March 2023
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00 issues in this vol.

PFIZER DEMONSTRATES COMMITTMENT TO ONCOLOGY WITH $43 BILLION ACQUISITION OF SEAGEN

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-approved and marketed  ADC therapies. This collaboration is forecasted to contribute $10+billion in risk-adjusted revenues in 2030 to Pfizer's oncology portfolio.

Pfizer aims to accelerate the next generation of cancer breakthroughs by leveraging Seagen’s ADC technology and it's existing marketed products: ADCETRIS, PADCEV, TIVDAK, and TUKYSA.

ICHNOS SCIENCES RECEIVES ORPHAN DRUG DESIGNATION (ODD) FOR BISPECIFIC ANTIBODY, ISB 1442

MULTIPLE MYEOLMA

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

ISB 1442 could have a significant impact in an area of unmet need in MM, where therapies can develop resistance and decreased effectiveness over time.

THE SUMMIT OF AMERICAS ON IMMUNOTHERAPIES FOR HEME MALIGNANCIES

HEME MALIGNANCIES

This annual conference brings together experts todiscuss new developments in the treatment of patients with leukemia, lymphoma, multiple myeloma, and stem cell transplantation. Multiple oral treatment options were were presented including CELMoDs, a therapy type that has gained significant interest recently. One particular CELMoD, mezigdomide [CC-92480], isattracting attention due to it's efficacy even in treating triple-class or quad refractory or BCMA-exposedmultiple myeloma.

There remains a large unmet need for patients with refractory multiple myeloma. Patient quality-of-life and compliance would be significantly improved if oral agents can be used in place of IV therapies.

PFIZER’S ELRANATAMAB RECEIVES FDA AND EMA FILING ACCEPTANCE FOR THE TREATMENT OF RELAPSED/REFRACTORY MULTIPLE 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 or refractory multiple myeloma. The FDA's decision on the application is expected this year. The EMA has also accepted the marketing authorization application.Elranatamab is designed to bind to B-cell maturation antigen (BCMA), which is highly expressed on the surface of multiple myeloma cells, and CD3 receptors found on the surface of T-cells. Patients who received elranatamab in the Phase2 MagnetisMM-3 clinical trial as their first BCMA-targeted therapy achieved an objective response rate of 61%, with an 84% probability of maintaining the response at nine months. Priority Review is intended to direct attention andresources from regulatory authorities toward drugs that, if approved, could offer significant improvements over existing options for serious conditions in order to make these drugs available to patients faster.

As an off-the-shelf treatment, BCMA bispecific antibodies have the potential to improve the treatment paradigm and greatly impact patients lives.

IASO BIO'S CT103A IS GRANTED RMAT (REGENERATIVE MEDICINE ADVANCED THERAPY) AND FTD (FAST TRACK DESIGNATION) DESIGNATIONS BY THE FDA

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/refractory multiple myeloma. RMAT designation is intended to help the FDA facilitate the efficient development of drugs that qualify and address unmet medical needs for serious or life-threatening diseases. Fast Track designation is designed to accelerate the development and review of treatments for serious and life threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available. CT103A previously received ODD from the FDA.

The introduction of novel therapies and modalities is providing oncologists an increasing number of options in multiple myeloma.
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