The Antibody Society

In business news, Bambusa Therapeutics, Inc. announced the successful completion of its oversubscribed Series A financing of approximately $90 million. The round was led by new investor RA Capital Management, with participation from new investors including Janus Henderson Investors, Redmile Group, Invus, and ADAR1 Capital Management. All existing investors also participated. The funding will support the advancement of Bambusa's lead programs through Phase I trials and drive further pipeline development. Since its founding in May 2024, Bambusa has built a robust pipeline of long-acting bispecific antibodies, leveraging validated targets and biological synergy to create best-in-disease therapies for I&I indications. Two of Bambusa's four programs are on track to enter the clinic in Q1 2025 and mid-2025, respectively. BBT001, Bambusa's lead candidate, is a bispecific antibody incorporating a number of features intended to supplant the current standard of care for a range of dermatological conditions. BBT002 is a bispecific antibody created as a "platform in a molecule" with applications across respiratory, dermatology, and gastroenterology indications. Bambusa's additional development candidates, BBT003 and BB004, also have best-in-disease potential in the inflammatory bowel diseases and rheumatological indications. #mabs https://lnkd.in/eBsf5MZr

Congratulations to Lundbeck! The company announced that the US Food and Drug Administration has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug (Lu AF82422), a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently initiated MASCOT, a phase III trial to assess efficacy and safety of amlenetug for the treatment of MSA. Amlenetug is a human IgG1 monoclonal antibody that recognizes all major species of alpha-synuclein. #mabs https://lnkd.in/dtdWc_BR

Thanks for the follow up and summary of the story, Ian Wilkinson! While AI and ML have great potential and tremendous progress has been made in the past 5 years (and we look forward to advances in the use of these technologies in the future), challenges WRT claims about de novo discovery and transparency are not new. For a viewpoint circa 2019, see the Perspective article "De novo discovery of antibody drugs – great promise demands scrutiny". From the abstract: We live in an era of rapidly advancing computing capacity and algorithmic sophistication. “Big data” and “artificial intelligence” find progressively wider use in all spheres of human activity, including healthcare. A diverse array of computational technologies is being applied with increasing frequency to antibody drug research and development (R&D). Their successful applications are met with great interest due to the potential for accelerating and streamlining the antibody R&D process. While this excitement is very likely justified in the long term, it is less likely that the transition from the first use to routine practice will escape challenges that other new technologies had experienced before they began to blossom. This transition typically requires many cycles of iterative learning that rely on the deconstruction of the technology to understand its pitfalls and define vectors for optimization. https://lnkd.in/e5qmzaYe

Congratulations to CSL! The company announced that the European Commission has approved ANDEMBRY® (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema in adult and adolescent patients aged 12 years and older. ANDEMBRY inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body. ANDEMBRY comes with a convenient patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection. ANDEMBRY was approved by the Australian Therapeutic Goods Administration on January 14, 2025, the United Kingdom's Medicines and Healthcare products Regulatory Agency on January 24, 2025. #mabs https://lnkd.in/eUgfrP6q

In regulatory affairs news, Lindis Biotech GmbH and Pharmanovia announced that catumaxomab has received marketing authorisation from the European Commission, making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe. Under a licensing agreement, LINDIS has granted Pharmanovia the exclusive rights to bring catumaxomab to market and spearhead its launch across Europe. Catumaxomab is a T cell engaging bispecific antibody targeting epithelial cellular adhesion molecule (EpCAM) on tumor cells and CD3 on T cells. Catumaxomab was originally granted marketing authorisation under the brand name Removab in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. The product has not been marketed since 2014 and on 2 June 2017 the product was withdrawn from the EU due to commercial reasons. #mabs https://lnkd.in/e7jkmrtd.

In pipeline news, Xilio Therapeutics, Inc. announced three wholly-owned preclinical programs for masked T cell engagers targeting prostate-specific membrane antigen (PSMA), claudin 18.2 (CLDN18.2) and six-transmembrane epithelial antigen of prostate 1 (STEAP1). Specifically: Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in the third quarter of 2025 and submitting an investigational new drug application (IND) in the first quarter of 2027. Xilio anticipates nominating a development candidate for its CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND in the second quarter of 2027. Xilio anticipates nominating a development candidate for its STEAP1 program in the SEECR format in the first half of 2026 and submitting an IND in the second half of 2027. https://lnkd.in/e9vAa76G

Thanks for sharing your thoughts on this important topic, Puja Sapra!

Thanks for sharing, Genentech

Hmm, interesting... We will watch for molecules fitting this description.

In business news, AbbVie and Xilio Therapeutics, Inc. announced a collaboration and option-to-license agreement to develop novel tumor-activated, antibody-based immunotherapies, including masked T-cell engagers, leveraging Xilio's proprietary technology. Under the terms of the agreement, Xilio will receive $52.0 million in total upfront payments, including a $10.0M equity investment, and will be eligible to receive up to approximately $2.1 billion in total contingent payments for option-related fees and milestones plus tiered royalties. #mabs https://lnkd.in/eSJt3fnp