SNAPSHOT

Abivax’s standout Phase 3 ulcerative colitis results overshadowed by cancer concerns

Abivax reported positive topline Phase 3 data for its oral ulcerative colitis drug, obefazimod, which met all primary and secondary endpoints and delivered exceptionally high clinical remission rates. Despite the strong efficacy, the company’s stock fell as investors focused on malignancy cases reported during the trial.

Why it matters: Ulcerative colitis patients need more durable treatment options, and obefazimod’s results suggest it could become a major new therapy. However, even isolated safety concerns can influence regulatory reviews, physician adoption, partnerships, and commercial success.

Backstory: Obefazimod is a first-in-class miR-124 enhancer designed to regulate inflammatory pathways rather than block a specific cytokine or receptor. The Phase 3 ABTECT maintenance trial enrolled 580 patients who had already responded to induction therapy.

Big picture: The data reinforce growing interest in novel immune-modulating approaches for inflammatory bowel disease. But in today’s biotech market, investors increasingly weigh safety risks as heavily as efficacy, especially in late-stage trials.

Zoom in: Both 25 mg and 50 mg doses achieved the FDA primary endpoint of clinical remission at Week 44. Remission rates reached 50.8% and 51.3%, versus 10.4% for placebo. Placebo-adjusted remission rates were 39.3% and 40.3%, which some analysts described as among the strongest seen in a large Phase 3 ulcerative colitis study.

Yes, but: Safety concerns emerged after reports of prostate cancer, breast cancer, colonic dysplasia, and several non-melanoma skin cancers in treatment groups.

What’s next: Abivax plans to submit obefazimod to the FDA before year-end. The company also expects Phase 2b Crohn’s disease induction data in mid-2027.

SNIPPETS

What’s happening in biotech today?

🩺 Renal run: Travere Therapeutics has licensed Everest Medicines’ oral BTK inhibitor, civorebrutinib, for rare immune-mediated kidney diseases in a deal worth $112.5 million upfront and up to $1.03 billion in total. Travere gains rights outside China and parts of East and Southeast Asia. Civorebrutinib targets B-cell signaling and has shown encouraging phase 1/2 results in primary membranous nephropathy, including reduced autoantibodies and proteinuria, high remission rates, and stable kidney function. Travere views the therapy as a potential best-in-class treatment across multiple rare kidney diseases, while Everest says the partnership will accelerate global development and commercialization efforts.

🚀 AVZO launch: Rallybio has announced a reverse merger with privately held cancer drug developer Avenzo Therapeutics, marking its second merger attempt after a planned combination with Candid Therapeutics collapsed when Candid was acquired by UCB. The merged company will operate as Avenzo Therapeutics, trade on Nasdaq under the ticker “AVZO,” and be supported by $215 million in new financing, with enough cash to fund operations through 2028. Avenzo, which has raised roughly $450 million and built a pipeline of four Phase 1 cancer drugs licensed from Chinese biotech firms, focuses on next-generation CDK inhibitors and bispecific antibody-drug conjugates (ADC). The combined company will be led by Avenzo’s current leadership and aims to advance its oncology pipeline through multiple upcoming clinical milestones.

📈 Survival surge: Bristol Myers Squibb’s bispecific ADC izalontamab brengitecan (iza-bren), acquired through an $800 million deal, delivered strong phase 3 results in China, significantly improving outcomes for previously treated triple-negative breast cancer (TNBC) patients. Compared with chemotherapy, iza-bren reduced the risk of death by 40%, extended median overall survival to 15.9 months from 12.5 months, and improved progression-free survival by 71%. The EGFRxHER3-targeting ADC also showed a survival benefit in esophageal squamous cell carcinoma, highlighting broader potential across tumor types. BMS is advancing iza-bren into global first-line TNBC studies, where it may compete with established TROP2-targeted ADCs such as Gilead’s Trodelvy and AstraZeneca/Daiichi Sankyo’s Datroway. While those drugs hold a first-mover advantage, BMS sees opportunities through combination therapies and a potentially favorable safety profile, including a low rate of interstitial lung disease observed in the TNBC trial.

🫁 Lung lifeline: At ASCO 2026, Takeda highlighted the promise of IBI363 (also known as TAK-928), a first-in-class PD-1/IL-2 bispecific antibody licensed from Innovent Biologics in a deal worth $1.2 billion upfront and up to $10.2 billion in milestones. New phase 1 data in immunotherapy-resistant non-small cell lung cancer (NSCLC) showed encouraging long-term survival, with more than 40% of patients in key dose groups alive after 24 months and median overall survival reaching 18.2 months in squamous NSCLC. The therapy is designed to combine PD-1 blockade with targeted IL-2 activation of tumor-specific T cells. The collaboration reflects Takeda’s broader strategy of partnering globally for innovative oncology assets, with Innovent emerging as a key development and commercialization partner.

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