Aptose adds 60% on lead asset rebrand

 Aptose spent a long time fruitlessly chasing the non-covalent BTK inhibitor leaders with its lead project, CG-806, but judging by this morning’s 60% share price uplift what it really needed was a rebrand. The asset now has an INN, luxeptinib, and – more importantly – a complete remission. This was seen not in a chronic lymphoblastic leukaemia/lymphoma study, where luxeptinib would be expected to hit BTK, but in an acute myelogenous leukaemia trial, relevant for its separate effect on Flt3. Aptose yesterday said the CR occurred in a patient given 450mg twice daily, but gave no details about the subject’s Flt3 status. However, it made much of pharmacology, saying the molecule inhibited Flt3 more potently than the marketed Flt3-targeted drugs Vanflyta, Xospata and Rydapt. With the non-covalent BTK space now the domain of efficacious Lilly and Merck & Co projects perhaps a mechanistic focus switcheroo to Flt3 was in order, but it did not end there: Aptose now calls luxeptinib a “cluster-selective” agent inhibiting “clusters of related kinases” including PDGFR-alpha, CSF1R, Akt, Ras, Erk, Stat and Syk. Amazingly there is no added toxicity, Aptose claims, saying luxeptinib is “not a dirty kinase inhibitor”.

Source: Aptose presentation.

https://www.evaluate.com/vantage/articles/news/snippets/aptose-adds-60-lead-asset-rebrand

Pfizer taps HIV, hep C antiviral research for COVID-19 pill trial

 Pfizer has already seen major success with its BioNTech-partnered COVID-19 vaccine, but, now, the Big Pharma is hoping to add to the arsenal with a pandemic pill using old antiviral technology.

The U.S. giant said it has kick-started a new, early-stage U.S. trial of an oral anti-COVID-19 med known as PF-07321332, which should be given to patients as soon as they see signs of infection. The theory is this will dampen the virus’s ability to cause severe disease or death.

Current antibody drugs from the likes of Eli Lilly and Regeneron are given through an infusion and have struggled to reach enough patients, with new variants also causing concern that they can outrun some of the original antibodies.

Pfizer is using an older, tried and tested method: PF-07321332 is a protease inhibitor that has been used for many years against a range of infections including HIV and hepatitis C. The hope is this will be able to hit back at the virus and with few side effects, given we already have many years’ worth of data on this tech.

It also can be prescribed and taken outside of a secondary care setting, rather than via infusion clinics or in hospitals, as the current crop of antibody drugs have to be. It follows similar work from the likes of Merck and biotech partner Ridgeback and their midstage effort molnupiravir as well as Roche and Atea Pharmaceuticals’ antiviral AT-527.

Drugs against the virus have, however, had a tough time in testing, with failures and setbacks for a number of experimental and repurposed drugs over the past year slowing attempts for a knockout vaccine-therapeutic approach to stop the virus in its tracks and prevent those with the disease from getting very sick.

As well as a pill, Pfizer is also working on a study using an intravenously administered antiviral candidate in another early-stage trial, but this one is for hospitalized COVID-19 patients.

“Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus,” said Pfizer’s chief scientific officer, Mikael Dolsten, M.D., Ph.D., in a statement.

“Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic.”

https://www.fiercebiotech.com/biotech/pfizer-taps-hiv-hep-c-antiviral-research-for-covid-pill-trial

BrainStorm climbs on stem cell data from small multiple sclerosis trial

 BrainStorm Cell Therapeutics has presented phase 2 data on its stem cell therapy in patients with multiple sclerosis (MS). The small, open-label clinical trial linked autologous therapy NurOwn to a 25% improvement in measures of mobility and dexterity in around 14% of patients.

New York-based BrainStorm has primarily assessed its autologous mesenchymal stromal stem cells in patients with amyotrophic lateral sclerosis (ALS). BrainStorm harvests the cells from a patient’s own bone marrow and induces them to secrete neurotrophic factors. With a phase 3 ALS trial failing last year and the FDA taking the unusual step of publicly stating the “data do not support the proposed clinical benefit of this therapy,” the importance of MS to BrainStorm has ratcheted up.

Investigators enrolled 20 patients with progressive MS in the phase 2, but only 18 were treated. The treated patients received three doses of NurOwn with two months between each dose. The study was primarily designed to assess the safety of NurOwn but covered efficacy in secondary endpoints. Two patients discontinued due to treatment-related adverse events.

“Prespecified 25% improvements in the timed 25-foot walk and 9-hole peg test from baseline to 28 weeks were observed in 14% and 13% of NurOwn treated patients, respectively,” BrainStorm wrote in a statement to disclose the data. ClinicalTrials.gov lists “timed 25-foot walking speed or 9-Hole Peg Test - change from baseline” as a secondary endpoint, without referencing a 25% target. It is unclear how there is a one percentage point difference in response rates in a 20-subject clinical trial.

BrainStorm compared the proportion of patients experiencing a 25% improvement favorably to data from a matched Brigham & Women's Hospital cohort. No patients in the 48-subject matched cohort experienced such an improvement.

Overall, BrainStorm saw a 10% mean improvement in the walking test from baseline and a 4.8% gain in the peg test of finger dexterity when performed using the dominant hand compared to declines of 1.8% and 1.4%, respectively, in the control cohort. 

BrainStorm also saw an eight-letter improvement in scores on a visual function test—a level other groups have said is clinically meaningful—in 47% of patients. Two-thirds of subjects experienced a three-point improvement in a measure of cognitive processing. A four-point or 10% improvement is the definition of responder used by the Multiple Sclerosis Outcome Assessments Consortium.

Shares in BrainStorm rose 21% following the release of the results. 

https://www.fiercebiotech.com/biotech/brainstorm-climbs-stem-cell-data-from-small-multiple-sclerosis-trial

Thermo Fisher Scientific Launches Device to Monitor Air for Coronavirus

 Thermo Fisher Scientific Inc. Wednesday unveiled a device that collects samples of indoor air to test for pathogens, including the virus that causes Covid-19.

The device, called the AerosolSense Sampler, collects samples of ambient air and traps pathogens using a substrate. The samples can later be analyzed in a laboratory using polymerase chain reaction testing to test for SARS-CoV-2--the Covid-19 virus--or other pathogens.

Although the machine does not produce immediate results, it could help institutions confirm that the pathogen was present in a particular place and time, Thermo Fisher said. That information could help businesses, schools and other institutions make decisions about how to respond if people test positive for the disease or become symptomatic.

Thermo Fisher said that it expects individual testing would continue to be a foundational component of Covid-19 surveillance and public-health measures.

https://www.marketscreener.com/quote/stock/THERMO-FISHER-SCIENTIFIC-14623/news/Thermo-Fisher-Scientific-nbsp-Launches-Device-to-Monitor-Air-for-Coronavirus-32774456/

EU Commission to Propose Making it Easier to Block Covid-19 Vaccine Exports

 The European Commission is proposing to make it easier for European Union governments to block Covid-19 vaccine exports, a step that would likely escalate tensions with the U.K. and potentially damage ties with other countries.

The proposal will be debated at a meeting of EU leaders on Thursday and Friday where it looks likely to receive backing. However, the real test of its significance will be the guidance handed down by leaders on how broadly the export ban should be used.

Struggling with its own vaccine program, the EU's executive in late January allowed member states to stop vaccine exports from the bloc provided the move had backing from the European Commission.

However, the instrument has been used just once, when Italy blocked a batch of vaccines destined for Australia. Since late January, the EU has shipped 380 vaccine batches abroad, totalling more than 40 million vaccines, including more than 10 million to the U.K. despite the continued difficulties facing the bloc's vaccine campaign.

The commission has been contemplating barring exports to the U.K., whose own vaccine program has moved rapidly but which hasn't exported any vaccines. Senior U.K. and EU officials have been in talks in recent days on a possible compromise which would prevent British vaccine imports, which have so far mainly been of the Pfizer vaccine, being hit.

Those discussions have centered around ideas for sharing vaccine production from the Dutch-based plant Halix which is manufacturing vaccine ingredients for AstraZeneca. EU officials confirmed on Wednesday reports that millions of vaccines produced at the plant have been filled and finished at a site in Italy. No export request has yet been made for the vaccines.

Under the European Commission's proposal, EU governments would be able to take into account new criteria in deciding whether to stop an export. One would be whether the recipient country was also exporting vaccines or vaccine ingredients to the EU. Another would be how advanced the country was in vaccinating its own population or the epidemiological situation there in general.

EU officials said Wednesday the intention of the broader mechanism was to secure the EU's vaccine supply but they said it wouldn't allow EU member states to seize vaccine stocks produced by a company and that the aim is not to introduce sweeping new export bans.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-EU-Commission-to-Propose-Making-it-Easier-to-Block-Covid-19-Vaccine-Exports-32773637/

India delays big exports of AstraZeneca shot as infections surge at home

 India has put a temporary hold on all major exports of the AstraZeneca coronavirus shot made by the Serum Institute of India (SII), the world’s biggest vaccine-maker, to meet domestic demand as infections rise, two sources told Reuters.

The move will also affect supplies to the GAVI/WHO-backed COVAX vaccine-sharing facility through which more than 180 countries are expected to get doses, one of the sources said.

COVAX has so far received 17.7 million AstraZeneca doses from the SII, of the 60.5 million doses India has shipped in total, and many countries are relying on the programme to immunise their citizens.

There have been no vaccine exports from India since Thursday, the foreign ministry’s website shows, as the country expands its own immunisation effort.

“Everything else has taken a backseat, for the time being at least,” said one of the sources. Both sources had direct knowledge of the matter, but declined to be named as the discussions are not public.

“No exports, nothing till the time the India situation stabilises. The government won’t take such a big chance at the moment when so many need to be vaccinated in India.”

India’s foreign ministry and the SII did not immediately reply to requests for comment.

SOME DELAYS ALREADY 

The SII has already delayed shipments of the AstraZeneca drug to Brazil, Britain, Morocco and Saudi Arabia.

UNICEF, the U.N. children’s agency that is procuring and distributing vaccines for COVAX, had no comment.

COVAX has a deal to buy 1.1 billion doses of the AstraZeneca and Novavax shots that the SII is making in bulk, mainly for low- and middle-income countries.

UNICEF in Vietnam said in a statement on Wednesday that vaccine production issues had led to delays in deliveries to all countries that were due to receive vaccines through COVAX.

It did not specify the origin of those delays, although Vietnam was not expected to receive doses from the SII.

Indian Prime Minister Narendra Modi’s cabinet decided this week to widen its inoculation drive by including everyone above 45 from April 1, and many states battling a surge in infections have demanded that all adults be covered.

With 11.7 million cases, India has reported the highest number of coronavirus infections after the United States and Brazil.

Currently, only the elderly and those over 45 with other health conditions are eligible for vaccinations in India. Health and frontline workers were first in line when India began its drive in mid-January.

India has so far administered more than 51 million doses, of which 47 million are the SII’s locally-made version of the AstraZeneca vaccine. The rest is the COVAXIN vaccine developed in India by Bharat Biotech.

The government has so far asked the SII to supply around 141 million doses. The company has also accounted for nearly all of India’s vaccine exports.

The SII plans to boost monthly production to 100 million doses from April/May, from up to 70 million now, Reuters reported earlier this month.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine-excl/exclusive-india-delays-big-exports-of-astrazeneca-shot-as-infections-surge-sources-say-idUSKBN2BG29X

Anthem To Acquire myNEXUS, Home Health Benefits Manager

 Anthem, Inc. (NYSE: ATNM) today announced that the company has entered into an agreement to acquire myNEXUS, Inc. (“myNEXUS”), a comprehensive home-based nursing management company for payors. myNEXUS delivers integrated clinical support services for approximately 1.7 million Medicare Advantage members across 20 states.

“Providing timely care for members in their homes allows for both excellent personalized care as well as the comfort of being in preferred environments,” said Prakash Patel, M.D., Anthem Executive Vice President, and President, Anthem Diversified Business Group. “Bringing the right level of whole person care into the home has been demonstrated to improve outcomes, reduce readmissions and improve members’ and their family’s experience of wellbeing.”

myNEXUS deploys a user-friendly platform for providers to highly automate the home visit authorization process, speed time to care, increase provider effectiveness and improve member satisfaction. The digital platform combines an advanced analytic rules engine, with a clinical staff of over 250 clinicians to effectively plan for and to optimize home care. Additionally, myNEXUS has established a nationwide network of high performing home health providers and nurse agencies including nine of the top ten highest quality national and local providers.

Juan Vallarino, CEO of myNEXUS, said, “The myNEXUS team is thrilled to be partnering with Anthem to build upon the value we deliver to our customers and their members. The strength of Anthem’s Diversified Business Group platform will allow us to broaden our capabilities as we strive to transform how quality healthcare is delivered to the people we serve.”

This transaction aligns with Anthem’s strategy to manage integrated, whole person multi-site care and support, by providing national, large-scale expertise to manage nursing services in the home and facilitate transitions of care. The myNEXUS solution and network will enhance Anthem’s continued expansion to deliver care for members in a coordinated manner, leveraging both high touch support and technology driven capabilities.

Anthem is acquiring myNEXUS from an investor group led by WindRose Health Investors, a New York-based healthcare private equity firm. The acquisition is expected to close in the second quarter of 2021 subject to customary closing conditions. Upon closing, myNEXUS will operate as a wholly-owned subsidiary of Anthem and will join Anthem’s Diversified Business Group. Financial terms of the transaction were not disclosed. The company’s 2021 EPS guidance remains unchanged as a result of this acquisition. Anthem’s legal advisors are White & Case LLP and Faegre, Biddle, Drinker & Reath LLP. Latham & Watkins LLP and Waller Lansden Dortch & Davis, LLP are acting as legal advisors for myNEXUS.

https://www.businesswire.com/news/home/20210324005316/en/Anthem-Inc.-To-Acquire-myNEXUS-Home-Health-Benefits-Manager