North America Equity Research
02 October 2019
U.S. Biotechnology
Bispecific Deep Dive: When All You Need is a Helping
Hand
Biotechnology – Large Cap
Cory Kasimov
AC
(1-212) 622-5266
cory.w.kasimov@jpmorgan.com
Bloomberg JPMA KASIMOV <GO>
Matthew T Holt, Ph.D.
(1-212) 622-9602
matthew.t.holt@jpmorgan.com
Gavin Scott
(1-212) 622-0579
gavin.scott@jpmorgan.com
Neena M Bitritto-Garg, CFA
(1-212) 622-8967
neena.m.bitritto-garg@jpmchase.com
J.P. Morgan Securities LLC
See page 41 for analyst certification and important disclosures.
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Bispecific molecules aim to capture the best of both worlds by tweaking a familiar off-
the-shelf antibody approach to generate high efficacy products in a way that is
reminiscent of newer, and more complex, therapeutic modalities (e.g., CAR T). With a
few approved bispecifics on the market that have demonstrated proof-of-concept for
this modality more broadly, many of the largest biopharma companies have a zoo full
of different bispecific molecules / formats that are taking on increased importance
within company pipelines. While much debate remains around where exactly
bispecifics will fit into the therapeutic landscape (e.g., CAR T killers?), what is not up
for debate is the importance of getting up to speed on where bispecifics are today and
where they might be going in the future. Hence this report (**SLIDE DECK
attached**), which we intend to be the first in a series on this potentially disruptive
platform.
Within our attached SLIDE DECK you’ll find: (1) an introduction to the
bispecific concept and molecule design; (2) an overview of bispecific
manufacturing and administration; (3) a look at current bispecific data sets within
the field of oncology (CD19, CD20, and BCMA-targeted T cell redirecting
therapies); and (4) a nearly comprehensive view of the bispecific landscape.
Bispecifics expand the reach of off-the-shelf approaches, harnessing the power
of antibody specificity, by adding a helping hand. The potential of bispecific
molecules come from their off-the-shelf nature and ability to target multiple entities
in a way that affects / mimics biological processes (e.g., re-directing T cells,
modulating cell surface receptors). The approval of the CD19-directed bispecific T-
cell engager Blincyto in 2014 invigorated the field within oncology, while the
clinical (and commercial) success of Hemlibra in hemophilia A has showcased the
potential of bispecifics in non-oncology indications.
Recent progress has led to a massive R&D effort throughout the BioPharma
space. There are 100s of bispecific programs worldwide and a wave of R&D
exploring ways to understand and improve upon current approaches. Players in this
space include: BMY/CELG, JNJ, ROG, PFE, AMGN, REGN, GMAB, MGNX
and many, many more. From many of these players, we expect a continued focus on
bispecific therapies for the foreseeable future.
Although the bispecific concept is relatively straight forward, bispecific design,
manufacturing and administration can be complex. The main premise of
bispecific molecules is that they can specifically bind to two different targets. Given
the complicated and nuanced nature of the biological processes bispecifics aim to
replicate, there are many aspects to be considered during development that include:
target, design, format, and manufacturing. We highlight these aspects in much detail
in our deck.
We’ve previously also dug deep into the evolving CAR-T and BCMA
landscapes. You can find the latest iteration of those comprehensive decks
here...CAR-T & BCMA.