SNAPSHOT

Janux stock plunges 48%, but analysts still back T-cell therapy as best-in-class

Janux Therapeutics' stock took a dive of nearly 50% after releasing new data on its prostate cancer T-cell engager, JANX007, despite analysts maintaining confidence in its long-term potential.

Why it matters: Investor sentiment may be shaky, but analysts see JANX007 as a strong contender in the prostate cancer immunotherapy space, with promising safety and efficacy signals.

Backstory: In late 2022, Janux wowed with early data showing strong prostate-specific antigen (PSA) reductions in all patients. The latest update shows solid, but not as striking, results, triggering market disappointment.

Big picture: T-cell engagers are an emerging class of cancer immunotherapies aiming to direct the immune system to destroy tumor cells. JANX007 is part of a growing pipeline targeting prostate cancer, alongside efforts from Novartis, Amgen, and Johnson & Johnson.

Zoom in: 8 of 27 patients (30%) showed partial tumor responses—down from a previous 50%. PSA50 response (≥50% reduction in PSA levels) was seen in 86% of patients, PSA90 in 54%. Median progression-free survival was 7.3 months overall; 7.9 months for higher doses (6-9 mg). Safety profile was favorable: One mitigation strategy showed zero grade 3 cytokine release syndrome (CRS) cases.

What’s next: Janux is continuing its phase 1b trials and expects new data in 2026. Analysts believe improved dosing and CRS protocols could lead to outpatient use and stronger results.

SNIPPETS

What’s happening in biotech today?

🌀IL-6 spinout: Tiziana Life Sciences announced plans to spin out its IL-6-targeting drug candidate, TZLS-501, into a new publicly listed immunology-focused company, citing growing interest from major pharmaceutical companies in IL-6 pathway therapeutics. This decision follows heightened industry activity, notably Novartis’ $1.4 billion acquisition of Tourmaline Bio, which underscored the value of IL-6-focused treatments. TZLS-501, a dual-action monoclonal antibody licensed from Novimmune in 2017, has not yet entered clinical trials but is designed to block IL-6 receptor signaling and reduce circulating IL-6 cytokines. Existing Tiziana shareholders will receive shares in the spinout, while Tiziana shifts its primary focus to foralumab.

🏅 Survival win: Imvax is advancing its personalized brain cancer therapy IGV-001 toward FDA discussions despite missing the primary endpoint in a phase 2b trial for newly diagnosed glioblastoma. While the treatment did not significantly extend progression-free survival compared to placebo, it showed a notable improvement in median overall survival, 20.3 months versus 14 months, representing a 6.3-month, or 45% gain. Imvax emphasized this survival benefit as clinically meaningful and highlighted the absence of drug-related serious adverse events. Given the FDA's preference for overall survival as an endpoint, Imvax hopes the data will support regulatory progress, especially amid limited advances in glioblastoma treatments over the past two decades.

🧫 Organoid assist: On December 2, 2025, the FDA issued draft guidance proposing reduced reliance on primate testing for certain experimental monoclonal antibody drugs, allowing drugmakers to use alternative “weight-of-evidence” approaches to assess safety before human trials. These alternatives include data from related drugs, in vitro tests for off-target effects, and shorter studies in non-primate species, as well as “human-relevant” models like organoids. The move aims to lower development costs, speed up early-stage research, and maintain safety while reducing the use of animal testing. This initiative is part of broader FDA efforts to modernize drug development and maintain U.S. competitiveness amid rapid biotech growth in China.

🧠Alzheimer’s twist: Vandria has released first-in-human data for VNA-318, a novel small molecule targeting mitochondrial health in Alzheimer’s disease (AD). Unlike traditional AD therapies that focus on amyloid or tau, VNA-318 induces a temporary metabolic switch by inhibiting glycolysis, prompting cells to rely on mitochondrial oxidative phosphorylation. This mechanism activates mitophagy—the removal of damaged mitochondria—and exerts anti-inflammatory effects. Vandria calls this dual impact "mitophagy-plus." The drug’s early human data aligns with preclinical models, positioning it as a potential complement to existing AD treatments. VNA-318 is one of the few mitophagy-targeting compounds advancing clinically in Alzheimer’s.

🚀Series A push: Axoltis Pharma, a French biotech focused on neurodegenerative diseases, has raised €18 million ($20.9 million) in a Series A funding round to support the development of its lead candidate, NX210c, currently in Phase II trials for amyotrophic lateral sclerosis (ALS). The round was co-led by FIDAT Ventures and Cenitz, with additional support from private investors, business angels, and participants in an equity crowdfunding campaign via Capital Cell. The funding will help advance Axoltis’s efforts to bring novel ALS therapies closer to market.

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