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Lantheus Announces Strategic Collaboration with NanoMab to Provide a Novel Biomarker for Clinical Development and Management of Immuno-Oncology Therapies

May 30, 2019 Off By BusinessWire

Lantheus expands into immuno-oncology and pharmaceutical services
business through the license of NanoMab’s NM-01, an anti-PD-L1
imaging biomarker, designed to evaluate tumor immune activity and
potentially guide future patient selection for immuno-oncology treatment

NORTH BILLERICA, Mass.–(BUSINESS WIRE)–Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), parent company
of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the
development, manufacture and commercialization of innovative diagnostic
imaging agents, today announced that it has entered into a strategic
collaboration and license agreement with NanoMab Technology Limited
(“NanoMab”), a privately-held biopharmaceutical company focusing on the
development of next generation radiopharmaceuticals to be used in the
development of immuno-oncology therapies. This collaboration will
provide the first broadly-available imaging biomarker research tool to
pharmaceutical companies and top academic centers conducting research
and development on immuno-oncology treatments, including combination
therapies.

Since the first programmed cell death protein 1 (PD-1) inhibitors
launched in 2014, the global checkpoint inhibitor market has grown to
greater than $14 billion in 2018 and is anticipated to continue growing
at a double-digit rate¹. Currently more than 1,500 clinical
trials on checkpoint inhibitors are ongoing according to the Cancer
Research Institute, an increase of six fold in the last three years².

Although PD-(L)1 checkpoint inhibitors have achieved impressive results
in certain patient populations, improving response rates and extending
survival across multiple tumor types, challenges remain in optimizing
the use of these therapies. Across tumor types, only about 20% of
patients respond to treatment with checkpoint inhibitors, even with the
use of PD-L1 immuno-histochemistry assays to select patients³.
There is a need for biomarkers that improve utilization of
immunotherapies by identifying those patients most likely to benefit
from therapy, which may also serve to avoid unnecessary cost to patients
and health systems.

Under the collaboration agreement, Lantheus will license NanoMab’s
NM-01, a proprietary radiopharmaceutical biomarker camelid single-domain
antibody that has demonstrated a high affinity for PD-L1 protein. NM-01
could provide a specific, non-invasive approach to diagnosis, including
use in whole-body imaging, or virtual biopsy. NM-01 potentially allows
detection of PD-L1 expression in immuno-oncology studies, either before
or during immuno-oncology treatment. Lantheus will provide NM-01 as a
clinical research tool, together with support and analytics, to
pharmaceutical companies and the largest academic centers conducting
clinical research in immuno-oncology.

“Our collaboration with NanoMab provides Lantheus the opportunity to
extend our diagnostic and radiopharmaceutical expertise into the fast
growing market of immuno-oncology,” said Mary Anne Heino, President and
Chief Executive Officer of Lantheus. “We already serve the oncology
field with several radiopharmaceutical agents and are excited to work
with NanoMab to bring the first broadly available PD-L1 imaging research
tool to the global pharmaceutical community.”

“NanoMab is proud to partner with Lantheus for the development and the
commercialization of NM-01, as we think our unique technology can help
progress innovation in immuno-oncology,” said Ting Hong Hoi, CEO of
NanoMab. “Lantheus has the infrastructure, established expertise and the
reach to best optimize the value of NM-01 for patients and our
shareholders.”

NM-01 is in Phase 1 clinical development with 21 patients currently
enrolled in a study that will eventually recruit a total of 50 patients.
The agent has a short half-life and provides diagnostically significant
results in approximately two hours. Early Phase 1 study data was
published in the February 22, 2019 issue of the Journal of Nuclear
Medicine (Xing et al.). NanoMab plans to file an Investigational
Medicinal Product Dossier (IMPD) in the United Kingdom in the second
half of 2019.

About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus
Holdings, Inc. is the parent company of LMI, a global leader in the
development, manufacture and commercialization of innovative diagnostic
imaging agents and products. The Company is headquartered in North
Billerica, Massachusetts with offices in Puerto Rico and Canada. For
more information, visit www.lantheus.com.

About NanoMab Technology Limited
NanoMab Technology Limited
is a privately-held biopharmaceutical company focusing on the
development of next generation radiopharmaceuticals for cancer precision
medicine to address the unmet diagnostic and medical needs of cancer
patients around the world. NanoMab’s goal is to develop a pipeline of
theranostic couple camelid antibodies with its proprietary camelid
antibodies platform to address the unmet diagnostic and medical need for
cancer patients around the world. For more information, visit www.nano-mab.com/en/.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” as defined
under U.S. federal securities laws, including statements about future
events and outcomes. Forward-looking statements may be identified by
their use of terms such as anticipate, can, could, potential, plan, and
other similar terms. Such forward-looking statements are subject to
risks and uncertainties that could cause actual results to materially
differ from those described in the forward-looking statements. Readers
are cautioned not to place undue reliance on the forward-looking
statements contained herein, which speak only as of the date hereof. The
Company undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future developments
or otherwise, except as may be required by law. Risks and uncertainties
that could cause the Company’s actual results to materially differ from
those described in the forward-looking statements are discussed in our
filings with the Securities and Exchange Commission (including those
described in the Risk Factors section in the Company’s Annual Reports on
Form 10-K and our Quarterly Reports on Form 10-Q).

1. GlobalData. Drug Sales and Consensus Forecast Advance Export – Drug
Details: Immune Checkpoint Modulator.
2. Cancer Research Institute. http://www.cancerresearch.org/scientists/clinical-accelerator/landscape-of-immuno-oncology-drug-development/pd-1-pd-l1-landscape.
Accessed May 29, 2019.
3. Xu-Monette Zy, Zhang M, Li J and Young KH
(2017) PD-1/P-L1 Blockage: Have We Found the Key to Unleash the
Antitumor Immune Response? Front. Immunol. 8:1597.doi:
10.3389/fimmu.2017.01597