Cullinan Bets $700M+ in Back-Heavy China Deal for Autoimmune T Cell Engager

 

Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.

Like its Big Pharma peers, Cullinan Therapeutics is turning to China for novel drug candidates. The company on Wednesday inked a licensing deal with Genrix Bio, gaining global rights to the Chongqing-based biotech’s velinotamig, a bispecific T cell engager being studied for autoimmune diseases.

In a note to investors on Wednesday evening, analysts at William Blair said velinotamig “complements” Cullinan’s autoimmune portfolio well, particularly CLN-978, which the company is developing for systemic lupus erythematosus (SLE), rheumatoid arthritis and Sjögren’s disease.

Under the terms of Wednesday’s agreement, Cullinan will pay $20 million upfront for the exclusive rights to develop and commercialize velinotamig outside the Greater China area. Though this initial investment is relatively small, the agreement puts Cullinan on the hook for up to $292 million in development and regulatory milestones and up to $400 million in sales-based milestones.

Like CLN-978, velinotamig is a bispecific antibody that binds to both BCMA and CD3, proteins found on the surface of various immune cells. For velinotamig in particular, this mechanism of action allows cytotoxic T cells to target and destroy BCMA-expressing cells, which are often abnormally activated in autoimmune conditions.

As per Cullinan’s announcement, velinotamig has a higher affinity for BCMA than it does CD3, which William Blair said will help “drive specific recruitment and activation of T cells while minimizing safety liabilities from non-specific T-cell activation.” Along with CLN-978, Cullinan can “target the treatment of both B-cell and plasma-cell mediated autoimmune indications,” the analysts added.

Genrix has also previously tested the drug in multiple myeloma. According to a Thursday morning note from Leerink, in a Phase II trial, it showed “superior overall response rate (85%) vs. approved agents (58-71%). Genrix is planning to run a Phase I autoimmune study in China later this year, after which Cullinan will take charge of all of velinotamig’s subsequent clinical development. Cullinan will focus its efforts on autoimmune diseases, though it has not yet specified with specific indications it intends to prioritize.

Cullinan on Wednesday also reiterated that its cash runway will be enough to keep the lights on through 2028, though William Blair noted that the company might “require additional capital in the future for continued development and potential commercialization.” The deal with Genrix does not affect Cullinan’s runway projection.

With the Genrix deal, Cullinan joins the growing group of biopharma companies looking to China to boost their pipelines. Most recently, Astellas last week pledged more than $1.5 billion for Evopoint’s Claudin18.2-targeting antibody-drug conjugate, which the pharma will leverage for solid tumors. Novo Nordisk and AstraZeneca have also turned eastward in recent months, each with their own multibillion-dollar contracts.

https://www.biospace.com/business/cullinan-bets-700m-in-back-heavy-china-deal-for-autoimmune-t-cell-engager

EU Regulators Confirm Rare Vision Loss Risk for Novo’s Semaglutide

 

Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.

European regulators have confirmed that Novo Nordisk’s semaglutide increases the risk of a rare eye condition that can cause vision loss. The conclusion from the European Medicines Agency (EMA) affirms two studies that suggested the link back in December 2024.

The EMA’s safety committee said that non-arteritic anterior ischemic optic neuropathy (NAION) is indeed a rare safety risk of semaglutide, which is marketed as Wegovy for weight loss and Ozempic for diabetes. The committee said the side effect occurs in up to one in 10,000 people who take semaglutide.

Given the evidence, based on non-clinical studies, clinical trials, post-marketing surveillance and medical literature, the committee has recommended that semaglutide’s labels be updated to include the “very rare” risk, according to the Friday announcement.

Breaking down the risk further, the EMA committee explained that the studies it reviewed showed that adults with type 2 diabetes who took the drugs had an approximately twofold increase in the risk of developing NAION, with an estimated two cases of the condition per 10,000 patient years of treatment. A patient year corresponds to one person taking semaglutide for one full year.

“If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay,” the EMA committee said. “If NAION is confirmed, treatment with semaglutide should be stopped.”

In December 2024, the Danish Medicines Agency announced a plan to review the new eye safety risk that had been seen in several patients taking Ozempic. Two studies conducted in the country suggested that patients who receive the GLP-1 medicine have an increased risk of developing NAION. At that point, 19 cases of the condition had been reported.

The EMA followed suit a few days later, launching an investigation into the evidence. With the review completed, the committee will send its recommendation to the Committee for Medicinal Products for Human Use (CHMP), which will forward it on to the European Commission that can then issue a legally binding decision.

https://www.biospace.com/policy/eu-regulators-confirm-rare-vision-loss-risk-for-novos-semaglutide

'Collapsing Immigration Makes US Jobs Data Harder to Read for Fed'

 

A sharp decline in immigration is keeping a lid on the unemployment rate even as the economy slows.

Government data out Friday showed the size of the workforce shrunk in May, in part because of the biggest back-to-back decline in the number of foreign-born workers in the labor force since 2020. That left the jobless rate unchanged at 4.2% even as the number of people out of work rose.

https://www.bloomberg.com/news/articles/2025-06-06/collapsing-immigration-makes-us-jobs-data-harder-to-read-for-fed

Trump urges Fed's Powell to cut interest rates by full percentage point

 President Donald Trump on Friday called on Federal Reserve Chairman Jerome Powell to lower interest rates by a full percentage point.

"'Too Late' at the Fed is a disaster!" Trump wrote in a post on Truth Social. "Europe has had 10 rate cuts, we have had none. Despite him, our Country is doing great. Go for a full point, Rocket Fuel!"

Trump's post came after the release of the Labor Department's May employment report, which showed the U.S. economy added 139,000 jobs in the month. The figure was stronger than the estimate of economists polled by LSEG, who projected a gain of 130,000 jobs, but cooler than the downwardly revised increase of 147,000 jobs added in April.

The president's comments also follow the European Central Bank's (ECB) decision to cut interest rates on Thursday.

The ECB has now lowered borrowing costs eight times, or by 2 percentage points, since last June, seeking to prop up a eurozone economy that was struggling even before erratic U.S. economic and trade policies dealt it further blows.

With inflation now safely in line with its 2% target and the cut well-flagged, the focus has shifted to the ECB's message about the path ahead, especially since at 2%, rates are now in the "neutral" range where they neither stimulate nor slow growth.

The president, in a separate Truth Social post on Friday, said cutting interest rates would allow the U.S. to reduce short- and long-term interest rates on debt that is "coming due."

"If ‘Too Late’ at the Fed would CUT, we would greatly reduce interest rates, long and short, on debt that is coming due," Trump wrote. "Biden went mostly short term. There is virtually no inflation (anymore), but if it should come back, RAISE "RATE" TO COUNTER. Very Simple!!! He is costing our Country a fortune. Borrowing costs should be MUCH LOWER!!!"

The market currently expects a near-zero chance of a rate cut after the Fed's next meeting on June 17-18, according to the CME FedWatch tool.

Trump most recently demanded Powell to lower interest rates on Wednesday, after ADP reported companies in the private sector added just 37,000 jobs in May. The figure was the lowest since March 2023.

https://www.foxbusiness.com/economy/trump-urges-feds-powell-cut-interest-rates-full-percentage-point-rocket-fuel

Mamdani’s anti-Israel stance disqualifies him AND anyone who supports him

 Zohran Mamdani couldn’t even pretend he supports Israel’s right to exist as actually Israel: Bad as everyone was on stage at the first Democratic mayoral debate, he disqualifies himself with that stance alone.

And, incidentally, exposes anyone who endorses him as perfectly fine with promoting antisemitism.

That includes not only Rep. Alexandria Ocasio-Cortez, who’s tried to distance herself a tad from her most viscerally antisemitic Squad-mates but still endorsed Mamdani the day after the debate, but also state Sen. John Liu, who announced his support even as he insisted they disagreed on Israel.

Sorry, John: When Jews are being gunned down in our nation’s capital, and firebombed at a peaceful Boulder vigil, it’s no time to set aside that difference.

As for the debate, it was a mess of an event the Campaign Finance Board set up: Too many candidates onstage jockeying for time; too many moderators doing the same — producing an obsessive focus on “differences” most voters don’t care about.

At least they got to the Gaza war near the end of the two-hour affair, with a discussion that led Mamdani to declare, “I believe Israel has a right to exist” — but when the moderator prompted, “As a Jewish state?,” he replied merely, “As a state with equal rights.”  

As others quickly pointed out, that’s not Israel’s right to exist at all.

“There are 22 Arab Muslim states. In Mamdani’s world, there isn’t room for one Jewish state. He doesn’t want a Jewish state,” notes Joseph Potasnik of the New York Board of Rabbis.

Mamdani’s dodge comes as no surprise; he has proudly denounced the war against Hamas and his Democratic socialists go even further, with one faction even cheering last month’s Jew-targeting DC assassin.

No, this isn’t the only reason for New Yorkers to reject Mamdani’s candidacy; his “free stuff” agenda would devastate the city’s housing stock and indeed its entire economy.

But the Israel issue counts big: Mamdani wouldn’t even put his name on an Assembly resolution denouncing the Holocaust.

Early voting starts June 14, primary day is June 24: If you’re a registered Democrat, make a point of supporting only your picks among the other candidates.

https://nypost.com/2025/06/05/opinion/zohran-mamdanis-anti-israel-stance-disqualifies-him-and-anyone-who-supports-him/

Liberals turn killers, racists, and haters into martyrs

 by Douglas Murray

Why do parts of the left and the media keep asking for sympathy in all the wrong places?

In recent months, we have had to put up with crazed activists like Taylor Lorenz claiming that Luigi Mangione is a “revolutionary” and a “morally good man” because she finds him “handsome.”

Unfortunately, he is also on trial for gunning down a father of two in cold blood on Sixth Avenue.

In the eyes of many people, that still counts against a man.

And then there has been the bizarre defense of absolutely anybody whom ICE has tried to deport.

It doesn’t matter whether the people being deported are gang members, violent criminals or serial abusers: If ICE wants them out, then the illegals must be defended.

In quick succession, we went from protesters and Democratic lawmakers objecting to ICE taking illegal aliens from their homes, to protesting when they are taken to a courtroom.

Above the law?

Then there was the case of Hannah Dugan, the Milwaukee judge who was arrested in April.

She is accused of helping an illegal alien to evade arrest.

But rather than see the law take its course, Democrats kept suggesting that it was the Trump administration that had broken the rules, not the judge, and the judge who deserves our sympathy.

Wisconsin Gov. Tony Evers claimed that the Trump administration was “undermining the judiciary,” and Senate Minority Leader Chuck Schumer called her arrest “an attack on the separation of powers.”

But isn’t it a bad idea for a judge to try to help someone evade the law?

Doesn’t it “undermine the judiciary” for a judge to apparently help a man accused of battery to slip out of her courtroom through a side door so that waiting federal agents could not detain him?

And if you think so, then why make a hero of Dugan?

Why pretend that what she is accused of doing is in any way excusable?

Why not at least wait for the law to take its course — and not make heroes of people who have done deeply unheroic things?

It is the same here in New York, where the authorities, student groups and others continue to try to make a “free speech martyr” out of Mahmoud Khalil.

In their estimation, Khalil was simply an exemplary student, even though he wasn’t a student.

And he apparently has to be given all the rights of a US citizen, even though he isn’t a US citizen.

Just because all he did was spend 18 months helping to cause civil unrest and bring about what his group called “the total eradication of Western civilization.”

“But” — so many people said — “Khalil has a pregnant wife.”

In which case you might have thought that Khalil would have tried to be on better behavior while enjoying the hospitality and benefits of this country.

But no — it is he who has to be made into the martyr, he and his family who have to be given the sympathy, and he and his family who have to be said to have suffered so much.

Bizarre new height

This week, this strange desire to extend sympathy to the worst people reached a bizarre new height.

Habiba Soliman is the daughter of Mohamed Soliman.

He is the man who was in this country illegally and who last week firebombed Jewish Americans while they were protesting peacefully in Boulder, Colo.

You might have thought in the wake of that gruesome attack — an attack that Soliman had apparently been planning for a year — sympathy might go to a number of people.

Most obviously, you might think that it would go toward the 12 people who were badly injured in Soliman’s attack — victims including a Holocaust survivor, set on fire on the streets of a US city.

By a man who should never have been here.

And who seems to have had links with Hamas.

But oh, no.

The real victims — we are being told — are Soliman’s family.

Because the immigration authorities have looked at Soliman’s illegal status and have arrested his wife as well as Habiba and her four siblings.

Why should the sympathy go to them?

Well, take the title of USA Today’s story on the case: “Habiba Soliman wanted to be a doctor. Then, her father firebombed Jewish marchers in Boulder.”

Oh, no!

If only that little stumbling block hadn’t arisen, we could have had another doctor in about a decade.

What a bummer.

CNN chose to go with a similar angle, saying, “The family’s arrest threatens to derail what looked to be a promising academic career for Soliman’s oldest daughter, who graduated days before her father’s attack and had recently won a ‘Best and Brightest’ scholarship from the Colorado Springs Gazette.”

Pity for ‘terrorist’s kin

We have been told that before the attack, Habiba Soliman apparently wrote an application for a scholarship in which she said that being in the US, “I learned to adapt to new things even if it was hard. I learned to work under pressure and improve rapidly in a very short amount of time. Most importantly, I came to appreciate that family is the unchanging support.”

And then her dad decided to carry out a terrorist attack.

As a result, it is Soliman’s family who are now being pitied.

While the victims of their family member, ranging in age from 25 to 88, are swiftly passed over.

The Trump administration has repeatedly said it wants to prioritize the deportation of people who are in the US illegally, who have committed crimes and who support terrorism.

It is an effort not only to clear up the open borders mess left by President Joe Biden — or whoever was in charge of the autopen in those years.

It is also an effort to dissuade violent criminals and terrorists from thinking this country is an entirely safe space to operate from.

But there is a cost to committing crimes.

And there are costs for carrying out acts of terrorism.

If one of those costs is inconvenience to your loved ones, then perhaps you should think twice about it first.

Because the sympathies of the American public have been stretched quite far enough.

https://nypost.com/2025/06/05/opinion/douglas-murray-liberals-turn-killers-racists-and-haters-into-martyrs/

Kennedy looks to fast-tracking approvals for rare disease drugs

Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways to fast-track approval for rare disease treatments and remove obstacles to their path to market.

Kennedy made the comments at a U.S. Food and Drug Administration meeting to discuss cell and gene therapies, where panelists called for faster regulatory processes as they warned that other countries may overtake the U.S. in drug development.

"We are going to continue to figure out new ways of accelerating approvals for drugs and treatments that treat rare diseases, and we're going to make this country the hub of biotechnology innovation," Kennedy said.

Other members included industry executives, researchers and FDA staffers, among them Vinay Prasad, the FDA's top vaccine and biologics official.

The appointment of Prasad as the head of the FDA's Center for Biologics Evaluation and Research had stoked fears that he could raise the bar for companies to get approval for new drugs, including what are known as accelerated approvals for new potential treatments of serious conditions.

Prasad vowed at the meeting to rapidly make therapies available at the first sign or promise of biomedical success or action.

Shares of therapy developers Sarepta, Dyne Therapeutics and Lexeo Therapeutics were trading between 1% and 3% higher in afternoon trading. U.S.-listed shares of uniQure rose 8.19% to $16.18.

Panel members said that the slower regulatory process for rare disease treatments risks the United States' position as a leader in the biotechnology sector at a time when drug development in China is accelerating.

"The path to approval is seen as so arduous. If firms feel there is no credible way to get new products approved here, they will simply relocate trials overseas or abandon them," panel member Carl June from University of Pennsylvania.

"We cannot afford that exodus," said June.

https://www.yahoo.com/news/us-health-secretary-kennedy-looks-181800562.html