Regeneron, Illumina join $320m Truveta investment

 Regeneron and Illumina have joined a major investment in health data specialist Truveta that will support the creation of a major new genome project.

The two companies, along with 17 US health systems, will collectively take a $320 million stake in Truveta, with Regeneron putting up the lion's share (almost $120 million), while Illumina is contributing $20 million to its Series C.

The cash injection will go towards the Truveta Genome Project, which aims to compile genetic data on tens of millions of consented and de-identified volunteers to create what will be "the largest and most diverse database of genotypic and phenotypic information ever assembled," claims the company.

It will tap into Truveta's platform – based on electronic medical record data and updated daily – which covers more than 120 million people in the US, harvesting anonymised patient care information from tens of thousands of clinical care sites across most states.

The Regeneron Genetics Center (RGC) will use leftover biospecimens from routine lab tests to sequence up to ten million exomes – all of the exons in a genome that code for proteins – which, according to the biopharma company, will "accelerate drug discovery and transform patient care."

After the initial sequencing, the biospecimens will be stored to support future multi-omics sequencing studies, while Truveta and its partners will also use the data to advance drug discovery, improve clinical trials, and train artificial intelligence models.

The announcement comes hard on the heels of another population-based study involving the RGC. Last week, a major population proteomics study using UK Biobank patient samples, backed by 14 pharma companies, got underway on 600,000 patient samples.

"Just like volunteering to be an organ donor on your driver's license is a simple act of service with a profound impact, the Truveta Genome Project enables each of us to anonymously contribute to dramatically accelerate progress in discovering the science of humanity, improving the health of our families and communities, and lowering the cost of care," commented Truveta's co-founder and chief executive, Terry Myerson.

"Discoveries from smaller datasets have led to important new approaches to help prevent heart disease and restore hearing in children with certain forms of congenital deafness – it is so exciting to envision where a complete representative genomic dataset will guide us."

Regeneron said RGC will have exclusive rights to perform all research-related sequencing on samples collected under the collaboration, in addition to access to the de-identified electronic health record (HER) data provided by each of the consented study participants.

Meanwhile, Regeneron and Truveta said they plan to use the data in the development of new approaches for healthcare delivery and population health management.

"By combining Regeneron's expertise in genetics and drug development with Truveta's extensive phenotypic data and collaboration of leading US health systems, we hope to create the 'big data' that will empower the next generation of drug discovery, as well as enable new approaches to healthcare analytics and healthcare management," remarked Regeneron's chief scientific officer, George Yancopoulos.

https://pharmaphorum.com/news/regeneron-illumina-join-320m-truveta-investment

Merus and Biohaven Strike New ADC Collaboration

 

On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.

Late Sunday, the Dutch oncology company Merus and Connecticut-based Biohaven announced a co-development and licensing partnership that will leverage each company’s respective tech.

Under the terms of the deal, Merus will generate three antibodies—one of which is already in preclinical studies—and Biohaven will transform each of them into antibody-drug conjugates (ADCs) using the company’s in-house platform. Financial details were not disclosed.

Reactions from market analysts were warm if restrained. “We view the deal as an incremental positive, providing longer-term optionality to [Merus’s] pipeline,” wrote BMO Capital Markets analysts Etzer Darout and Lukas Shumway.

Merus, which finished 2024 strong with an FDA greenlight on its monoclonal antibody Bizengri for certain non-small cell lung cancers and pancreatic cancers, is set to get an undisclosed upfront payment and licensing fees from Biohaven from the first developed program coming out of the partnership. The collaboration also requires both companies to share in external development and commercialization costs.

Biohaven’s pipeline covers a range of conditions, but the deal with Merus is specifically aimed at cancers. “We believe this collaboration with Merus will accelerate our ability to create highly differentiated multispecific ADCs, leveraging Biohaven’s innovative conjugation and payload technologies to deliver optimized ADCs with the potential to significantly benefit patients across various cancer types through an enhanced efficacy and safety profile,” Brian Lestini, president of Biohaven’s oncology division, said in a statement.

Vlad Coric, M.D., Biohaven’s chairman and CEO, is speaking Monday evening at the J.P. Morgan Healthcare Conference in San Francisco. In addition to the new Merus partnership that could be up for discussion, Biohaven in December reported positive Phase I for an IgG-degrading treatment aimed at a variety of different autoimmune diseases, with other clinical trials on the backs of various treatments aimed at major depression, obsessive-compulsive disorder, and spinocerebellar ataxia also ongoing.

https://www.biospace.com/deals/merus-and-biohaven-strike-new-adc-collaboration

CDC Study Confirms Bird Flu Strain Very Mild; Mass Cull Tied to Chicken-to-Human Transmission

 By Nicolas Hulscher, MPH

The CDC study titled Highly Pathogenic Avian Influenza A(H5N1) Virus Infections in Humans was just published in The New England Journal of Medicine:

BACKGROUND

Highly pathogenic avian influenza A(H5N1) viruses have caused widespread infections in dairy cows and poultry in the United States, with sporadic human cases. We describe characteristics of human A(H5N1) cases identified from March through October 2024 in the United States.

METHODS

We analyzed data from persons with laboratory-confirmed A(H5N1) virus infection using a standardized case-report form linked to laboratory results from the Centers for Disease Control and Prevention influenza A/H5 subtyping kit.

RESULTS

Of 46 case patients, 20 were exposed to infected poultry, 25 were exposed to infected or presumably infected dairy cows, and 1 had no identified exposure; that patient was hospitalized with nonrespiratory symptoms, and A(H5N1) virus infection was detected through routine surveillance. Among the 45 case patients with animal exposures, the median age was 34 years, and all had mild A(H5N1) illness; none were hospitalized, and none died. A total of 42 patients (93%) had conjunctivitis, 22 (49%) had fever, and 16 (36%) had respiratory symptoms; 15 (33%) had conjunctivitis only. The median duration of illness among 16 patients with available data was 4 days (range, 1 to 8). Most patients (87%) received oseltamivir; oseltamivir was started a median of 2 days after symptom onset. No additional cases were identified among the 97 household contacts of case patients with animal exposures. The types of personal protective equipment (PPE) that were most commonly used by workers exposed to infected animals were gloves (71%), eye protection (60%), and face masks (47%).

CONCLUSIONS

In the cases identified to date, A(H5N1) viruses generally caused mild illness, mostly conjunctivitis, of short duration, predominantly in U.S. adults exposed to infected animals; most patients received prompt antiviral treatment. No evidence of human-to-human A(H5N1) transmission was identified. PPE use among occupationally exposed persons was suboptimal, which suggests that additional strategies are needed to reduce exposure risk. (Funded by the Centers for Disease Control and Prevention.)

https://petermcculloughmd.substack.com/p/new-cdc-study-confirms-current-h5n1

Russia, Iran To Sign 'Comprehensive Strategic Partnership' Treaty This Week

 Russia and Iran have unveiled plans to sign a "comprehensive strategic partnership" treaty on Friday when Iranian President Masoud Pezeshkian visits Moscow.

The two nations dubbed 'pariahs' by much of the West have seen their cooperation and relations grow in the context of the Ukraine war. "On January 17, Vladimir Putin will hold talks with the President of the Islamic Republic of Iran Masoud Pezeshkian, who will come to Russia on an official visit," the Kremlin announced Monday.

The much anticipated treaty has long been in the works, since at least last summer, news of which caused President Zelensky to say there's an axis of rogue states conspiring to defeat Ukraine. This has included North Korea as well, which has lost troops helping Moscow defend Kursk region.

As for the treaty to be signed by the week's close, it was previewed as heavily focused on defense and security cooperation. "It will confirm the parties' desire for closer cooperation in the field of defense and interaction in the interests of peace and security at the regional and global levels," Russian Foreign Minister Sergey Lavrov had earlier stated.

Putin with Iranian President Masoud Pezeshkian soon after the latter's election.

Putin and Pezeshkian in addition to signing the agreement are expected to discuss "prospects for the further expansion of bilateral cooperation, including in trade and investment, transport and logistics and the humanitarian sphere, as well as topical issues on the regional and international agenda," the Kremlin said.

Already, the two sides cooperate deeply on drones. Russia has since the Ukraine war's start been using Iran-produced 'Shahed' kamikaze drones against Ukrainian cities, and Iran has reportedly set up a major UAV production facility on Russian soil at Moscow's invitation. 

Moscow and Tehran early last month lost a key Middle East ally upon the fall of Bashar al Assad, after Islamic insurgents rampaged across the country and the demoralized and underpaid Syrian Army quickly collapsed. Turkey was widely seen as supporting the insurgents with intelligence and equipment, and likely other NATO states played a background role as well.

As for Iran, it sees the treaty as further safeguarding independence and national sovereignty:

Discussing the specifics of the deal, Jalali told Iran's state-run Young Journalists Club (YJC), "The independence and security of our country, as well as self-reliance, are crucial elements, and we are not particularly inclined to align ourselves with any specific bloc."

"National independence is of great importance to the Islamic Republic of Iran. After all, we have been paying the price for it for 45 years," he added in an article published Saturday.

But both countries have come under far-reaching US and EU sanctions for what's happening in Ukraine. Western intelligence has warned against the transfer of Iranian ballistic missiles to Russia in the context of the Ukraine war as well. While there have been some reports suggesting this has happened, there's as yet no definitive evidence.

https://www.zerohedge.com/geopolitical/russia-iran-sign-comprehensive-strategic-partnership-treaty-week

L.A. Residents Sue Edison Utility Over Potential Role In Palisades Fire

 Update (1320ET):

Energy company Edison International was sued on Monday for its alleged role in igniting at least one of the wildfires in Los Angeles County. 

Bloomberg reports, "The lawsuit is on behalf of a group of homeowners, renters, business owners and others with properties destroyed by the Eaton Fire in the Pasadena area," adding, "The suit alleges a Southern California Edison pole holding power lines was the cause of the blaze that leveled the town of Altadena."

X users said...

Shares of Edison International plunged 13% on Monday morning, bringing the total decline since the fires started nearly one week ago to 28%. The daily RSI (14D) has fallen to 7.9. 

Zooming in on the most oversold RSI ever... 

Edison did not comment on the suit that appeared on the Los Angeles Superior Court website on Monday morning. 

Meanwhile, it's only a matter of time before lawsuits are filed against the City of Los Angeles or even the State of California for gross negligence. These lawsuits will likely cite improper forest management, cuts to fire budgets, and the mishandling of the Palisades Reservoir, given that city officials knew very well about dry conditions and wind storms ahead of the first full week of the new year.

 *   *   * 

Firefighters are racing to contain three active wildfires in Los Angeles County as Santa Ana winds are forecasted to return Monday morning. The fires have scorched 40,000 acres, forced the evacuation of at least 150,000 residents, and claimed 24 lives. Residents are expressing outrage at far-left Democratic politicians in the county and state, blaming them for negligence in the spread of the Palisades Fire. At the same time, AP News tried to provide cover for Democrats and blame the fire's spread on 'climate change.' 

The National Weather Service has issued "Particularly Dangerous Situation" red flag warnings for the Ventura and Los Angeles counties through Wednesday. Gusts are expected to be between 50 and 65 mph, with dry air that will worsen conditions for firefighters and likely lead to more evacuations. 

There are currently three fires burning (list courtesy of LA Times): 

Palisades Fire:

Burned 23,713 acres and numerous homes, businesses and landmarks in Pacific Palisades and westward along Pacific Coast Highway, toward Malibu. As of late Sunday, the fire was 13% contained. Many parts of Pacific Palisades, Malibu, Santa Monica, Calabasas, Brentwood and Encino are under evacuation orders or warnings. More than 12,000 structures remain threatened. Officials estimate that more than 5,300 structures, including many homes, have been damaged or destroyed.

Eaton Fire:

Burned 14,117 acres and many structures in Altadena and Pasadena. Additional evacuation orders were mandated Thursday afternoon when fire climbed toward Mt. Wilson. Other mandatory evacuations were lifted as city officials notified residents in Glenoaks Canyon and Chevy Chase Canyon that it was safe to return to their homes. As of 8 p.m. Sunday, the fire remained 27% contained. Officials say 7,000 structures have been burned in the fire.

Hurst Fire:

Burned 779 acres in the area around Sylmar. Evacuation orders have been lifted. As of Sunday night, the fire was 89% contained, according to Cal Fire.

Fire Map (LA Times):

Latest Zero Hedge headlines:

• 10 Dead, 10,000 Structures Burned In Los Angeles Area Inferno As Fire Damage Could Exceed $150 Billion

• "Do Not Panic Buy": Officials Urge Calm As LA Fire Crisis Disrupts Main Fuel Pipeline To Las Vegas

• "We're Not Screwing Around": LA Sheriff Declares Curfew Amid Arson & Looting Chaos

• California-Based Insurer Crashes Amid Billions In LA Area Fire-Damage Losses

• Arson Threats A "Major Issue" In Wildfire-Ravaged Los Angeles County

• California Imposes 1-Year Insurance Cancellation Freeze In Areas Ravaged By Wildfires

• Palisades Fire Crisis Intensifies Ahead Of Windstorm Event Early Next Week

• Three Military Humvees, Machine Gun Mounts, Stolen Outside Of Los Angeles

• Palisades Fire Threatens New Upscale Communities As Santa Ana Winds Return

• California's Insurance Crisis Just Got A Whole Lot Worse

• AP News Heavily Ratioed For Blaming Palisades Fire On Climate Change

• Why Was Pacific Palisades Reservoir Empty? It Gets Worse...

Latest LA Times headlines:

• Increasing winds bring potential for 'explosive fire growth' across LA County this week

• Death toll from Palisades and Eaton fires climbs to 24. 

• Newsom to deploy an additional 1,000 National Guard members to LA.

• Investigators study Eaton Canyon electrical tower area as possible origin of Altadena fire

On Sunday, Captain Andrew Cruz from the LA County Sheriff's Incident Management Team said a curfew in the fire zones remains in place. 

"Nightside, we continue to support the efforts here at the Palisades Fire with 104 sworn personnel plus 16 National Guard soldiers," Cruz said.

Looters were out in force over the weekend, ransacking mansions in the Palisades area despite police and National Guard deterrence.

"Yes. Please be careful in some areas, as there is non-zero risk of armed looters. Cybertruck side panels are bulletproof to subsonic projectiles (handguns, shotgun & Tommy gun), but the glass is not, so make sure to duck if you see anyone wielding a gun. This is not fiction," Elon Musk wrote on X. He noted earlier, "We are going to position Cybertrucks with Starlinks and free WiFi in a grid pattern in the areas that most need it in the greater LA/Malibu area." 

Palisades transformed into an inferno. 

The debate over gross negligence centers on why the Palisades Reservoir was not filled before the fire.

"Incompetence in the limit is indistinguishable from sabotage," Musk wrote on X. He's referring to LA Mayor Karen Bass and Gov. Gavin Newsom. There's a lot of controversy about fire budget cuts and the mismanagement of resources. 

For the households that lost everything, it's time to hold the radical leftist politicians in charge accountable. This is unacceptable.

https://www.zerohedge.com/weather/inferno-plagued-palisades-braces-santa-ana-windstorm-death-toll-rises

Moderna cuts sales forecast on weaker vaccine demand

 Moderna (MRNA) cut its 2025 forecast by $1 billion Monday, citing weak demand for its newest vaccine as well as slow sales for its COVID-19 vaccine.

The company now expects $1.5 billion to $2 billion in revenue for 2025. Moderna's stock slid more than 20% in early trading Monday on the news to $33.05 per share — a fraction of its COVID highs of nearly $450 per share in 2021.

CEO Stéphane Bancel revealed the forecast at the annual JPMorgan healthcare conference in San Francisco and noted the company would continue its cost-cutting strategies into 2025

"In 2024, we achieved $3 billion to 3.1 billion in product sales, approval of our RSV vaccine, and continued to adapt our COVID-19 business for the endemic setting. At the same time, we reduced our cash operating cost by over 25% compared to 2023 and aim to reduce 2025 cash costs by $1 billion with a plan for an additional $500 million cost savings in 2026," Bancel said in a statement.

The 2024 winter virus season has seen slower respiratory vaccine demand, including for COVID and RSV, which most severely impact children and elderly adults. Moderna launched its RSV vaccine last year, following earlier approved vaccines from Pfizer (PFE) and GSK (GSK).

Walgreens' (WBA) earnings results for fiscal year 2024 last week also signaled a vaccine demand slowdown that could hit other vaccine makers during the upcoming earnings cycle. The retail pharmacy giant reported fewer than 1 million COVID vaccine sales in fiscal 2024, compared to 4.7 million in the previous year.

Analysts caution there could be more pain ahead for the once-thriving biotech.

Leerink Partners analyst Mani Foroohar noted that in addition to the sales guidance, two other products in the company's pipeline aren't looking strong in the near term.

"We are not surprised to see the stock down over 20% given (1) reduced FY24 sales guidance, (2) lack of clarity on COVID/flu combo, and (3) miss on interim CMV efficacy. All represent headwinds to growth prospects in 2025 — with CMV the largest single line-item at risk among the three — putting risk of future dilutive equity issuance on the table as return to profitability looks increasingly remote, and MRNA’s position in the S&P500 increasingly tenuous," Foroohar wrote to clients Monday.

https://finance.yahoo.com/news/moderna-cuts-sales-forecast-on-weaker-vaccine-demand-162509497.html

Blue Owl Leads Around $4 Billion Debt Deal for PCI Pharma

 

• Would mark one of the biggest private credit deals this year
• Transaction is for refinancing debt and a new term loan

Blue Owl Capital Inc. is leading a private credit transaction of roughly $4 billion for PCI Pharma Services, according to people with knowledge of the matter, in what would be one of the largest direct lending deals of the year.

The transaction includes an approximately $3 billion unitranche loan that would refinance the company’s existing debt, the people said, asking not to be named discussing a private transaction. In addition, lenders are in discussions to provide a delayed-draw term loan of more than $1 billion, though the size could still change, they said.

https://www.bloomberg.com/news/articles/2025-01-13/blue-owl-leads-around-4-billion-debt-deal-for-pci-pharma