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.