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Kuur Therapeutics Announces Publication of Interim Phase 1 Data for CAR-NKT Cell Therapy KUR-501 in Nature Medicine

Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies, today announced the publication in Nature Medicine of interim findings from its ongoing phase 1 GINAKIT2 clinical trial collaboration with Baylor College of Medicine and Texas Children’s Hospital, in high risk relapsed refractory (R/R) patients with neuroblastoma, a form of childhood cancer.

The interim results demonstrated that expressing the CAR with interlukin-15 (IL-15), a natural protein that supports NKT survival, enhanced the tumor-fighting capabilities and in vivo persistence of autologous NKT cells. Two of three patients studied showed tumor reduction following CAR-NKT infusion: one classified as stable disease and the other as a partial response. Imaging revealed a dramatic reduction in the size and metabolic activity of bone metastases in the patient with the partial response. CAR-NKT cells demonstrated a favorable safety profile and localized to the site of the neuroblastoma tumors.

Kuur is the first company to test CAR-NKT cell therapy in patients. The company’s revolutionary platform engineers CARs on invariant NKT cells, a subset of T lymphocytes. NKT cells represent the next generation of CAR therapy, because this innovative approach harnesses the innate tumor-homing properties of NKT cells, a specialized type of lymphocyte that eliminates tumor-supportive macrophages, activates anti-tumor NK, dendritic and CD8 T cells, and does not induce graft versus host disease when used in an allogeneic setting.

“These results validate the biology of CAR-NKT cells in that they home to tumor and marrow, expand and have tumor killing properties. They also demonstrate safety and enhanced tumor homing capabilities, offering distinct advantages over other cell types for the treatment of solid and hematological tumors,” said Kurt C. Gunter, MD, CMO of Kuur. “Using our novel engineering platform, we have manufactured CAR-NKT cells with high purity and added IL-15 to the CAR construct, which further increases in vivo persistence and anti-tumor activity. We look forward to continuing our research with the experts in cellular and gene therapy at Baylor as we aim to leverage the CAR-NKT cell approach to create more precise and effective therapies for cancer patients, including allogeneic therapies.”

The results published were derived from the three heavily pre-treated, R/R metastatic neuroblastoma patients in dose level 1 (3×106 CAR-NKTs/m2) of the GINAKIT2 clinical study. These data were originally presented at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in May 2020. The trial is currently enrolling at the fourth and highest dose level.

About KUR-501

KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in the phase 1

Genprex to Present at the Alliance for Regenerative Medicine’s Virtual Cell and Gene Meeting on the Mesa

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, today announced that it will be presenting at the Alliance for Regenerative Medicine’s (ARM) virtual Cell and Gene Meeting on the Mesa, taking place October 12-16, 2020. Michael Redman, Executive Vice President and Chief Operating Officer of Genprex, will lead the company’s presentation.

The 2020 Cell and Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days where attendees will be able to watch company presentations on-demand, in addition to two live-streaming panels each day. The Cell and Gene Meeting on the Mesa is the sector’s foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.

For more information on the conference, or to register, please visit https://www.meetingonthemesa.com.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute

Approximately 40 percent of babies born with sickle cell disease in Texas are in Houston

There are about 180 babies born with sickle cell disease in Texas each year, and approximately 40 percent (70 children) are born in Houston.

The Houston Health Department said in a press release that of the estimated 100,000 Americans living with the condition, approximately 7,000 are Texans, and Houston has more diagnoses than in any other region.

Sickle cell disease is a rare genetic blood condition that ultimately causes organ damage, including severe episodes of pain that can last up to a week and can result in multiple hospitalizations throughout a lifetime.

Kennedy Cooper is one of the estimated 1,500 children in Houston living with the disease. In a blog post for Texas Children’s Hospital, Cooper shared her journey, recalling moments where she felt ashamed to take medicine in front of friends and had to miss out on activities she loves because of her condition.

COVID IN PEOPLE OF COLOR: Texas’ tallying method further confirms that COVID-19 is deadlier for Black and Hispanic people


“It’s not really fun to take medicine in front of friends at sleepovers,” she shared. “I’ve tried countless techniques to avoid this, including sneaking my medicine bag into the bathroom while others were distracted or waiting until everyone was sleeping to take my medicine. I’ve also had to turn down invitations to countless pool parties because the pool temperature was usually never warm enough for me.”

She’s able to shrug if off most of the time, “but sometimes you just can’t help but notice how different you are from everybody else,” she said.

Dr. Titilope Fasipe, chair of the Houston Sickle Cell Collaborative, is also a sickle cell patient. She was diagnosed at age 1, and wants every child to know that they can still lead a long, fulfilling life.

“I’m one of the ones who made it to adulthood and I’m happy, but I’m also respectful of the fact that so many more did not, and that’s part of what pushes me at times,” she said, as reported by KPRC Click2Houston’s Haley Hernandez.

Fasipe said we need more research and treatments for “this devastating disease that affects so many people in our community.”

If you want to learn more about the disease, the sickle cell collaborative and health department will host their 2020 Sickle Cell Advocacy Summit on October 8.

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The Senate must act to reauthorize cell transplantation program

Earlier this week, the House passed the TRANSPLANT Act, a bill Rep. Doris MatsuiDoris Okada MatsuiDemocratic lawmaker calls telehealth expansion the ‘silver lining’ of pandemic The Hill’s 12:30 Report: Delegates stage state-centric videos for the roll call Overnight Health Care: Obama leans into Trump criticism on coronavirus | CDC gives 3-month window for COVID-19 immunity MORE (D-Calif.) and I sponsored. It reauthorizes the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory, which will help tens of thousands of Americans of all ages who suffer with diseases like blood cancer, sickle cell anemia, inherited metabolic or immune system disorders and 70 otherwise fatal blood disorders. Every three minutes someone is diagnosed with a blood cancer throughout the nation. This is an especially important issue for seniors, as older Americans are the fastest growing age group of patients needing marrow transplants.

The mission of the national registry is to match patients and donors and to ensure the timely transportation of lifesaving cellular products throughout the United States and around the world. Over the past 30 years, more than 100,000 lifesaving and life-extending transplants have been facilitated through the national registry. Today, more than 22 million volunteers in the national registry are willing to answer the call to save a life. In partnership with other registries around the world, the program has access to more than 35 million donors. The National Marrow Donor Program(NMDP)/Be The Match registry is doing incredible work despite unprecedented challenges. While facing travel restrictions and other pandemic-related logistical dilemmas, this partnership has delivered a second chance at life to more patients than ever before. Surprisingly, the program completed more transplants in June of 2020 than in any single month in the program’s history and has conducted more than 3,000 transplants over the first six months of the public health emergency. This was only made possible by having the status of a federally-authorized program that is recognized by other federal, state and local agencies and foreign governments. Additionally, a CDC waiver allowed international bone marrow couriers to deliver cellular products from abroad to waiting U.S. patients, despite the European pandemic travel restriction, ensuring that more than 350 awaiting U.S. patients got their second chance at life.

Since its inception, the CW Bill Young Cell Transplantation Program has always enjoyed broad bipartisan support in both chambers of Congress because the donations made through this program literally save lives. The program has been reauthorized by Congress every five years, and is currently set to expire unless urgent action is taken. It is absolutely imperative that the House and Senate act swiftly and in unison to ensure that this critical life-saving work continues. Should the program’s authorization lapse at the end of September, there is concern that the program may not be able to operate as efficiently during the continuing public health emergency. My colleagues and I in the House recognize that this federal program provides critical support in the advancement of research for better treatments and the