Cigna takes Virgin Pulse for its health plan members

 Cigna Healthcare has reached an agreement to include the Virgin Pulse health and wellness digital programme in a digital portal used by millions of US customers in its health plan.

From the start of next year, Cigna customers who receive coverage through their employer and use its myCigna portal will be able to access the Virgin Group company's digital health platform, centred around Homebase for Health, a programme which uses artificial intelligence and behavioural science to help people take control of their mental, physical, and social wellbeing.

Homebase for Health allows users to set various personal health goals, track their daily progress, and received feedback based on the data they have submitted, as well as earn financial rewards for meeting their objectives.

Participants can log their own results on measures such as minutes exercised, weight, and time slept, harvest data from wearable devices such as the Apple Watch, and get on-demand digital content to help them live a healthier lifestyle. They can share their activity with co-workers, family, and friends to encourage each other to achieve their health goals.

It also links directly to other programmes, like Whil for reducing stress and building resilience, the fitness, mindfulness, and nutrition system Wellbeats, Koa Health for workplace wellbeing, and Sworkit, which provides at home workouts and fitness plans.

Virgin Pulse recently reported the results of a study involving more than 90,000 Homebase for Health users that showed that a group engaged with the platform achieved improvements in key metabolic indicators compared to a matched control group that barely interacted with it.

Active users with obesity, hypertension, and prediabetes/diabetes saw statistically significant improvements in body mass index (BMI), blood pressure, and blood glucose levels compared to controls over the course of a year.

The company also recently expanded the range of digital health services via an agreement with Headspace, which layered the psychiatry, therapy, clinical care, self-guided care, behavioural health coaching, and employee assistance programmes into Homebase for Health.

"Digital health programs improve health outcomes and enhance vitality for individuals and their communities," said Heather Dlugolenski, senior vice president of commercial strategy and solutions at Cigna Healthcare.

"For employers, investing in employee wellbeing directly translates into a more productive workforce and a thriving business," she added. "That's what we're offering through this enhanced digital platform in partnership with Virgin Pulse."

https://pharmaphorum.com/news/cigna-takes-virgin-pulse-its-health-plan-members

Anika upped to Outperform from Market Perform by Barrington

 Target $24

https://finviz.com/quote.ashx?t=ANIK&p=d

Eloxx: Response in All Patients Treated with ELX-02 in Phase 2 for Alport Syndrome

 All three patients (100% response rate) treated with ELX-02 showed an improvement in podocyte foot process effacement post-treatment in kidney biopsies assessed by electron microscopy demonstrating the disease modifying effect of ELX-02

Podocyte foot process effacement is a hallmark of Alport syndrome

Together with previously announced rapid and sustained proteinuria remission in one patient in Phase 2 clinical study, these biopsy results strongly support decision to advance ELX-02 into a pivotal trial in Alport syndrome

https://finance.yahoo.com/news/eloxx-pharmaceuticals-reports-drug-response-120000129.html

CNS Updates Results from On-Going Potentially Pivotal Glioblastoma Study

 Data presented at the 2023 SNO/ASCO CNS Cancer Conference

Berubicin currently being evaluated in an ongoing potentially pivotal study for the treatment of Glioblastoma Multiforme (GBM) with topline data from interim analysis expected before year end

https://www.biospace.com/article/releases/cns-pharmaceuticals-nasdaq-cnsp-presents-updated-results-from-on-going-potentially-pivotal-study-of-berubicin-in-adult-patients-with-recurrent-gbm-who-grade-iv-after-failure-of-standard-first-line-therapy/

FDA Delays PDUFA Date for Valneva’s Chikungunya Shot

The FDA has delayed its PDUFA action date for Valneva’s investigational chikungunya vaccine VLA1553 to the end of November, the company announced Monday. The original decision was due by the end of August.

The regulator extended the review period “to allow sufficient time to align and agree on a phase 4 program,” as required under the agency’s accelerated approval pathway, according to Valneva’s announcement. The FDA did not request additional clinical data to support the application.

VLA1553, a live-attenuated investigational shot, could be “the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease,” Valneva Chief Medical Officer Juan Carlos Jaramillo said in a statement. This makes its Phase IV plan all the more important as it will set a “future standard” for the industry.

Despite the PDUFA delay, Valneva still expects to launch the product in 2023 if it gets approval. The extension also does not affect regulatory submissions in other territories.

In June 2023, the French biotech released Phase III findings showing that VLA1553 elicits a strong immune response. The data, published in the medical journal The Lancet, demonstrated high rates of seroprotection reaching 98.6% in adults aged 18 to 64 years and 100% in those 65 years old and above.

VLA1553 is also designed to be given in a single dose and can elicit immunity in a matter of weeks, which is crucial to preventing chikungunya outbreaks.

Monday’s PDUFA delay, however, could give its chief competitor Bavarian Nordic some time to catch up. Last week, the Danish biotech also released Phase III data for its vaccine candidate CHIKV VLP showing that the investigational shot could induce anti-chikungunya antibodies in 98% of patients aged 12 to 64 years.

In addition, 97% of inoculated study participants developed these antibodies within two weeks of vaccination, which indicates that the candidate elicits “a rapid onset of protective levels of immunity,” the company said in its announcement.

These data followed an earlier release, in June 2023, showing that the vaccine candidate was likewise effective in older adults aged 65 and above.

Bavarian Nordic will use the results of both studies for regulatory applications next year, and anticipates potential product launch in 2025.

Valneva and Bavarian Nordic are the frontrunners in the race to bring a chikungunya vaccine to the market after Merck discontinued its chikungunya program in February 2023, as reported by Fierce Biotech, citing a company spokesperson who said that the cuts were part of a routine pipeline reorganization.

https://www.biospace.com/article/fda-pushes-back-pdufa-date-for-valneva-s-chikungunya-shot/

FDA Puts 2seventy bio’s CAR-T Trial on Formal Hold After Patient Death

 The FDA has issued a clinical hold for 2seventy bio’s Phase I trial of its experimental CAR T cell therapy for acute myeloid leukemia, the company announced Monday with its second-quarter earnings. The regulatory move comes after the company’s partner Seattle Children’s in June paused the trial following the death of a patient in the trial—the first child to receive the second dose level of the treatment. 

In the past couple months, 2seventy and Seattle Children’s, the hospital conducting the trial, have been investigating the incident, the company said in its press release. 

“This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study. 2seventy bio and Seattle Children’s will continue to work with FDA to provide the root cause analysis and proposed changes for the clinical study. Based on upcoming discussions with FDA, 2seventy bio and Seattle Children’s plan to amend the study accordingly and resume this study as soon as possible.” 

Original story posted June 14:

2seventy bio’s CAR-T Trial Halted After Pediatric Death

On Wednesday, 2seventy bio announced its partner, Seattle Children’s, paused a Phase I CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. 

The child was the first to receive the second dose level of 2seventy’s investigational drug-regulated CAR T-cell treatment. The therapy utilizes the company’s DARIC technology to enable “on-demand” control of the engineered T-cell responses. The Phase I trial is the first-in-human study of the DARIC T cell platform.  

The root cause of the Grade 5 (fatal) event is under investigation, and 2seventy is in communication with FDA. At the same time, the company assesses the data surrounding the serious adverse event and the “potential next steps for the study,” CMO Steve Bernstein said in a statement. The trial was slated to enroll 18 patients with a primary completion date of February 2024. 

While CAR T-cell therapies have had clinical success in blood cancers, the therapies also come with a fair share of risks. CRISPR Therapeutics lost a patient after being treated with its one-time CAR T therapy CTX110 in 2020. Since then, the company has released positive trial data for patients with relapsed or refractory CD19+ B-cell malignancies and initiated a Phase II study. 

After two patients in a solid tumor trial died, Tmunity Therapeutics halted the development of its PSMA-specific, TGFβ-resistant cell therapy to treat prostate cancer in 2021. The patients died from a known side effect of CAR-T therapy—immune effector cell-associated neurotoxicity syndrome (ICANS). Kite Pharma has since scooped up Tmunity, leaving out the failed therapy from the acquired pipeline. 

Last fall, Celyad Oncology stopped the development of its CAR T-cell therapy after two patient deaths. The FDA had lifted its clinical hold after five months, but the company chose to drop the program after a strategic review due to the costs and delays associated with the temporary hold. 

Having spun out from bluebird bio, 2seventy already has one commercialized CAR-T cell therapy. Partnered with Bristol Myers Squibb, Abecma was the first T-cell therapy for multiple myeloma. Currently approved for patients who have failed at least four prior lines of treatment, recent data for the BCMA CAR-T cell therapy have the companies gunning for FDA approval for earlier treatment in this patient population. 

https://www.biospace.com/article/2seventy-bio-s-car-t-cell-trial-paused-by-partner-after-pediatric-death-/

Stock screen spotlights 20 companies whose earnings estimates rose most

 Here's the list again, now showing how the stocks have performed, excluding dividends, with summaries of analysts' opinions:

Company                               Ticker  2023 price change  2022 price change  Share "buy" ratings  Aug. 11 price  Consensus price target  Implied 12-month upside potential 
Iron Mountain Inc.                     IRM                  21%                -5%                  56%         $60.47                  $61.50                                 2% 
PulteGroup Inc.                                             82%               -20%                  82%         $82.77                  $98.38                                19% 
D.R. Horton Inc.                       DHI                  38%               -18%                  59%        $123.01                 $145.35                                18% 
Live Nation Entertainment Inc.         LYV                  24%               -42%                  76%         $86.61                 $109.94                                27% 
Moderna Inc.                           MRNA                -43%               -29%                  45%        $101.49                 $180.21                                78% 
Amazon.com Inc.                        AMZN                 65%               -50%                  93%        $138.41                 $169.63                                23% 
Royal Caribbean Group                  RCL                 108%               -36%                  63%        $102.82                 $118.47                                15% 
Weyerhaeuser Co.                        WY                   7%               -25%                  58%         $33.02                  $38.89                                18% 
Marathon Petroleum Corp.               MPC                  29%                82%                  79%        $149.75                 $152.76                                 2% 
Nvida Corp.                            NVDA                180%               -50%                  86%        $408.55                 $515.55                                26% 
NVR Inc.                               NVR                  33%               -22%                  29%      $6,156.73               $6,610.00                                 7% 
Meta Platforms Inc. Class A            META                151%               -64%                  88%        $301.64                 $374.80                                24% 
Caterpillar Inc.                       CAT                  19%                16%                  42%        $285.22                 $286.48                                 0% 
Alexandria Real Estate Equities Inc.   ARE                 -16%               -35%                 100%        $122.12                 $155.78                                28% 
KLA Corp.                              KLAC                 27%               -12%                  50%        $478.98                 $537.00                                12% 
Molson Coors Beverage Co. Class B      TAP                  25%                11%                  21%         $64.22                  $69.69                                 9% 
General Electric Co.                    GE                  37%               -11%                  60%        $114.60                 $127.95                                12% 
T. Rowe Price Group                    TROW                  3%               -45%                   0%        $112.33                 $104.33                                -7% 
Martin Marietta Materials Inc.         MLM                  35%               -23%                  61%        $455.44                 $510.66                                12% 
Sherwin-Williams Co.                   SHW                  15%               -33%                  53%        $273.72                 $299.58                                 9% 
                                                                                                                                                                  Source: FactSet 

https://www.morningstar.com/news/marketwatch/20230814180/stock-screen-spotlights-20-companies-whose-2