Clene Nanomedicine Secures Crucial Patent for Gold Nanocrystal MS Treatment

 Clene Nanomedicine was awarded a crucial patent from the U.S. Patent and Trademark Office for its patented clean-surfaced gold nanocrystals used for treating patients with multiple sclerosis.

The patent marks the first one the company has secured for its gold nanocrystal technology in multiple sclerosis, a neurological disease estimated to impact more than 1 million people in the United States. Clene is currently assessing its lead asset CNM-Au8 in a Phase II trial for the treatment of chronic optic neuropathy in multiple sclerosis.

CNM-Au8 is designed to catalyze bio cellular reactions, and so far the company has seen the asset live up to its promise in clinical studies. In Phase I studies, CNM-Au8 was deemed safe and in preclinical studies, the asset demonstrated both remyelination and neuroprotective effects.

Data published by Clene has shown that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by multiple disease-relevant neurotoxins.

In an interview with BioSpace, Clene Chief Executive Officer Rob Etherington said the company is thrilled to have been awarded this patent. Because MS is one of the largest markets in neurodegenerative diseases, the patent is important to the company as it moves forward in its clinical studies.

“We have said from the beginning that what we are doing with nanotherapeutics is unique to Clene. This patent will allow us to exclude others from using a similar program for multiple sclerosis,” Etherington said.

Etherington explained that CNM-Au8 is not designed to target a specific protein, nor it is designed to block or antagonize something, like most drugs. Rather, Clene’s compound is designed to enhance the intracellular biological actions necessary to repair and reverse neuronal damage, Etherington said.

New data is expected from Clene’s REPAIR-MS Phase II study of CNM-Au8 in the second half of 2021. Prior interim results from this study showed CNM-Au8 was associated with improvements across key central nervous system (CNS) bioenergetic metabolites.

Additionally, Clene’s VISIONARY-MS Phase II study is evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in stable relapsing MS patients with chronic visual impairment. Interim data from the VISIONARY-MS trial demonstrated notable, exposure-related median improvements in the primary endpoint. Completion of enrollment is expected by the end of 2021.

“While the only approved treatments for MS today are immunomodulators, we see an opportunity to treat MS through a completely different mechanism of action utilizing the therapeutic bioenergetic effects of catalytic gold nanocrystals, such as CNM-Au8,” Etherington said.

Clene Chief Scientific Officer Mark Mortenson said it’s important to have a strong defensive line of patents that protects state of matter claims for suspensions and solutions, as well as processes for making the materials, devices for conducting the unique electro-crystal chemistry processes, and methods of using the novel materials, such as in this instance of using clean-surfaced gold nanocrystals for treating patients with MS. The newly-awarded patent, the company’s 112^th, provides protection for about a decade with the possibility for an extension, he added. The patent marks the first one in the United States for the method of treating MS with CNM-Au8.

“It gives us a nice runway,” Mortenson noted.

In addition to the multiple sclerosis study, Clene is assessing CNM-Au8 in Parkinson’s disease and Amyotrophic Lateral Sclerosis (ALS).

Not only is the company developing its gold nanocrystal compound, Clene is developing a silver and zinc asset for COVID-19. CNM-AgZn17 is Clene’s second key asset intended for broad anti-viral and anti-microbial use. A Phase II study is planned in Brazil to treat acutely symptomatic non-hospitalized patients with COVID-19.

The patent award follows closely on the heels of a merger with Tottenham Acquisition I Limited that netted the company $31.9 million to advance its research and development. The reverse merger secured Clene a spot on the Nasdaq Stock Exchange under the ticker symbol CLNN.

Etherington said the company expects to report additional business and clinical milestones. Moretenson said the company anticipates different governments across the globe to act on about 30 different patent applications in the coming months and year.

“We remain excited about the potential of their platform to improve neurological function,” Etherington said.

https://www.biospace.com/article/clene-nanomedicine-secures-crucial-patent-for-gold-nanocrystal-ms-treatment/

Nestle CEO Seeks Ways to Help With COVID-19 Vaccine Roll Out

 Nestle is looking at ways to help pay for COVID-19 vaccines and projects to inoculate populations where the world's largest food company operates, Chief Executive Mark Schneider said on Tuesday.

The Swiss group said it has already donated extensively to the Red Cross and other organisations to help cover the financial cost of vaccination programmes, Schneider said, but would now look at going further.

"We will also try to find ways to either sponsor the payment for the vaccine or sponsor the way it gets applied in communities where we are present," Schneider told the Forum Horizon event in Lausanne.

"The price of a vaccine for an advanced economy is negligible...but to a developing country which has been struggling already with all the impacts of COVID, on top of that to pay for the vaccine and for the services to get it applied is going to be very significant," he added.

The specific details of how Nestle would help still needed to be worked out, Schneider said, describing the project as a "work in progress".

"The most important ingredient is not there, and that's the vaccine itself," he said.

The maker of KitKat chocolate bars and Nescafe instant coffee is also looking at stepping up protections for its own staff, after introducing rigid testing at its sites and making mask wearing mandatory.

The Swiss company would look at immunising its own workers against the new coronavirus as soon as possible. Nestle employs around 290,000 people around the world.

"As soon as it is possible, and in full compliance with all federal and cantonal laws, if there is a way to make a service like this available to our people on site, we would be the first ones to try and do it," Schneider said.

https://www.medscape.com/viewarticle/945124

EU drugs regulator begins rolling review of Novavax COVID-19 vaccine

 Europe's drugs regulator said on Wednesday its panel is reviewing Novavax's COVID-19 vaccine on a rolling basis, to speed up potential approvals as the region reels from surging infections due to new variations of the virus.

The human medicines committee of the European Medicines Agency will review data from ongoing trials of the U.S.-based company's vaccine, NVX-CoV2373, as they become available until there was enough for conditional approval, the regulator said. (https://bit.ly/2Len9jR)

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-EU-drugs-regulator-begins-rolling-review-of-Novavax-COVID-19-vaccine-32349124/

UK to lead G7 discussion on COVID economic recovery on February 12

 Britain will chair a meeting of finance chiefs from the Group of Seven rich nations on Feb. 12 to try to map a way out of the global economic crisis inflicted by COVID-19 and to find a solution to an international tax wrangle too.

British finance minister Rishi Sunak and Bank of England Governor Andrew Bailey will co-host an online meeting of their peers from the United States, Japan, Germany, France, Italy and Canada, as well as the European Central Bank, Britain’s finance ministry said.

“Recognising that a global crisis needs global solutions, the Chancellor will work with his counterparts to address the shared economic challenges facing our domestic and global economies, and seek to achieve a strong and sustainable economic recovery from coronavirus,” the ministry said.

The administration of new U.S. President Joe Biden has said it will work with other countries to secure an economic recovery and tackle difficult climate and international tax issues, a change in tone from former president Donald Trump.

Britain is chairing the G7 this year at a time when the global economy is still reeling from the impact of lockdowns, prompting governments to spend trillions of dollars to stave off the worst of the damage.

Vaccination programmes are now underway, raising the prospect of a recovery later this year. But the different pace of the rollouts is likely to mean some regions lag behind with the euro zone at particular risk of a slow recovery.

Climate change and biodiversity loss would be made a central priority ahead of the COP26 conference to be hosted by Britain in November, the British finance ministry said.

“This in addition to working closely to reach a global solution on tax challenges created by digitalisation on the economy, and supporting the global sustainable financing of COVID-19 vaccines, therapeutics and diagnostics,” it said.

Nearly 140 countries are negotiating the first update in a generation to rules for taxing cross-border commerce, reflecting the dominance of big digital companies like Google, Apple, Amazon and Facebook.

British Prime Minister Boris Johnson is due to host the first in-person summit of G7 leaders in nearly two years in June in a seaside village in Cornwall, western England, to discuss rebuilding from the pandemic and climate change.

https://www.reuters.com/article/us-health-coronavirus-britain-g7-exclusi/exclusive-uk-to-lead-g7-discussion-on-covid-economic-recovery-on-february-12-idUSKBN2A32L0

Novo’s Rybelsus launch defies Covid-19

 Launching a diabetes drug during a global pandemic sounds like a recipe for disaster. But Novo Nordisk has beaten 2020 forecasts for its oral GLP-1 agonist, Rybelsus, despite Covid-19: full-year product sales were DKK1.87bn ($303m), versus EvaluatePharma sellside consensus of $279m. And any fears that Rybelsus could cannibalise Novo’s older injectable GLP-1 Ozempic have also been allayed, as over 80% of Rybelsus prescriptions were for patients new to the GLP-1 class. However, things look set to remain tough: face-to-face promotion has been on hold since November, a situation that could continue for some time with ongoing lockdowns. The sellside sees Rybelsus as Novo’s second-biggest product in 2026, with sales of over $5bn; however, this figure will rocket if a long shot in Alzheimer’s pays off. One thing not likely to change is Novo’s focus on internally developed assets and early-stage deals, despite the imminent retirement of its chief scientific officer, Mads Krogsgaard Thomsen, announced today. The Danish group’s research and M&A strategy will remain the same, its chief executive, Lars Fruergaard Jørgensen, told a media call this morning, particularly as Mr Thomsen is being replaced by his “lieutenants”, Marcus Schindler and Martin Holst Lange.

https://www.evaluate.com/vantage/articles/news/snippets/novos-rybelsus-launch-defies-covid-19

Amgen slams the brakes on a clutch of cancer drugs

 Amgen is pausing and stopping a whole series of next-gen cancer assets as it tries to figure out the best way forward for its early oncology programs.

Buried in its annual financial results, released Tuesday night, is evidence the Big Pharma, which is hoping for success and approval with its closely watched KRAS hopeful sotorasib, is having a tougher time making its other next-gen assets work.

There is a slew of updates here: First up is AMG 701 (aka pavurutamab), a half-life extended BiTE molecule targeting B-cell maturation antigen for relapsed or refractory multiple myeloma, which saw new data published at the American Society of Hematology meeting late last year.

Amgen said it is now pausing enrollment in the ongoing phase 1 ”while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA,” but it “expects to resume patient enrollment” in the coming months.

Analysts at Jefferies said they believe this pause is due to “protocol modifications for safety mitigation (we think from cytokine release syndrome),” a common but potentially deadly side effect and one many companies have had to balance with efficacy from their immuno-oncology meds.

There’s a second pause for AMG 673, another half-life extended BiTE molecule targeting CD33, which is on a hiatus “while we gather further information on the CD33 program through progression of AMG 330.”

That drug is a bispecific antibody that works by targeting CD33, an antigen widely expressed on the surface of acute myeloid leukemia cells, and then using another antigen, CD3, on the surface of T cells, to enable the latter to target the former.

At the American Society of Clinical Oncology meeting last summer, Amgen presented phase 1 data from ‘330 in certain leukemias, but these disappointed some analysts with relatively low efficacy and high rates of cytokine release syndrome. A path forward for the drug could include different blood cancers and a combo approach.

Two other programs have been hit with stoppages: AMG 596, another BiTE molecule but one targeting EGFR variant III for glioblastoma, a deadly form of brain cancer, has been halted “as we prioritize our portfolio.”

And finally, a phase 1 test of its oral MCL-1 inhibitor AMG 397 was paused “with focus shifting to the intravenous MCL-1 inhibitor AMG 176,” which is currently in phase 1 for blood cancers.

https://www.fiercebiotech.com/biotech/amgen-slams-brakes-a-clutch-cancer-drugs-as-reality-bites

Biogen tosses out Parkinson's hopeful cinpanemab

 As Biogen hopes and prays for a (now delayed) FDA approval of its controversial Alzheimer’s disease hopeful aducanumab, a key, closely watched pipeline asset has failed and been tossed out.

Buried in its annual results (PDF) published Wednesday morning, Biogen said the phase 2 study of BIIB054 (cinpanemab) in Parkinson’s disease “did not achieve proof-of-concept” and missed its primary and secondary endpoints

Biogen said it has now discontinued development of the drug and “will apply learnings to future efforts in Parkinson’s disease.”

As part of that cull, the pharma took a GAAP impairment charge of around $75 million during the fourth quarter.

Cinpanemab, which works as an anti-alpha synuclein (syn) monoclonal antibody, was being studied in the midstage SPARK study, with its primary endpoint being MDS-UPDRS total score, a measure of impairment and disability, versus a dummy treatment.

It was looking to rival Roche and Prothena’s syn drug prasinezumab, although this too has been beset by setbacks as it recently failed to beat placebo on MDS-UPDRS total score, although it saw enough to continue on with development. This follows a string of experimental drug failures over the years in Parkinson's R&D.

The drug had been a key weapon in Biogen’s arsenal but now hits the scrap heap at a time when its full-year guidance rests, literally, on the approval of aducanumab, which was rejected by the FDA’s expert panel late last year.

https://www.fiercebiotech.com/biotech/biogen-tosses-out-parkinson-s-hopeful-cinpanemab-pays-75m-for-its-syn