Anchiano: Speculation Around Investor Letter

A shareholder letter caught the interest of investors. The letter being sent to shareholders details a special meeting taking place on March 15. The head of the letter notes that the meeting is for a proposed merger vote that will affect shareholders’ investment in the company.

Anchiano Therapeutics announced back in December plans to merge with Chemomab.  The merger will have the management team of the combined company mostly made up of leaders from Chemomab. However, ANCN CEO Neil Cohen will serve on its Board of Directors.

It’s also worth pointing out that Anchiano Therapeutics started clinical trials for one of its treatments last month. This has it working to treat liver, skin, and lung fibrosis-related diseases. 

https://investorplace.com/2021/03/ancn-stock-speculation-around-investor-letter-sends-anchiano-therapeutics-soaring/

AI tags Lilly rheumatoid arthritis med Olumiant as potential Alzheimer's treatment

 Could janus kinase (JAK) inhibitors like Eli Lilly’s rheumatoid arthritis drug Olumiant be repurposed to treat Alzheimer’s disease? Researchers at Harvard University and Massachusetts General Hospital have set out to find the answer to that question with a new clinical trial that was born from artificial intelligence.

The researchers used a type of AI called machine learning to identify existing drugs that might be able to prevent neuronal death in Alzheimer’s. The screen pulled up a list of 15 FDA-approved drugs as candidates for repurposing in Alzheimer’s, and five of them were JAK inhibitors, they reported in the journal Nature Communications.

JAK proteins fuel inflammation and have long been suspected to play a role in Alzheimer’s. The researchers landed on JAK inhibitors after using machine learning to model the response of brain neural cells to a variety of drugs. The AI tool allowed them to determine whether those changes correlated with known molecular markers of Alzheimer’s severity. They were also able to use it to identify trends among the proteins targeted by the drug prospects. 

They applied the screen to 80 FDA-approved drugs. After JAK inhibitors turned up as the top contenders, they selected Olumiant (baricitinib) for a new clinical trial that will start soon at Mass General and Holy Cross Health in Fort Lauderdale, Florida, they said in a statement.

Other research teams are exploring drug repurposing in Alzheimer’s. In 2019, Brown University scientists discovered that lamivudine, approved to treat HIV back in 1995, reversed inflammation and other signs of aging in mice—leading them to suggest the drug could be studied for its potential in Alzheimer’s.

BioXcel Therapeutics is repurposing an old sedative, dexmedetomidine, for use in treating acute agitation in dementia patients, including those with Alzheimer’s. The company announced last week that it expects to discuss its phase 2 results with the FDA next quarter and that it hopes to start phase 3 trials in the second half of the year.

In addition to uncovering JAK inhibitors as promising prospects in Alzheimer’s, the Mass General and Harvard researchers also landed on several cancer drugs, such as the EGFR inhibitors Tykerb from Novartis and Iressa from AstraZeneca. All could be targets for further investigation, they noted.

The researchers said in the study that using AI to find drug prospects in Alzheimer’s could be particularly useful, because while the disease has telltale signs like amyloid plaques and neuronal loss, the exact mechanisms by which it develops and progresses are largely a mystery.

AI “allows for unbiased assessment of biological processes or drug candidates even when disease mechanisms are not explicitly known. This is valuable from a neuropathological perspective,” the researchers wrote.

The clinical trial of Olumiant will enroll patients with mild cognitive impairment and confirmed Alzheimer’s, Mass General said in the statement.

https://www.fiercebiotech.com/research/ai-uncovers-eli-lilly-s-rheumatoid-arthritis-drug-olumiant-as-potential-alzheimer-s

J&J used virtual trial approach from IQVIA for phase 3 COVID-19 vaccine

 Johnson & Johnson recently nabbed an emergency use authorization from the FDA for its single-shot COVID-19 vaccine, but today it said its trials for the shot had largely been done virtually through IQVIA.

As is becoming the norm since the first wave of the pandemic a year ago, more and more contract research organizations have been offering so-called siteless trials that can run large parts of a test from people’s homes using new technologies.

Today, we found out that IQVIA, a major CRO player, has been running virtual trials for the J&J shot since September for its key phase 3 program. Big Pharma companies can often be a little secretive as to which CRO they are using for certain trials, but now we know IQVIA has been running its later-stage efforts.

We don’t know how much the deal to run these cost J&J, but we do know from the brief update that it has tapped IQVIA’s “suite of decentralized trial solutions” that uses its on-site and remote study platform predominately through a mix of telehealth technologies, virtual oversight and digital patient engagement strategies.

“These capabilities enabled participants to be screened remotely to determine their risk status, to schedule an appointment at a nearby site, and to report potential COVID-19 symptoms and other study data remotely throughout the study,” the CRO said.

Having such a high-profile company and trial program use a siteless approach will likely add more kudos to the virtual trial technology.

https://www.fiercebiotech.com/biotech/johnson-johnson-has-been-using-a-virtual-trial-approach-from-iqvia-for-its-phase-3-covid

Reviv Global and V-Health hope digital passport will reopen Vegas

 Reviv Global and partner V-Health Passport are backing their technology to allow the hospitality industry to reopen safely in resorts such as Las Vegas.

V-Health Passport makes use of the Code technology from VST Enterprises and was launched with the backing of Zara and Mike Tindall MBE in 2020 as a way of opening up the global economy.

Reviv have introduced this secure technology to hotels, bars and restaurants, as a solution to allow them to reopen.

The company said that everyone in attendance will be safe in the knowledge that the people they are socialising with, will have a valid code and would need to have tested negative for COVID-19 prior to allowing entry.

The public will be asked to download the VPassport app, before heading off to their restaurant, bar or conference.

They will be required to obtain and take a rapid antigen test for COVID-19 and their results will then be uploaded onto a health pass, which will contain their secure code.

This can then be scanned on entry by members of staff when they arrive at their chosen venue, proving they are negative and able to enter the premises safely.

People without a smartphone will be able to print off their certification and codes, which are available from a website portal.

Louis-James Davis, CEO and Founder of V-Health Passport said: “It has been great to have Reviv Global as a partner over the last 12 months working on our ‘fit-to-fly’ campaigns and now, moving into other global markets. The V-Health Passport was built to be multipurpose and it will thrive in a city such as Las Vegas”.

Vegas has been hit hard by the pandemic – earlier this week gambling firm Las Vegas Sands Corp announced it is to sell its properties there for $6.25 billion, exiting the gambling hot spot after three decades to focus on Asian markets.

Digital passports and similar schemes showing COVID-negative or vaccination status could also re-open other parts of the economy including airports and tourism.

https://pharmaphorum.com/news/reviv-global-and-v-health-hope-digital-passport-will-reopen-vegas/

Valneva, Pfizer Start Phase 2 Study for Lyme Disease Vaccine

 

• The Phase 2 study will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate’s pediatric program

• VLA15 will be tested at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg

• VLA15 is the only Lyme disease vaccine candidate in active clinical development

Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. (NYSE: PFE) today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.

As announced in December 20201, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It will be the first VLA15 study to include a pediatric population (aged 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6).

https://sports.yahoo.com/valneva-pfizer-announce-initiation-phase-060000252.html

Baxter to support fill and finish of 60-90 mln Moderna vaccine doses

 Baxter International Inc will provide fill and finish sterile production services for about 60-90 million doses of Moderna Inc's COVID-19 vaccine in 2021, the companies said on Monday.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-nbsp-Baxter-to-support-fill-and-finish-of-60-90-mln-Moderna-vaccine-doses-32632370/

India seeks funds from alliance to match China's vaccine push

 

India has urged the United States, Japan and Australia to invest in its vaccine production capacity, an Indian government source told Reuters, as the so-called Quad alliance tries to counter China's growing vaccine diplomacy.

Beijing has committed to provide at least 463 million doses of its home-made COVID-19 vaccines through exports and donations across the world from Asia to Africa, Europe and Latin America, according to Reuters calculations.

Two senior Indian officials said the Quad alliance, grouping the United States, Japan, Australia and India, was stepping up efforts to expand global vaccination to counter China's growing soft power. India, the world's biggest vaccine maker, believes it is best placed to steer the effort, they added.

Asked for comment, a U.S. State Department spokesperson did not refer to India's request for funds or to China but said Washington was deeply focused on expanding global vaccination, manufacturing and delivery.

"Secretary (Antony) Blinken spoke with his Quad counterparts on February 18 to discuss cooperation on COVID-19 response and recovery and climate change, among other issues," the official told Reuters.

There was no comment from the Australian government. But a government source said a global recovery from the COVID-19 pandemic was a policy priority for the country and its Quad partners. Australia is exploring a number of options to work with partners to enhance stability and prosperity in the region, the source said.

Japan's Foreign Minister Toshimitsu Motegi told a news conference on Friday that the four countries discussed the "necessity and importance of international cooperation to ensure equal access to vaccines for developing countries," at the February meeting, but nothing was decided.

An Indian foreign ministry spokesman did not respond to a request for comment.

One of the two Indian sources, an official who has direct knowledge of Quad alliance discussions, said the group had had several meetings about global vaccination.

"India has more vaccine options than any other Asian country at this point of time," said the source, declining to be named as he was not authorised to talk on the matter. "India expects members of the Quad alliance to pay to ramp up production.

A second Indian source said that at the February virtual meeting, the Quad countries discussed ways to "encourage alternative medical supply chains, thereby implying less dependency on China".

A top political advisory body in Beijing, the Chinese People's Political Consultative Conference, said concerns that China was using vaccines to sway other countries were "extremely narrow-minded."

China's purpose was to make vaccines available globally, the foreign ministry said.

BILLIONS OF DOSES

Indian companies such as the Serum Institute of India (SII), Bharat Biotech, Biological E and Cadila Healthcare have the combined capacity to produce billions of doses of their own vaccines or contract-manufacture for others.

SII, the world's biggest single manufacturer, is producing the Oxford University-AstraZeneca vaccine for many countries and will soon start making the Novavax shots in bulk.

India is also trying to sell a vaccine created by Bharat Biotech and the state-run Indian Council of Medical Research to 40 countries including Brazil, the Philippines and Zimbabwe. Bharat Biotech says it can make about 700 million doses of the shot a year.

Indian vaccine makers are also planning to produce more COVID-19 vaccines developed by the United States and Russia, including Johnson & Johnson.

A top Indian vaccine official told Reuters in January that the government had also held discussions with U.S. companies Pfizer Inc and Moderna Inc about making their shots in India.

Serum's Novavax partnership holds "the key to the Quad's diplomatic alliance in vaccines and push China out of regional vaccine sales", one of the Indian sources said.

"The focus is also on making sure the Quad alliance secures all the key markets for vaccines," he said.

Indian companies will also produce about 300 million doses of Russia's Sputnik-V vaccine, but the source said Washington was not keen on helping expand Moscow's clout in vaccines.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/India-seeks-funds-from-Quad-alliance-to-match-China-s-vaccine-push-32629193/