On September 22, 2020 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announced today that the Company will host an investor conference call and webinar to discuss the Company’s NASH-RX clinical trial and to introduce its new CEO, Joel Lewis (Press release, Galectin Therapeutics, SEP 22, 2020, View Source [SID1234565472]). The Investor Call is scheduled for Tuesday, September 29, 2020, at 4:00 p.m. EDT.

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The presentation can be accessed by dialing (844) 899-6544 and entering the conference ID: 3695038 or at the following webcast link: View Source A copy of the presentation to be used for the call can be found on the Company’s website at View Source

The call is expected to last one hour, including a Q&A session that will follow the formal remarks. The Company encourages the investment community to submit their questions in advance to: [email protected] and no later than Friday, September 25th at 4 PM EDT.

On September 22, 2020 GT Biopharma, Inc. (OTCQB:GTBP)(GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology reported it completed treatment of the first patient enrolled at Dose Level 3 in its GTB-3550 TriKE Phase I/II clinical trial (Press release, GT Biopharma, SEP 22, 2020, View Source [SID1234565471]).

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The first patient treated with GTB-3550 at a 25mcg/kg/day dose showed a decrease in AML blast levels from 18% to 12% in the bone marrow. Additionally, we observed an increase in the patient’s NK cell activity and numbers attributable to the IL-15 component of the TriKE molecule with no appreciable increase of a hyper-active T-cell population which could have resulted in cytokine release syndrome (CRS) or other T-cell associated toxicities. The patient experienced no adverse reactions including no constitutional symptoms such as fever, tachycardia, or chills. We also observed improvement in marrow cellularity, a decrease in AML blast levels, and improving platelet and red blood cells numbers. The patient will be retreated with an additional round of GTB-3550 therapy at the 25mcg/kg/day dose.

The open-label, dose-escalation Phase I portion of the trial will evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia (AML) or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550. The Phase II portion of the trial is planned to further evaluate the efficacy of GTB-3550 in this patient population.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "we are pleased to see a reduction in AML blast levels at a dose of 25mcg/kg/day of GTB-3550." Mr. Cataldo further stated "we hope to see the continued absence of toxicity, and see additional signals of efficacy as we continue to dose escalate GTB-3550."

On September 22, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive T cell therapy targeting neoantigens and designed to improve upon the limitations of TIL and TCR therapies (Press release, Genocea Biosciences, SEP 22, 2020, View Source [SID1234565470]). The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.

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"GEN-011 builds on the power of our ATLAS platform, as demonstrated in our GEN-009 clinical trial, to identify the relevant neoantigens which drive robust anti-tumor T cell responses in patients, regardless of HLA type," said Chip Clark, President and Chief Executive Officer of Genocea. "Using a patient’s peripheral T cells, already programmed to kill cancer cells with relevant neoantigens, enables this non-engineered therapy to rapidly scale. We therefore believe GEN-011 may eventually offer efficacy, accessibility and cost advantages to patients and providers."

Genocea plans to enroll up to 24 patients across several tumor types in the Phase 1/2 trial. In one cohort, patients will receive multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion. In the other cohort, patients will receive a single GEN-011 dose after lymphodepletion and a high dose of IL-2.

On September 22, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported the expansion of the Advanced Cell Diagnostics (ACD)-branded RNAscope technology with release of the new RNA-Protein Co-Detection Assays (Press release, Bio-Techne, SEP 22, 2020, View Source [SID1234565469]). The RNAscope technology is an advanced in situ hybridization (ISH) assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues.

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Bio-Techne’s new Co-Detection Assays allow researchers to simultaneously examine cell-type specific gene expression and identify cellular sources of secreted proteins. Typical ISH and immunohistochemistry (IHC) are complementary techniques, bridging the gap between RNA and protein analysis. Yet, protocol optimizations, at a single cell level, may be quite challenging, especially at a risk of losing limited samples. The new workflow now enables a wider range of IHC-validated antibodies to be combined with RNA ISH at a greatly improved success rate, while saving costly optimization time and preserving precious samples.

"We are thrilled to extend our leadership in RNA in situ analysis into spatial multi-omics with the release of the RNA-Protein Co-Detection Assays," commented Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "These new assays combine the strengths of our proprietary RNAscope core technology with our extensive antibody portfolio to provide new insights into cellular mechanisms."

The new assays utilize Bio-Techne’s patented RNAscope and BaseScope signal amplification and background suppression technologies to deliver supreme specificity and sensitivity with optimal signal-to-noise detection. Using RNA-Protein Co-Detection Assays, advanced scientific questions can be addressed, such as interactions of pathogens and host cell markers in infectious diseases and understanding complexities of splice variants and biomarker levels in cancer biology. In addition, the new assays enable researchers, utilizing antibodies in their studies, to correlate RNA-protein expression and evaluate antibody specificity.

"The new RNA-Protein Co-Detection Assays are an important advance for investigators studying the biological processes in single cells and within precious tissue samples," stated Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "At Bio-Techne, we are proud that our IHC expertise and high-quality R&D Systems and Novus Biologicals antibody offerings can be combined with the power of RNAscope and BaseScope detection."

On September 22, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company’s VP of Business Development, Dr. Sari Fishman, is participating in two conferences where she will conduct one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson (Press release, Can-Fite BioPharma, SEP 22, 2020, View Source [SID1234565468]). Both conferences include scheduled virtual partner meetings for Can-Fite, live sessions, and virtual networking.

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BioPharmAmerica Digital
September 21-24, 2020
BIO-Europe Digital
October 26–29, 2020
Can-Fite recently announced achieving primary and secondary endpoints in its Phase II study of Namodenoson in NASH. Interim top-line results are expected before the end of 2020 in two Phase III studies of Piclidenoson in rheumatoid arthritis and psoriasis. Additional trials are ongoing or expected to start in COVID-19 and liver cancer. Can-Fite has received approximately $18 million in upfront and milestone payments to date through licensing and distribution deals for its drug candidates.