On August 20, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported it has engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization ("CRO") for its upcoming Berubicin clinical trials (Press release, CNS Pharmaceuticals, AUG 20, 2020, View Source [SID1234563917]).

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Worldwide is a a full-service, midsize, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. Worldwide specializes in therapeutic areas where there remain unmet medical needs, including CNS disorders and oncology. Worldwide provides proactive insight and operational support and has successfully managed clinical trials across more than 60 countries.

"Designing and operating trials in areas of high unmet medical need, such as glioblastoma, is a challenging and complex task for any company. We are excited to bring on a high caliber partner such as Worldwide, which has extensive expertise in CNS and oncology, as our CRO for the upcoming Berubicin clinical trials," commented John Climaco, CEO of CNS Pharmaceuticals. "Engaging Worldwide is one of the key pieces of our preparations. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Berubicin’s clinical development. We believe that with Worldwide’s deep clinical CNS and oncology experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase II Berubicin trials in adults in the US and Poland as well as our Phase I pediatric trial."

"The relationship between CNS Pharmaceuticals and Worldwide exemplifies state-of-the-art strategic program development – innovative program design coupled to exceptional clinical and operational acumen for a compound that offers considerable promise to both adults as well as children with such devastating illnesses," commented Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer at Worldwide. "Speaking on behalf of our organization, it is a privilege to express our personal and professional commitment to its success."

The Company’s decision to engage Worldwide as its CRO for the upcoming Berubicin clinical trials is the latest milestone in a series of recent preparation achievements. The Company has been active in implementing its strategic plan and engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) for the production of Berubicin drug product. The decision to add both Pii and BSP as manufacturers of Berubicin was part of the Company’s strategy to implement a dual-track drug product manufacturing strategy. The Company believes this dual-track strategy will help mitigate COVID-19 related risks, diversify its supply chain, and provide for localized availability of Berubicin. Furthermore, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

On August 20, 2020 CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, reported that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for the first-in-class drug candidate CT041, autologous chimeric antigen receptor (CAR) T cells for the treatment of claudin18.2-positive solid tumors (Press release, Carsgen Therapeutics, AUG 20, 2020, View Source [SID1234563916]).

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CT041, a humanized CAR-claudin18.2 T-cell therapy developed by CARsgen Therapeutics for patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, previously received IND clearance from the United States Food and Drug Administration (FDA) in May 2020. CT041 is the first claudin18.2-targeted CAR T-cell therapy IND cleared for clinical trials in China.

"Annual incidence of gastric cancer in China has already exceeded 600,000 cases. Pancreatic cancer is also one of the malignancies with highest unmet medical needs. Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable, and new treatment options are urgently needed," said Professor Lin Shen, principal investigator from Beijing Cancer Hospital, Peking University in China. "Claudin18.2 is abundant in a variety of human malignancies including gastric, pancreatic, esophageal cancer, and biliary tract tumor, which indicates that claudin18.2 is a highly attractive target for cancer immunotherapies. We will continue to advance the clinical trial and facilitate its translation into robust clinical benefits."

"The IND clearance by the NMPA is an important regulatory milestone in the clinical development and commercialization of CT041 anti-claudin18.2 CAR T cells," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year[1] . Gastric and pancreatic cancer are among the malignancies with the highest unmet medical needs. Our goal is to develop novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

On August 20, 2020 IONpath, Inc., the leader in high-definition spatial proteomics, reported the appointment of Sander Gubbens, PhD, as its new CEO (Press release, IONpath, AUG 20, 2020, View Source [SID1234563915]). Dr. Gubbens was most recently President of Gatan, which revolutionized the field of cryoEM with the breakthrough K2 electron counting camera under his leadership, ultimately leading to Gatan’s recent acquisition by Ametek from Roper Technologies for $925M. He replaces Harris Fienberg, PhD, company co-founder and former CEO.

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"Sander is a very accomplished, well-rounded operational leader with a track record of opening up new market opportunities in life science research by developing transformational technologies in collaboration with academic and industrial customers and partners," said IONpath Board member Mike Dybbs of Samsara BioCapital. "Under Sander’s leadership, Gatan transitioned from an R&D company to a market-driven company known for its high-quality products and industry-leading technology. We are thrilled to give him a similar opportunity at IONpath. We also want to thank Harris Fienberg for his leadership over the last six years building the company and helping drive the adoption of IONpath’s MIBI technology by leading cancer research centers around the world."

Dr. Gubbens brings over 30 years of experience in developing and commercializing best-in-class technologies for life science, materials science, and semiconductors to IONpath. As president of Gatan, he developed the organization into the leading manufacturer of instrumentation and software used to enhance and extend the operation and performance of electron microscopes, a position he held for over six years after earlier roles as COO, General Manager, and Senior VP of R&D and Engineering. Prior to Gatan, he worked in senior engineering and R&D roles at KLA-Tencor, the leading manufacturer of process control solutions for the semiconductor industry. Dr. Gubbens holds 17 patents and is a board member at Combinati, a maker of digital PCR instrumentation. He earned his PhD in Applied Physics from the Delft University of Technology in The Netherlands and an MBA from the Haas School of Business at UC Berkeley.

"I am thrilled to join IONpath as it executes on its vision of delivering actionable spatial proteomic insights from tissue samples and continues to drive demand for its revolutionary products and services in immuno-oncology and adjacent markets," said Dr. Gubbens. "IONpath’s unmatched technical capabilities in spatial proteomics paired with our team of pathologists and data scientists position us as the leader of this exciting and expanding field in medical discovery."

IONpath’s MIBI (Multiplexed Ion Beam Imaging) technology is delivering on the promise of spatial proteomics by providing novel insights for translational medicine researchers. By enabling sensitive detection and quantification of the expression of multiple biomarkers while retaining spatial relationships, MIBI delivers the information needed to understand the tissue microenvironment with the throughput and reproducibility required for clinical studies.

On August 20, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) reported that the United States Patent and Trademark Office has issued patent No. 10,744,257 entitled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company’s Selective Target Antigen Removal System (STARS) technology (Press release, Qualigen, AUG 20, 2020, View Source [SID1234563914]).

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STARS is a DNA/RNA-based treatment device candidate for the removal of viral and tumor-produced compounds from a patient’s blood. The STARS technology utilizes a filtration cartridge designed for use in a standard dialysis machine, and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal.

"This patent strengthens our intellectual property portfolio and increases our number of issued patents to 26, or 45 including jointly held patents. Our strategy is to continue to protect our proprietary technologies in the U.S. and globally," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Although STARS is in the early stages of development, our in vitro studies have demonstrated encouraging proof-of-concept results and we look forward to advancing this program as a target-and-removal therapy for a broad range of diseases."

The STARS development program utilizes technology and expertise from the Company’s FastPack point-of-care diagnostic system, which has been in use worldwide for nearly 20 years for the detection of cancer and other diseases. The Company plans to develop STARS for cancer applications to remove inflammatory factors and inhibitory checkpoints from blood, thus reducing pain and helping the body’s immune system fight the disease, as well as for infectious diseases to remove viruses and other foreign agents.

On August 20, 2020 Immunovia reported that published second quarter interim report for January – June 2020 (Press release, Immunovia, AUG 20, 2020, View Source;june-2020-301115788.html [SID1234563913]). It is available on Immunovia’s website.

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"During Q2, we successfully handled COVID-19 challenges beyond our control, strengthened

the company’s economic position, began the expansion of our sales, marketing, and customer service organizations, and are now, despite the COVID-19 pandemic, aiming to launch the first-ever test for early detection of pancreatic cancer during Q4 2020.

During the entire quarter, we provided continuous updates on our focused measures to minimize the impact of the COVID-19 pandemic on our employees, the company, and our commercialization efforts. As we announced in May, we were forced to adjust the company’s timeline and launch date for IMMray PanCan-d to Q4 2020, due to the shutdown of the state of Massachusetts, which directly impacted important activities at our laboratory in Marlborough, MA. We were able to reopen the Marlborough laboratory on May 25, 2020, and we have since been able to continue working with the greatest possible speed, energy, and enthusiasm.

On June 4th, we successfully implemented one of the largest capital raises ever for a non-

USA-based diagnostic company. Immunovia announced a directed new share issue of approximately SEK 400 million. The capital from this new directed share issue is now being used for commercialization activities in conjunction with the launch of IMMray PanCan-d, our top priority. This capital raise allows Immunovia to take the next step in establishing itself as a world leader in the early detection of complex illnesses such as cancer and autoimmune disease. It also allows the company to be more resilient against any market volatility and ensures that we can fully commit to our launch preparations and commercialization.

We ended the quarter with our first virtual investment day, which included presentations by Immunovia’s chairman, Carl Borrebaeck; VD, Mats Grahn; Chief Commercial Officer, Laura Chirica; Senior VP Sales North America, Michael Pettigrew; and Dr. Thomas King, Medical Director as well as a comprehensive and interactive Q&A session with Immunovia’s stakeholders. A highlight of the event was a virtual tour of our Marlborough laboratory. A recording of the event can be found on our website.

On behalf of the board and the entire Immunovia team, we thank you for your continued support of Immunovia’s effort to positively impact the lives of those at risk of pancreatic cancer. We are launching IMMray PanCan-d in Q4 of this year!."

– Excerpt from the CEO Mats Grahn’s comment on the report

Seond Quarter Interim Report for January – June 2020 Call Details:

Immunovia invites to a teleconference (in English) for investors, analysts and media on Thursday, August 20, 2020 at 16:30 CET.

Mats Grahn, CEO will present Immunovia and comment on the second quarter interim report for the period January – June 2020 followed by a Q&A session.

Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below and provide the conference code Immunovia to the operator:

Conference Code: (to provide to the operator) Immunovia

Immunovia Webcast:https://channel.royalcast.com/immunovia/#!/immunovia/20200820_1

For more information, please contact:

Julie Silber, Director of Investor Relations, Immunovia

Email: [email protected]

Tel: +46 7 93 486 277

There will be an MP3-file available at Immunovia’s webpage under Investors/Financial Reports (View Source) for those who want to listen to the telephone conference afterwards. The file will be available within two hours after the conference has ended.

This information is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16:00 CET on August 20, 2020.