The Antibody Society

Join us on??????????? ????, ????????, ???? ???? ???? ???????for a webinar with?Dr. Jenna Guthmiller, Assistant Professor at the?University of Colorado Anschutz Medical Campus and?winner of the ???????? ?????????? ???????????? ?????????????? ???????????? ??????????, as she explores new frontiers in antibody research.? ? Jenna’s research explores how broadly protective antibody responses develop against rapidly evolving pathogens, a critical step in designing next-generation vaccines.? ? She has received numerous prestigious awards for her work, including the ?????? ????????????????’?? ?????? ?????????????????? ??????????, ?????? ?????????????????? ??????????, ?????? ?????? ?????? ???????????? ??????????.?? ? In this session, she’ll share insights into her research, her career journey, and how we can harness antibody science to advance vaccine design.? ? The webinar is open to all members of?The Antibody Society. Whether you’re an early-career scientist, a researcher, or an antibody enthusiast, this is one you won’t want to miss!? ? Registration is Open: https://lnkd.in/ekXrVfdH

?????? ???????????????? ?????????????? (????????): ?????? ?? ???????? ???????????????????? ???????? ???? ?????? ?????????? & ?????????????? ?? ????????????: ???????? ?????? ??????????????????! Are you a student, post-doc, or early career scientist within academia or the biotech/pharmaceutical industry? Do you have a specific research focus related to antibodies? If so, we invite you to submit an abstract related to your research by April 25, 2025! The abstracts will be reviewed by our judges, and 10 participants will be selected to present posters connected to their abstracts at The Antibody Engineering and Therapeutics Conference in Basel, Switzerland in June 2025. Each selected participant will receive 1 FREE attendance pass to AET Basel! In addition, some selected participants will be given the opportunity to give a short 5–10-minute oral presentation of their poster (space available). Abstract Requirements: Provide an abstract below that includes the conference title (i.e., AET Basel), the title of your research topic, name(s) of author(s), and relevant industry/academic affiliations. Limit the abstract to half a page. Note: transportation and accommodation costs are not included in the free attendance pass prize; participants will need to arrange their own transportation and accommodation. This opportunity is not available to those who are currently registered attendees of the conference. ?????? ?????? ???????? ???????? ???? ???????????? ???????? ???????????????? ??????????! https://lnkd.in/eSFzHjaN

Episode 17 of the #OnAIRR Podcast is here! ?? Episode: 17 (S03E02) | Release Date: March 2025 We're excited to share our latest conversation with Dr. Bjoern Peters, Professor at the La Jolla Institute for Immunology, who discusses how high-quality immunological data is crucial for better computational methods, including AI-based diagnostics. Dr. Peters is deeply involved in developing community guidelines for standardization and reuse of immunological data. Together with Sette lab, they developed the Immune Epitope Database (IEDB) — the world's largest resource for immune epitope data. Dr. Peters discusses the challenges of consolidating immune data and shares his insights on the importance of high-quality datasets over algorithmic improvements. Listen now via your favorite podcast platform or here: https://lnkd.in/duNYHe7e ?? We’d love to hear your thoughts! Drop us a message in the inbox at [email protected] or join the conversation on social media using the hashtag #OnAIRR ?? Hosts: Dr. @ulrikstervbo & Dr. @zhaoqingding ?? New episodes will be released monthly #OnAIRR #AIRRCommunity #Immunology #Podcast

In clinical trials news,?Bluejay Therapeutics announced that the first patient has been dosed in its AZURE-1 global pivotal clinical trial evaluating brelovitug (also known as BJT-778) for the treatment of chronic hepatitis D (CHD). Brelovitug is an investigational, highly potent, pan-genotypic, fully human IgG1 monoclonal antibody that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus (HDV) and the hepatitis B virus. AZURE-1 is a global, randomized, controlled study of brelovitug as a monotherapy for adults living with CHD compared to delayed treatment. This study is being conducted in the United States and other countries around the world.? #mabs https://lnkd.in/eKn9m-qV

In a paper newly published in Protein Sciences, Regeneron affiliated authors present an effective workflow for assessing potential quality attributes of bispecific antibodies through charge-based enrichment followed by the evaluation of domain-specific charge heterogeneity and potency, revealing differential susceptibility of each bispecific arm to post-translational modification. Jennifer Nguyen, et al. Comparison of enriched charge variants from different anti-CD3 bispecific antibodies reveals differential susceptibility of each bispecific arm to post-translational modification. Protein Science. Mar 21, 2025. From the abstract: Charge heterogeneity is an important quality attribute of therapeutic antibodies, and a detailed understanding of charge heterogeneity arising from post‐translational modifications (PTMs) is required by regulatory agencies during drug development. Among antibody therapeutics, the bispecific antibody with two distinct Fab domains targeting distinct antigens provides additional complexity to the charge profile. In this study, charge variant species were enriched from three bispecific antibodies (bsAbs) each containing one anti‐CD3 binding arm designed with differential affinity to CD3. The charge heterogeneity corresponding to each anti‐CD3 arm within each enriched fraction was evaluated using a domain‐specific, digestion‐assisted imaged capillary isoelectric focusing (icIEF) method known as DiCE. Through fractionation, we observed that the anti‐CD3 arm of each bispecific antibody exhibited different distributions of acidic variants, even when the anti‐CD3 arms were identical based on primary sequence. Reduced peptide mapping was performed on specific fractions to identify unique site‐specific PTMs that were uncovered or enriched through fractionation. In each case, the bispecific arm that was most susceptible to PTMs exhibited a more basic isoelectric point. Conformational stability analysis of each bispecific antibody using differential scanning calorimetry suggested that the more basic Fab arm tended to be correlated with a lower melting temperature, although it is unclear the extent to which PTMs on the basic arm may contribute to reduced conformational stability. Overall, these results provide additional evidence that each of the two arms of a bispecific antibody may exhibit differential susceptibility to post‐translational modification and that this susceptibility is likely correlated with subtle differences in overall bispecific antibody structure, which is influenced by electrostatic properties inherent to the primary sequence. Future studies to obtain high‐resolution structures of full‐length bispecific antibodies by crystallography or cryo‐electron microscopy may help to elucidate the driving force for susceptibility to PTMs in bispecific antibodies. https://lnkd.in/erszEvA2

Thanks for sharing these insights, Sebastian Giehring!

In a paper newly published in mAbs, Chugai Pharmaceutical Co., Ltd.-based authors offer insights on the prediction of human pharmacokinetics of Fc-engineered therapeutic monoclonal antibodies using human FcRn transgenic mice. From the abstract: This study aims to establish an approach for predicting the human pharmacokinetics of Fc-engineered mAbs with enhanced FcRn binding mutations using Tg32 mice. MAbs were intravenously administered at 10?mg/kg in the absence or presence of IVIG (1000?mg/kg) in Tg32 mice. Pharmacokinetic parameters (CL, Q, Vc, and Vp) estimated in Tg32 mice were compared with clinical data. Optimal allometric scaling exponents were determined to improve the accuracy of human pharmacokinetic predictions for Fc-engineered mAbs. Moreover, we predicted the plasma concentration-time profile after IV injection in humans using parameters estimated based on an optimized exponent. While normal mAbs exhibited a higher CL in the presence of IVIG compared to its absence, Fc-engineered mAbs showed comparable CL in both conditions. The larger difference in CL between normal and Fc-engineered mAbs observed in the presence of IVIG closely matched clinical study results. A significant positive correlation between Tg32 mice and humans was observed in the CL of Fc-engineered mAbs in both the absence and presence of IVIG. The estimated optimal exponents for CL, Q, Vc, and Vp?were 0.73, 0.60, 0.95, and 0.87, respectively. Using these exponents, the plasma mAb concentration-time profile after IV injection in humans was accurately predicted. This study establishes a robust methodology for accurately predicting the human pharmacokinetics of Fc-engineered mAbs using Tg32 mice, achieving prediction accuracy comparable to that of cynomolgus monkeys. This approach, as a viable alternative to cynomolgus monkeys, can accelerate the preclinical development of promising Fc-engineered mAbs with enhanced FcRn binding. #mabs https://lnkd.in/eiFZZv78

In clinical trials news, Helicore Biopharma Inc. announced that the first participant has been dosed in its first-in-human Phase 1 study of HCR-188 for the treatment of obesity. HCR-188 is a first-in-class monoclonal antibody designed to bind to circulating GIP ligand, unlike antibodies that bind the GIP receptor (GIP receptor antagonists). This is a first-in-human Phase 1 randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in volunteers who are overweight or obese and who do not have diabetes mellitus (ClinicalTrials.gov identifier?NCT06845943).? #mabs https://lnkd.in/eRn9zQhb

Congratulations to Scholar Rock! The Company announced that the FDA granted Priority Review for Biologics License Application (BLA), with a PDUFA date of?September 22, 2025, and the EMA accepted Marketing Authorisation Application (MAA) for apitegromab as a treatment for Spinal Muscular Atrophy (SMA). Apitegromab’s regulatory submissions are based on positive efficacy and safety data from the pivotal Phase 3 SAPPHIRE trial (NCT05156320), for which the Company reported positive topline data in October 2024, as well as supportive data from the Phase 2 TOPAZ trial and long-term extension ONYX trial. Apitegromab is a fully human IgG4 mAb inhibiting myostatin activation by selectively binding the pro- and latent forms of myostatin in the skeletal muscle. It is the first muscle-targeted treatment candidate in SMA to demonstrate clinical success in a pivotal phase 3 clinical trial. Apitegromab has been granted Fast Track, Orphan Drug and Rare Pediatric Disease designations by the FDA, and Priority Medicines (PRIME) and Orphan Medicinal Product designations by the EMA for the treatment of SMA. https://lnkd.in/eFWbmSXi

At NextGen Biomed by Oxford Global, Silvia Crescioli, Business Intelligence Creator at The Antibody Society, delivered a compelling presentation on the evolving landscape of ???????????? ???? ???????????????? ?????????????????????? & ?????????????? ?????????? ???? ???????? & ???????????????????????????? ????????, sparking great discussions among attendees. Her talk covered: - Emerging trends in ADC clinical development and approvals - Shifts in payloads, targets, and the rise of bispecific ADCs - Progress in unconventional ADC development Given the strong interest, we are pleased to share the presentation with our broader network. Kudos to Silvia Crescioli and Janice Reichert from The Antibody Society’s Business Intelligence team for their exceptional work in analyzing and sharing key industry insights. Access the presentation here: https://lnkd.in/gQt-JBJg