On June 22, 2020 ESSA Pharma Inc. (Nasdaq: EPIX); (TSXV: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported new preclinical data on ESSA’s clinical candidate, EPI-7386, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Virtual Annual Meeting II (Press release, ESSA, JUN 22, 2020, View Source [SID1234561367]).

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In an oral poster presentation titled, "Preclinical development of the second-generation N-terminal domain androgen receptor inhibitor, EPI-7386, for the treatment of prostate cancer", a robust preclinical characterization of EPI-7386 including androgen receptor (AR) binding, gene expression analyses and the toxicologic profile was presented. The studies highlight new information about EPI-7386 including:

Full-length AR target engagement by EPI-7386 was confirmed in a cellular thermal shift assay.
In vitro cellular gene expression analyses demonstrate that EPI-7386:
Inhibits AR transcriptional activity similar to enzalutamide but with a few notable qualitative and quantitative differences in an enzalutamide-sensitive cellular model.
In the same cellular model, combination treatment of EPI-7386 with enzalutamide displays broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone.
Shows superior activity to enzalutamide in an AR-V7-driven cellular model by modulating both AR-FL and AR-V7-driven gene expression.
Toxicology studies evaluating the safety profile of EPI-7386 demonstrate that:
Very high plasma exposures of EPI-7386 were achieved across all studies.
Tolerability in 28-days tox studies in rats and dogs at AUC ≤ 2,000,000 ng*hr/mL, with activity seen on androgen-sensitive target organs in dogs.
The highest doses tested were characterized as the HNSTD (highest non-severely toxic dose) and only exhibited body weight loss and reduced food consumption. The drug plasma exposures achieved at this high dose were 7-10 fold higher than the efficacious exposures achieved in mouse xenograft models.
The starting clinical dose of EPI-7386 will be 200 mg given once-daily
"Our latest transcriptomic analyses add to the breadth of preclinical data supporting the development of EPI-7386 broadly in prostate cancer. With the favorable toxicologic profile of EPI-7386 observed in our IND-enabling studies at very high exposures, we will initiate dosing at 200 mg per day, which potentially could allow us to efficiently reach biologically relevant blood levels of EPI-7386 in patients," said Dr. David R. Parkinson, President & Chief Executive Officer. "We will soon begin dosing patients in our Phase 1 monotherapy study of EPI-7386 in castration-resistant prostate cancer patients whose tumors are progressing on current anti-androgens.".

On June 22, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, reported positive ex vivo data demonstrating the ability of a laboratory version of the Company’s Hemopurifier to capture tumor-derived exosomes in several forms of cancer (Press release, Aethlon Medical, JUN 22, 2020, View Source [SID1234561366]). The data were presented in e-poster format by Dr. Annette Marleau, the Company’s Senior Director of Research, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, on June 22, 2020.

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Exosomes are subcellular particles that are shed from both normal and malignant cells and have been shown to mediate multiple mechanisms of tumor growth and spread. The e-poster, titled, "Targeting Tumor-Derived Exosomes using a Lectin Affinity Hemofiltration Device", highlights data from ex vivo studies which demonstrate that a laboratory version of the Hemopurifier effectively captures and removes substantial quantities of exosomes from fluid samples that are circulated through the device. The data show that the Hemopurifier can clear exosomes that originate from plasma from patients with diverse cancers, including head and neck cancer, melanoma, ovarian cancer, esophageal cancer and breast cancer. The e-poster is available online at View Source!/9045/presentation/7490.

"Despite abundant research on tumor-derived exosomes and their role in cancer growth and immunosuppression, a clinical strategy for influencing exosomes in oncology has been unavailable," said Timothy C. Rodell, M.D., Chief Executive Officer of Aethlon. "The ability to effectively target and capture exosomes that exhibit signatures of malignancy and immunosuppression offers a potentially powerful therapeutic strategy for cancer. By reducing the presence of tumor-derived exosomes in the circulation of cancer patients, we believe the Hemopurifier may have the potential to improve the benefits of existing cancer treatment regimens and emerging immuno-oncology drugs. Our recently announced Early Feasibility Study in patients with head and neck cancer being treated with pembrolizumab (KeytrudaÒ) may provide human clinical data to complement these in vitro studies."

On June 22, 2020 BERG, a clinical-stage biotech that employs artificial intelligence (AI) to research diseases and develop innovative treatments, reported five presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, being held from June 22- 24, 2020 (Press release, Berg, JUN 22, 2020, View Source [SID1234561365]).

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Two presentations feature outputs of the BERG Interrogative Biology platform. One focuses on BERG’s Interrogative Biology discovered oncology target BPM 42522, its lead molecule, and mechanism of action leading to its anti-cancer properties. The other highlights validation of the BERG pan-cancer model by an independent study (Behan FM et al., (Nature, 2019 Apr 10). Three other presentations demonstrate the translational impact from current collaborations with institutions including BIDMC/Harvard, Stanford University and Uniformed Services University of the Health Sciences along with Walter Reed National Military Medical Center.

"We are making significant advances with BERG’s Interrogative Biology platform, by partnering with several thought leaders in the field of oncology at the upcoming AACR (Free AACR Whitepaper) meeting," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "This week, we will present the preliminary results of a lead molecule that modulates BPM 42522, as a direct result from BERG’s platform as well. None of this would be possible without the continued support of our partners around the world."

"BERG’s pioneering work in analyzing large molecular datasets with Bayesian Artificial Intelligence for identification of therapeutic targets with high translational potential, clearly illustrates the impact of our work in improving drug discovery as well as the success rates of our developments," said Professor Vikas P. Sukhatme, M.D., Sc.D., Dean of the Emory School of Medicine, Chief Academic Officer of Emory Healthcare, and a member of BERG’s Scientific Advisory Board.

Presentation Details at the AACR (Free AACR Whitepaper) Virtual Meeting:

Presentation title

Abstract title/number

Presenters

Date/time

Identification of Molecular Targets 2

Interrogative Biology platform identifies a ubiquitin pathway and its utility in cancer is supported by small molecule modulators

Abstract # 2943/17

Stephane Gesta, Shefali Sharma, Pragalath Sundararajan, Mingshu Huang, Kayleigh Gray, Maria Nastke, Arcan Guven, Anne Diers, Shiva Kazerounian, Suwagmani Hazarika, Eric M. Grund, Vivek K. Vishnudas, Niven R. Narain, Rangaprasad Sarangarajan

June 22, 2020

9:00am-6:00pm

Virtual Meeting II: E-Posters

Mechanisms of Drug Action 3

BPM31510, a Coenzyme Q10 (CoQ10) containing lipid nanodispersion, enhances radiation effects to prolong survival in a rodent glioblastoma model

Abstract # 2968/15

Jiaxin Sun, Milton Merchant, Anne R. Diers, Shiva Kazerounian, Stephane Gesta, Niven R. Narain, Rangaprasad Sarangarajan, Seema Nagpal, Lawrence Recht

June 22, 2020

9:00am-6:00pm

Virtual Meeting II: E-Posters

Recent Biomarker Discovery Techniques

Impact of hemolysis on multi-omic pancreatic cancer biomarker discovery: Derisking precision medicine biomarker development

Abstract # 2860/14

Michael A. Kiebish, Punit Shah, Valerie Bussberg, Vladimir Tolstikov, Rick Searfoss, Kennedy Ofori-Mensa, Eric M. Grund, Abena Darkway, Emily Y. Chen, Bennett Greenwood, Ellaine Adu Ntoso, Leonardo Rodrigues, Mia Liu, Elder Granger, Chas Bountra, Rangaprasad Sarangarajan, A J. Moser, Niven R. Narain

June 22, 2020

9:00am-6:00pm

Virtual Meeting II: E-Posters

Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes 2

Integrated proteomic and informatic assessment of ER+HER2- and ER-/HER2-breast tumors

Abstract # 5311/20

Guisong Wang, Punit Shah, Vladimir Tolstikov, Praveen-Kumar Raj-Kumar, Jiafang Liu, Lori A. Sturtz, J. Leigh Fantacone-Campbell, Rebecca Zingmark, Jeffrey A. Hooke, Mary L. Cutler, Kris Richardson, Leonardo Rodrigues, Valerie Bussberg, Rangaprasad Sarangarajan, Niven R. Narain, Hai Hu, Michael A. Kiebish, Albert J. Kovatich, Craig D. Shriver

June 22, 2020

9:00am-6:00pm

Virtual Meeting II: E-Posters

Identification of Molecular Targets 2

Benchmarking targets from cancer models using causal interference based drug-target and phenotype identification (Interrogative Biology) cross-validates "high-priority" targets identified in CRISPR-CAS9 screen

Abstract #2929/3

Leonardo O. Rodrigues, Lixia Zhang, Poornima Tekumalla, Stephane Gesta, Vivek K. Vishnudos, Michael A. Kiebish, Niven R. Narain, Rangaprasad Sarangarajan

June 22, 2020

9:00am-6:00 pm

Virtual Meeting II: E-Posters

Full abstracts of the posters are available on the AACR (Free AACR Whitepaper) web site at View Source!/9045.

On June 22, 2020 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today presented a poster during the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting to be held as a virtual meeting from June 22-24, 2020 (Press release, Cellular Biomedicine Group, JUN 22, 2020, View Source [SID1234561364]).

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Poster Title:

"Selecting Clinical Lead of TCRs Targeting Alpha-Fetoprotein-Positive Liver Cancer on Balance of Risk and Benefit"

Session:

Session PO.IM02.04 – Adoptive Cell Therapy 5

Poster No:

6589 (Board 1)

Authors:

Cellular Biomedicine Group, Inc, Gaithersburg, MD;

Georgia Cancer Center, Augusta University, Augusta, GA

Date:

Monday, June 22, 2020

Time:

9:00 a.m.to 6:00 p.m. EDT

Location:

San Diego Convention Center, Exhibit Halls A-F, Poster Virtual Meeting II:

E-Posters

Website:

View Source!/9045/presentation/7124

C-TCR055 is CBMG’s proprietary clinical lead of TCR-T which specifically recognizes the HLA-A*02:01 restricted AFP158-166 peptide that is highly expressed in hepatocellular carcinoma (HCC) and other solid tumors. Preclinical studies suggested that C-TCR055 has optimal anti-tumor activities and a good safety profile. CBMG is currently conducting a Phase I clinical study in unresectable HCC in Fudan University Affiliated ZhongShang Hospital in Shanghai, China (NCT03971747).

ABSTRACT

Background: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer with a poor prognosis and limited therapeutic options. Alpha-fetoprotein (AFP), an established clinical biomarker of HCC, has been employed as an attractive target for T cell-based immunotherapy against this disease given its high expression in the tumor and restricted expression in normal tissues. We have identified a number of T cell receptors (TCRs) recognizing the HLA-A*02:01 restricted AFP158-166 peptide FMNKFIYEI, providing a TCR candidate pool for identifying TCRs with optimal clinical benefit.

Methods: To select the ideal AFP TCR for clinical use, we evaluated the efficacy and safety profile of 7 TCRs on balance of their potency and specificity by testing their reactivity to normal and transformed cells covering a variety of primary cell types and HLA serotypes, and potential protein candidate in human genome by an extensive alanine scan (X-scan).

Results: We first selected three TCR candidates based on the in vitro anti-tumor activity. Next we eliminated two potential cross-reactive TCRs based on their reactivity against normal and transformed cells covering a variety of primary cell types and HLA serotypes, respectively. We then excluded the potential cross-reactivity of the selected TCR with protein candidates in human genome identified by X-scan.

Conclusion: To date we have selected an AFP TCR with the optimal affinity, function, and safety profile, bearing properties that are expected to allow AFP TCR redirected T cells to specifically differentiate between AFP levels on tumor and normal tissues. An early phase clinical trial using T cells transduced with this TCR to treat HCC patients (NCT03971747) has been initiated.

On June 22, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported the results of two preclinical studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting II (Press release, Rakuten Medical, JUN 22, 2020, View Source [SID1234561363]). These studies further demonstrate the mechanism of action of Rakuten Medical’s Illuminox technology platform with its antibody-IRDye 700DX conjugate and how this unique technology induces tumor cells and enhances the adaptive immune response.

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"We are excited to present data on the mechanism of action of the Illuminox technology to induce rapid cell membrane disruption of cells targeted with the antibody-IRDye 700DX conjugate and the induction of cell necrosis and immunogenic cell death," said Miguel Garcia-Guzman, Ph.D., Chief Scientific Officer, Rakuten Medical. "Consistent with this mechanism of action, the study also shows that Illuminox treatments induce robust anti-cancer effects in immunocompetent animals by activating tumor specific innate and adaptive anticancer immunity with long term immune memory."

The following preclinical poster presentations were showcased during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting II:

"Molecular mechanism of action of photoimmunotherapy with antibody-IR700 dye conjugates: Role of singlet oxygen in cell membrane disruption and necrotic cell death." (Abstract 480), presented by Roger Heim, Rakuten Medical.

This poster investigates the mechanism of action of Rakuten Medical’s proprietary Illuminox photoimmunotherapy through a series of preclinical experiments. These data describe the unique biophysical processes by which photoimmunotherapy with antibody-IR700 dye damages cell membranes and induces cell death.

"Anticancer activity by photoimmunotherapy is driven by adaptive immune responses and induces vaccinal effects in mice." (Abstract 949), presented by C. Daniel De Magalhaes Filho, Rakuten Medical.

This poster confirms previous data demonstrating that photoimmunotherapy induces cell death in tumor cells and ignites an immune response against the tumor [Hsu M, et al. AACR (Free AACR Whitepaper) 2019].

In this study, mice implanted with photoimmunotherapy-treated tumor cells rejected new tumor challenges, indicating that photoimmunotherapy induces immunogenic cell death and activates immune responses in the host mice protecting against future tumor challenges.