by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
5/4/2024
March 2024 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Biotech sector raised $11 billion in follow-on offerings in the best quarter result in 3 years
Biotechnology companies raised around $11 billion in follow-on stock offerings in first quarter of 2024, which is the highest quarterly total in three years. This is a recovery sign after period of downturns that caused numerous companies to restructure – in 2023, more than 120 public biotechs laid off staff.
Interleukin-15 and Interleukin-2
Medicenna to provide clinical update on MDNA113 trial at AACR meeting
Medicenna announced that two posters will be presented at AACR Annual Meeting 2024. The company will present an update from its Phase 1/2 ABILITY-1 Study including anti-tumor activity, safety, pharmacokinetic and pharmacodynamic data following treatment with MDNA11, the only long-acting, ‘beta-enhanced not-alpha’ IL-2 super-agonist in clinical development. In addition, pre-clinical data for MDNA113, a novel first-in-class tumor-targeted and tumor-activated bi-functional anti-PD1-IL-2 Superkine, will also be presented at the conference.
Antibody-Drug Conjugates
Pfizer announced positive OS in Phase 3 of Adcetris in patients with relapsed or refractory DLBCL
Pfizer announced that a Phase 3 study of the ADC Adcetris in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory DLBCL showed a statistically significant and clinically meaningful improvement in OS compared to lenalidomide and rituximab plus placebo.
Cell Therapies
FDA approved Breyanzi as first and only CAR-T for adults with relapsed or refractory CLL and SLL
BMS announced that FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. This indication is approved under accelerated approval based on response rate and duration of response.
Other Innovative Treatment Areas
FDA dings Regeneron for seeking accelerated approval before launching trials to confirm benefit
Regeneron announced that FDA has issued Complete Response Letters for the BLA for odronextamab in relapsed/refractory follicular lymphoma and in R/R DLBCL, each after two or more lines of systemic therapy.
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