- Kodiak Sciences (NASDAQ:KOD) has announced that the first patients have been treated in three Phase 3 studies of KSI-301, an anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER studies) and macular edema due to retinal vein occlusion (BEACON study).
- Additional Phase 1b study data showed, treatment-naïve patients, after three loading doses, 72% of Wet age-related macular degeneration (wAMD) and 79% of diabetic macular edema patients have achieved a six-month or longer treatment free interval at least once during follow-up. In Retinal Vein Occlusion, 81% of patients achieved a four-month or longer treatment free interval at least once during follow-up.
- Patient recruitment in U.S. for DAZZLE Phase 2b/3 study of KSI-301 in treatment-naïve wAMD is complete, though in Europe is ongoing, and Kodiak expects to complete DAZZLE enrollment this year.
- The company expects to submit KSI-301 marketing application in 2022.
- https://seekingalpha.com/news/3619804-kodiak-sciences-advances-late-stage-studies-ksiminus-301-in-vision-loss-disorders
Monday, October 5, 2020
Kodiak Sciences advances late-stage studies with KSI-301 in vision loss disorders
INmune Bio to present interim data from early-stage Alzheimer’s study
- INmune Bio (INMB +4.2%) announces data presentation from Phase Ib study of XPro1595 in patients with Alzheimer’s. Data were presented at International Conference on Alzheimer’s Drug Discovery meeting.
- The Phase Ib study continues to enroll patients.
- In July, the company announced positive prelim data study that showed a 40.6% reduction in major white matter anterior/posterior tract important for language and short-term memory.
- https://seekingalpha.com/news/3619842-inmune-bio-to-present-interim-data-from-early-stage-alzheimer-s-study
Nvidia building UK supercomputer to boost COVID-19 research
U.S. chip giant Nvidia said on Monday it is building Britain's most powerful supercomputer, which will use artificial intelligence to help researchers solve pressing medical challenges, including those related to COVID-19.
GSK and AstraZeneca, which are both involved in coronavirus vaccine research, will be two of the first pharmaceutical companies to harness the power of the machine, Nvidia said.
The Cambridge-1 computer, which is expected to come online by the end of the year in Cambridge, east England, will be a NVIDIA DGX SuperPOD system capable of delivering more than 400 petaflops of AI performance, the company said.
That would mean it ranks 29th on the Top 500 list of the world's most powerful supercomputers, it said.
Cambridge is also home to Arm, the British chip designer that Nvidia has agreed to buy from Japan's SoftBank for $40 billion.
Nvidia has previously said it intended to create an AI Center of Excellence in the university city, featuring an Arm-based supercomputer, which will serve as a hub of collaboration for researchers, scientists and startups across the UK.
The separate Cambridge-1 supercomputer will be made available to researchers from industry and academia.
"The Cambridge-1 supercomputer will serve as a hub of innovation for the UK, and further the groundbreaking work being done by the nation's researchers in critical healthcare and drug discovery," said Jensen Huang, founder and CEO of Nvidia, in his GPU Technology Conference keynote speech.
Trump's Covid-19 Treatment Seeks to Boost Immune Response
The experimental infusion doctors have given to President Trump seeks to counter a problem affecting many older Covid-19 patients: an ineffective immune response.
Among other treatments, Mr. Trump has taken a drug cocktail from Regeneron Pharmaceuticals Inc. that hasn't been approved for broad use but aims to jump-start an immune defense by supplying antibodies to help fight the coronavirus that causes Covid-19. The company says its results suggest the infusion can help people infected with the coronavirus who haven't yet produced their own antibodies.
The approach makes sense in elderly patients, whose bodies are often less able to fight off pathogens, said Janko Nikolich-Zugich, an immunologist and gerontologist who is a professor at the University of Arizona. "You don't control the virus as quickly as you should" with older patients, he said.
A growing body of research points to the immune system as a key reason why the elderly are so susceptible to serious cases of Covid-19. As a person ages, the system undergoes "immunosenescence," gradually losing its ability to mount a response to infection as robustly as it once did. The complicated mechanisms of the immune system don't work together as well, leading to a slower and less-powerful defense.
In addition to his age, 74, Mr. Trump's weight also may raise concerns about his immunity, as obesity has been tied to impaired response. And a study published in the journal Nature this August also highlighted the possibility that older men, in particular, might tend to mount a less-robust immune response to the virus.
About 80% of deaths in the U.S. have been among those 65 and older, and about 31% of deaths are among people aged at least 85 years, according to death-certificate data from the Centers for Disease Control and Prevention. This is partly because the elderly are often frailer, and they also have higher rates of conditions such as heart disease and diabetes that are risk factors for severe impact from Covid-19.
But their immune systems are another important factor, researchers say. "When you challenge a body with a virus or a vaccine, there's just not the vigorous response," said Cari Levy, a geriatrician who is a professor at the University of Colorado.
Older people often produce fewer, and less-effective, antibodies. These y-shaped proteins are supposed to bind to invading pathogens, neutralizing them and signaling to the body to destroy them.
"It's slower, it's unreliable -- you probably don't make as many" antibodies, said Peter Chin-Hong, a professor of medicine at the University of California, San Francisco. The hope is that treatments like Regeneron's experimental cocktail might help fill that gap early in the infection process, potentially slowing the initial spread of the virus.
Elderly immune systems also often have problems generating the powerful soldiers known as T-cells, which supply a main line of defense against invaders. Production of these cells, from a gland in the chest known as the thymus, drops sharply over the course of a person's life. They can also lose some of their function.
One recent study suggests that older men have a harder time getting their T-cells into action. New research published this August in Nature looked at 98 patients infected with the coronavirus and found evidence that the immune response varied by gender.
"Especially men of older age were very impaired with respect to T-cell activation," said Akiko Iwasaki, a professor of immunobiology at Yale University who led the study. Those men who had the least T-cell response tended to have worse Covid-19 outcomes, she said.
There is no treatment currently available that would help with Covid-19 patients' T-cells, she said. Potentially a future vaccine might do this, but vaccines are often less effective in older patients.
But even as vital parts of an elderly person's immune system are performing sluggishly, another response can cause trouble by firing up too much. As the body fails to contain the virus quickly, the immune system may produce too many of a type of protein called cytokines. These can damage blood vessels and allow fluid to seep into the lungs.
It isn't clear why this "cytokine storm" effect is triggered in some patients but not others. But elderly people tend to have a higher level of inflammation, and cytokines, said Amber Mueller, a molecular biologist who is a postdoctoral research fellow at Harvard Medical School.
This greater baseline level of inflammation is one reason the soldier T-cells are less effective, and it sets the stage for the dangerous overproduction of cytokines, she said.
President Trump remained hospitalized early Monday, after doctors offered conflicting signals about how he is faring with Covid-19. The president sought to project confidence and vigor over the weekend.
Enlivex: Positive Allocetra Trial Results in Severe/Critical COVID-19 Patients
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today reported positive top-line results of an investigator-initiated clinical trial of AllocetraTM in COVID-19 patients in severe/critical condition.
The clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients had complete recovery from their respective severe/critical condition and were released from the hospital after an average of 5.5 days (severe) and 8.5 days (critical), following administration of AllocetraTM, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated.
https://finance.yahoo.com/news/enlivex-reports-positive-allocetra-trial-100000050.html
Novartis/Amgen Aimovig shows positive effect in episodic migraine
- Novartis (NYSE:NVS) and Amgen (NASDAQ:AMGN) present results reinforcing the long-term safety and efficacy profile of Aimovig (erenumab-aooe) in patients with episodic migraine (EM) at the Migraine Trust Virtual Symposium.
- Results from the five-year, open-label treatment period of a Phase 2 study in EM prevention showed Aimovig helped patients achieve sustained reductions in monthly migraine days (MMD) and in use of acute migraine-specific medication (AMSM), such as triptans.
- The study enrolled 383 patients with EM who completed a 12-week double-blind, placebo-controlled treatment period (DBTP). Average MMD reduction was 5.3 days from the DBTP baseline of 8.7 days.
- Patients who used AMSM to treat their migraine headaches experienced an average reduction in AMSM use of 4.4 days from the DBTP baseline of 6.2. The most common side effects were nasopharyngitis, upper respiratory tract infection and influenza.
- The safety profile was consistent with the double-blind treatment phase of the study, with no increases in adverse event rates over five years of exposure.
- Additional studies highlighting Aimovig will be presented at the Migraine Trust Virtual Symposium, including interim results of the LIBERTY open-label extension study as well as efficacy and safety results of Aimovig in the EMPOwER study.
- https://seekingalpha.com/news/3619662-novartis-amgen-aimovig-shows-positive-effect-in-patients-episodic-migraine
Bristol Myers Opdivo + Yervoy again shows underwhelming response in melanoma study
- Bristol Myers Squibb (NYSE:BMY) announces results for the co-primary endpoint for CheckMate-915, a randomized Phase 3 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma.
- The addition of Yervoy to Opdivo did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population.
- The safety profiles for Opdivo monotherapy and the combination of Opdivo plus Yervoy were consistent with previously reported studies at this dose and schedule, with no new safety signals observed.
- The study was designed to determine if dual immunotherapy has the potential to bring additional benefits to patients in this setting.
- In November 2019, BMY announced that a statistically significant benefit was not reached for the co-primary endpoint of RFS in patients whose tumors expressed PD-L1 <1%.
- https://seekingalpha.com/news/3619670-bristol-myers-opdivo-yervoy-again-shows-underwhelming-response-in-melanoma-study
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