BioPharm International - April 2025

BioPharm International - April 2025

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12 BioPharm International ® Next-Generation Biotherapeutics April 2025 www.biopharminternational.com Oncology Ma rch Biosciences received F DA Or pha n Dr ug Desig n at ion i n Febr u a r y 2025 for it s T-cel l ly m- phoma therapy, MB-105. The T-cell therapy treats relapsed/refractor y CD5-positive T-cell lymphoma a nd i s a f i rst-i n-cla ss, autologou s, CD5-t a rgeted C A R T- ce l l t he r ap y (6). I n 202 3 , M a r c h t e a me d up w it h C T MC to de ve lop M B -105. "O u r u n ique r isk-sha r ing model a l lows us to col laborate w it h organizations like March Biosciences to accelerate t he development and manufact ure of in novative cel l t herapies, l i ke M B-105, a nd br i ng t hem i nto t he c l i n ic w it h a con si s tent a nd sca l able m a nu- f ac t u r i ng process," Boc k sa id at t he t i me of t he announcement (7). Conclusion The market for immunotherapies is growing, and treatments for cancers, including those to treat solid tumors, are advancing. "It's one of the most exciting times to be developing new therapies for oncology and for cancer treatments," Hein says. "You're see- ing a number of new therapeutic modalities emerge. Some of these are re-envisioning or retargeting of more classic modalities. But where I've really been excited, both for this company and my prior com- pany, is really around the emergence and impact of immunotherapies." References 1. Liu, B.; Zhou, H.; Tan, L.; Siu, K.T.H.; and Guan, X-Y. Exploring Treatment Options in Cancer: Tumor Treatment Strategies. Signal Transduction Targeted Ther. 2024, 9, 175. DOI: 10.1038/s41392-024-01856-7 2. National Cancer Institute. CAR T Cells: Engineer- i ng Pat ient s' Im mu ne Cel ls to Treat T hei r Ca n- cers. Cancer.gov (accessed April 4, 2025). https:// w w w.c a nce r.g o v/a b out- c a nce r/ t r e a t me nt/r e - search/car-t-cells 3. AstraZeneca. Imfinzi Approved in the EU as First and Only Immunotherapy for Limited-Stage Small Cell Lung Cancer. Press Release. March 17, 2025. 4. Shilpa Biologicals. Shilpa Biologicals Pvt Ltd Signs Strategic Development Partnership with mAbTree Biologics AG for a Novel Immuno-Oncology Asset. Press Release. March 17, 2025. 5. Pfizer. US FDA Approves Pfizer's ADCETRIS Com- bination Regimen for the Treatment of Relapsed/ Refractory Diffuse Large B-Cell Lymphoma. Press Release. Feb. 12, 2025. 6. March Biosciences. March Biosciences Receives FDA Orphan Drug Designation for MB-105, a First- in-Class CD5 CAR-T Cell Therapy, for T-Cell Lym- phoma. Press Release. Jan. 28, 2025. 7. March Biosciences. March Biosciences and CTMC Form Strategic Alliance to Propel Innovative Can- cer Cell Therapies. Press Release. Sept. 11, 2023. ■ Novel Oncology Biotherapeutics: Gene Therapies Andrew Moreo, head of Process D e v e l o p m e n t a n d P r e - c l i n i c a l Manufacturing at Andelyn Biosciences, talks with BioPharm International® about the benefits and challenges of gene therapies developed to treat cancer. Novel Oncology Biotherapeutics: CAR T-Cell Therapy Sarah Hein, co-founder and CEO of March Biosciences, sat down with BioPharm International® to talk about novel modalities for cancer treatment. Emerging Therapies in Oncology: Tumor-Infiltrating Lymphocytes BioPharm International® spoke with Jason Bock, founder and CEO of CTMC, to find out about the newest cancer treatments, specifically developments in tumor-infiltrating lymphocytes.

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