VC Firm Flagship Raises $3.6B to Create, Support 25 ‘Breakthrough’ Companies

 Life sciences investment firm Flagship Pioneering announced Wednesday that it has raised $3.6 billion with an eye toward creating and advancing around 25 new “breakthrough” companies.

The raise consists of $2.6 billion that will go into Flagship Fund VIII, along with $1 billion in “side funds” which include sector-specific partnerships, according to the venture capital firm. Flagship will use the money to back companies working in AI, human health and sustainability.

The investment strategy is in line with Flagship’s funding priorities in recent years. Founder and CEO Noubar Afeyan in a statement pointed out that in the last six years, the life sciences incubator has “pioneered AI-enabled platforms that transform drug discovery, speed up the drug development process and gain new insights into human health and sustainability.”

“By leveraging the power and potential of generative AI, we’re embracing a future in which companies are created and expanded in ways we have not previously experienced, with the prospect for unprecedented impact,” Afeyan said.

With Wednesday’s announcement, Flagship has now raised $6.4 billion in total funding since 2021. The VC also has aggregate operating capital of $10.9 billion and $14 billion of assets under management. Since its last fund in 2021, Flagship has poured $5.8 billion of equity capital into its ecosystem of companies.

Flagship has created more than 100 companies to date, a roster that includes some prominent industry players such as Moderna, Sana Biotechnology and Denali Therapeutics.

More recently, Flagship launched Prologue Medicines and its proprietary DELVE platform, which looks through the viral proteome for therapeutic molecules. Powered by advanced computational techniques, the start-up can then assess the potential of these viral proteins to treat diseases. Prologue debuted in May 2024 with $50 million in backing from the life sciences incubator.

In June 2023, Flagship also unveiled Empress Therapeutics. Based in Cambridge, Massachusetts, the startup is focused on advancing small-molecule drugs by using the technological advancements from biologic drug development. Like Prologue, Empress entered the market with $50 million in funding from Flagship.

Many of Flagship’s startups have since gone on to partner with Big Pharma players. Last month, Flagship-backed ProFound Therapeutics inked a potential $7 billion contract with Pfizer to develop first-in-class therapies for obesity. In May 2024, Flagship’s Metaphore Biotechnologies entered into an obesity agreement with Novo Nordisk, leveraging its molecular mimicry approach to advance next-generation treatments.

https://www.biospace.com/article/vc-firm-flagship-pioneering-raises-3-6b-to-create-support-25-breakthrough-companies/

MSM Launches 'Muh Russia' Election Narrative As Brands Collude To Silence Dissent

 While the Democratic party melts down over Joe Biden's cognitive decline - an obvious risk to US national security, the 2024 election wouldn't be complete without a Trump-Russia narrative.

To that end, the Wall Street Journal reports that the Russian government has launched a 'whole-of-government" effort to influence the US presidential election in favor of Donald Trump - who, for some reason, Russia held off on invading Ukraine while he was president (and ostensibly wouldn't have sent $175 billion and counting in US aid to combat).

Citing unnamed 'senior US intelligence officials,' the Journal writes:

The officials didn’t mention Trump by name, but said that Russia’s current activity—described as covert social-media use and other online propaganda efforts—mirrored the 2020 and 2016 election cycles, when Moscow also favored Trump and sought to undermine Democratic candidates, according to U.S. intelligence agencies.

Of course, Russia's 2016 'influence campaign' amounted to roughly $100,000 in Facebook ads, which "didn’t reference any specific presidential candidate, or even the election itself," largely targeting BLM members and 'Pokemon Go' aficionados.

Insidious.

That said, the officials say that the activity witnessed so far this election cycle "isn’t on the scale or scope seen in 2016, when Russia’s actions included a hack-and-leak of Democratic Party emails, rudimentary cyber-probing of some state election systems and other actions intended to undermine Democratic nominee Hillary Clinton’s campaign."

Hacked emails, you say?

Edit: And as ZeroHedge reader 'The Wolverine' notes in the comments below: 'Remember that time Adam Schiff interviewed the President of CrowdStrike and refused to release the transcript for months and months?'

• Bombshell: Crowdstrike admits ‘no evidence’ Russia stole emails from DNC server

According to the new report, Russia is seeking to influence specific voting groups, including those in swing states, and promote divisive narratives while denigrating specific politicians, the anonymous US intelligence officials told reporters, without mentioning the specific voters or politicians who have been allegedly targeted.

But wait, there's more!

The Kremlin "is also working to influence members of Congress and is broadly seeking to undermine U.S. support for Ukraine in its war with Russia," according to the anonymous officials - one of whom said that Russia was the "pre-eminent threat" to the election, while Iran was a 'lesser threat at the moment,' and aims to be a 'chaos agent' by exacerbating social tensions.

"We have observed actors tied to Iran’s government posing as activists online, seeking to encourage protests, and even providing financial support to protesters," said Avril Haines, the director of national intelligence, in a separate Tuesday statement.

Brands Collude to Silence

While democracy grapples with this new Russia election malarkey, we can't forget that free speech threatens narrative control efforts.

To that end, the world's largest brands, owned by elites, are now colluding to control online speech, according to an interim staff report released on Thursday by the House Judiciary Committee.

The report details a coordinated effort by the World Federation of Advertisers (WFA) and its Global Alliance for Responsible Media (GARM) initiative to demonetize and suppress disfavored content across the internet.

The Power Players Behind GARM

The WFA, a global association representing over 150 of the world’s biggest brands and over 60 national advertiser associations, created GARM in 2019. This alliance quickly amassed significant market power, representing roughly 90% of global advertising spend, which amounts to nearly one trillion dollars annually.

GARM’s Steer Team reads like a who’s who of corporate America, including heavyweights such as Unilever, Mars, Diageo, Procter & Gamble (P&G), GroupM, AB InBev, L'Oréal, Nestlé, IBM, Mastercard, and PepsiCo. These corporations not only wield immense economic influence but are now revealed to be leveraging this power to control online discourse under the guise of "brand safety."

Collusion and Censorship

The Committee report details multiple instances of GARM’s coordinated efforts to influence and censor online content. Perhaps the most notable example is the recommendation for a boycott of Twitter following Elon Musk’s acquisition. GARM members, including Danish energy company Ørsted, were advised to pull their advertising from Twitter, a move that significantly impacted Twitter’s revenue. Internal emails show GARM's satisfaction with the result, with GARM leader Rob Rakowitz boasting about the impact on Twitter's financials.

"GARM recommended that its members 'stop all paid advertisement' on Twitter in response to Mr. Musk’s acquisition of the company. GARM’s internal documents show that GARM was asked by a member to 'arrange a meeting and hear more about [GARM’s] perspectives about the Twitter situation and a possible boycott from many companies." -House Judiciary Committee

Unilever was particularly miffed that Musk released internal communications which became known as the Twitter Files, specifically over the Hunter Biden laptop story:

"Unilever, through GARM, also expressed issues with Mr. Musk exposing the truth about how Twitter, prior to Mr. Musk’s acquisition, censored the Hunter Biden laptop story."

Spotify and its star podcaster, Joe Rogan, also came under GARM’s scrutiny. Despite not placing advertisements on Rogan’s podcast, GARM pressured Spotify to take action against Rogan for his comments on COVID-19. This included threatening to review Spotify’s entire Trust & Safety policies and pushing for a public condemnation of the platform.

"GroupM knew there was no brand safety concern because it did not buy advertisements on Mr. Rogan’s podcast, but it still sought to silence Mr. Rogan’s views anyway."

Meanwhile, "On February 10, 2022, Coca-Cola emailed Mr. Rakowitz regarding 'evaluating Spotify to better access the Joe Rogan Experience' and noting that the 'particular issue (misinformation) does not exactly fit cleanly into [Coca-Cola’s] policy."

Political Influence and Targeting Conservative Media

GARM's influence extends into the political realm as well. The report notes efforts by GARM and its members to flag a Trump campaign advertisement as misinformation during the 2020 presidential election. This advertisement, which questioned Joe Biden's debate performance, was scrutinized by Unilever and other GARM members, who pushed Facebook to take action against it.

Conservative news outlets have been particular targets of GARM’s exclusion lists, curated with input from biased organizations like the Global Disinformation Index (GDI) and NewsGuard. These exclusion lists disproportionately flag right-leaning sites such as Fox News, The Daily Wire, Breitbart News, New York Post, and The Federalist as purveyors of misinformation, thus cutting off their advertising revenue and limiting their reach.

Actually insidious...

https://www.zerohedge.com/political/its-time-again-msm-launches-muh-russia-election-narrative-brands-collude-silence-dissent

NATO To Launch Initiatives On Ukraine, AI, Disinformation, And Cyber

 by Daniel Teng via The Epoch Times,

U.S. National Security Advisor Jake Sullivan has revealed NATO, along with four partner nations, will launch new initiatives around Ukraine, artificial intelligence, disinformation, and cybersecurity.

“Each initiative is different, but the main goal is the same: Harness the unique strengths of highly capable democracies to address shared global challenges,” he told the NATO Summit Defense Industry Forum on July 9.

The latest initiative ties Australia, New Zealand, South Korea, and Japan to NATO’s changing focus and aim to modernise capabilities.

Mr. Sullivan said the group was overhauling its command structure so partner nations could “rapidly shift to [a] war footing” if needed and know where to take orders from.

Further, NATO will implement “regionally focused plans” to ensure the body has the weapons and force needed to confront threats from “any direction or even multiple directions at once.”

“This is about readiness,” he said. “Under the new model, allies will know how many troops they are expected to muster in a crisis—and how quickly. For example, within 10 days, allies could have 100,000 forces where they need to be.

“Within a month, that number would double. And in the ensuing weeks, it would grow to 500,000.

“That has never been done before. NATO has now done it.”

Mr. Sullivan said the alliance’s focus was about counteracting the military expansion from Russia, Iran, North Korea, and the Chinese Communist Party.

“What happens in Europe impacts the Indo-Pacific. What happens in the Indo-Pacific impacts Europe,” he said.

The “no limits” partnership between Moscow and Beijing has raised concerns that conflict in Ukraine could have ramifications in the Asia-Pacific.

“For us to think that we live in a sequestered part of the world that is not affected by those conflicts is, frankly, foolishness,” warned former Australian Attorney-General George Brandis, in a speech to the Australian National University.

Meanwhile, NATO Secretary General Jens Stoltenberg said the alliance would push for the 2 percent floor on defence spending to become a requirement going forward, not just an aspiration.

“This is a result of a collective decision and collective responsibility,” Mr. Stoltenberg said.

https://www.zerohedge.com/geopolitical/nato-launch-initiatives-ukraine-ai-disinformation-and-cyber

10X Genomics cut to Hold from Buy by Deutsche Bank

 Target to $25 from $55

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

Lantheus Surge On Medicare Proposal

 Lantheus stock rocketed to a 13-month high Wednesday after a Medicare proposal suggested hiking the reimbursement rate for diagnostic radiopharmaceuticals.

North Billerica, Mass.-based Lantheus Holdings (LNTH) makes diagnostics and drugs using radiopharmaceutical technology.

Oftentimes, the Centers for Medicare and Medicaid Services packages the cost for a diagnostic in this space with the drug. But that doesn't always adequately account for the cost of certain specialized tests, CMS said in its proposal. The agency proposes paying separately the cost of any diagnostic radiopharmaceutical that costs more than $630 a day.

"This update should address challenges for patients in assessing these prescribed nuclear medicine tests with higher-cost radiopharmaceuticals," the agency said.

https://www.investors.com/news/technology/lantheus-stock-nears-record-high-radiopharmaceutical-diagnostic-medicare/

Longeveron Regenerative Medicine Advanced Therapy (RMAT) Tag for Mild Alzheimer’s

 Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease. Lomecel-B™ is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer’s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B™ is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease.

https://www.globenewswire.com/news-release/2024/07/10/2911026/0/en/Longeveron-Announces-U-S-FDA-Grants-Lomecel-B-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-the-Treatment-of-Mild-Alzheimer-s-Disease.html#

Kazia Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma

 GBM AGILE trial data shows clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma

 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics. 

GBM AGILE STUDY
GBM AGILE is an adaptive phase II/III global trial sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world's foremost clinical, translational, and basic science researchers, from institutions such as Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute. The trial is designed to efficiently screen for and characterize the response of glioblastoma (GBM) patients to novel investigative agents. Utilizing a complex innovative design, Bayesian principles are applied to the primary endpoint (Overall Survival) comparison of the investigational agents to patients receiving Standard of Care (SOC) enrolled from the study start (also referred to as cumulative control population).  In general, secondary analyses and endpoints are assessed based on established statistical models in comparison to the control patients enrolled at the same time as the investigational agent (concurrent control population).

Paxalisib is the third drug candidate to complete its evaluation in the study and was evaluated in newly diagnosed glioblastoma patients with unmethylated MGMT promoter status as well as in patients with recurrent disease.

GBM AGILE Paxalisib Results

Kazia CEO, Dr John Friend stated, "We are excited to have shown a 3.8 month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard of care arm. Having comparable Overall Survival data across two independent studies is a compelling outcome in this difficult to treat glioblastoma population. We look forward to discussing possible approaches for an accelerated approval pathway for paxalisib with the FDA."

A total of 313 newly diagnosed unmethylated (NDU) patients and recurrent patients being treated at top US cancer hospitals were randomized in Stage 1 to either a paxalisib treatment arm (60 mg/day) or the SOC concurrent control arm from January 2021 to May 2022.  The cumulative control arm was enrolled from July 2019 (GBM Agile study start date) to May 2022.

For the primary analysis the median Overall Survival (OS) was 14.77 months for paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75).

For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the paxalisib arm (n=54) versus 11.89 months for concurrent SOC (n=46). In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months).

The secondary analysis results are consistent with the previously reported Company-sponsored phase II study, where median OS was 15.7 months (n=27) for paxalisib treated NDU patients compared to 12.7 months historically reported with temozolomide in this patient group (Wen 2022).

Paxalisib was well tolerated in GBM-AGILE, and no new safety signals were identified in this patient population.

An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for paxalisib (n=100). Similar results in this population have been reported in the other two drug candidates that have completed the GBM AGILE trial. Kazia is currently pursuing further analyses of this data to elucidate potential signals for further consideration.

Based on the totality of data available from all completed paxalisib clinical studies in newly diagnosed unmethylated GBM patients, Kazia will request a meeting with the US Food & Drug Administration (FDA) to discuss the results and determine if a potential path to accelerated approval is appropriate for paxalisib. 

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Full data including secondary endpoints from the paxalisib arm of the GBM AGILE study is expected to be presented at a scientific meeting later this year.

https://www.prnewswire.com/news-releases/kazia-therapeutics-announces-phase-iiiii-clinical-trial-results-for-paxalisib-in-glioblastoma-302193414.html