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Friday, April 25, 2025

Why Biotech Stars Summit Therapeutics and BioNTech Plunged, Even as Chinese Rival Surged

 Shares of biotech companies involved in the development of monoclonal antibody cancer therapies were moving all over the place on Friday. Both U.S.-based Summit Therapeutics (NASDAQ: SMMT) and BioNTech (NASDAQ: BNTX) were down significantly, plunging 36.1% and 15.4%, respectively, in Friday's trading.

The severe moves were likely related to a Chinese rival in the PD-1/VEGF bispecific antibody area, Akeso (OTC: AKES.F), receiving FDA approval for a cancer drug that utilizes similar technology, as well as an additional approval in China. As a result, Akeso shares were up 11.7% on Friday.

Of note, Akeso is also a close partner of Summit, making the divergent moves all the more interesting.

Today, Akeso announced that the Food and Drug Administration (FDA) had approved penpulimab-kcqx, Akeso's first internally developed biologic drug, for the treatment of nasopharyngeal carcinoma (NPC), a type of cancer that develops near one's sinuses. In addition, Akeso also disclosed it had received approval for ivonescimab by China's National Medical Products Administration (NMPA) for use against PD-L1-positive non-small cell lung cancer.

Of note, bispecific antibodies use proteins to block receptors in immune cells that cancers target to stop the immune system from responding, while also stimulating immune cells to fight cancer cells.

It's odd that Summit is plunging so much, given that Ivonescimab is its drug, which Summit developed in partnership with Akeso. However, only Akeso has the rights to the drug in China.

Earlier this week, Summit disclosed positive phase 3 trial data for ivonescimab in combination with chemotherapy in a Chinese trial. In response, the stock skyrocketed. Today, that trial's results were cited by the NMPA as grounds for approval. However, the U.S. approval process may be more lengthy. Given that Summit is still awaiting FDA approval for ivonescimab in the U.S. Europe, Canada, and Japan, where it has rights, investors may be selling Summit's stock after its big run earlier this week and buying Akeso, since Akeso may receive revenue and profit from the drug quicker.

The negative reaction for Summit may also be that Akeso may be able to bring penpulimab-kcqx to other cancers or that its other in-house developed cancer drugs could potentially compete with ivonescimab. That being said, Akeso's FDA-approved drug is currently targeted for NPC, not lung cancer.

BioNTech is famous for developing one of the mRNA vaccines for COVID-19, but it also has significant bispecific antibody pipeline aimed at fighting cancer. BioNTech augmented its bispecific antibody cancer platform last fall when it acquired Biotheus for $800 million, which currently has a late-stage monoclonal antibody drug BNT327/PM8002 aimed at several types of cancers. Given that a competitor already has FDA approval and that BioNTech's drugs are still in late-stage trials, investors may also be selling BioNTech for Akeso's stock as well.

The good news is that cancer patients will soon be able to take advantage of two new drugs, ivonescimab as well as Penpulimab-kcqx. The bad news for investors is that competition in this exciting field is fierce, and the financial outlook for each of these companies as a result of developing these drugs is highly uncertain. Thus, the fast-changing competitive field in these exciting biotechnologies feeds the boom-and-bust action you've seen this week with Summit, and really with BioNTech in the COVID versus post-COVID periods.

Investors in these stocks should be very aware that early-stage biotech stocks have huge upside but also bust potential, and to invest within your risk tolerance accordingly.

https://www.msn.com/en-us/money/markets/why-biotech-stars-summit-therapeutics-and-biontech-plunged-even-as-this-chinese-rival-surged-today/ar-AA1DDpIy

Therapies Rivaling SMMT’s Ivonescimab: Instil

 Developing bispecific antibodies that target two proteins, namely PD-1 and VEGF, has been one of the lucrative areas in the treatment of cancer of late. Companies like BioNTech BNTX and Instil Bio TIL are also developing their respective PD-1/VEGF-targeting antibody candidates, namely BNT327 and AXN-2510.

Despite the competition, we believe Summit enjoys the advantage of being ahead in clinical development over the BioNTech and Instil Bio therapies. The BNTX and TIL candidates are still at least a couple of years away from reaching the same clinical development position as SMMT.

In November, Merck signed a deal with China-based LaNova Medicines for the latter’s LM-299, which is also based on the same mechanism as ivonescimab. Merck intends to advance the drug's clinical development “with speed and rigor for patients in need.”


https://finviz.com/news/23133/heres-why-summit-therapeutics-stock-soared-15-on-friday

Summit Therapeutics shares tumble following interim analysis

Summit Therapeutics Inc. (NASDAQ:SMMT) stock plummeted 37% after the company announced an interim analysis requested by Chinese health authorities showed a positive trend for its drug Ivonescimab compared to Pembrolizumab in PD-L1 positive advanced NSCLC, but failed to reassure investors.

The analysis, part of the HARMONi-2 Phase III trial conducted in China, revealed a hazard ratio of 0.777 at 39% data maturity, suggesting a potential 22% reduction in the risk of death compared to Pembrolizumab. Despite these results, the market responded negatively, reflecting concerns over the preliminary nature of the data and the uncertainty it brings.

Summit’s press release highlighted the approval of Ivonescimab by the NMPA in China for front-line PD-L1 positive advanced NSCLC and the company’s ongoing enrollment in the HARMONi-7 study. The global HARMONi-7 trial is evaluating Ivonescimab monotherapy against Pembrolizumab monotherapy with registration intent for the United States and other regions.

Ivonescimab is a novel bispecific antibody that targets PD-1 and VEGF, potentially offering improved efficacy and safety over existing treatments. It is currently involved in multiple Phase III trials and has been administered to over 2,300 patients worldwide. Summit has initiated clinical development of Ivonescimab in NSCLC, with several trials underway, including HARMONi and HARMONi-3, and is activating sites in the United States for HARMONi-7.

Despite the optimistic view from Summit’s leadership, the stock’s significant drop indicates that investors may be seeking more conclusive evidence of Ivonescimab’s efficacy and market potential. The company expects to announce top-line results from the HARMONi trial in the middle of this year, which may provide further clarity on the drug’s prospects and impact on the company’s financial performance.

https://in.investing.com/news/stock-market-news/summit-therapeutics-shares-tumble-following-interim-analysis-93CH-4792987

Another bitcoin treasury coming

 

  • Shares of Cantor Equity Partners—a blank check company headed by the son of President Trump's commerce secretary—continued to soar after announcing plans on Wednesday to form the world's third-largest corporate Bitcoin treasury.
  • Cantor will merge with Twenty One, which will own 42,000 bitcoin and be majority-owned by stablecoin issuer Tether and its affiliated exchange Bitfinex.
  • Twenty One follows in the footsteps of Michael Saylor's Strategy, the world's largest corporate holder of Bitcoin.

Wall Street's getting a new Bitcoin treasury.

Shares of Cantor Equity Partners (CEP)—a blank check company headed by Brandon Lutnick, son of President Trump's commerce secretary—soared 50% on Thursday, a day after it announced a deal to take “Bitcoin-native” Twenty One, “a newly formed entity,” public via SPAC merger.1 The stock has risen more than 200% since Wednesday's announcement.

Twenty One is expected to go public with more than 42,000 bitcoin, the third-largest corporate bitcoin treasury in the world. The company will be majority-owned by stablecoin issuer Tether and its affiliated exchange Bitfinex, which are supplying 31,500 bitcoin. Investment holding company SoftBank has agreed to purchase some of Tether’s shares to take “significant minority ownership.”2

In a pitch to private investors, the company said it would “leverage its Bitcoin to generate returns for shareholders and benefit from Bitcoin’s potential for price appreciation.”3

The Trump administration was one element of the company's pitch. In March, Trump ordered the creation of a bitcoin reserve and has advocated for Congress and federal agencies to develop a regulatory framework for cryptocurrencies.

Twenty One follows in the footsteps of Michael Saylor’s Strategy (MSTR), formerly MicroStrategy, which in recent years has morphed from a company that makes software to a company that issues stock to collect Bitcoin. Beyond accumulating Bitcoin, Twenty One says it plans “to accelerate Bitcoin adoption” at the corporate and sovereign level through media operations and develop “Bitcoin-related financial and advisory services.”3

The company will be led by Jack Mallers, the founder and CEO of Strike, a payments platform.4 Mallers, the company said, is “one of Bitcoin’s most influential advocates” and “was instrumental” in El Salvador’s decision to become the first country to recognize Bitcoin as fiat currency

https://www.investopedia.com/another-bitcoin-treasury-is-coming-to-wall-street-twenty-one-lutnick-trump-11721669

How Trump Can Beat the Universities

 by John Hinderaker

A more or less open state of war exists between President Trump and academia. Opening shots have been fired, most notably by Harvard in its lawsuit seeking to restore funding that the administration has frozen. As I wrote here, I expect that Harvard will win that case.

But that is a battle, not the war. At Legal Insurrection, my friend Louis Bonham lays out a strategy that seems promising. It begins with the fact that universities, to receive federal funding, must certify that they do not engage in illegal discrimination. Universities submit this certification routinely, but the fact is that most of them do, under the holding of the Harvard and University of North Carolina cases. Louis Bonham explains:

Through a recent “Dear Colleague” letter, the Trump administration has warned schools that any programs or practices that favor or disfavor anyone based on race, color, ethnicity, national origin, etc. are illegal under federal law, and thus the annual nondiscrimination certifications require the school to aver that they do not have any such programs or practices.

But faced with the choice of foregoing federal funds (which would be fiscally impossible for most schools) and ending DEI programs (which the school may view as a moral imperative, regardless of their illegality), most schools will likely choose door number 3: they will falsely certify that they do not have discriminatory programs or practices, but will continue them sub rosa. This is the same attitude evidenced by UC Berkeley law school Dean Erwin Chemerinski’s admission (on video) that notwithstanding the Supreme Court’s SFFA decision, his school continues to engage in “unstated affirmative action,” but that “if ever I’m deposed I’m going to deny I said this to you.”

What to do about it? Bonham suggests using the False Claims Act:

The False Claims Act (31 U.S.C. § 3730; the “FCA”) was passed over 150 years ago to address a seemingly intractable problem: widespread fraud by defense contractors during the Civil War. Under the FCA, a person who knowingly submits a false claim to the government is liable for three times the government’s damages plus additional penalties. For example, a hospital that knowingly obtains $10 million from the federal government on bogus Medicare invoices would be liable to the government for over $30 million.

That is obviously a potent hammer. But that isn’t all:

But while the government can bring such claims itself, the FCA has another important component: the ability for whistleblowers (i.e., people with inside information of the fraud) to bring FCA suits in the government’s name, and receive a reward of up to 30% the funds recovered. Such private prosecutions are known as qui tam actions, and the vast majority of the billions recovered annually under the FCA arise from them.

Do the math: if Harvard received $2 billion in federal funds, and were found to discriminate, it could be liable for $6 billion, and a qui tam whistleblower would be in line for up to $1,800,000,000 (minus his attorney’s fee). That would get someone’s attention!

Say that you are an employee (or even a professor or administrator), and are privy to the school’s hush-hush communications on how it is going to “resist” the Trump administration and the Supreme Court by continuing their race preferences in admissions and hiring, and that the school’s administration is behind the effort.

If the school signs a nondiscrimination certification, and thereafter receives, say, $500 million in federal funds, turning whistleblower could yield you upwards of $75 million (which, even net of a 40% contingency fee for your lawyers, would be still be a huge payday). Now add the fact that the potential reward goes to the first person to blow the whistle (i.e., “you snooze, you lose”), and you can see the incentives this creates.

Yes. And if a couple of schools are forced to repay triple the amount they got from the federal government, the rest would take notice. Even their most sacred values–DEI–would be sacrificed to fiscal necessity.

As Louis Bonham concludes, “It’s time to unleash the hounds.”

And, of course, a school that engages in race discrimination–like Harvard and nearly every selective college–can lose its tax-exempt status.

https://www.powerlineblog.com/archives/2025/04/how-trump-can-beat-the-universities.php

Trump Takes His Biggest Step Yet Toward Restoring Meritocracy

Measured in Trump time, it took them eons to get around to it, but the White House has finally taken the most important step it can to restore meritocracy to American society: eliminating disparate-impact theory from civil rights analysis and enforcement.

Disparate-impact theory holds that if a neutral, colorblind standard of achievement or behavior has a disproportionately negative effect on underrepresented minorities (overwhelmingly, on blacks), it violates civil rights laws. It has been used to invalidate literacy and numeracy standards for police officers and firemen, cognitive skills and basic knowledge tests for teachers, the use of SATs in college admissions, the use of grades for medical licensing exams, credit-based mortgage lending, the ability to discipline insubordinate students, and criminal background checks for employees and renters. It has been used to eliminate prosecution for a large range of crimes, including shoplifting, turnstile jumping, and resisting arrest; to end police tactics such as proactive stops (otherwise known as stop, question, and frisk); and to purge safety technologies like ShotSpotter and speeding cameras from police departments.

In none of those cases has it ever been demonstrated that the disfavored standard was implemented to exclude blacks or other minorities from a position, opportunity, or right. The genius (if a diabolical one) of disparate-impact theory was that it obviated any need to show discriminatory intent on the part of a targeted employer or institution. Discrimination was inferred simply by the effect of the colorblind standard.

Disparate-impact theory preserved the hegemony of the civil rights regime long after the original impetus for that regime had all but disappeared. One would be hard-pressed today to find any mainstream institution that discriminates against blacks in admissions, hiring, or promotion. The reality, in fact, is the opposite: every mainstream institution is desperate to hire and promote as many remotely qualified blacks as possible; it is white males who are disfavored and excluded from positions based on their skin color.

If those black-welcoming institutions continued to employ a single standard of achievement, and that standard disqualified blacks at a disproportionate rate, civil rights enforcers would declare that they had uncovered yet another redoubt of white supremacy. The diversity bureaucracy in universities and the corporate world would send out the message that blacks continue to face discrimination at every turn and that they should take refuge in a victim identity.

Disparate-impact analysis was the linchpin of the “systemic racism” argument, since the only present-day proof of racism in American society is the underrepresentation of blacks in the professions and their overrepresentation in the criminal-justice system.

Meantime, the real cause of disparate impact—the yawning academic skills and crime gaps—was kept assiduously offstage.

Now all that may be changing. The presidential Executive Order of April 23, 2025, “Restoring Equality of Opportunity and Meritocracy,” sets out the policy of the United States to “eliminate the use of disparate-impact liability in all contexts to the maximum degree possible.”

To that end, it starts the process of repealing disparate-impact regulations accreted to the Civil Rights Act of 1964 by subsequent administrations and requires the cataloguing of state laws that impose disparate-impact liability, among other actions.

Most momentously for law enforcement, the executive order initiates the review of federal consent decrees that rely on disparate-impact analysis (i.e., almost all of them), with the implied goal of dissolving those decrees. (A consent decree is a negotiated settlement, overseen by a judge and his representative, binding a government entity to an elaborate set of reforms.) Dissolving such decrees will not only liberate police departments from a costly yoke of superfluous red tape but will also defund the federal monitor racket, whereby monitors earn millions of dollars declaring for years on end that the overseen police department has yet to comply punctiliously with an average of 200 or so mandated reforms, often regarding paperwork.

Left-wing groups are understandably up in arms. They charge the administration with a “fundamental shift in legal philosophy.” That is true, but it was disparate-impact theory itself that constituted a radical departure from the premises of the Civil Rights Act of 1964. President Donald Trump merely restores the 1964 law to its original understanding. That pioneering legislation banned intentional discrimination only; disparate-impact theory was a judicial amendment made six years later in response to how, even in 1971, finding invidious intentional discrimination was becoming too difficult to satisfy the advocates.

The Left complains as well that Trump’s’ executive order embraces a “formalist, colorblind conception of equality.” Yes—and so does the Constitution.

President Trump and his Cabinet must move quickly. His executive order can be reversed by a hostile successor administration; the disparate-impact regime can be resurrected with another flip of the presidential pen. The White House needs to persuade Congress to clarify that civil rights mean freedom from discrimination—not the legitimization of “reverse discrimination.” Congress must amend 1960s-era statutes to confirm explicitly their original colorblind intent.

Such a process of congressional clarification will trigger a long overdue debate: Is the United States still disfigured by systemic racism that requires the dismantling of meritocratic standards? Or are we ready to live in a nation where we can be confident that the doctor who walks through an emergency room door is there because of his medical expertise, not his race?

Will the Democratic Party Soon Cease to Exist? Ask George!

 by Roger Simon

Whether the Democrat Party will soon cease to exist depends, in the grand tradition of their President Bill Clinton, on what your definition of the word “soon” is.

Yes, it’s a deliberately ambiguous term, but most human-created institutions move on eventually or get replaced, political parties not being an exception. Where are the Whigs and the Bull Moose?

Is it the Democrats time to go?

They have had quite a run, having been founded by Thomas Jefferson in 1792, likely against the wishes of George Washington who opposed the formation of political parties. According to the Mount Vernon website, the father of our county “… feared that partisanship would lead to a ‘spirit of revenge’ in which party members would not govern for the good of the people, but for power.”

What’d he know? (Do I need to apply /sarc?)

But why are the Democrats in such terrible shape now?

The estimable Matt Margolis writes the following at my former popsicle stand PJ Media:

“Can you believe it? The Democrats, once the supposed champions of the working class, have exposed themselves as nothing more than elitist snobs who couldn't care less about real Americans. Recent polling has confirmed what conservatives have known all along: the Democratic Party is now the domain of overeducated, snobby, wealthy liberals who look down on anyone who doesn't share their ‘enlightened’ worldview.”

Matt was channeling the views of Democrat strategist (whatever that second word means) Doug Sonic in a conversation with Mark Halperin. I concur with all except for the introductory “Can you believe it?” Of course we can believe it. How could we not? This has been conventional thinking for anyone to the right of Trotsky for months, if not years. Polls, including the presidential election, have been showing it for quite a while too.

What those polls and recent events are now beginning to demonstrate is the Democrats no longer have a party. In our two-party system this is not all that surprising because the tents are so big it is always difficult to unite around one vision. But how extreme the divide is in the Democrats’ case portends a coming breakup and/or bankruptcy—one way or another, “soon.”

One Democrat wing we could call the Woke Left. Despite all the noise in the streets, it seems as if they are contracting even with Bernie and AOC on tour in private jets doing their bests to deride oligarchy. (Maybe it’s an inadvertent comedy tour. Those who get excited about the audience numbers should remember we are a country of 340 million so its pretty easy to fill the house for just about anything… Okay, not Biden, but recall the audiences for various evangelists that dwarf AOC’s wildest dreams. Billy Graham is said to have preached to some 215 million in one of his 400 crusades.).

Whether I’m right about the contraction or not, however, is finally moot. The Wokeys are far from a majority. Let’s give them a generous 30% of the Democratic Party. Their group at least believes in something, as wrong-headed, toxic and anathema to most Americans as it is.

Who then are the other 70% and what do they actually stand for, other than the obvious (Trump hatred). This is the wing of James Carville, Jake Tapper, Bill Maher, and a number of relatively anonymous pols few of whom are as identifiable as these TV stars.

The Carville-Tapper wing has nothing but TDS to offer, which has made Carville in particular behave like a man on the brink of a nervous breakdown. Interestingly, he almost never mentions actual policies he would institute, only that he hates Trump more than Hitler and that the Woke Wing is killing the party, that latter being a reasonable assumption.

Tapper made our eyes roll by publishing a book “exposing” a coverup in which he heavily participated (hiding Biden’s unbelievably obvious senility ). The real purpose of this book is a desperation move to separate himself from policies that have long looked ridiculous and that he probably knew were but was paid an exorbitant salary to lie about. Take about living a life in bad faith. This is true of a significant part of the Democrat punditry and media that engaged in this masquerade for years. Imagine the mental games you have to play on yourself to keep this up.

Recently, Maher reneged a bit on his Trump hatred after having dinner with POTUS who—shock of shocks—turned out to be a relatively normal human being. This perfectly reasonable encounter created consternation in both wings of his party further underscoring that TDS was their entire policy, or what passes for one.

Unfortunately, that is the problem in its essence. No one, not even they themselves, knows what 70% of the Democrat Party stands for anymore. It’s all tired virtue signaling or references to the past, to the glory days of Clinton and Obama. But what exactly is that past? No one has much to say specifically because the specifics are scant.

Further, much of what was happening in the Clinton era—a relatively secure border, some lip-service-only attempts to reduce government spending and so forth— are being executed far more effectively by Donald Trump now.

Democratic Party politicians are sitting ducks for those replay videos from years ago, you see all over X—the ones that show both Clintons and Barack advocating for the very things for which they criticize Trump now.

So what are these mainline Dems actually trying to do?

Let’s call the question and go back to that initial statement from the father of our country—partisanship leads to a “spirit of revenge” in which party members would not govern for the good of the people, but for power.

The “spirit of revenge” is not exactly Norman Greenbaum’s “Spirit in the Sky” (play it if you don’t remember it—it’s an upper).

As for power, those Democrats took the old “Power to the People” of their youths and adapted it into“Power for me.”

Unfortunately, this reprehensible behavior is not unique to the Democrats because it is endemic to our big tent configuration. Inside the tent revenge and power competition often develops and plays out in highly neurotic ways, brother on brother on sister on sister on brother on sister and so forth and back again.

Who are the people who instigate this behavior in the GOP? The envious? The click happy? The overly competitive? The power hungry, as G. Washington might say?

Scoundrel time, in Lilian Hellman’s words, did not and does not exist uniquely on the left.

As evidence of all of the above and since this is Yom HaShoah, Holocaust Remembrance Day, I feel constrained once more to condemn the growing shameful group of self-described conservatives and libertarians that seem to suffer from JDS—Jew Derangement Syndrome. It’s rather evident who they are now. Like TDS and MDS, JDS belongs in the garbage can with all bigotries.

It’s also worth noting in our current situation how generous the aforementioned father of our country was to the Jewish people and their contribution to the founding of our country (see Haym Solomon, if you don’t know what he did. You wouldn't be here without him.).

In 1790 Washington wrote a famous letter to the Hebrew Congregation of Newport, Rhode Island. It concluded:

“May the Children of the Stock of Abraham, who dwell in this land, continue to merit and enjoy the good will of the other Inhabitants; while every one shall sit in safety under his own vine and figtree, and there shall be none to make him afraid. May the father of all mercies scatter light and not darkness in our paths, and make us all in our several vocations useful here, and in his own due time and way everlastingly happy.”

Were we ever lucky to have had George Washington as the father of our country! If ever there were someone to live up to, he is it. As we used to say in the blog era, read the whole thing.

https://americanrefugees.substack.com/p/will-the-democratic-party-soon-cease