On April 26, 2021 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has increased its share capital from 39,748,635 to 49,272,952 through the issue of 9,524,317 new registered shares at a nominal value of CHF1 each to Addex Pharma S.A, its 100% wholly-owned subsidiary (Press release, Addex Therapeutics, APR 26, 2021, View Source [SID1234578461]). The new shares, issued from the Company’s authorized capital, are listed on the SIX Swiss Exchange. The transaction has been executed to provide the Group with additional future financing flexibility.

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"This transaction provides us with financing flexibility as we advance two programs into clinical trials, including our lead program dipraglurant for Parkinson’s disease levodopa-induced dyskinesia, and four programs towards IND-enabling studies," said Tim Dyer, CEO of Addex. "We also look forward to the start of our third clinical program, ADX71149 for epilepsy which is being executed by our partner, Janssen Pharmaceuticals Inc."

On April 26, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the B. Riley Securities Neuroscience Conference being held virtually (Press release, TG Therapeutics, APR 26, 2021, View Source [SID1234578488]). The fireside chat is scheduled to take place on Wednesday, April 28, 2021 at 9:00 AM ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

On April 26, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported that new data demonstrating an unexpected synergy between its inducible pluripotent stem cell (StemVacs-V iPSC) derived immunotherapy product with low dose cyclophosphamide in evoking potent immune mediated cancer regression (Press release, Therapeutics Solutions International, APR 26, 2021, View Source [SID1234578507]).

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In a series of experiments, the Company demonstrated that its previously announced stem cell derived tumor endothelial-like cell vaccine1 enabled non-toxic doses of cyclophosphamide, an established chemotherapeutic agent, to induce significant reduction of established lung cancers, brain cancers, and skin cancers in animal models. Furthermore, it was demonstrated that reduction of tumors was associated with increased infiltration of immune cells.

"Previous companies, such as Batu Biologics, have demonstrated the clinical safety of using the immune system to selectively kill the blood vessels that feed cancer2, which was validated by FDA clearance3 to initiate clinical trials," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "As a physician who sees firsthand the suffering of cancer patients caused by current chemotherapy protocols, the thought of leveraging the patient’s own immune system to allow for increased efficacy with reduced toxicity is extremely exciting."

"From a business perspective, one of the significant hurdles preventing advancement in cancer therapeutics is lack of interdisciplinary collaboration," said Famela Ramos, Vice President of Business Development. "The demonstration that our immunotherapy possesses ability to potentiate anticancer activities of existing therapeutics, thus allowing for utilization of lower doses while retaining efficacy, is a game changer in my opinion."

"The idea that killing tumor blood vessels weakens cancer, and thus allows for lower doses of chemotherapy to be effective is very attractive. This concept has been validated in clinical trials which involved combinations of chemotherapy with the antiangiogenic activities of the monoclonal antibody drug Avastin," said Timothy Dixon, President and CEO of the Company. "Based on side-to-side comparisons, our stem cell based immunotherapy appears substantially more efficacious in inducing immune mediated "choking" of the tumor blood supply and demands deeper investigation."

On April 26, 2021 Biocon Biologics Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), reported that Abevmy 100 & 400 mg, a biosimilar of Bevacizumab co-developed with Viatris Inc. (NASDAQ: VTRS) has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (Press release, Biocon, APR 26, 2021, View Source [SID1234594756]).

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Abevmy 100 & 400 mg, a biosimilar Bevacizumab, is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

"The European Commission’s approval of our biosimilar Bevacizumab will enable us to offer this biologic therapy to cancer patients in the EU along with our partner Viatris. The addition of biosimilar Bevacizumab will strengthen our portfolio of biosimilars for cancer in the EU, which include biosimilar Trastuzumab and biosimilar Pegfilgrastim. This approval is an outcome of a great team effort and years of hard work and underlines our commitment to expand affordable access to life-saving biosimilars and make an enduring impact on global health."

On April 26, 2021 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that the Company has received the second milestone payment related to its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, APR 26, 2021, View Source [SID1234578462]).

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Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG), is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. OS Therapies recently completed a financing, triggering the second milestone payment. Under the agreement, Advaxis has the opportunity to receive additional clinical, regulatory, and sales-based milestone payments as well as royalties on future product sales. Additional details of the financial terms have not been disclosed.

"This funding milestone for OS Therapies brings OST-HER2, originally ADXS-HER2, one step closer to the clinic," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are confident in the potential of OST-HER2, which had been approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, and are proud to have played a role in the development of this important new candidate for osteosarcoma patients. We look forward to the team at OST advancing the program, building upon our early Phase 1 data evaluating ADXS-HER2."

Mr. Berlin continued, "This milestone payment provides Advaxis additional capital as we build momentum across our growing ADXS-HOT neoantigen-directed off-the-shelf clinical programs. To date, we have assembled a robust clinical and translational data set which suggests our unique approach has the potential to enhance and/or restore responses to checkpoint inhibitors in lung cancer. We look forward to leveraging these resources as we advance ADXS-503, currently being evaluated in our Phase 1/2 study in NSCLC, and ADXS-504 for early-stage prostate cancer, which is on-track to enter the clinic in Q2 2021."