Sartorius #2 eBook - 2019 - 13

Importance of mAb Discovery and Development in Immunotherapy

with reduced off-target damage, and redirect FcR- and non-FcR-expressing
immune cells to kill target cells.
Bispecifics are estimated to capture 58% of the antibody therapy market by 2023. But
by 2030, molecules belonging to other product classes having different mechanisms
of action, such as blocking cytokines, dual targeting, and half-life extension, are
collectively projected to capture almost 75% of the market, with highly lucrative
deals emerging between pharma and biotech companies.
Xencor and Novartis announced in 2016 that Novartis will codevelop two of
Xencor's T-cell-engaging XmAb bsAbs targeting acute myeloid leukemia and B-cell
malignancies as part of a broader collaboration potentially generating up to up
$150 million up front for Xencor.
Moreover, last year, U.K.-based F-star and Germany's Merck KGaA established a
strategic collaboration to develop and commercialize five of F-star's bispecific
immuno-oncology antibodies (mAb2™). The deal, which is potentially worth $1.13
billion, includes F-star's lead preclinical asset, FS118, and four additional bsAbs
selected from F-star's platform. FS118 targets lymphocyte activation gene 3 (LAG-3)
and programmed death-ligand 1 (PD-L1).
To date, such bi- or tri-targeted antibodies have received marketing approval
including blinatumumab (Blincyto), Amgen's anti-CD19/CD3 bispecific T-cell BiTE
approved by the FDA in 2015 for the treatment of refractory B-cell acute lymphoblastic leukemia. And on March 29, 2018, the agency granted accelerated approval to
Blincyto for the treatment of adult and pediatric patients with B-cell precursor acute
lymphoblastic leukemia in first or second complete remission with minimal residual
disease greater than or equal to 0.1%.
Amgen acquired the antibody through its $1.16-billion cash acquisition of Micromet.
The deal provided Amgen with both a cancer immunotherapy based on the bsAb
fragment blinatumumab and the underlying technology that produced it.
Blinatumumab is a fusion protein made up of the variable regions of two single-chain,
variable fragments linked by a nonimmunogenic five-amino-acid chain. The antibody
13 |

GENengnews.com

The ability to bind two or more unique epitopes gives
bsAbs greater versatility than conventional mAbs
because they can target multiple pathways, cross-link
cell surface receptors, pretarget oncological epitopecontaining cell types, deliver therapeutics with reduced
off-target damage, and redirect FcR- and non-FcRexpressing immune cells to kill target cells.

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Sartorius #2 eBook - 2019

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