by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
1/4/2025
February 2025 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
First rounds of FDA layoffs led by the new Health Secretary form uncertain environment
The investors are concerned about how Federal workforce reductions would affect FDA and its ability to meet its PDUFA objectives. The Valentines Day massacre led by the new Health Secretary RFK led to chaos and uncertainty and vision of a biotech bull market seems increasingly difficult to conjure.
Antibody-Drug Conjugates
FDA approved Adcetris for treatment of patients with large B-cell lymphoma
Pfizer announced that FDA has approved the supplemental BLA for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
Interleukin-15 and Interleukin-2
ImmunityBio and Beigene to run Phase 3 of Anktiva plus PD-1 in NSCLC
ImmunityBio has entered into a collaboration and supply agreement with BeiGene to conduct a confirmatory randomized Phase 3 clinical trial combining BeiGene’s tislelizumab, a PD-1 checkpoint inhibitor, and ImmunityBio’s Anktiva. The Phase 3 ResQ201A-NSCLC study aims to confirm the efficacy and safety of combination ANKTIVA plus PD-1 therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy.
Cell Therapies
Cargo Therapeutics discontinued its CAR-T treatment firi-cel in Phase 2 study of firi-cel
CARGO Therapeutics, a clinical-stage biotech company advancing next generation, potentially curative cell therapies for cancer patients, announced that it has elected to discontinue FIRCE-1, a Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma whose disease relapsed or was refractory to CD19 CAR T-cell therapy.
Other Innovative Treatment Areas
Odronextamab BLA accepted for FDA review for the treatment of follicular lymphoma
Regeneron announced that FDA has accepted for review the resubmission of BLA for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025.
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