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Wednesday, June 11, 2025

Lilly Bites Again in $650M Muscle-Preserving Treatment Pact With Juvena

 

The deal is Lilly’s second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins.

After signing a deal to create long-acting GLP-1 agonists last week, Eli Lilly is back with another biotech deal that aims to improve its weight loss empire. This time, the Zepbound maker is offering up to $650 million in milestones to leverage Juvena Therapeutics’ AI drug hunting platform for new treatments to preserve muscle mass and function.

Details of the deal were slim, with the financial breakdown not disclosed. Lilly is providing an undisclosed upfront payment, equity investment and milestones through the deal. The Indianapolis-based behemoth will receive an exclusive license to develop lead candidates for each target discovered. If the program moves forward, Lilly will take over research, development and commercialization.

This is the second deal that Lilly has signed in a week, after putting up to $870 million on the line with Camurus to create long-acting versions of molecules against GLP-1 and other incretins. Under the pact, which included $290 million upfront, Lilly gains access to Camurus’ long-acting delivery technology.

Through the Juvena deal, Lilly will gain access to the biotech’s AI-enabled screening platform called JuvNET, which maps the therapeutic potential of stem cell-secreted proteins to find new muscle-targeting drug candidates that can improve body composition and muscle health.

The companies did not disclose whether the resulting therapeutics will be combined with Lilly’s existing drugs, however, Juvena Chief Scientific Officer Jeremy O’Connell said in a statement that the collaboration will “aim to accelerate innovation that advances the standard of care in obesity management.”

Juvena, a member of BioSpace’s 2024 NextGen Class, emerged in 2022 with $41 million and a plan to use AI to find proteins secreted by regenerative stem cells. The biotech focused on myotonic dystrophy, sarcopenic obesity and obesity. Just last month, Juvena launched its first clinical program with JUV-161, a muscle regenerating endocrine therapy for myotonic dystrophy type 1 and sarcopenia. The initial first-in-human trial will feature healthy volunteers.

https://www.biospace.com/business/lilly-bites-again-in-650m-muscle-preserving-treatment-pact-with-juvena

Novo Ups Obesity Ante With $800M+ Deep Apple Pact for Oral, Non-Incretin Drugs

 

For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors.

Novo Nordisk is partnering with San Francisco’s Deep Apple Therapeutics to develop novel non-incretin oral drugs for obesity in a deal worth up to $812 million.

The partners did not provide a detailed breakdown of the financial terms in the Wednesday announcement, only revealing that the Danish drugmaker will pay an upfront fee plus research costs and milestone payments. Deep Apple will also be eligible to receive royalties on sales of any product that arises from the partnership.

In exchange for its investment, Novo will gain access to Deep Apple’s proprietary engine, which the biotech will use to discover and optimize potential drug compounds. Novo, in turn, will have the exclusive global right to take these assets through investigational new drug-enabling studies and into clinical development, as well as manufacture and commercialize them across all indications.

Seeking to stay at the forefront of innovation in the obesity space, Novo’s arrangement with Deep Apple will look for therapeutic targets outside the incretin family of hormones. Current weight-loss therapies—including Novo’s Wegovy and Eli Lilly’s Zepbound—mimic these gut-derived hormones, such as GLP-1 and GIP, in turn regulating blood sugar levels and suppressing appetite by inducing the feeling of fullness.

In recent months, however, drugmakers have been looking for ways to go beyond the incretin paradigm, potentially unlocking more effective and safe weight-loss therapies. Chief of these non-incretin targets is amylin, a pancreatic peptide that, like GLP-1, lowers blood glucose concentrations and slows the emptying of the stomach. Amylin-based weight-loss therapies could improve the quality of weight reduction, with less loss of lean mass by focusing on lowering fat.

Novo is chasing after amylin with CagriSema, a combo therapy that brings together its GLP-1 receptor agonist semaglitude—the active ingredient of Wegovy—with the long-acting amylin analog cagrilintide. But things haven’t been going smoothly, with Phase III data released in December 2024 that left investors disappointed. Results from the REDEFINE 1 trial demonstrated a 22.7% reduction in body weight at 68 weeks, below Novo’s own bar of 25% weight-loss.

Though the miss was modest, the effect on Novo’s shares was not: The readout triggered a massive selloff that wiped some $72 billion from the drugmaker’s market cap.

Regaining Footing With a Differentiated Engine

Wednesday’s Deep Apple partnership could be part of Novo’s attempt to steady its footing in the non-incretin race. In an email to BioSpace, Deep Apple CEO Spiros Liras said that the partners will go after a “novel” target that, “unlike most other obesity targets, is not represented by any program in clinical development.”

Without naming what this target was, Liras added that it “has the potential to impact both weight loss and weigh loss maintenance.”

In developing therapies for this target, the partners will leverage Deep Apple’s proprietary drug discovery platform, which uses cryoEM, a method that involves imaging frozen biomolecules to better visualize the target, Liras told BioSpace. This approach will let Novo and Deep Apple find novel pockets on the target molecule, which they can then use to screen for potential therapeutic molecules.

“A key differentiator here is that we rely exclusively on virtual screening for hit identification,” Liras continued, noting that the biotech also applies machine learning models to better assess each potential candidate and determine which have high chances of clinical success. The process takes about three to four months.

“Deep Apple’s work to date has yielded unique structural insights which provide opportunities to explore multiple pharmacological functions of the target,” Liras said, adding that the collaboration could also eventually cover adjacent indications. “Cardiovascular and metabolic disease is the scope of the collaboration—that includes obesity but is not limited to obesity.”

https://www.biospace.com/business/novo-ups-obesity-ante-with-800m-deep-apple-pact-for-oral-non-incretin-drugs

BMS Expands Radiopharma Presence With $1.35B Biobucks Deal for Philochem

 

Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.

Bristol Myers Squibb is trying to unlock an alternative pathway to treating prostate cancer. The company’s radiopharma-focused subsidiary RayzeBio has fronted $350 million to partner with Italian-Swiss biotech Philochem to advance an early-stage small-molecule radiotherapeutic targeting a novel biomarker.

BMS is also promising up to $1.35 billion in development, regulatory and commercial milestones, plus mid-single to low-double-digit royalties on global net sales. BMS and Philochem expect to close the transaction in the third quarter, pending customary clearances and approvals.

Philogen, Philochem’s parent company, surged 20% on Wednesday morning.

The star of Wednesday’s agreement is OncoACP3, a small-molecule radiotracer that targets a biomarker called ACP3. According to Philochem, ACP3 is highly expressed in prostate cancer—but not in healthy tissue—and at levels that match or exceed that of PSMA, which is currently the prevailing target of choice for prostate cancer therapies. “A side-by-side comparison between ACP3 and PSMA . . . has shown that ACP3 is more abundantly expressed in prostate cancer than PSMA,” the biotech wrote on its website.

OncoACP3 is a small-molecule ligand that has high affinity for the ACP3 protein. Notably, it can carry both Lutetium-177 and Actinium-225—both currently the most common payloads for radiopharmaceuticals.

In a statement on Wednesday, RayzeBio president Ben Hickey said that by potentially opening an alternative pathway to PSMA, the Philochem partnership “provides a differentiated entry” for BMS “into the prostate cancer arena.”

The decision to zero in on a novel prostate cancer target could also help BMS distinguish itself in a radiopharma field that is becoming increasingly crowded. Currently leading the pack is Novartis, which owns two FDA-approved therapies: Lutathera, indicated for gastroenteropancreatic neuroendocrine tumors, and Pluvicto, which targets PSMA and is approved for prostate cancer.

Another pharma trying to catch Novartis is AstraZeneca, which entered the ring in March 2024 with the $2.4 billion acquisition of Fusion Pharmaceuticals, which gave the pharma its lead radiopharma asset FPI-2265, an actinium-based radioconjugate that is being developed for prostate cancer—and targets PSMA.

Also in the running is Eli Lilly, which spent $1.4 billion to buy Point Biopharma in October 2023 and $1.1 billion for Aktis Oncology in May 2024. Anchoring its radiopharma pipeline is PNT2002, another PSMA-targeting candidate for prostate cancer.

https://www.biospace.com/business/bms-expands-radiopharma-presence-with-1-35b-biobucks-deal-for-philochem

Everything Soars Higher As Rate-Cut Odds Jump After CPI 'Miss'

 A 'disappointing' CPI print (cooler than expected) has promoted a surge higher in the market's expectation for rate-cut...

Source: Bloomberg

Prompting a surge higher in EVERYTHING.

Stocks spiked...

Treasuries were aggressively bid with 10Y yields sdown 5bps...

Source: Bloomberg

The dollar fell...

Source: Bloomberg

Helping gold to accelerate...

Source: Bloomberg

Goldman said that this would be a materially dovish print (<0.25% MoM for Core CPI) would prompt the bond market to add back at least 2x 25bp rate cuts (it already has) and for Equities to react positively (up 2-2.5%) to the bull steepening that likely ensues.

What excuse will Powell come up with next to NOT cut?

https://www.zerohedge.com/markets/everything-soars-higher-rate-cut-odds-jump-after-cpi-miss

Always Ready, Always There: Democrats Mobilize Against National Guard Deployment

 by Jonathan Turley,

Gov. Gavin Newsom was in his element this week. After scenes of burning cars and attacks on ICE personnel, Newsom declared that this was all “an illegal act, an immoral act, an unconstitutional act.” No, he was not speaking of the attacks on law enforcement or property. He was referring to President Donald Trump’s call to deploy the National Guard to protect federal officers.

Newsom is planning to challenge the deployment as cities like Glendale are cancelling contracts to house detainees and reaffirming that local police will not assist the federal government.

Trump has the authority under Section 12406 of Title 10 of the U.S. Code to deploy the National Guard if the president is “unable with the regular forces to execute the laws of the United States.”

The Administration is saying that that is precisely what is unfolding in California, where mobs attack vehicles and trap federal personnel.

Most critics are challenging the deployment on policy grounds, arguing that it is an unnecessary escalation. However, even critics like Berkeley Law Dean Erwin have admitted that “Unfortunately, President Trump likely has the legal authority to do this.”

There is a fair debate over whether this is needed at this time, but the President is allowed to reach a different conclusion. Trump wants the violence to end now as opposed to escalating as it did in the Rodney King riots or the later riots after the George Floyd killings, causing billions in property damage and many deaths.

Courts will be asked to halt the order because it did not technically go through Newsom to formally call out the National Guard.

Section 12406 grants Trump the authority to call out the Guard and employs a mandatory term for governors, who “shall” issue the President’s order. In the memo, Trump also instructed federal officials “to coordinate with the Governors of the States and the National Guard Bureau.”

Newsom is clearly refusing to issue the orders or coordinate the deployment.

Even if such challenges are successful, Trump can clearly flood the zone with federal authority. Indeed, the obstruction could escalate the matter further, prompting Trump to consider using the Insurrection Act, which would allow troops to participate directly in civilian law enforcement.

In 1958, President Eisenhower used the Insurrection Act to deploy troops to Arkansas to enforce the Supreme Court’s orders ending racial segregation in schools.

The Trump Administration has already claimed that these riots “constitute a form of rebellion against the authority of the Government of the United States.” In support of such a claim, the Administration could cite many of the Democratic leaders now denouncing the claim.

After January 6th, liberal politicians and professors insisted that the riot was an “insurrection” and, in claiming that Trump and dozens of Republicans could be removed from ballots under the 14th Amendment.

Liberal professors insisted that Trump’s use of the word “fight” and questioning the results of an election did qualify as an insurrection. They argued that you merely need to show “an assemblage of people” who are “resisting law” and “using force or intimidation” for “a public purpose.” The involvement of inciteful language from politicians only reinforced these claims. Sound familiar?

Democrats are using this order to deflect from their own escalation of the tensions for months. From Minnesota Gov. Tim Walz calling ICE officers “Gestapo” to others calling them “fascists” and “Nazis,” Democratic leaders have been ignoring objections that they are fueling the violent and criminal responses. It did not matter. It was viewed as good politics.

While Newsom and figures like Sen. Cory Booker (D., N.J.) have called these “peaceful” protests, rocks, and Molotov cocktails have been thrown at police as vehicles were torched. Police had to use tear gas, “flash bang” grenades, and rubber bullets to quell these “peaceful” protesters.

There appears little interest in deescalation on either side. For the Trump Administration, images of rioters riding in celebration around burning cars with Mexican flags are only likely to reinforce the support of the majority of Americans for the enforcement of immigration laws.

For Democrats, they have gone “all in” on opposing ICE and these enforcement operations despite support from roughly 30 percent of the public.

Some democrats are now playing directly to the mob. A Los Angeles City Council member, Eunisses Hernandez, reportedly urged anti-law enforcement protesters to “escalate” their tactics against ICE officers:  “They know how quickly we mobilize, that’s why they’re changing tactics. Because community defense works and our resistance has slowed them down before… and if they’re escalating their tactics then so are we. When they show up, we gotta show up even stronger.”

So, L.A. officials are maintaining the sanctuary status of the city, barring the cooperation of local police, and calling on citizens to escalate their resistance after a weekend of violent attacks. Others have posted the locations of ICE facilities to allow better tracking of operations while cities like Glendale are closing facilities.

In Washington, Jeffries has pledged to unmask the identities of individual ICE officers who have been covering their faces to protect themselves and their families from growing threats.

While Democrats have not succeeded in making a convincing political case for opposing immigration enforcement, they may be making a stronger case for federal deployment in increasingly hostile blue cities.

*  *  *

Jonathan Turley is the Shapiro Professor of Public Interest Law at George Washington University and the author of “The Indispensable Right: Free Speech in an Age of Rage.”

https://www.zerohedge.com/political/always-ready-always-there-democrats-mobilize-against-national-guard-deployment

OKYO First Treatment for Neuropathic Corneal Pain?

OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company, announced that CEO Gary S. Jacob will present at the Bio International Convention 2025 in Boston. The presentation will focus on urcosimod, the company's lead clinical drug candidate being developed to treat neuropathic corneal pain (NCP). NCP is a severe ocular condition affecting tens of thousands globally, causing chronic and severe eye discomfort, with no current FDA-approved treatment. The presentation will take place during the convention scheduled for June 16-19, 2025, at the Boston Convention & Exhibition Center.

Kazia Paxalisib Successfully Combats Triple-Negative Breast Cancer Resistance in Preclinical

Kazia Therapeutics (NASDAQ: KZIA) has unveiled groundbreaking preclinical research published in Molecular Cancer Therapeutics demonstrating that its lead drug paxalisib shows promise in treating triple-negative breast cancer (TNBC). The study, conducted at QIMR Berghofer Medical Research Institute, revealed that paxalisib can effectively reprogram the tumor microenvironment and enhance immune response when combined with immunotherapy. Key findings show that paxalisib's dual targeting of PI3K and mTOR inhibits cancer cell growth, increases T cell infiltration, and demonstrates synergistic antitumor activity when combined with KEYTRUDA, leading to tumor regression in preclinical models. The company has already initiated a Phase 1b clinical trial testing paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, with the first patient dosed.