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Platform Technology Designation Program for Drug Development
https://www.fda.gov/media/178938/download
Just a reference back to the SNY/NVAX deal when I was skeptical of combining two protein-based vaccines (one adjuvanted) from two different developers and it's clear I'm long Moderna.
As you may already know I have more confidence in the safety and tolerability of mRNA combination vaccines as opposed to protein-based. We will know more this quarter (fingers crossed).
Let's face it, the threat of mRNA combination vaccines forced companies like GSK, PFE, and SNY to explore the idea of combinations to remain competitive.
Second US worker infected with cow-linked bird flu
What if Nuvaxovid isn't approved in the U.S. by the 2025/2026 season? If you have followed NVAX in the past don't say this can't happen.
These "candidate vaccines" will soon be relics of the past. They are admittingly less than perfect. mRNA vaccines are the solution where a perfectly matched vaccine can be designed within a day. The government needs to put together a consortium of mRNA contract manufacturers willing and able to step into a wartime production footing in case of an outbreak.
The author makes a good point concerning egg cultured vaccines and bird flu. Not a desirable combination. However he's wrong about the storage requirements of mRNA vaccines. Moderna's latest vaccines are refrigerator stable.
Well, that explains the price action
Moderna and Pfizer In Talks With U.S. To Make a Bird Flu Vaccine
Moderna and Pfizer are in talks with the federal government over a potential avian flu vaccine program, the head of the U.S. government’s pandemic response administration said late Wednesday.
The disclosure came amid a run-up in shares of vaccine makers. Moderna stock spiked in Wednesday trading, climbing 13.7% over the course of the day amid swelling concerns over the avian influenza outbreak in U.S. cattle.
After the market closed, the Assistant Secretary of Preparedness and Response at the Department of Health and Human Services, Dawn O’Connell, said on a press call that the agency is in conversation with both Moderna and Pfizer about making avian influenza vaccines using messenger RNA-based technology.
“We continue to have active conversations with both manufacturers, and the negotiations are ongoing,” O’Connell said. “We are looking to wrap this up and have something to say very soon.”
Moderna confirmed to Barron’s that the company is in discussions with the federal government about “advancing our pandemic flu candidate.”
Pfizer did not immediately respond to a request for comment.
O’Connell also said that the agency last week had begun the process of converting 4.8 million doses of avian influenza vaccine from bulk product in the government’s stockpile to finished doses ready to be administered.
She said that the filling of the doses would not disrupt the production of seasonal flu vaccines. “It takes a couple of months to be able to fill and finish vaccine doses,” O’Connell said. “So we had these already in hand in bulk, but thought it mades sense, given what we were seeing.”
The Wednesday press call came shortly after the Centers for Disease Control and Prevention announced the second known human case of the virus since it was detected in late March in dairy cattle.
There are no immediate signs that the virus is about to cause a human pandemic, and the Centers for Disease Control and Prevention says that the current public health risk remains slow.
Still, the second human case in the U.S. came amid an ominous drumbeat of news headlines, including a report on Wednesday of Australia’s first-ever human avian flu infection. Investors appear to be looking ahead to a possible avian influenza vaccination campaign.
Moderna, which became a household name in 2020 with its quick work developing a Covid-19 vaccine, hasn’t made any recent announcements on its work on a human avian influenza shot. Last year, the company began early-stage tests of a number of avian flu vaccines that target different strains of the virus.
The stock, however, keeps going up. Moderna shares have climbed 20% just this week, and 45% since the end of last month. In an email to investors midday on Wednesday, Mizuho healthcare equity strategist Jared Holz wrote that new worries over bird flu were having a major impact on vaccine stocks in general, and Moderna in particular.
“MRNA has already gained $20bn in market cap in just the past week alone, we believe in large part to the increased focus on this bird-flu situation,” Holz wrote.
Other vaccine stocks are climbing as well. Shares of CureVac, which, like Moderna, develops messenger RNA-based vaccines, were up 21% on Wednesday. Shares of Novavax which makes a Covid-19 vaccine, were up 6.3%. Even vaccine stalwarts like GSK
and Sanofi saw their American depositary receipts climb slightly on Wednesday, and Pfizer shares were up 2%.
In response to a question from Barron’s earlier on Wednesday, Moderna confirmed that it is testing a vaccine that targets an avian influenza virus in the same family as the one causing the current outbreak in a continuing Phase 2 study. According to a federal registry of clinical trials, the trial should be completed in July.
The number of dairy farms with confirmed cases of the avian influenza virus known as H5N1 continues to rise, and was up to 51 as of midweek, according to the U.S. Department of Agriculture. Public health officials have long feared H5N1 for its potential to cause a human pandemic, and the unprecedented spread of the virus through these domestic cattle herds has put federal agencies on high alert.
As Barron’s reported in April, the U.S. has had a program in place for roughly two decades to prepare to vaccinate Americans if H5N1 or a similar virus were to begin spreading among humans. That program, however, likely wouldn’t be able to produce enough doses to protect the entire population in a pandemic emergency.
Unlike the 2020 federal government effort to roll out a Covid-19 vaccine, in which the government funded private companies to develop their own shots, the pandemic influenza program is aimed at creating a government shot using components made under contract by multiple manufacturers.
Today, federal stockpiles hold some finished vaccine doses, and building blocks that could be used to make many more. GSK and CSL Seqirus, under contract with the Department of Health and Human Services, are currently testing vaccines that target a strain of H5N1 that is closely related to the one currently circulating in dairy cattle. Sanofi is also involved in the government program.
Federal officials told Barron’s in March that in the event of a pandemic, they would be able to supply 135 million doses over the course of four months. Since the vaccine requires two doses, that would only be enough to inoculate roughly 68 million people in a country of more than 330 million.
O’Connell’s announcement Wednesday indicated that the government has begun to prepare that supply for a potential rollout.
Drugmakers and the government are limited in their ability to begin making H5N1 vaccine doses before a pandemic begins because doing so could threaten the production of the seasonal influenza vaccines, which is done in the same facilities.
Moderna hadn’t been part of the government’s pandemic vaccine stockpile program. it isn’t clear what role the company might play if an avian influenza pandemic were to emerge.
Analysts weren’t convinced by Wednesday’s rally. “We expect shares to retrace today’s gains (barring very unlikely emergence of a H5N1 pandemic) as focus returns to fundamentals,” Leerink Partners analyst Mani Foroohar wrote of Moderna in a Wednesday note.
In conclusion, § 1498 does not apply to private commercial activities in which private companies
manufacture and sell products for use by private parties in the marketplace.
I heard CEO Stephane Bancel discuss this patent exclusion and it's clearly the company's position as a plaintiff seeking damages from PFE.
As far as royalty rates go I would guess mid-single digits is a best case scenario for ABUS but we are speculating here.
only focusing on COVID vaccine sales in regards to their litigation, we're talking Pfizer sales of $100b+ and Moderna $40b+
Just an observation on NVAX. They filed their 10-Q and the 8-K for their earnings release yet what's notably absent is the 8-K announcing the SNY deal (as of the time of this post). Anyone care to guess why?
I suspect some developers, more specifically protein-based vaccine developers, are frontrunning this decision and are already manufacturing JN.1 COVID vaccine to give the appearance they are competitive in development time and scalability yet if there was another pandemic it would become clear they are not due to time constraints.
Just an observation on NVAX. They filed their 10-Q and the 8-K for their earnings release yet what's notably absent is the 8-K announcing the SNY deal (as of the time of this post). Anyone care to guess why?
SNY must believe either that the NVAX platform can enable you to pick a flu strain on VERY short notice
SNY will commercialize NVAX’s existing COVID vaccine and will develop a combination COVID/flu vaccine incorporating NVAX’s “Matrix-M” adjuvant technology
The Moderna presentation yesterday showed some alarming healthcare data. COVID vaccine rates this year in the U.S. are running at one quarter that of flu while COVID hospitalization rates are twice as high. Providing protein-based vaccines doesn't seem to be fully filling the gap in compliance. This could mean the FDA is seeking other ways to boost vaccine numbers this season. P3 data for mRNA-1083, the flu/covid combo will be released this quarter. If the combo can demonstrate non-inferior efficacy and equivalent safety to both mRNA-1010* (flu) and mRNA-1283 (next-gen COVID) it could potentially be considered for EUA in this calendar year.
*mRNA-1010 showed superiority to an active comparator in P3 and a filing is expected this year. mRNA-1283 expected to receive EUA.
I don't want you further upsetting NVAX investors
PFE/MRNA—1Q24 COVID-vaccine worldwide_market_share—>68/32 in favor of PFE.
The remaining 93% is the CVD market for which no generic has an FDA-approved ANDA or sANDA.
with patient’s insurance permitting Amarin to maintain a 57% market share against 5-6 generics who have no sANDA approved by FDA for Vascepa treatment of the much broader CVD indication.
continued clinical advancement of the ex-vivo oncology construct CT-0525+Pembro in HER2+ solid tumors.
CARM belatedly released their earnings on April 1ST. No accounting issues were at hand yet the company did announce a cost cutting restructuring (pipeline and workforce) along with the resignation or perhaps removal of a director. During the two year working relationship with Moderna the company seems to have come to the revelation that they are a Car-Monocyte platform company as opposed to a company focused on ex-vivo CAR-Macrophages in oncology. Their analogy is Car-Mono works like a pro-drug of Car-Macro, monocytes are being converted into macrophages within tissue, with a 5x higher dosing advantage and one day development time as oppose to five days for Car-Macro.
https://ir.carismatx.com/static-files/6fb480b2-625c-4101-9118-a0623cac87ef
There's a lot to discuss on slide 6 of the 04/24 investor presentation. The prudent cost cutting measure of halting development of CAR-Macro CT-0508 makes sense along with the continued clinical advancement of the ex-vivo oncology construct CT-0525+Pembro in HER2+ solid tumors. What doesn't make sense is labeling CT-1119 a "Next-Gen CAR (*using SIRP knockdown technology)", which targets mesothelin+ solid tumors, yet at the same time halting pre-clinical development of this program while advancing an unnamed CAR in liver fibrosis which is still in the discovery stage. For now CT-1119 only looks good as a CAR-Mono pipeline placeholder in a company trying to rebrand itself. How else can they make themselves look good? Would it be in CARM's best interest to make their sole development partner look bad?
Two years ago MRNA signed an exclusive, worldwide, in-vivo, CAR-Monocyte license for twelve co-developed constructs in oncology.
https://www.prnewswire.com/news-releases/moderna-and-carisma-establish-collaboration-to-develop-in-vivo-engineered-chimeric-antigen-receptor-monocytes-car-m-for-oncology-301456651.html
If you look at slide 6 you will see the two MRNA partnered constructs are listed as CAR-Macrophages in their pipeline. Carisma goes through great lengths to downplay their ex-vivo CAR-MACRO constructs and highlight their ex-vivo CAR-Mono constructs yet it appears there's a chance the partnered constructs may be mislabeled. If they are mislabeled is MRNA aware, perhaps condoning mislabeling for competitive purposes? Or is there a legal disagreement that may have led to the late 10-K filing in which CT-1119 is shelved and a director axed? You can read through the entire now released CARM 10-K and you will never see "Moderna" and "CAR-Monocyte" in the same sentence. Only the ambiguous, generic term CAR-M which is highly subjective.
BTW the company refuses to answer my questions on this topic.
(EGRX)—For reasons that are unclear to me, more and more biotech companies are failing to file SEC reports on time; here’s the latest instance
Thoughts and observations on CARM
This is a restructured company through a reverse merger one year ago this month. The last three quarters they released their earnings on the 23RD of May, August, and November respectively. Now they are a month late reporting out their fourth quarter. Why the delay? It's hard to imagine that there could be a restatement or a earnings related issue after one year. Maybe just a small cap. company wrestling with putting together their first annual 10-k filing?
Another interesting development is that ABBV reported a 6.8% stake on the 13TH of this month. To my knowledge ABBV has no outstanding business relationship with this company.
The price and volume action on the stock doesn't indicate anything is afoot but the late filing and the ABBV sake taken together is intriguing, Thoughts or comments?
https://www.sec.gov/Archives/edgar/data/1485003/000110465924033949/tm248577d1_sc13g.htm
Enrollment was delayed by mismanagement of some trial sites by the CRO
It was licensed from Ligand if that helps w the patent search
Didn't you make the call on VRUS years ago?
Feel free to chime in if you have any players you like in hep B
to me no one seems particularly close
If two cohorts were closed prematurely wouldn't this be documented under "History of Changes"?
Notably, VAXX closed two of the four cohorts in this trial prematurely
Further, Paxlovid is expected to receive full FDA approval (rather than just an EUA) soon, which will enable PFE to market the drug more aggressively.
Do you know of a competitor drug that is far superior?
No but that's my point. Sometimes a flawed drug can dominate the market.
Paxlovid is a crappy drug. Anyone who launches the next gen without the DDIs and with convenient dosing is going to own the market like Tamiflu owned flu.
Spreading your wealth between reputable brokers is the right strategy but this option is being taken away from investors through anti-competitive mergers like the TD Ameritrade/Schwab deal. There's no benefit for clients while insurance levels are being cut in half (if you did business with both). Fortunately the deal is still being challenged on the individual level after being shoehorned in by the Trump DoJ.
https://news.bloomberglaw.com/antitrust/schwab-ordered-to-face-suit-seeking-to-unwind-td-ameritrade-deal