Lecanemab

Sanofi is making a bold $470 million move to accelerate its presence in neurodegeneration by acquiring Vigil Neuroscience. The deal, announced on May 22, targets VG-3927, an oral TREM2 agonist poised to begin Phase II clinical trials for Alzheimer’s disease later this year. Shareholders will also receive an extra $2 per share payout if the candidate reaches its first commercial sale.   Early clinical data from VG-3927 showed a dose-dependent 50% reduction in soluble TREM2 levels in cerebrospinal fluid, marking a promising biological response. The drug allows once-daily oral dosing, potentially offering a more patient-friendly option in a field long dominated by complex biologics.   Since 2023, the Alzheimer’s landscape has transformed dramatically. Lilly and Eisai have launched new anti-amyloid therapies like Donanemab and Lecanemab, following FDA approvals. Meanwhile, Roche, BMS, and now Sanofi are investing through acquisitions and licensing deals to catch up.   The competition is intensifying. BioArctic signed a $1.6 billion deal with BMS for next-generation Aβ antibodies. AbbVie acquired Aliada, gaining blood-brain barrier tech and an experimental antibody targeting 3pE-Aβ. Genentech is exploring gene-silencing therapies for Tau, via zinc finger epigenetic inhibitors.   Despite these advances, the path is treacherous. From 1998 to 2017, 97% of Alzheimer’s drug trials failed, making it one of the most unforgiving therapeutic areas. This year, AstraZeneca exited several neuroscience collaborations, including its Alzheimer’s project with Lilly, highlighting ongoing volatility in the space.

Pfizer and 3SBio's PD-1xVEGF deal, the FDA's first approval for an Alzheimer's disease blood test and Samsung Biologics' planned spinoff of Samsung Bioepis made our news this week. Pfizer is paying $1.25 billion to join the PD-(L1)xVEGF bispecific race. The FDA has granted its first official approval to a blood-based Alzheimer's disease test in a potential boon to anti-amyloid drugs. Samsung Biologics plans to spin off its biosimilars business. And more.1. Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, MerckIn another major PD-(L)1xVEGF bispecific deal, Pfizer is shelling out $1.25 billion upfront for ex-China rights to 3SBio’s clinical candidate SSGJ-707. The deal includes up to $4.8 billion in milestones and a $100 million equity investment in the Chinese company. The drug is slated to enter phase 3 in China, with the first late-stage trial to test its mettle in first-line, PD-L1-positive non-small cell lung cancer.2. FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's LumipulseFor Eisai and Biogen's Leqembi, first FDA-approved Alzheimer's blood test will take time to boost launch: analystThe FDA has issued the first approval for an Alzheimer’s disease blood test. The approval went to Fujirebio Diagnostics’ Lumipulse G pTau 217/beta-amyloid 1-42 plasma ratio test for the assessment of amyloid plaques. Eisai and Biogen have suggested that blood-based tests have the potential to boost the uptake of anti-amyloid antibodies such as Leqembi by replacing cumbersome PET scans or cerebrospinal fluid tests at least for some patients. But Mizuho analyst Salim Syed argued that payer reimbursement and physician user behavior remain key factors affecting how these tests could help Leqembi grow.3. CDMO Samsung Biologics telegraphs spinoff of biosim unitSamsung Biologics plans to spin off its biosimilars outfit Samsung Bioepis as the CDMO tries to allay concerns around potential conflicts of interest. Following the spinoff, Samsung Bio will focus on its contracting business, while Samsung Bioepis will continue to work on biosimilar products. The spinoff is planned for Oct. 1, subject to possible changes.4. Stars align for CRISPR Tx, Sirius as pair pens siRNA collab with a focus on thrombotic diseaseCRISPR Therapeutics is paying $25 million upfront in cash and $70 million in equity to work on multiple siRNA targets with Sino-American company Sirius Therapeutics. The initial focus is Sirius’ lead program, a long-acting, factor XI-inhibiting anticoagulant for thromboembolic disorders. Under the deal, CRISPR can pick up to two more siRNA targets.5. WuXi Biologics slims down again, handing off German plant to CDMO Terumo for $167MWuXi Biologics is shedding another facility, this time selling its site in Leverkusen, Germany, site to fellow CDMO Terumo for 150 million euros ($167 million). With the deal, WuXi Bio has finished its strategic review of all its sites, leaving the company to focus on building out its large Singapore site.6. With Illumina sequencers under an import ban, PacBio expands its footprint in ChinaAs Illumina faces a DNA sequencer ban in China, rival manufacturer PacBio is expanding a distribution agreement with local company Haorui Gene. Under the new deal, the Xi’an-based company will now distribute the recently launched Vego benchtop system, growing the reach of PacBio's hi-fi long-read sequencers.Other News of Note:7. After WHO loses its top donor in US, Novo Nordisk Foundation and China step up with large contributions8. Eisai mounts targeted TV ad push to raise awareness of Leqembi9. CDMO Bora Biologics expands operations in San Diego in wake of acquisition by Tanvex10. SK defeats Pfizer in Korean patent feud, opening new lines of business for pneumococcal vaccine11. SK Life Science starts TV ad campaign to drive patients to seizure drug Xcopri