Genmab

Genmab, a Danish biotech leader in antibody-based therapeutics, partners with Oslo University Hospital researchers Victor Greiff and Fridtjof Lund-Johansen to develop such drugs using AI. The 4-year collaboration includes funding and access to industry-scale data for AI model training, benefiting both parties.

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

UniTox, a dataset of 2,418 FDA-approved drugs, uses GPT-4o to summarize and rate drug-induced toxicities, covering eight types. It achieves 85-96% concordance with clinicians and up to 93% accuracy in predicting molecular toxicity, surpassing existing models. UniTox bridges gaps in toxicity evaluation across multiple organ systems, offering insights into toxicity patterns and correlations.

The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.

Regeneron's Ordspono shows promise in treating r/r MZL with 77.1% ORR and CR rate, but faces challenges like low long-term adherence and regulatory delays. It received EU approval for r/r FL and DLBCL, but US market adoption is pending confirmatory trials. Competitors like AbbVie and Genmab's Epkinly pose threats with more convenient administration routes.

Genmab announced positive long-term data from two ongoing Epcoritamab trials for diffuse large B-cell lymphoma.

EPCORE NHL-2 trial results show epcoritamab combo achieved 100% ORR and 87% CR in high-risk DLBCL patients. EPCORE NHL-1 trial data demonstrates durable responses and safety of epcoritamab monotherapy in R/R DLBCL. Both analyses presented at ASH.

AstraZeneca presented interim results of AZD0486, a CD19xCD3 BiTE, at ASH 2024, showing 96% ORR and 85% CR in r/r FL patients. AZD0486's CRS rate of 45% with all grade 1 events compares favorably to Epkinly and similarly to Lunsumio. A phase II trial is underway, with potential for first-in-class approval and $158 million in global sales by 2030.