Merck adds to biopharma’s AI agenda with up to $510M+ Protillion pact

 

Merck will use Protillion Biosciences’ tech to design biologic therapies for therapies across undisclosed indications.

The next stop on biopharma’s AI train is Merck, which is bringing on California’s Protillion Biosciences to combine large-scale data generation and AI design to advance a suite of novel biologic therapies.

Merck is making an undisclosed upfront payment, according to a Tuesday release, as well as offering up to $510 million in R&D and commercial milestones. The companies did not name the specific targets or disease areas they plan on addressing, only saying that they will collaborate on “multiple therapies.”

For its investment, Merck will gain access to Protillion’s Prot-MaP technology, a “megascale data generation platform” that the biotech claims will provide training sets specifically tailored to protein design AI models.

This approach can simultaneously and quantitatively assess protein therapy candidates “at a massive scale” to find those that are likely to be specific to and have high affinity for their intended targets, as well as have “uncompromised manufacturability,” according to Protillion’s website.

Protillion’s tech “offers a compelling opportunity” for Merck’s drug development capabilities, Juan Alvarez, vice president of discovery biologics at Merck Research Laboratories, said in a statement. The platform has the “potential to transform the speed and precision with which we characterize protein landscapes and identify novel therapeutic candidates,” he added.

AI is quickly becoming a central force in biopharma as more and more companies—including the industry giants—integrate the technology into drug development processes. Eli Lilly in particular has been investing heavily in AI. In April, the pharma put up to $2.25 billion on the line to bring on Profluent Bio and its machine learning platform to design therapeutic enzymes for a variety of genetic targets.

Last month, Lilly struck again, along with Bristol Myers Squibb and Incyte, minting respective AI alliances to integrate machine learning models into different parts of their operations, such as data sharing and corporate and commercial functions.

Most recently, Alnylam earlier this month gave $30 million to Inceptive Nucleics, gaining access to a machine learning engine that learns the underlying biology behind diseases. Alnylam, which has earmarked a total of $2 billion for this agreement, will use Inceptive’s approach to optimize its siRNA design and selection.

The AI wave also saw the second largest financing round in biopharma history, with Alphabet’s Isomorphic Labs bringing in $2.1 billion in May, despite having no asset in the clinic yet.

https://www.biospace.com/deals/merck-adds-to-biopharmas-ai-agenda-with-up-to-510m-protillion-pact

Jazz strikes new chord with AbCellera in T cell engager pact that could top $2.4B

 

Jazz Pharmaceuticals is diversifying its oncology strategy, orchestrating a new antibody deal with AbCellera that offers $56 million upfront, plus $792 million in biobucks for each of the three initial programs.

Jazz Pharmaceuticals is banding together with AbCellera, paying $56 million cash and offering up to some $2.46 billion in total to develop next-generation T cell engagers for hard-to-treat cancers.

The collaboration features AbCellera’s multispecific T cell engager (TCE) platform, science that will be fine-tuned in hopes of creating candidates for multiple gastrointestinal (GI) cancers and other solid tumors for which current treatments fall flat.

AbCellera will perform discovery and early-stage research for two initial programs, with plans to start a third discovery program in the next year, according to a Wednesday release.

For each program, Jazz can opt in for a fee that would grant the biopharma exclusive rights to the candidate. Should Jazz exercise its option, AbCellera could be in line to receive up to $792 million in milestone payments per program, plus tiered royalties.

For the work on the first two programs, Canada-based AbCellera will receive $56 million upfront. The biotech will get another $28 million when work on the third program begins. Under the terms of the deal, the partners can also tack on two additional programs, though potential payments for these were not disclosed.

“This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology,” Jazz Chief Scientific Officer Josh Allen said in the release. “We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies for GI cancers and other solid tumors into clinical development and to develop meaningful innovation for patients.”

For Truist analysts, the move underscores Jazz’s growing focus on GI cancers. The expansion builds off Ziihera, a bispecific HER2-directed antibody that has secured priority review for a label expansion into first-line HER2+ gastroesophageal adenocarcinoma, with an FDA decision expected on or by Aug. 25.

“We view continued external BD as reinforcing the balanced-portfolio thesis as JAZZ’s onco lean-in and diversification effort has been lively,” Truist wrote in a Wednesday morning note.

“While this deal brings additional oncology flavor to the JAZZ platform, we continue to anticipate recurring BD activity in rare disease spaces,” the analysts added.

The move also comes directly after Jazz’s alkylating drug Zepzelca failed to improve overall survival for patients with relapsed metastatic small cell lung cancer in a Phase 3 trial last week. The study brings a
second line expansion into question, Truist analysts said in a June 12 note, adding, however, that they see the first-line indication as the primary growth driver.

Now Jazz will have access to AbCellera’s platform, which includes proprietary panels of CD3-binding antibodies and rapid testing systems to help design multispecific drugs.

“Building on years of experience in TCEs, we are pleased to partner with Jazz Pharmaceuticals to leverage AbCellera’s differentiated TCE platform to bring forward novel cancer treatments for GI cancers and other solid tumors,” AbCellera founder and CEO Carl Hansen said in a prepared statement.

AbCellera has also teamed up with AbbVie, last year expanding an existing deal to include TCEs for oncology.

https://www.biospace.com/deals/jazz-strikes-new-chord-with-abcellera-in-t-cell-engager-pact-that-could-top-2-4b

Edgewise slides as cardiomyopathy challenger to BMS, Cytokinetics falls short

 

Although Edgewise Therapeutics’ hypertrophic cardiomyopathy asset missed expectations, Truist Securities called the data “excellent,” leaning on a safety profile that could eliminate the need for risk evaluation and mitigation strategies.

Edgewise Therapeutics’ investigational drug improved hemodynamic and biomarker outcomes in patients with hypertrophic cardiomyopathy, but the degree of benefit seems to have left investors underwhelmed.

The Colorado biotech dipped as much as 15% Tuesday morning on the readout, hitting $31.20 per share. The biotech’s stock recovered slightly throughout the day, ending the trading session at $33.95.

Edgewise is evaluating its drug candidate EDG-7500 in the Phase 2 CIRRUS-HCM trial, a multi-part open-label trial of patients with obstructive (oHCM) and non-obstructive (nHCM) hypertrophic cardiomyopathy. The 12-week data presented Tuesday involved 20 patients with oHCM and 33 with nHCM.

In the oHCM cohort, EDG-7500 led to improvements in hemodynamic measures in 90% of treated participants. In the same group, 74% of patients achieved either normalized levels of NT-proBNP—a biomarker indicative of the severity of heart failure—or at least a 50% reduction from baseline. EDG-7500 also resulted in a 24-point mean improvement on the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score, a tool used to assess heart failure symptoms and their impact on the patient’s life.

While analysts at Stifel said in a Tuesday note that these oHCM data look “solid,” they added that “investor attention had shifted to nHCM” after Cytokinetics’ Phase 3 ACACIA-HCM readout last month. There, EDG-7500 improved KCCQ scores by 12-13 points, according to a company presentation—a result that Stifel called “disappointing” compared with Cytokinetics’ FDA-approved Myqorzo (aficamten), which elicited a 11.4-point improvement in KCCQ clinical summary score in nHCM patients.

In this patient population, “the hope was that [Edgewise’s] ‘7500 could meaningfully improve beyond aficamten,” Stifel explained.

“EDG-7500 looks clearly active, but the numbers here are still small, it’s open-label, and also we don’t have any data on” maximal exercise performance, a registrational endpoint for HCM drugs, Stifel added. The KCCQ outcome in nHCM, the group added, “arguably doesn’t look all that different from” cardiac myosin inhibitors such as Myqorzo.

Aside from Cytokinetics, BMS also has a cardiac myosin blocker, Camzyos, approved for oHCM. The drug made more than $1 billion last year.

Truist Securities came out in defense of EDG-7500, however, calling Edgewise’s mid-stage data “excellent” and saying that the drug could become “a preferred HCM option.” In particular, the analysts wrote in a Tuesday investor note that “the KCCQ improvement for nHCM patients appeared to be increasing over time with no plateau” at the 12-week data cutoff.

Truist also noted that treatment with EDG-7500 led to no meaningful changes in left ventricular ejection fraction (LVEF) in both oHCM and nHCM cohorts, and that none of the patients saw their LVEF drop below 50%. Such a safety profile, according to the analysts, could eliminate the need for risk evaluation and mitigation strategies (REMS), which is required when using Myqorzo or Camzyos.

“We believe a REMS-less HCM drug, potentially such as EDG-7500, could greatly facilitate treatment in HCM and potentially additional future indications,” Truist noted.

https://www.biospace.com/drug-development/edgewise-slides-as-cardiomyopathy-challenger-to-bms-cytokinetics-falls-short

uniQure to file accelerated-approval BLA for Huntington’s gene therapy

 uniQure to file accelerated-approval BLA for Huntington’s gene therapy AMT-130 in Q3 2026 after FDA agrees 3-year Phase I/II data can support filing

https://finviz.com/stock?t=QURE&p=d

IceCure FInancing; U.S. ProSense breast cancer cryoablation install base up 70% on FDA authorization.

 

IceCure Medical prices $5.5 million private placement at $3.00 per share and issues new Series D and E warrants

• Private placement is with a single healthcare-focused institutional investor participating in the $5.5 million financing round.
• Company agrees to reprice certain March 2026 warrants, subject to shareholder approval of the warrant repricing terms.
• U.S. ProSense breast cancer cryoablation install base rises 70% following FDA marketing authorization.

https://finviz.com/stock?t=ICCM&p=d

Fed holds interest rates steady in Warsh's first meeting, with more officials projecting hikes this year

The Federal Reserve held interest rates steady on Wednesday for the fourth consecutive policy meeting this year. Central bank officials signaled that they're looking to hold rates steady — but are close to hiking rates once.

The central bank voted in a unanimous decision — the first since last June — to hold its benchmark interest rate in the range of 3.5% to 3.75%.

In a close call, Fed officials see holding rates or possibly hiking once this year before cutting once again next year. The shift comes after policymakers projected one 2026 rate cut in March, but the job market has firmed and inflation has risen to the highest level in three years, pushed up by higher energy prices from the conflict in the Middle East.

Only 18 officials of the Fed's 19-member Federal Open Market Committee submitted interest rate projections. One member declined to submit projections. This year, eight officials see holding rates steady, three officials see one rate hike, five see two rate hikes, and one sees four hikes.

The Fed dramatically shortened its policy statement and dropped language signaling that its next move would be a rate cut.

The language previously stated that "in considering the extent and timing of additional adjustments to the target range for the federal funds rate, the Committee will carefully assess incoming data, the evolving outlook, and the balance of risks."

In the new statement, officials noted that the economy is expanding at a "solid" pace despite elevated uncertainty, in part due to the conflict in the Middle East. They said that inflation remains elevated, in part reflecting supply shocks that have driven up price increases in certain sectors, including energy.

"The committee will deliver price stability," officials said in their statement

Inflation is now seen rising 3.6%, compared with 2.7% previously, on a headline basis. On a "core" basis, officials see inflation at 3.3%, compared with 2.7% previously.

The Consumer Price Index rose 4.2% in May, reaching the highest level in three years, driven largely by higher energy prices. Stripping out volatile energy and food prices, "core" inflation ticked up to 2.9% from 2.8% in April, nearly a full percentage point above the Fed's 2% target.

The Fed's preferred inflation gauge, the Personal Consumption Expenditures index, is worse, showing higher "core" inflation of 3.3% in April with expectations for it to rise to 3.5% for May.

The Fed expects lower GDP this year, by 0.2% to 2.2% vs. 2.4% before. The unemployment rate is seen holding steady at 4.3%, down from 4.4% previously.


This is Kevin Warsh's first meeting as chair, following a rocky confirmation process that saw him in place just in time. He is scheduled to hold a press conference at 2:30 p.m. ET.

https://finance.yahoo.com/economy/policy/article/fed-holds-interest-rates-steady-in-warshs-first-meeting-with-more-officials-projecting-hikes-this-year-140000745.html

https://www.zerohedge.com/geopolitical/musk-supports-nuremberg-style-trials-after-uk-rape-gang-inquiry-release