On September 22, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that George Buchman, Ph.D., Vice President, Preclinical & Process Development, Catalent Cell & Gene Therapy, will present at the World Vaccine Congress, which will take place virtually on Sept. 28 – October 1, 2020 (Press release, Catalent, SEP 22, 2020, https://www.catalent.com/catalent-news/advantages-of-oncolytic-viruses-as-immunotherapies-to-be-discussed-by-catalent-gene-therapy-expert/ [SID1234565476]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On Sept. 30 at 4:05 p.m. EST, Dr. Buchman will present "Next-Generation Vaccines and Oncolytic Viruses: Current Challenges and Future Promise", giving an overview of the benefits and limitations of oncolytic viruses as immunotherapies. His presentation will discuss the manufacturing and analytical considerations, as well as a collaborative study that evaluates a new technology to assess transfection efficiency.

Dr. Buchman joined Catalent through its acquisition of Paragon Gene Therapy in 2019. He has more than 30 years of experience in the biotech industry, and has held roles at companies including Life Technologies (now Thermo Fisher), Celera Genomics and Gene Logic. Dr. Buchman obtained a bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and a doctorate in biochemistry from University of Maryland.

On September 22, 2020 ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, to evaluate the combination of ALX148, an investigational next generation CD47 blocker, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with Head & Neck Squamous Cell Carcinoma (HNSCC) (Press release, ALX Oncology, SEP 22, 2020, View Source [SID1234565475]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.

These new studies will be initiated based on promising data from ALX148 in combination with pembrolizumab generated by ALX Oncology in a Phase 1b trial evaluating patients with HNSCC that was the basis for ALX148’s Fast Track Approval granted by the U.S. Food and Drug Administration. Phase 1b trial results presented at ASCO (Free ASCO Whitepaper) 2020 showed that patients with HNSCC who had progressed on prior platinum therapy and who had never received a checkpoint inhibitor treated with ALX148 in combination with pembrolizumab demonstrated a 40% objective response rate (ORR), a median progression-free survival (PFS) of 4.6 months with a median overall survival (OS) that was not reached.

"ALX148 was designed for use in combination to maximize clinical activity with a range of anti-cancer agents. We believe that blocking the CD47 myeloid checkpoint pathway bridges the innate and adaptive immune response against cancer to enhance efficacy. This collaboration builds upon the compelling combination activity observed in patients with ALX148 and KEYTRUDA," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our goal is to transform treatment options for patients with cancer by developing ALX148 as a foundational checkpoint immunotherapy."

ALX Oncology owns worldwide commercial rights to ALX148.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."