BTLA

Plus, news about Essential Pharma, ADC Therapeutics, Caliway Biopharmaceuticals, AnaptysBio, Andera Partners and NewAmsterdam Pharma: Elevation’s ADC deal: The biotech will pay up to $368 million in upfront payments and biobucks to Lonza’s Synaffix, which will get access to its clinical-stage ADC platform and other technologies. — Kyle LaHucik Bavarian Nordic closes San Diego site: The Danish drugmaker is closing a site in California and laying off 48 employees, according to a WARN notice . The site came from Bavarian’s acquisition of part of Emergent BioSolutions last year. The company will “continue to have a significant footprint in the US,” a spokesperson told Endpoints News . — Kyle LaHucik Essential Pharma’s €900M recapitalization and €300 million financing: The financing will allow Essential to “build on its diversified portfolio and late-stage pipeline across established and rare disease medicines,” according to the company. AlpInvest, a subsidiary of Carlyle Global Investment Solutions, is leading the recapitalization, while Sixth Street is providing the financing facility. — Katherine Lewin ADC Therapeutics’ early-stage data for Zynlonta-Columvi combo: In 18 patients with diffuse large B cell lymphoma, the best overall response rate was 94%, and the complete response rate was 72%. Of the 13 patients who achieved a complete response, 12 remain in complete response as of the cutoff of Nov. 20. The company reported low-grade cases of CRS and ICANS, but no high-grade cases, and 24% of patients experienced grade 3 or 4 neutropenia. — Lei Lei Wu Caliway’s lipolysis injectable to enter Phase 3 in 2025: In a Phase 2b study , Caliway’s drug met all the primary and secondary endpoints, with 76.7% of patients achieving at least a 1-grade improvement on the Abdominal Fat Rating Scale at 12 weeks. The most common side effect was injection site reactions. — Katherine Lewin AnaptysBio’s drug fails in atopic dermatitis: The San Diego biotech said ANB032 failed the primary and secondary endpoints in a Phase 2b study. The Sanofi-backed biotech is now ending development of the BTLA agonist. The stock $ANAB closed 32% lower on Wednesday. — Kyle LaHucik Andera Partners sells 40% stake: The European investment firm, which has a life sciences unit, sold a 40% minority equity interest to global asset manager New York Life Investments. Andera’s biotech portfolio includes Inventiva and Nouscom. — Kyle LaHucik NewAmsterdam upsized its offering. It raised $416.5 million, up from the $300 million it initially planned to bring in. — Jaimy Lee

SAN DIEGO, CA, USA I December 11, 2024 I AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that investigational ANB032, a BTLA agonist, did not meet the primary and secondary endpoints in any of the doses studied in the global, 201-patient ARISE-AD trial as a monotherapy for moderate-to-severe atopic dermatitis (AD) or eczema. ANB032 was well tolerated with no safety signals observed. “While ANB032 was safe and well tolerated, we’re disappointed by these efficacy results in AD and will discontinue further investment in this asset. Moving forward, our resources and capital will be focused on the rest of our exciting autoimmune portfolio,” said Daniel Faga, president and chief executive officer of Anaptys. “PD-1 is a co-inhibitory receptor found preferentially on activated T cells. We look forward to sharing for rosnilimab, a depleter and agonist targeting PD-1+ T cells, top-line Phase 2b rheumatoid arthritis data in February 2025 and top-line Phase 2 ulcerative colitis data in Q1 2026, followed by Phase 1b data from our two additional programs.” The ARISE-AD study evaluated the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of ANB032 monotherapy in patients with moderate-to-severe AD. The study enrolled 201 patients with a mean baseline EASI score of 27.3 in the U.S., Canada, Europe, Australia and New Zealand, who were either biologics naïve (n=168) or biologics experienced (n=33), defined as having received treatment with dupilumab or other IL-13 therapies. Patients were randomized to receive for 12 weeks either 100mg of subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks (Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and secondary endpoints were assessed at Week 14. Regardless of prior treatment experience, ANB032 did not meet the primary endpoint of the proportion of patients who achieved at least a 75% improvement from baseline in Eczema Area and Severity Index score (EASI-75), or any of the secondary endpoints at Week 14, including EASI-90, mean change in baseline EASI or a 4-point reduction in itch severity as measured by the peak Pruritus Numerical Rating Scale (PNRS) versus placebo. Absolute response rates on key endpoints in patients treated with ANB032 approached the minimum target product profile with durable off-drug responses; however, higher placebo rates outside of the historical norm, particularly in the U.S., were observed. ANB032 was well tolerated across all doses with no safety signals observed. Consistent with prior studies, data demonstrate a favorable safety and tolerability profile for ANB032, with one participant across all three active dose arms with a serious adverse event (SAE) of worsening AD and two placebo participants with SAEs. There was no dose relationship or imbalance in AEs and no safety signals observed. The most common (>5%) AEs observed were nasopharyngitis, atopic dermatitis and headache. “We are sincerely grateful to all of the patients and clinicians who participated in this important trial, without whom we would not be able to continue to learn about how best to treat this debilitating chronic disease,” said Paul Lizzul, M.D., Ph.D., chief medical officer of Anaptys. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Its lead program, rosnilimab, a depleter and agonist targeting PD-1+ T cells, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. Other antibodies in its portfolio include ANB033, an anti-CD122 antagonist, in a Phase 1 trial and ANB101, a BDCA2 modulator, soon to enter clinical development. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist ( Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn . SOURCE: AnaptysBio

CAMBRIDGE, MA, USA I November 04, 2024 I HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604 . HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform. The therapy is designed to restore immune tolerance in inflammatory and immunology diseases by stimulating BTLA signaling in immune cells. “HFB200604 represents our first autoimmune program to advance into clinical development, highlighting HiFiBiO’s innovative approach to rapidly translating patient insights into impactful therapies,” said Liang Schweizer, Ph.D., Founder, Chairperson, and CEO of HiFiBiO Therapeutics, “We are excited to leverage our DIS® platform to address the challenges of patient heterogeneity in inflammatory and immunology diseases, with the aim of achieving higher response rates.” Francisco Adrian, Ph.D., CSO of HiFiBiO Therapeutics, added “We are thrilled to bring our best-in-class BTLA agonist HFB200604 to patients suffering from inflammatory and immunology diseases. Our single-cell immune profiling data suggest that BTLA agonism could be a highly effective approach to reducing immune activation, and we look forward to translating compelling preclinical findings into meaningful clinical outcomes.” HiFiBiO plans to begin a single ascending dose (SAD) Phase 1 clinical study in a healthy volunteer cohort, followed by a multiple ascending dose (MAD) study in patients with selected inflammatory and immunology diseases identified through the HiFiBiO DIS® platform. HFB200604 HFB200604 is a best-in-class BTLA agonist monoclonal antibody designed to suppress activated T and B cells. Preclinical studies have shown that HFB200604 effectively inhibits T and B cell activation and demonstrated in vivo activities in a mouse model. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com SOURCE: HiFiBiO Therapeutics