011 Feb;137(2):183-92. doi: 10.1007/s00432-010-0957-x. Epub 2010 Nov 11. PMID: 21069385; PMCID: PMC3018596.
[6] Doepker MP, Holt SD, Durkin MW, Chu CH, Nottingham JM. Triple-Negative Breast Cancer: A Comparison of Race and Survival. Am Surg. 2018 Jun 1;84(6):881-888. PMID: 29981619.
[7] Yin L, Duan JJ, Bian XW, Yu SC. Triple-negative breast cancer molecular subtyping and treatment progress. Breast Cancer Res. 2020 Jun 9;22(1):61. doi: 10.1186/s13058-020-01296-5. PMID: 32517735; PMCID: PMC7285581.

Featured image: Attendees during the San Antonio Breast Cancer Symposium being held at the Henry B. Gonzalez Convention Center in San Antonio, TX. Photo Courtesy: 2021 © AACR/Scott Morgan 2021. Used with permission.

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