Search This Blog

Tuesday, November 1, 2022

Pfizer falls short with infant respiratory vaccine

 Pivotal data from Beyfortus, Sanofi and Astrazeneca’s preventative respiratory syncytial virus antibody for infants, left the door open for Pfizer and its candidate, RSVpreF. But mixed topline results from a maternal protection trial suggest that Pfizer has failed capitalise on the opportunity. The Matisse study only met one of its two co-primary endpoints, evaluating severe medically attended lower respiratory tract illness, failing on less severe illness. As ever, cross-trial comparisons are tricky, particularly as it is unclear how Pfizer defined severe versus less severe disease. But on the face of it RSVpreF looks to have fallen short of the bar set by Beyfortus. Pfizer did not give details on hospitalisations, a secondary endpoint of its study. The infant RSV market is expected to be smaller than the adult segment, with SVB analysts seeing peak sales of $2.7bn versus $6bn respectively; Pfizer and GSK are already fighting it out in adults. If Sanofi and Astra are to prevail commercially it will take a shift in mindset, but the groups are adamant that any infant could receive Beyfortus, regardless of risk. And Sanofi’s head of vaccines, Jean-Francois Toussaint, previously told Evaluate Vantage that Beyfortus would be “priced like a vaccine”.

Cross-trial comparison of RSVpreF vs Beyfortus
 RSVpreF, MatisseBeyfortus, Melody
 90 days6 months150 days
Reduction in medically attended LRTI57%*51%*75%
Reduction in severe medically attended LRTI82%69%N/A
Reduction in hospitalisationsN/AN/A62%*
*Not statistically significant vs placebo. Source: Company release & NEJM.

 

Late-stage infant RSV prevention pipeline 
ProjectCompanyDescriptionDetails 
Nirsevimab (SP0232)Sanofi/AstrazenecaFusion antibodyEU CHMP recommendation Sep 2022; FDA filing due Q4 2022
RSVpreF (PF-06928316)PfizerProtein subunit vaccine, unadjuvantedMatisse toplined Nov 2022, FDA filing due Q4 2022
Clesrovimab (MK-1654)Merck & CoFusion antibodyPh3 MK-1654-007 in high-risk infants ends 2025; ph2/3 MK-1654-004 in healthy infants, ends 2024
RSVPreF3 (GSK3888550A)GSKProtein subunit vaccine, unadjuvantedDiscontinued
Source: Evaluate Pharma & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/trial-results-snippets/pfizer-falls-short-infant-respiratory-vaccine

Rocket Pharma started at Buy by BTIG

 Target $35

https://finviz.com/quote.ashx?t=RCKT&p=d

HI-Bio Launches with $120M and Two MorphoSys Assets in Immune-Mediated Space

 With $120 million in backing, Human Immunology Biosciences (HI-Bio) launched two assets licensed from MorphoSys AG aimed at severe immune-mediated diseases.

Felzartamab, an anti-CD38 antibody, targets a protein expressed on the surface of mature plasma cells whose dysfunction drives multiple immune-modulated diseases. 

It is believed that felzartamab can deplete plasmablasts and plasma cells, which will remove cells that produce disease-causing autoantibodies, the company noted. HI-Bio plans to evaluate felzartamab for two kidney diseases, antibody-positive membranous nephropathy ( aMN) and IgA nephropathy (IgAN).

Prior to the licensing deal, MorphoSys had already conducted early clinical work. Interim data from a Phase IIa study announced last year showed felzartamab has the potential to rapidly and substantially reduce anti-PLA2R auto-antibody titers, which are serological markers for aMN. 

The other asset, HIB210, is an anti-C5aR1 antibody. HI-Bio is running HIB210 in a Phase I program assessing the drug candidate's safety. The company intends to evaluate the drug in multiple programs for immune-mediated diseases.

HI-Bio holds exclusive worldwide rights for felzartamab, except for China, and exclusive worldwide rights, except for China and South Korea, for HIB210.

Beyond MN and IgAN, HI-Bio did not specifically identify any diseases within the space it was targeting.

The company noted that many of these diseases are caused by cellular dysfunction, particularly within plasma cells, neutrophils, mast cells and other cells responsible for the secretion of antibodies, signaling mediators, tissue repair and allergic responses.

HI-Bio expects its drug programs to target, modulate or deplete these cellular drivers of disease with therapeutics.

Travis Murdoch, chief executive officer of HI-Bio, said immune-mediated diseases "represent a landscape where the scale of unmet need and potential patient benefit is truly enormous."

As much as 4% of the world's population may have one of these immune-mediated diseases, HI-Bio noted in its announcement.

The company claimed that few targeted therapies are available for autoimmune, allergic and inflammatory diseases that can be referred to as immune-mediated diseases.

Many of the therapies that are available for these patients are considered broad-acting and do not address the root causes of the disease. HI-Bio estimates the unmet medical need of this community of patients could be valued at $150 billion by 2025. 

Beyond the two assets licensed from MorphoSys, HI-Bio's developmental programs are backed by a technology that incorporates human genetics, human immunophenotyping, data sciences and therapeutic engineering. 

The toolkit harnesses insights from R&D efforts to profile the immune phenotypes that drive IMDs, according to the company. 

Beyond Murdoch, the HI-BIO executive team includes Matthew Albert, chief translational officer, Ariella Kelman, senior vice president of development and Jaideep Dudani, head of portfolio development.  

As part of the deal, MorphoSys has taken a 15% stake in HI-Bo. 

The financing was backed by ARCH Ventures, Jeito Capital, Monograph Capital and other unnamed investors. 

For France-based Jeito Capital, the investment in HI-Bio is the firm's first in the United States and the eleventh to date. 

https://www.biospace.com/article/hi-bio-launches-with-120-million-and-two-morphosys-assets/

Pentagon Confirms US Boots Are On The Ground In Ukraine

 Two bombshell reports by the Associated Press and Washington Post Monday and Tuesday have confirmed that the United States has boots on the ground in the Ukraine conflict. Crucially, these troops are performing tasks separate from mere embassy security. 

The American troops are said to be performing "inspections" of US weapon caches after last week the State Department and Pentagon unveiled a new plan to track US-supplied weapons in efforts to implement accountability for the billions of dollars worth of arms and ammunition transferred to Ukrainian forces since near the start of the war eight months ago.

"A small number of U.S. military forces inside Ukraine have recently begun doing onsite inspections to ensure that Ukrainian troops are properly accounting for the Western-provided weapons they receive, a senior U.S. defense official told Pentagon reporters Monday," the AP/WaPo reporting revealed.

A Pentagon briefing confirmed this "small" contingency of troops has been advised to not do inspections "close" to the front lines of fighting

The official, who spoke on condition of anonymity to provide a military update, would not say where the inspections are taking place or how close to the battlefronts the U.S. troops are getting. The official said U.S. personnel can’t do inspections "close to the front lines," but said they are going where security conditions allow.

There have already been "several inspections" overseen by U.S. Defense attache and a US Office of Defense Cooperation team based out of the Ukrainian capital. The report underscores that "U.S. President Joe Biden has ruled out any combat role for U.S. forces inside Ukraine." 

However, what's clear is that despite the White House's ruling out of "combat" troops, this is the start of perhaps inevitable 'mission creep' - as has been seen in other conflict zones (such as Syria). If US troops are doing inspections of Ukrainian arms and ammo, and presumably Russia is currently targeting any and all Ukrainian military bases, this puts American troops and assets in Russia's crosshairs, greatly increasing the possibility that the US and Russia could stumble into a direct shooting war.

In a follow-up Tuesday report, The Washington Post detailed the following

U.S. monitors have conducted in-person inspections for only about 10 percent of the 22,000 U.S.-provided weapons sent to Ukraine that require special oversight.

U.S. officials, who spoke on the condition of anonymity to provide details that have not been made public previously, said they are racing to deploy new means for tracking weapons seen as having a heightened risk of diversion, including Stinger surface-to-air missiles and Javelin antitank missiles, amid what they describe as Ukraine’s "super hot conflict."

National Security Council spokeswoman Adrienne Watson says the Ukrainians have been cooperating as willing partners in weapons accountability and implementing measures ensuring proper chain of custody. "While we recognize the unpredictability of combat, the United States and Ukraine have cooperated to prevent illicit weapons diversion since Russia’s further invasion began earlier this year," she said.

Like with Syria before, it's likely the White House and Pentagon will carefully avoid acknowledging wording like "boots on the ground" in their press statements...

The initiative is broadly being seen as part of Biden admin efforts to assuage Republican anger in Congress, after complaints have grown louder over the unaccountable "wild West" way in which Pentagon weapons have proliferated in Ukraine - as even CNN months ago underscored

This week Finland has been among the first European countries to document the spread of West-supplied weaponry outside of Ukraine's borders and into the hands of criminal elements, as we detailed previously"Weapons shipped [by various countries] to Ukraine have also been found in Sweden, Denmark and the Netherlands," Finland's federal National Bureau of Investigation chief Christer Ahlgren was quoted by national broadcaster Yle as saying.

Russia has already long warned it will attack foreign weapons shipments, transport convoys, and warehouses found in Ukraine... but how long before Russian forces target American military inspectors on the ground behind the front lines? The longer the grinding conflict drags on, the greater potential for such a disastrous scenario, whether intentional or not.

* * *

While at this point we could rightly call the Ukraine conflict a "proxy war" between Russia and US-NATO, all signs point to a steady slide into direct conflict. Now that Pentagon "inspectors" are confirmed on the ground in Ukraine (notably without any Congressional vote), expect the White House to vehemently deny that this marks any level of an escalation as far as Washington's direct involvement... again, despite the evident danger of American soldiers placed in "harm's way" - potentially being under Russian bombs.

https://www.zerohedge.com/geopolitical/pentagon-confirms-us-boots-ground-ukraine-close-front-lines

Anika Therapeutics Cingal Tops Steroid For Osteoarthritis Pain Relief

 

  • Anika Therapeutics Inc  announced that Cingal met its primary endpoint in a Phase 3 Study (Cingal 19-01), demonstrating superiority over triamcinolone hexacetonide (TH) steroid alone at 26 weeks post-treatment. 
  • Cingal is a combination product of cross-linked hyaluronic acid (HA) proven to provide long-lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief to treat the pain of knee osteoarthritis (OA). 
  • Cingal is currently sold in more than 35 countries outside the U.S.
  • Anika will engage with the FDA on the next steps for U.S. regulatory approval in the coming months. 
  • In parallel, Anika is exploring the potential to advance Cingal through commercial partnerships in the U.S. and select Asian markets.
  • In addition, Cingal demonstrated strong performance for pain reduction with 66% improvement in Pain Index (-44.3mm from baseline), and 90% of subjects were deemed to be OMERACT-OARSI Responders, a recognized method of evaluating responder rates based on improvement in pain and function.
  • Cingal was well-tolerated in the study, with only transient and non-serious adverse events (e.g., arthralgia, injection site pain, swelling, stiffness) related to the study injections.

Ukrainian Air Force says it has no effective defense against ballistic missiles Iran plans to ship to Russia

 Ukraine’s Air Force on Tuesday said it currently has no effective defense against the types of ballistic missile that Iran is preparing to ship to Russia to use in its war against Ukraine.

Yuriy Ihnat, spokesperson for Ukraine’s Air Force Command, said the range of the Iranian ballistic missiles being supplied, with “one having a range of 300km the other 700km,” will allow Russian forces to strike anywhere inside Ukraine.

“There is a high probability that they will be delivered to the north above Ukraine [border], from where they can be launched to threaten the entire Ukraine,” Ihnat said at a press conference in Kyiv on Tuesday.

Earlier on Tuesday, CNN reported that Iran is preparing to send about 1,000 additional weapons, including surface-to-surface short range ballistic missiles and more attack drones for Russia to use against Ukraine. 

Asked whether Ukraine’s Armed Forces were ready to defend against these types of Iranian ballistic missiles, Ihnat replied that they “will take all measures and means of protection against these missiles” that they can. 

However, Ihnat warned “currently we have no effective defense against these missiles. It is theoretically possible to shoot them down, but it is very difficult to do it with the means we currently have.” 

Ihnat said he believed Russia is being sent the Iranian ballistic missiles to boost its dwindling supply of Russian-built Iskander-M missiles.

“It is obvious that these missiles are coming to them to supplement these Iskanders, because they are actually running out of Iskanders,” he said.

Mykhailo Podolyak, adviser to the head of the Office of the President of Ukraine, called Tehran “an accomplice of aggression.”

“Transferring missiles to the Russian Federation, Iran knows that it will attack our cities. Teaching Russians to use drones, it knows that they will attack Ukraine’s energy sector, provoking waves of refugees to EU,” he tweeted.

https://www.cnn.com/webview/europe/live-news/russia-ukraine-war-news-11-01-22