Search This Blog

Monday, December 14, 2020

Apellis remains a top pick at Baird after AstraZeneca/Alexion deal

 

  • The drug portfolio of Alexion Pharmaceuticals (NASDAQ:ALXN) is led by C5-inhibitors: Ultomiris (ALXN1210/ravulizumab-cwvz) and Soliris (eculizumab). In the wake of its proposed merger with AstraZeneca (NASDAQ:AZN), even clinical-stage biopharmaceutical companies focused on complement-mediated therapies have gained attention.
  • With a price target of $70, Baird reiterates its “outperform’ rating on Apellis Pharmaceuticals (NASDAQ:APLS) as it highlights the ‘long-term value’ of the company’s C3-mediated experimental therapy, pegcetacoplan (APL-2). The shares jumped +8.8% today.
  • Apellis have partnered with Swedish Orphan Biovitrum (OTCPK:BIOVF) in developing pegcetacoplan, currently undergoing a Phase 3 study against paroxysmal nocturnal hemoglobinuria. The experimental therapy is being reviewed by the EUA and with a Priority Review designation, the FDA has set May 14, 2021, as the target action date.
  • Doing a back of the envelope calculation, Baird projects $2.4B of value for pegcetacoplan in PNH, and along with $1B of cash, ‘the PNH franchise alone will constitute the vast majority of APLS' $3.6B market cap,’ the analysts argue.
  • ‘With additional systemic pegcetacoplan indications (CAD, HSCT-TMA, C3G, and ALS) and pegcetacoplan in ophthalmology mega-market GA all serving as free call options,’ the note ‘reiterates APLS as one the top smid-cap ideas in 2021.’
  • https://seekingalpha.com/news/3644229-apellis-remains-top-pick-baird-after-astrazeneca-alexion-deal

IDEAYA, I-Mab, Immunic to be added to NASDAQ Biotechnology Index

 

  • IDEAYA Biosciences (IDYA -1.5%), I-Mab (IMAB +2.4%) & Immunic (IMUX +3.9%) were selected for addition to the NASDAQ Biotechnology Index, effective Dec.21, 2020 before market opens.
  • "Since its IPO on Nasdaq in January 2020, I-Mab has successfully executed many important business milestones and significantly elevated its capital market profile. The inclusion in the NBI, following the first annual review by Nasdaq since our IPO, further validates I-Mab's progress and potential in delivering value to shareholders. We look forward to sharing many more achievements in 2021 and beyond," I-Mab director & CFO Mr. Jielun Zhu commented.
  • In comparison to the gain in the iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB) past 1-year performance, which tracks the index, IDYAIMAB and IMUX have garnered higher returns in the same period.
  • https://seekingalpha.com/news/3644196-ideaya-biosciences-i-mab-immunic-will-be-added-to-nasdaq-biotechnology-index

Pfizer-BioNTech UK Covid Vax Launch Slows Due to Allergic-Reaction Monitoring

 British doctors say rolling out the Pfizer Inc.-BioNTech SE Covid-19 vaccine beyond hospitals will take longer than anticipated because of logistical challenges and complications thrown up by news in the U.K. of allergic reactions after the injection.

Following two severe allergic reactions on Dec. 8, the first day of the U.K. vaccination campaign last week, doctors were told to monitor patients for 15 minutes after each injection.

Logistical hiccups and the additional time required to monitor patients after a shot have added friction to an already-cumbersome immunization program and could signal challenges to come for the U.S. as health officials start vaccinating patients there.

Extra time required for observation means some U.K. doctors' offices pulled out of the local vaccination campaign before it started Monday because they don't have enough space to accommodate people in a socially distanced manner and still deliver the expected number of doses.

"You don't necessarily get through as many people because you've got the 15 minutes" waiting time, said Ruth Rankine, primary care director at the NHS Confederation, the membership body representing health-care staff in the U.K.'s state-run National Health Service. Each shot takes around eight minutes to administer, according to NHS exercises in preparation for the vaccine.

Initial planning for community rollout included a 15-minute waiting period after injections, but the requirement was dropped as more data about the vaccine became available, Mrs. Rankine said. The allergic reactions last week, however, prompted the U.K.'s Medicines and Healthcare products Regulatory Authority to reinstate the guidance on observation.

Combined with the general challenges of this vaccine, some doctors in the network of practices that make up the backbone of the NHS -- who are known as general practitioners, or GPs -- say they are rethinking how they vaccinate patients. Some have cleared their offices of other appointments or delayed taking part in the vaccination program, doctors say. Others haven't passed evaluations required to prove they are ready to deliver the complex vaccine.

Politicians had said the plan was to vaccinate all over-50s by the spring, but a person familiar with the rollout said there is "no definitive timeline. We want to make sure everything is done safely rather than to specific dates." The plan remains to vaccinate quickly and safely, the person said.

Around 100 local practice hubs, or groups of doctors offices across England, will this week start delivering the vaccine to nursing-home workers and people over 80 years old, who are also high-priority groups in other countries where the vaccine is being rolled out, including the U.S. There are more than 1,000 such hubs in England.

The clock started ticking Monday as soon as doctors offices received thawed-out vials of the vaccine, which is stored at temperatures of around minus 94 degrees Fahrenheit.

They have 3 1/2 days to deliver at least 975 doses of the two-dose shot, based on how long the vaccine lasts in the refrigerator and how long it takes to prepare for injection.

The U.K. became the first country in the West to begin vaccinating its general public last week, with the first shots of the Pfizer vaccine given in dozens of British hospitals.

Local family doctors are the first line of defense at the NHS. They routinely deal with around six million appointments a week in England and are adding vaccine delivery to their workload.

"We shouldn't forget that they are doing this on top of everything else that they are having to do," Mrs. Rankine said. "It's a really busy time for GPs anyway right before Christmas," when people get appointments in before the holidays and winter pressures add to the load.

The new vaccine requires specialist training, additional space and multiple checks to administer. Some doctors say doing all this while keeping patients socially distanced and following one-way systems on site isn't possible.

Unlike a flu shot that comes in ready-to-go vials, the Pfizer vaccine, which uses new technology called mRNA, must be diluted with sodium chloride solution and turned upside down and back again 10 times before being injected. Two people need to check the dose beforehand. Doctors are allocating around 8 minutes per shot, not including wait times. The flu vaccine takes under a minute to administer, Mrs. Rankine said.

Those taking part are required to offer their service seven days a week, and some are shifting other appointments to different offices to concentrate on vaccine delivery.

Doctors have to use at least 95% of the 975-doses in each refrigerated shipment, or they won't get paid for each shot they deliver. In case of surplus doses -- because of too few over-80s who can get to the doctors' office, or fewer-than-expected people turning up -- doctors have been advised to use the doses on health-care staff. "The overriding principle will be to avoid wastage," according to the British Medical Association, a trade union for doctors in the U.K.

Doctors will get 12.58 British pounds, or $16.78, for each shot delivered, paid after the second injection.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Rollout-of-Pfizer-BioNTech-Covid-19-Vaccine-Slows-in-U-K-Due-to-Allergic-Reaction-Monitori-32009057/

Canada administers country's first COVID-19 vaccination

 Canada kicked off its inoculation campaign against COVID-19 on Monday by injecting frontline healthcare workers, becoming just the third nation in the world to administer the Pfizer/BioNTech vaccine.

The first dose went to Anita Quidangen, a personal support worker at the Rekai Centre, a non-profit nursing home for the elderly in Toronto, Canada’s largest city. Healthcare workers in masks and white coats applauded after she was injected.

“Today really we turn a corner,” Dr. Kevin Smith, president and chief executive officer of the University Health Network, which runs the care home, said after the shot was administered. “I like to say that this is the shot that will be heard around the world.”

More than 60% of Canada’s 13,350 pandemic deaths overall have been in residences for the elderly, down from 80% in the first wave.

Prime Minister Justin Trudeau said the first recipients will be workers in hospitals and nursing homes, the most vulnerable segment of the elderly, as well as those living on remote aboriginal reserves.

https://www.reuters.com/article/health-coronavirus-canada-vaccine/canada-administers-countrys-first-covid-19-vaccination-idUSKBN28O17B

Russia trials COVID-19 vaccine for domestic animals, including mink

 Russia is close to completing clinical trials for a COVID-19 vaccine for domestic animals and mink and expects to begin the regulatory approval process in February, according to Russia’s agricultural safety watchdog.

The Federal Centre for Animal Health began developing the vaccine in spring after the authorities established the virus could be passed from humans onto some domestic animals.

Russia became the first country to give regulatory approval to a human vaccine -- Sputnik V -- in August, and is in the process of rolling it out across the country. Over 150,000 people have already received it.

The Russian animal vaccine is aimed at rabbits, mink, cats and some other animals. Clinical trials will end in January and the approval process is likely to begin at the end of February, Yulia Melano, an aide to the head of the agricultural safety watchdog, Rosselkhoznadzor, told Reuters.

The World Health Organization has expressed concern over the transmission of the virus between humans and animals. Denmark last month ordered the culling of all 17 million mink on its farms after concluding that a strain of the virus passed from humans to mink had mutated and spread back to humans.

Russia has said it believes there will be commercial interest in the new vaccine from its own animal fur breeders and from U.S. and EU businesses.

Two cases of COVID-19 have been registered in cats in Russia but its mink population has not been affected, according to the watchdog.

Ivan Nesterov, acting head of state fur company Russian Sable, told the Zvezda TV station last month that Russia was testing a vaccine and would vaccinate its minks once the process was finished.

The global fur trade, worth more than $22 billion a year, is reeling from Denmark’s decision to kill millions of farmed mink.

Worries of a sudden shortage of mink pelts, of which Denmark was the top exporter, have lifted prices by as much as 30% in Asia, the International Fur Federation (IFF) says.

https://www.reuters.com/article/health-coronavirus-russia-animal-vaccine/russia-trials-covid-19-vaccine-for-domestic-animals-including-mink-idUSKBN28O1HU

Codagenix, Serum Institute to begin UK trials of nasal COVID-19 vaccine in Jan.

 Codagenix Inc and India's Serum Institute said on Monday they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal COVID-19 vaccine.

The companies said 48 volunteers will be enrolled at three dose levels and expect to begin dosing the trial participants in the first week of January.

UK's Medicines and Healthcare Products Regulatory Agency (MHRA) approved the trial for the vaccine, COVI-VAC, after positive safety data in animal studies.

The vaccine candidate uses Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which works by re-coding genes of viruses into safe and stable vaccines.

COVI-VAC will not need a needle and syringe or ultra-cold storage, the companies said, potentially addressing logistical issues likely faced by other vaccine-makers.

Serum Institute of India, the world's largest vaccine producer by volume, has also partnered with British drugmaker AstraZeneca to conduct trials of its vaccine in India and produce the vaccine candidate if it secures approval.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Codagenix-Serum-Institute-to-begin-UK-trials-of-nasal-COVID-19-vaccine-in-January-32007136/

Legend Biotech on go with early-stage CAR-T candidate in blood cancer

 

  • The FDA has signed-off Legend Biotech's (LEGN +11.1%) investigational new drug application to evaluate LB1901, an autologous chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory T-cell lymphoma.
  • Upcoming Phase 1 multicohort study will enroll patients with relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma in the U.S., with primary objectives of the study are to characterize the safety and tolerability of LB1901 and to determine the recommended Phase 2 dose.
  • LB1901 targets CD4, which is a surface membrane glycoprotein uniformly expressed in a majority of TCL subtypes.
  • https://seekingalpha.com/news/3644107-legend-biotech-on-go-early-stage-stage-car-t-candidate-in-blood-cancer