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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

Pear Therapeutics to Participate in Upcoming Investor Conferences

Pear Therapeutics, Inc. today announced management’s participation in three virtual investor conferences in October 2020:

  • Cowen 9th Annual MedTools Conference – Answers Unlocked. Corey McCann, M.D., Ph.D., President and CEO, will participate in a panel discussion, Digital Therapeutics, at this virtual conference on Thursday, October 15, 2020 at 8:30 a.m. ET.

  • 7th Solebury Trout Private Company Showcase Co-Hosted by BMO and Davis Polk. Corey McCann will present at this virtual conference on Thursday, October 15, 2020 at 11:40 a.m. ET.

  • HLTH VRTL 2020 Conference – Evercore ISI Panel Series Digging into Digital Therapeutics: A New Dimension in Treatment. Corey McCann will participate in a panel discussion, CEOs on DTx, at this virtual conference on Friday, October 16, 2020 at 11:00 a.m. ET.

Pear Therapeutics is a privately held, prescription digital therapeutics company developing clinically validated, FDA-authorized software applications to treat serious disease.

About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

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Contacts

Media and Investors:
Meara Murphy, Director, Corporate Communications
[email protected]

 

Source Article

M Health Fairview Applauds PreferredOne as First in Minnesota to Cover Innovative Prescription Digital Therapeutics to Treat Addiction

Largest Minnesota health system urging others to cover the FDA-authorized treatments

PreferredOne, Fairview’s health benefits management company, is the first health insurance provider in Minnesota to cover two innovative prescription digital therapeutics (PDTs) to treat addiction: reSET® and reSET-O®, which are manufactured by Pear Therapeutics, Inc. The software-based treatments are authorized by the U.S. Food and Drug Administration (FDA) and are indicated to treat substance use disorder and opioid use disorder, respectively.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200930005985/en/

PreferredOne, Fairview’s health benefits management company, is the first health insurance provider in Minnesota to cover two FDA-approved prescription digital therapeutics to treat addiction. (Provided by Pear Therapeutics)

reSET and reSET-O are the first two PDTs to receive market authorization to treat disease from FDA. PDTs are apps that are downloaded to a patient’s mobile device after being prescribed. Both products, which are adjunctive to outpatient counselling, provide patients with algorithm-driven cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits. reSET is used as a monotherapy and reSET-O is used in combination with transmucosal buprenorphine.

“M Health Fairview is committed to ensuring our patients have coverage for these innovative mental health resources, and we’re excited that PreferredOne is leading the way in Minnesota by offering these products,” said Beth Heinz, executive of mental health and addiction services for M Health Fairview. “The only way to ensure broad access is for other payors to join us in reimbursing these products. Patients in all systems will benefit when more providers join this effort and enable physicians to prescribe these solutions.”

The COVID-19 pandemic arrived amid an ongoing addiction crisis, and it exacerbated health issues for many Minnesotans. Only 1 in 10 people with a substance use disorder receive treatment in the U.S., according to the Minnesota Department of Health.

“We applaud PreferredOne and M Health Fairview’s commitment to addiction and mental health coverage,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Now, more than ever, people struggling with substance use disorders need access to recovery support and treatment due to the impact of the pandemic. Together we can address this unmet need, and we hope that other health plans in Minnesota will join in taking this step to ensure access to innovative evidence-based therapeutics for all Minnesotans.”

About M Health Fairview

M Health Fairview is the newly expanded collaboration between the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine – expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.

About PreferredOne

PreferredOne, a wholly-owned subsidiary of Fairview Health Services, leads the market with products and services that conserve employer health plan dollars while helping more than 364,000 members achieve their best health. Comprehensive local and national provider networks together with an emphasis on health care cost and quality maximize the value of employee health

Better Buy: CRISPR Therapeutics vs. Editas Medicine

You can’t use traditional means to compare CRISPR Therapeutics (NASDAQ:CRSP) and Editas Medicine (NASDAQ:EDIT) because they are emerging biotech companies with little revenue, and several years between their current efforts and any form of profitability.

Both of these companies are developing medicines that edit genes, using the same CRISPR technology. The system is capable of eliminating mutated DNA that cause a particular disease, such as sickle-cell anemia, some types of blindness, or Alzheimer’s.

The potential for CRISPR gene-editing is enormous. A study by Market Insights puts the global gene therapy market at $18.1 billion by 2027, giving it a compound annual growth rate (CAGR) of 25.7%. Figuring out which gene-editing biotech to invest in depends less on their fundamentals and more on which one seems most capable of developing marketable therapies based on the available technology.

Hands of scientists working with test tubes in a laboratory.

Image source: Getty Images.

The case for CRISPR

CRISPR Therapeutics has certainly been kinder to shareholders since January. Its share price is up over 37% year to date, while the share price for Editas has been flat. Much of the enthusiasm surrounding CRISPR Therapeutics stems from two of its therapies that have shown progress this year.

The first is CTX001, which CRISPR has been developing with Vertex Pharmaceuticals (NASDAQ:VRTX) as a treatment for two genetic blood disorders: severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). According to CRISPR Therapeutics, CTX001 edits a patient’s stem cells from within their bone marrow and instructs those cells to produce high levels of fetal hemoglobin (HbF) in their red blood cells. HbF, a hemoglobin that carries oxygen, is present at birth but is replaced with the adult form of hemoglobin by the body as we age. The thought is fetal HbF will eliminate the need for transfusion in TDT patients and will help reduce the number of sickle crises experienced by SCD patients.

CTX001 is in two phase 1/2 trials: CLIMB-111 and CLIMB-121. CLIMB-111 involves five TDT patients and CLIMB-121 has enrolled two SCD patients. While the sample sizes are obviously small, the company says that all seven patients so far have achieved blood platelet engraftment. Based on those results, the U.S. Food and Drug Administration (FDA) has given CTX001 Orphan Drug and Fast Track Designation for both SCD and TDT.

CRISPR Therapeutics listed only $44,000 in collaborative revenue in the second quarter, but the important number is the company’s $945 million in cash reserves. At the company’s cash burn rate, these reserves can last nearly three years before the company needs an infusion of cash or a profitable therapy.

CRSP Chart

CRSP data by YCharts

The case for Editas Medicine

On Aug. 25, the FDA granted Editas Medicine’s therapy, EDIT-301, rare pediatric disease (RPD) designation to treat sickle cell disease. That means the company gets a voucher from the FDA to receive a priority review on a different drug or therapy. The FDA does this to encourage research into medications that affect fewer than 200,000 people in the United States.

Like CRISPR, Editas is getting help from