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 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 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 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and COVID-19 research, reported that the United States Patent and Trademark Office (USPTO) has issued the Company a new Notice of Allowance for a patent (Application No. 15/748,784) on anti-neoplastic compounds and methods targeting Quiescin Sulfhydryl Oxidase 1 (QSOX1), an enzyme important for tumor cell growth, invasion and metastasis (Press release, AXIM Biotechnologies, SEP 22, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-receives-notice-of-u-s-patent-allowance-for-proprietary-compounds-and-methods-targeting-tumor-metastasis-through-qsox1 [SID1234565474]).

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Earlier this year, Sapphire Biotech, a subsidiary of AXIM, announced that Skysong Innovations, LLC, the intellectual property management company for Arizona State University, exclusively licensed Patents, Technical Information and Materials (the "Technology") to Sapphire on behalf of ASU and the Mayo Clinic.

The licensed Technology includes SBI-183, which is covered by this patent. SBI-183 selectively targets QSOX1 and, in animal models, has been found to inhibit tumor growth, invasion and suppress metastasis of tumors by inactivating QSOX1.

"At our core, we are an oncology company dedicated to reducing metastasis in cancer patients around the world. This year, roughly 1.8 million people will be diagnosed with cancer in the U.S. alone and we hope to help as many of those people prolong their life as possible," said AXIM Biotech CEO John W. Huemoeller II. "This patent proves that the oncology research we are doing at AXIM is different from the approach others are taking and we are confident in our choice to do so."

Under this invention, AXIM intends to continue generating and testing analogs of SBI-183 to discover the most biologically active form of the compound. Currently, SPX-1009 has proven itself to be tenfold more potent in suppressing tumor invasion and metastasis in vitro than SBI-183. After further testing, SPX-1009 was shown to suppress invasion of breast, kidney and pancreas tumor cells in 2D and 3D invasion assays at tenfold lower concentrations than the parent compound SBI-183.

"I am enthusiastic about the future of analogs of our lead compound SBI-183. Since QSOX1 is a major player in metastasis, identification of QSOX1 inhibitors that suppress metastasis can be used in combination with other anti-neoplastic drugs to deliver a ‘one-two punch’ against cancer," said Dr. Douglas Lake, Ph.D. and co-founder of Sapphire Biotech.

On September 22, 2020 AIM ImmunoTech Inc. (NYSE American:AIM) reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands (Press release, AIM ImmunoTech, SEP 22, 2020, View Source [SID1234565491]).

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Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Prof. van Eijck states, "The overall survival of the experimental group was compared to a large historical control cohort matched for age, gender, stage of disease, and number of cycles of Folfirinox chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. These results were obtained with a very high degree of statistical significance. Based on these data, I see the potential for Ampligen as a meaningful extension of the standard of care for advanced pancreatic cancer, which we are planning to investigate further." A detailed clinical report and an article for publication are being prepared by Prof. van Eijck and his team at Erasmus MC.

AIM CEO Thomas K. Equels states: "We started this program in January 2017. These exceptional results from Erasmus exceed even our most optimistic expectations. I am deeply grateful to Prof. Casper van Eijck, his team at Erasmus, and Ronald Brus, MD, the guiding hand at myTomorrows, for their vision and careful diligence in implementing this important analysis of Ampligen as a single-agent therapy for late-stage pancreatic cancer. I extend deep gratitude to the government of the Netherlands for its pioneering support and commitment to advancing a critical medical innovation in a deadly cancer with very limited medical interventions. Medical advances in lethal unmet medical needs depend on this sort of outstanding clinical and governmental cooperation and support. We could not have accomplished this but for the support of the Netherlands."

AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA "fast-track" and possibly even FDA "breakthrough" designations and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States. AIM also plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If granted, this serves to extend a company’s exclusivity rights once a drug reaches market.