Market Overview

Checkmate Pharmaceuticals Announces Strategic Collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate Combination Therapy with CMP-001 and Avelumab


Phase Ib/II trial will evaluate safety, pharmacokinetics,
pharmacodynamics, efficacy of the immunotherapy combination in
PD-1/PD-L1-Refractory Advanced Squamous Cell Cancer of the Head and Neck

(Checkmate), announced that it has entered into a
clinical trial collaboration and supply agreement with the alliance
between Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate CMP-001,
a TLR9 agonist, in combination with avelumab*, a human anti-PD-L1
antibody. The collaboration will evaluate the safety and effectiveness
of CMP-001 administered in combination with avelumab in patients with
advanced squamous cell cancer of the head and neck (SCCHN) resistant to
a prior PD-1/PD-L1 inhibitor.

"This collaboration is an important next step in advancing our clinical
development program for CMP-001 into indications beyond melanoma, where
we already have demonstrated proof-of-concept,'' said Art Krieg, CEO of
Checkmate. "Merck KGaA, Darmstadt, Germany, and Pfizer are ideal
partners for Checkmate given their commitment to developing avelumab
broadly in the immuno-oncology field."

"Early data suggest CMP-001 exhibits clinically encouraging activity and
we are looking forward to investigating this compound in combination
with avelumab in advanced head and neck cancer," said Chris Boshoff,
M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early
Development and Translational Oncology, Pfizer Global Product
Development. "Our collaboration with Checkmate further demonstrates the
alliance's commitment to explore novel combinations with avelumab to
potentially improve patient outcomes."

"Combining avelumab with CMP-001 adds to our clinical development
strategy of IO combinations in different hard-to-treat cancers," said
Alise Reicin, Head of Global Clinical Development at the Biopharma
business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
operates as EMD Serono. "We look forward to working with Checkmate to
explore how the combination of these agents can potentially advance care
for these patients."

Avelumab has received accelerated approval** by the US Food and Drug
Administration (FDA) for the treatment of patients with metastatic
Merkel cell carcinoma (MCC) and previously treated patients with locally
advanced or metastatic urothelial carcinoma (mUC), and is under further
clinical evaluation across a range of tumor types under a global
strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.

*Avelumab is under clinical investigation for treatment of SCCHN in
combination with CMP-001 and has not been demonstrated to be safe and
effective for this use. There is no guarantee that avelumab will be
approved for SCCHN by any health authority worldwide.

About CMP-001

CMP-001 is a first-in-class CpG-A Toll-like receptor 9 (TLR9) agonist
that is encapsulated in a virus-like particle (VLP). CMP-001 is designed
to induce both innate and adaptive anti-tumor immune responses, thereby
converting immunologically "cold" tumors into immunologically "hot"
tumors, with the potential to mediate tumor regression. It is the only
CpG-A class TLR9 agonist in clinical trials and differs from other CpG
classes in clinical development by having a native DNA backbone that
induces the highest levels of type I IFN. Based on analyses of gene
expression in human tumors showing that increased IFN and related immune
gene expression is associated with better response to PD-1 inhibition,
it is believed that this mechanism of action may restore, enable or
improve responses to anti-PD-1/PD-L1 therapeutics.

CMP-001 is being evaluated in multiple tumor types to assess its safety,
activity, alternative routes of administration and combination with
other immunotherapies and modalities. For information on CMP-001 trials
that are currently recruiting patients, please visit

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody.
Avelumab has been shown in preclinical models to engage both the
adaptive and innate immune functions. By blocking the interaction of
PD-L1 with PD-1 receptors, avelumab has been shown to release the
suppression of the T cell-mediated antitumor immune response in
preclinical models.1-3 Avelumab has also been shown to induce
NK cell mediated direct tumor cell lysis via antibody-dependent
cell-mediated cytotoxicity (ADCC) in vitro.3-5 In November
2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical
development program, which involves at least 30 clinical programs,
including seven Phase III trials, and more than 8,600 patients across
more than 15 different tumor types. For a comprehensive list of all
avelumab trials, please visit

Approved Indications in the US**

The US Food and Drug Administration (FDA) granted accelerated approval
for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric
patients 12 years and older with metastatic Merkel cell carcinoma (mMCC)
and (ii) patients with locally advanced or metastatic urothelial
carcinoma (mUC) who have disease progression during or following
platinum-containing chemotherapy, or have disease progression within 12
months of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. These indications are approved under accelerated approval
based on tumor response rate and duration of response. Continued
approval for these indications may be contingent upon verification and
description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label

The warnings and precautions for avelumab (BAVENCIO®) include
immune-mediated adverse reactions (such as pneumonitis, hepatitis,
colitis, endocrinopathies, nephritis and renal dysfunction and other
adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in
patients treated with BAVENCIO for mMCC and patients with locally
advanced or metastatic UC include fatigue, musculoskeletal pain,
diarrhea, nausea, infusion-related reaction, peripheral edema, decreased
appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO,
please see

About Checkmate

Checkmate Pharmaceuticals is a clinical stage company that is leveraging
its expertise in the field of CpG oligonucleotides to discover and
develop immunotherapies designed to increase the efficacy of existing
immunotherapies and to provide new treatment options for patients and
their healthcare providers. Checkmate's lead product candidate, CMP-001,
is an investigational cancer immunotherapeutic that has been shown to
reverse resistance to PD-1 therapy in some patients.

Checkmate is a privately held company headquartered in Cambridge, MA.

Information regarding Checkmate is available at

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Marabelle A, et al. Combination strategies to enhance antitumor ADCC. Immunotherapy.
5. Hamilton G, Rath B. Avelumab: combining
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