On June 16, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR) and NorthStar Medical Radioisotopes, LLC reported a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19 (patients with SARS-CoV-2 infection) (Press release, Monopar Therapeutics, JUN 16, 2020, View Source [SID1234611968]). Monopar is a clinical-stage biopharmaceutical company and NorthStar is a commercial producer and supplier of medical radioisotopes. This collaboration combines NorthStar’s expertise in the innovative production, supply, and distribution of important medical radioisotopes with Monopar’s expertise in therapeutic drug development and its pre-IND stage humanized urokinase plasminogen activator receptor (uPAR) targeted monoclonal antibody known as MNPR-101, along with a proprietary portfolio of related monoclonal antibodies that target uPAR or its ligand uPA.

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The uPA system (comprised of the serine protease enzyme uPA and its receptor uPAR) has been demonstrated to be selectively expressed on aberrantly activated immune cells. In response to coronavirus infection, these rogue immune cells produce pro-inflammatory cytokines that can cause runaway inflammation throughout the body, commonly referred to as a cytokine storm. It is this systemic hyper-inflammatory state that is thought to be largely responsible for the severe lung injury and further multiple organ damage that contributes to poor outcomes and death in patients with severe COVID-19.

In this collaboration, Monopar and NorthStar plan to couple MNPR-101 to a therapeutic radioisotope supplied by NorthStar in order to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells. By eradicating these cells with a targeted RIT, the goal is to spare healthy cells while quickly reducing the cytokine storm and its harmful systemic effects.

"This collaboration is a powerful combination of unique scientific and technical expertise to help combat severe COVID-19," said Chandler Robinson, MD, CEO of Monopar Therapeutics. "The companies will be conducting a development program to determine if Monopar’s uPA/uPAR monoclonal antibodies can be transformed into RITs that are effective as treatments against severe COVID-19, as well as other corona viruses."

"We are pleased to work together with Monopar in the battle against COVID-19," said Stephen Merrick, CEO of NorthStar Medical Radioisotopes." Our hope is that, by joining forces, we can develop a targeted radiopharmaceutical treatment that has the ability to prevent patients with severe COVID-19 from being placed on ventilators and from dying."

"To help mitigate the cytokine storm and reduce deaths associated with COVID-19, our goal is to develop an RIT that selectively eliminates the rogue aberrantly activated immune cells that produce these cytokines," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "uPAR is selectively expressed on these rogue immune cells but not on healthy cells. An antibody carrying a therapeutic radioisotope could gain entry into these cells through uPAR and deliver its cytotoxic payload to kill these cells while sparing normal tissue."

"NorthStar will apply its expertise to identify and supply the optimal therapeutic radioisotope to couple with Monopar’s uPAR monoclonal antibodies," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "We will deploy the most appropriate development approaches and production technology to ensure that both development and, if successful, commercial-scale volumes of this radioisotope can be supplied in order to meet potential demand."

This targeted therapeutic approach to treating severe COVID-19 is supported by a recently published study (Rovina et al. 2020) demonstrating that soluble urokinase plasminogen activator receptor (suPAR), which is shed by aberrantly activated immune cells that make uPAR, is an early predictor of severe respiratory failure in COVID-19 and its presence increases as patients develop severe COVID-19.

On June 16, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported the publication of results highlighting the performance of the Oncotype DX Genomic Prostate Score (GPS) result in patients with unfavorable intermediate (UFI)-risk prostate cancer (Press release, Exact Sciences, JUN 16, 2020, View Source [SID1234561134]). Published in Urology, the new results demonstrate the GPS test is a strong independent predictor of critical outcomes in UFI-risk prostate cancer patients.

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"While men with very low-, low- and favorable intermediate-risk prostate cancer often choose between active surveillance and treatment, men with unfavorable intermediate-risk disease must make decisions about how aggressive their treatment plan should be," said Jennifer Cullen, Ph.D., M.P.H., lead author of the publication and Associate Director of Cancer Population Sciences at the Case Comprehensive Cancer Center in Cleveland. "These new findings, which demonstrate for the first time the GPS test as a strong predictor of critical endpoints in UFI-risk disease, indicate that Oncotype DX testing can aid physicians and UFI-risk prostate cancer patients in their decision-making process. The GPS score may help in decisions regarding treatment intensity and empower patients in their care choices."

For this new publication, additional statistical analyses were conducted of GPS results from two previously published cohort studies in men treated with radical prostatectomy. The study included 299 intermediate-risk patients, 175 of whom were classified as UFI-risk. Results showed that UFI-risk patients with a GPS test result >40 had outcomes consistent with high-risk disease and a poor prognosis, indicating they may benefit from more aggressive therapies. In contrast, UFI-risk patients with a GPS value <40 had outcomes similar to favorable intermediate-risk patients, suggesting less aggressive therapy may be needed.

The GPS test has been shown in multiple studies to be a strong independent predictor of several critically important outcomes in men with very low, low, and favorable intermediate-risk prostate cancer. Findings from these new analyses support guideline inclusion of the GPS test in the broader population of UFI-risk patients.1

"Men and families facing a prostate cancer diagnosis have many questions and tough decisions in determining the best course of treatment. Tools like the GPS test can help patients have confidence in navigating a treatment pathway," said Jamie Bearse, chief executive officer of ZERO – The End of Prostate Cancer. "This is an important step forward for expanding access and coverage for intermediate-risk prostate cancer patients, as they can use the GPS test to help best guide and determine their treatment."

About the Oncotype DX Genomic Prostate Score (GPS) Test
Developed by Genomic Health, a wholly-owned subsidiary of Exact Sciences Corp., and based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX GPS test is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor and the patient’s likelihood of prostate cancer metastasis and death at 10 years. The GPS test is included within NCCN Guidelines as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease and is covered by Medicare and multiple private insurance companies in the United States. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.

On June 16, 2020 Personalis, Inc., (Nasdaq: PSNL) a leader in advanced genomics for cancer, reported the company’s participation at the Precision: Breast Cancer Summit, which will be held online, June 16-17, 2020 (Press release, Personalis, JUN 16, 2020, View Source [SID1234561150]).

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Personalis will present "Enabling multidimensional tumor immunogenomics for advancing biomarker discovery," featuring the Personalis universal cancer immunogenomics platform, ImmunoID NeXTTM. Christelle Johnson, PhD, will present for Personalis.

Dr. Johnson will discuss challenges facing immuno-oncology translational and clinical researchers and review the importance of insights into the complex and dynamic interactions between the tumor and immune cells of the microenvironment. By combining highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics, the ImmunoID NeXT Platform enables multidimensional biomarker discovery utilizing a single sample preparation. This presentation will feature a case study demonstrating the ability of this immunogenomics profiling platform to uncover tumor escape mechanisms and identify composite biomarkers of potentially greater predictive capacity from patients treated with immune checkpoint blockade.

On June 16, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported the closing of its oversubscribed rights offering and the final results thereof (Press release, Pulse Biosciences, JUN 16, 2020, View Source [SID1234561168]).

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The rights offering resulted in the sale of 4,279,600 units consisting of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock (the "Units") at a price of $7.01 per Unit. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. 4,279,600 shares of common stock and 641,571 warrants were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $30 million. Total basic subscriptions and over-subscriptions received were almost $56.0 million. Additional proceeds of up to $4.5 million may be received through the exercise of warrants issued in the rights offering, if exercised. Each warrant is exercisable for one share of the Company’s common stock at an exercise price equal to $7.01. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Any excess subscription payments received by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent") will be returned by the Subscription Agent to investors, without interest or penalty, as soon as practicable.

After giving effect to the issuance of 4,279,600 shares of common stock in the rights offering (but excluding up to 641,571 shares of common stock underlying the warrants issued in the rights offering), the Company has 25,149,043 shares of common stock issued and outstanding.

Robert W. Duggan, the Chairman of the Company’s Board of Directors and the beneficial owner of approximately 43% of the Company’s outstanding common stock prior to this rights offering participated in the rights offering and purchased an aggregate of 2,561,873 Units. After giving effect to the rights offering, Mr. Duggan is the beneficial owner of approximately 46% of the Company’s outstanding common stock.

"Once again, I want to thank all participating stockholders, as well as the Board of Directors and the management team. In addition to participation by the Company’s Chairman, Robert Duggan, insider participation totaled approximately $1.1 million. We are grateful for the support and confidence that led us to the successful closing of this offering," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The completion of this rights offering provides funding for the continued progress towards commercialization of our proprietary CellFX System and the introduction our platform Nano-Pulse Stimulation technology first to the dermatology market. We are excited about the opportunity ahead and confident we can execute our strategy to create value for stockholders in our next phase of growth."

"I am very pleased with the execution of this Rights Offering. It was our priority to provide stockholders the opportunity to participate in funding the Company in an efficient and minimally dilutive manner," added Robert Duggan, Chairman of the Company’s Board of Directors. "I see tremendous value in the long-term opportunity for Nano-Pulse Stimulation technology and its potential to treat a variety of unmet needs across medical specialties. We are steadfast in our commitment to health innovation as we make this technology accessible to patients in future."

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

On June 16, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron") (Press release, Genprex, JUN 16, 2020, View Source [SID1234561135]). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company’s manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.

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Genprex’s upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda) in NSCLC is also planned.

"We are pleased with continued progress in the scale-up of our manufacturing processes. This new agreement with Aldevron increases our manufacturing capabilities in support of our clinical trials utilizing Oncoprex immunogene therapy in combination with targeted therapies and immunotherapies against lung cancer," said Rodney Varner, Chairman and Chief Executive Officer of Genprex.

"Our team is excited about the expansion of our manufacturing agreement and elevation of our long-standing relationship with Genprex," said Michelle Berg, President of GMP Nucleic Acids at Aldevron. "Aldevron’s GMP facility and campus buildout ensures we can meet the future manufacturing demands of companies experiencing significant growth such as Genprex; thereby enabling our ultimate goal of impacting the lives of patients."

Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data indicate that the resultant product when transfected into cancer cells both induces cell signaling that triggers programmed cell death and modulates the immune system so that the cancer cells are more susceptible to treatment.