Target to $235 from $304
Monday, February 7, 2022
Celltrion Applies to Initiate a Global Phase III Clinical Trial for Inhaled COVID-19 Antibody Cocktail
- Celltrion submitted an IND application for a global Phase III clinical trial of inhaled antibody cocktail therapy with CT-P59 and CT-P63; the company expects to enrol 2,200 patients with mild-to-moderate symptoms of COVID-19
- The inhaled COVID-19 antibody cocktail therapy and CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529)
- The inhaled COVID-19 antibody cocktail directly traps virus in airway mucus and rapidly eliminates the virus from the lungs using the muco-trapping antibody platform
Celltrion Group announced today it has submitted an Investigational New Drug (IND) application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19; the trial is expected to enrol 2,200 patients globally.
The inhaled COVID-19 antibody cocktail is a combination of monoclonal antibodies with regdanvimab (CT-P59) and CT-P63 and has been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant (B.1.1.529). The global Phase III clinical trial proposed in the IND is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail.
The muco-trapping antibody platform used for the inhaled COVID-19 antibody cocktail directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminates the virus from the lungs through the body's natural ability to clear mucus.
Evotec's loss is disappointing, but there is more in the locker
Germany’s Evotec might have built a hugely successful fee-for-service drug discovery business, but getting a product to market – albeit via its vast network of partnerships – remains an elusive goal. Its most advanced hope was eliapixant, a chronic cough project partnered with Bayer, so investor disappointment was understandable when the pharma giant handed back rights. The project works similarly to Merck & Co’s gefapixant, which received a CRL last month, and it is not inconceivable that the events are related; the class has known toxicity issues that have made it tough to establish an acceptable risk/benefit profile. But Evotec's 14% share price drop, erasing almost $1bn from the group’s market cap, feels steep. True, other projects on which Evotec stands to benefit are much earlier, but it will have plenty of other shots on goal in the coming years. The company claims to co-own 130 assets, most of which are preclinical, but a couple of oncology projects that recently entered phase 1 are worth watching. It is also worth remembering that Evotec is profitable and has been for many years – an attribute that should not be dismissed as the biotech bear market growls on.
| Moving through the clinic: Evotec's most advanced projects | |||
|---|---|---|---|
| Project | Description | Licensee | Details |
| Phase 2 | |||
| EVT 201 | GABA A receptor agonist; insomnia | Zhejiang Jingxin | Filing expected in China within next 18-24 months |
| Eliapixant (BAY1817080) | P2X3 antagonist; chronic cough | Bayer (WW) | Abandoned by Bayer Feb 2022 and all rights returned to Evotec |
| XP-105 (formerly BI 860585) | mTORC1/2 inhibitor; solid tumours | Xynomic | Originally developed under a collaboration with Boehringer Ingelheim, which licensed the project out in 2018 |
| Phase 1 | |||
| EVT 401 | P2X7 ion channel blocker; immunology and inflammation | Conba Group | Development appears restricted to China |
| BAY2328065 | P2X3 antagonist; endometriosis | Bayer | Presumed handed back as part of eliapixant discontinuation, which saw Bayer return rights to all P2X3 assets |
| EXS21546 | Undisclosed immuno-oncology mechanism, possibly targeting A2a | Exscientia | Ph1 development started 2021 |
| CNTX 6016 | Cannabinoid receptor 2 antagonist; pain | Centrexion | Ph1 trial started in 2021 |
| EVT894 | MAb against Chikungunya virus | None | In-house project? Ph 1 trial initiated by Evotec in 2021, clinical trial ID unknown |
| EVT801 | VEGFr3 inhibitor; cancer | Kazia Therapeutics | Originally developed under a collaboration with Sanofi; licensed to Kazia in April 2021, ph1 under way |
| BAY2395840 | Bradykinin B1 receptor antagonist; diabetic neuropathic pain. | Bayer (WW) | Ph1 trials about to commence |
| EVT8683 | elF2b activator; neurodegeneration settings | Bristol Myers Squibb | Said to be in ph1, clinical trial ID unknown |
| Source: Company presentation, Evaluate Pharma. Note: list not exhaustive. https://www.evaluate.com/vantage/articles/news/deals-snippets/evotecs-loss-disappointing-there-more-locker | |||
CVS, Medable to Expand Clinical Trial Access
Medable Inc. and CVS Health (NYSE: CVS) today announced a collaboration to expand clinical trial access and engagement for patients at select MinuteClinic™ locations via Medable’s clinical trials software platform. CVS Health Clinical Trial Services™ will manage the relationship.
The collaboration combines Medable’s software platform with CVS Health’s community reach and experienced MinuteClinic providers to effectively deliver clinical trials in a way that improves patient access, engagement and retention to advance research effectiveness.
Despite the importance of clinical trials, less than four percent of Americans participate in clinical studies. Additionally, 30 percent of participants drop out before study completion, and 80 percent of studies do not meet enrollment deadlines. While industry efforts are making progress in closing the gap in African-American clinical trial participation, Asian, Hispanic and Latino groups also continue to be significantly and consistently underrepresented.
https://finance.yahoo.com/news/medable-cvs-health-announce-collaboration-142400589.html
NJ Gov ending school mask mandate
New Jersey Gov. Phil Murphy (D) will reportedly lift the mask requirement in state schools for both students and employees in March.
The New York Times reported that the mandate in New Jersey schools will end in the second week of March, roughly two years after the pandemic began.
One week ago, Murphy he signaled that his state will need to "learn how to live" with the COVID-19 pandemic.
"We're not going to manage this to zero. We have to learn how to live with this," Murphy said of the pandemic on NBC's "Meet the Press."
According to local news outlet NJ.com, 102,237 students and 28,583 school staff members have been infected this school year through the week ending Jan. 30.
The reported move to end the statewide mandate in New Jersey comes after federal officials approved the COVID-19 vaccine for children as young as 5 years old and Pfizer said it has begun applying for authorization for its COVID-19 vaccine for children ages 6 months to 4 years.
Cases in the U.S. have fallen drastically from the peak during the omicron wave in mid-January, from approximately 800,000 new cases per day to about 350,000 per day, which is still quite high.
Murphy's office did not immediately respond to The Hill's request for comment.
In Pennsylvania, Gov. Tom Wolf (D) will allow school districts to modify or end mask mandates for K-12 students starting on Jan. 17.
"Unfortunately, the COVID-19 virus is now a part of our daily lives, but with the knowledge we’ve gained over the past 20 months and critical tools like the vaccine at our disposal, we must take the next step forward in our recovery," Wolf said in December when he announced the changes.
Murphy's reported decision also comes at a time when pandemic fatigue is high among the U.S. population. A recent poll by Monmouth University found that a large majority of Americans, 70 percent, agreed that "it’s time we accept that Covid is here to stay and we just need to get on with our lives."
Multiple people arrested at 'Freedom Convoy' protests in Ottawa
Canadian authorities have arrested multiple people in Ottawa who were part of a “Freedom Convoy” protesting COVID-19 vaccine mandates.
In a statement on Sunday, the Ottawa Police Service said it has launched 60 criminal investigations from the protests, stemming from mischief, property crimes and thefts all the way to hate crimes.
According to The Washington Post, Ottawa Police said they have made seven arrests in relation to property damage and other acts of “mischief” as of Sunday evening.
Police also said that multiple vehicles and fuel have been seized during the protests, according to the statement.
Authorities also issued more than 500 tickets over the weekend for notices such as “excessive honking” and seat belt violations, The Post reported.
“More than 100 Highway Traffic Act and other Provincial Offence Notices were issued including excessive honking, driving the wrong way, defective muffler, no seat belt, alcohol readily available and having the improper class of driving licence,” OPS said in its statement.
The city of Ottawa declared a state of emergency on Sunday in response to the second week of protests against local COVID-19 restrictions.
"Declaring a state of emergency reflects the serious danger and threat to the safety and security of residents posed by the ongoing demonstrations and highlights the need for support from other jurisdictions and levels of government," Ottawa Mayor Jim Watson said in a statement.
Truck drivers starting last month were required to enter Canada fully vaccinated against the virus, following a similar requirement the U.S. government implemented on truck drivers entering the country.
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