Teva Pharmaceutical Industries (TEVA) Piper Sandler Virtual Novel Targets in Immunology Symposium summary

Immunology R&D strategy

• Focuses on validated molecular targets and optimal antibody/protein engineering, leveraging expertise in biosimilars and innovative biologics.

• Combines targets such as TSLP and IL-13, and explores other combinations like TL1A, 23s, 17s, 31s, and 33s to increase efficacy and probability of success.

• Pursues both internal innovation and external collaborations, treating BD/M&A and in-house R&D as equally valuable sources of new assets.

• Utilizes AI-driven design for novel antibody combinations, exemplified by the TSLP/IL-13 program.

• IND submission for TSLP/IL-13 program planned by year-end, with strong preclinical and early clinical data supporting its potential.

IL-15 antibody program (408) and development funding

• IL-15 antibody targets vitiligo and celiac disease, with proof-of-concept data for vitiligo expected in H1 and celiac in H2 of this year.

• Vitiligo program aims for filing in 2031, celiac in 2034; Royalty Pharma funds vitiligo development with an option to expand to other indications.

• Up to $500M in R&D funding for vitiligo, justified by the need for large safety databases and extensive phase II/III studies.

• Phase III design mirrors industry standards, requiring two identically designed pivotal studies.

• Potential expansion into atopic dermatitis, alopecia areata, and other related indications based on preclinical data.

Scientific rationale and competitive landscape

• IL-15 blockade in vitiligo aims to prevent destruction of melanocytes by inhibiting resident memory T-cells, potentially offering more durable effects than JAK inhibitors.

• Current vitiligo treatments are limited to topical JAKs and UV therapy, with systemic options largely off-label and ineffective.

• IL-15 antibody offers quarterly dosing and a favorable safety profile, with early data showing tolerability similar to placebo.

• In celiac disease, IL-15 blockade prevents gut lining destruction and antibody production, with preclinical monkey data supporting efficacy.

• 408 is claimed to be more potent than competing IL-15 antibodies, with greater NK cell reduction.