ONCOLOGY

The definitive merger agreement was largely driven by Seagen's ADC (anti-bodydrug conjugate) technology. The company accounts for 4 of 12 total FDA-approvedand marketed  ADC therapies. This collaboration is forecasted to contribute $10+billion in risk-adjusted revenues in 2030 to Pfizer's oncology portfolio.

MULTIPLE MYEOLMA

This first-in-class biparatopic 2+1 BEAT® novel bispecificantibody targets CD38 and CD47 for the treatment ofrelapsed/refractory multiple myeloma (MM). Ichnos’proprietary Bispecific Engagement by Antibodies basedon the TCR (BEAT®) antibody platform is designed toenable more efficient production of bispecific andmultispecific antibodies that can engage multipletargets simultaneously. ODD is granted to therapies thatshow promise in the treatment, prevention, or diagnosisof rare disease or conditions that affect fewer than200,000 people in the United States.

HEME MALIGNANCIES

This annual conference brings together experts todiscuss new developments in the treatment of patientswith leukemia, lymphoma, multiple myeloma, and stemcell transplantation. Multiple oral treatment optionswere were presented including CELMoDs, a therapytype that has gained significant interest recently. Oneparticular CELMoD, mezigdomide [CC-92480], isattracting attention due to it's efficacy even in treatingtriple-class or quad refractory or BCMA-exposedmultiple myeloma.

MULTIPLE MYELOMA

The FDA has granted priority review for the Biologics License Application (BLA)for Pfizer’s elranatamab, a bispecific antibody, for treating relapsed orrefractory multiple myeloma. The FDA's decision on the application is expectedthis year. The EMA has also accepted the marketing authorization application.Elranatamab is designed to bind to B-cell maturation antigen (BCMA), which ishighly expressed on the surface of multiple myeloma cells, and CD3 receptorsfound on the surface of T-cells. Patients who received elranatamab in the Phase2 MagnetisMM-3 clinical trial as their first BCMA-targeted therapy achieved anobjective response rate of 61%, with an 84% probability of maintaining theresponse at nine months. Priority Review is intended to direct attention andresources from regulatory authorities toward drugs that, if approved, couldoffer significant improvements over existing options for serious conditions inorder to make these drugs available to patients faster.

MULTIPLE MYELOMA

FDA has granted both Regenerative Medicine Advanced Therapy (RMAT)designation and Fast Track Designation to IASO BIO's investigational drug BCMACAR-T CT103A (also known as equecabtagene autoleucel) for relapsed/refractorymultiple myeloma. RMAT designation is intended to help the FDA facilitate theefficient development of drugs that qualify and address unmet medical needs forserious or life-threatening diseases. Fast Track designation is designed toaccelerate the development and review of treatments for serious and lifethreatening diseases where no treatment exists or where the treatment indiscovery may be better than what is currently available. CT103A previouslyreceived ODD from the FDA.