Rezpegaldesleukin meets primary and key secondary endpoints in REZOLVE-AD Phase 2

CLINICAL AND REGULATORY

REZOLVE-AD Phase 2b of rezpeg meets primary and key secondary endpoints

The global Phase 2b study is being conducted in 393 patients with moderate-to-severe atopic dermatitis. Patients were randomized (3:3:3:2) to receive subcutaneous treatment with three doses of rezpegaldesleukin: a high dose of 24 μg/kg every two weeks (q2w), a middle dose of 18 μg/kg every two weeks (q2w), and a low dose of 24 μg/kg every four weeks (q4w), or placebo q2w. The primary endpoint and secondary endpoints were assessed at week 16. Following a 16-week induction period, rezpegaldesleukin-treated patients who achieved EASI percent score reductions of >50 were re-randomized (1:1) to continue at the same dose level on a q4w or q12w regimen through week 52 in a blinded maintenance period. Placebo patients with EASI percent score reductions of >50 percent continue to receive placebo q4w. The trial met its primary endpoint of the mean improvement in Eczema Area and Severity Score (EASI) from baseline at week 16 for all three dose arms of rezpegaldesleukin versus placebo (p<0.001).

All three dose arms also achieved statistical significance at week 16 for the key secondary endpoints of EASI-75 (percent of patients who achieve ≥75% reduction in EASI from baseline), EASI-50 (percent of patients who achieve ≥50% reduction in EASI from baseline) and BSA (mean percent improvement in Body Surface Area score from baseline). The q2w arms of rezpegaldesleukin (high and middle doses) achieved statistical significance at week 16 for the key secondary endpoints of vIGA-AD 0/1 (percent of patients achieving a score of 0 or 1 on the validated Investigator's Global Assessment for Atopic Dermatitis with ≥ 2-point reduction from baseline) and Itch NRS (percent of patients with baseline ≥ 4 who experienced a ≥ 4-point reduction in the Itch Numerical Rating Score from baseline). In addition, at week 16, the high dose of 24 μg/kg q2w achieved statistical significance on EASI-90 (percent of patients who achieve ≥ 90% reduction in EASI from baseline). When evaluating EASI-75 and EASI-90 by disease severity using baseline vIGA-AD score, similar responses were observed in severe patients (baseline vIGA-AD of 4) as in moderate patients (baseline vIGA-AD of 3). 

DEALS AND FINANCING

Teva and Fosun entered a strategic partnership to develop novel anti-PD1-IL2 therapy 

Teva and Fosun entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications. Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong, Macau and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies. Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases. 

Xilio Therapeutics announced closing of $50 million public offering 

Xilio announced the closing of its underwritten public offering of pre-funded warrants and accompanying common stock warrants for initial gross proceeds of approximately $50 million before deducting underwriting discounts and commissions and offering expenses. In addition, if all of the Series B warrants and Series C warrants are exercised in cash at their exercise price of $0.75 per warrant, Xilio would receive up to $100 million of additional gross proceeds by the second half of 2026, for total gross proceeds of up to $150 million before deducting underwriting discounts and commissions and offering expenses. The financing was co-led by new investors Coastlands Capital and Frazier Life Sciences and included participation from Gilead, Logos Capital, Samsara BioCapital and other new and existing institutional investors. Xilio intends to use the net proceeds received from the offering to advance the development of its product candidates and for working capital requirements and other general corporate purposes.