In February Novocure admitted that data from some of the clinical trials of its electric field-based cancer device would emerge later than expected. Today it seems the opposite might occur: the pivotal Lunar trial, assessing the Optune Lua technology in stage 4 platinum-resistant non-small cell lung cancer, looks as if it will be stopped early for efficacy. The study is comparing Optune Lua plus checkpoint inhibitors or docetaxel with the same drug regimen alone. An independent data monitoring committee has told Novocure that that it is “likely unnecessary and perhaps even unethical” for patients to be randomised into Lunar’s control arm. Neither is there a need to enrol the current target of 534 patients with 18 months’ follow-up; the DMC said around 276 patients, with a year’s follow-up, ought to provide sufficient power for Lunar’s endpoints. 210 had been enrolled by February, so final data could come next year, a year earlier than expected. Optune Lua is approved for mesothelioma, but NSCLC is a vastly larger market. Novocure’s share price rose 46% to an all-time high of $193 in early trade, giving the group a market cap of $21.5bn.
Tuesday, April 13, 2021
Roche's Spark in Gene-Therapy Collaboration With Senti Bio
Roche Holding AG's Spark Therapeutics unit on Tuesday said it signed a collaboration and option agreement with Senti Biosciences that could be worth more than $645 million to the privately held gene-circuit company.
Spark said the collaboration will combine its investigational gene therapies targeting the central nervous system, eye and liver with Senti's gene-circuit technology.
Spark said Senti will be responsible for designing, building and testing synthetic promoters for use in developing certain gene therapies, while Spark will have the option to license promoters and will be responsible for conducting preclinical, clinical and commercialization activities for any gene therapy candidates using the promoters.
Spark, which Roche acquired in 2019 for $4.8 billion, said the aggregate potential value of upfront, opt-in and milestone payments to South San Francisco, Calif.-based Senti could top $645 million.
Rigel: Positive Topline Data in Phase 2 COVID-19 med trial
Broad and consistent improvement in clinical outcomes including serious adverse events, mortality, ordinal scale assessment and number of days in the ICU
Rigel plans to share these results with health authorities, including the US FDA
Conference call and webcast today at 8:00 am ET/5:00 am PT
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19.
The trial, being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System, met its primary endpoint of safety. Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half. By day 29, there were three SAEs in the fostamatinib plus standard of care (SOC) group of thirty patients compared to six SAEs in the placebo plus SOC group of twenty-nine patients (p=0.23). Of these, there was a reduction for the disease related SAE of hypoxia in the fostamatinib group compared to placebo (1 vs 3, respectively; p=0.29).
Rigel will hold a live conference call and webcast today to discuss the Phase 2 trial results at 8:00 am Eastern Time (5:00 am Pacific Time).
Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
https://finance.yahoo.com/news/positive-topline-data-shows-fostamatinib-110000249.html
Danaher Lifts Revenue Growth Estimate
Danaher (DHR) - Get Report lifted its estimate of first-quarter core-revenue growth past the high end of its previous estimate.
For the quarter ended April 2, the Washington company estimated revenue grew 57%. Adjusted revenue including Cytiva moved up 29%.
In January, when Danaher reported for full-year 2020, the company estimated first-quarter 2021 adjusted core revenue including Cytiva would grow in the mid-to high-teens percent range.
And it pegged full-year 2021 adjusted core revenue up in the low-double-digits percent range.
“The better-than-expected [first-quarter] performance was broad-based across the portfolio, with particular strength in life sciences and diagnostics,” Danaher said in a statement.
Cytiva is the Marlborough, Mass., medical-technology company that Danaher purchased from General Electric (GE) - Get Report in March 2020 for $21.4 billion.
At last check Danaher shares were trading 1.6% higher at $238.60. The stock touched a 52-week high near $249 in mid-February and a 52-week low $147 exactly a year ago.
Danaher is set to report first-quarter results on April 22.
In an April analysis Barron's said investors looking for plays on the COVID vaccine rollout might look to Danaher.
The medical company’s product line includes primers and probe kits for diagnostic tests, and it sells rapid molecular tests and tests for antibodies and antigens.
And Barron’s said Danaher is broadly involved in vaccine production worldwide through Cytiva and its Pall Biotech business, both of which work with vaccine makers on output.
https://www.thestreet.com/investing/danaher-lifts-estimate-q1-revenue-growth
Novocure Accelerated Cancer Study Recommended
An independent board gave Novocure (NVCR) the go-ahead on Tuesday to recruit fewer patients for a study in lung-cancer treatment. The news sent NVCR stock rocketing.
After reviewing interim data, the Data and Safety Monitoring Board accelerated Novocure's late-stage study in non-small cell lung cancer. It stated Novocure doesn't need to reach 534 patients with 18 months of follow-up. Instead, it recommended the company test 276 patients with 12 months of follow-up time.
The news bodes well for Novocure's technology, tumor-treating fields. The body-worn device uses electrical fields to interrupt cell division. By doing so, it aims to prevent the process in which cancer spreads.
Novocure's study pits tumor-treating fields and cancer drugs known as checkpoint inhibitors against a regime of checkpoint inhibitors and chemotherapy.
J&J says delaying rollout of COVID-19 vaccine in Europe
Johnson & Johnson said on Tuesday it would delay the rollout of its COVID-19 vaccine in Europe and was reviewing cases of extremely rare blood clots in people after they received the shot with European health authorities.
U.S. federal health agencies on Tuesday recommended pausing the use of the COVID-19 vaccine as six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.