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Báo cáo khoa học: Investigations on the evolutionary conservation of PCSK9 reveal a functionally important protrusion pot

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We found a large, conserved protrusion on the surface of the PCSK9 catalytic domain and have performed site-directed mutagenesis experiments for 13 residues on this protrusion.. Whereas

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reveal a functionally important protrusion

Jamie Cameron1, Øystein L Holla1, Knut Erik Berge1,*, Mari Ann Kulseth1, Trine Ranheim1,

Trond P Leren1and Jon K Laerdahl2

1 Medical Genetics Laboratory, Department of Medical Genetics, Rikshospitalet University Hospital, Oslo, Norway

2 Centre for Molecular Biology and Neuroscience (CMBN), Institute of Medical Microbiology, Rikshospitalet University Hospital, Oslo, Norway

An elevated level of plasma low-density lipoprotein

(LDL) cholesterol is a major risk factor for coronary

heart disease The key factor regulating the level of

LDL cholesterol is the cell surface LDL receptor

(LDLR) [1] The number of LDLRs is regulated at the

transcriptional level [1] but is also

post-transcription-ally regulated by proprotein convertase subtilisin⁄ kexin

type 9 (PCSK9) [2], also known as NARC-1 [3]

Over-expression of PCSK9 in mice leads to reduced levels of

LDLR and increased levels of LDL cholesterol [2,4,5], whereas mice with no functional PCSK9 have increased levels of LDLR and reduced levels of LDL cholesterol [6]

Some aspects of the mechanism by which PCSK9 regulates the number of LDLRs have recently been identified Secreted PCSK9 binds to the epidermal growth factor-like repeat A (EGF-A) of the extra-cellular domain of the LDLR [7] PCSK9 bound to the

Keywords

evolutionary conservation; LDL cholesterol;

LDL receptor; PCSK9; structural

bioinformatics

Correspondence

J K Laerdahl, Centre for Molecular Biology

and Neuroscience (CMBN), Institute of

Medical Microbiology, Rikshospitalet

University Hospital, NO-0027 Oslo, Norway

Fax: +47 22 84 47 82

Tel: +47 22 84 47 84

E-mail: j.k.lardahl@medisin.uio.no

(Received 3 April 2008, revised 9 May 2008,

accepted 16 June 2008)

doi:10.1111/j.1742-4658.2008.06553.x

Proprotein convertase subtilisin⁄ kexin type 9 (PCSK9) interferes with the recycling of low-density lipoprotein (LDL) receptor (LDLR) This leads to LDLR degradation and reduced cellular uptake of plasma LDL Naturally occurring human PCSK9 loss-of-function mutations are associated with low levels of plasma LDL cholesterol and a reduced risk of coronary heart disease PCSK9 gain-of-function mutations result in lower LDL clearance and increased risk of atherosclerosis The exact mechanism by which PCSK9 disrupts the normal recycling of LDLR remains to be determined

In this study, we have assembled homologs of human PCSK9 from 20 ver-tebrates, a cephalochordate and mollusks in order to search for conserved regions of PCSK9 that may be important for the PCSK9-mediated degra-dation of LDLR We found a large, conserved protrusion on the surface of the PCSK9 catalytic domain and have performed site-directed mutagenesis experiments for 13 residues on this protrusion A cluster of residues that is important for the degradation of LDLR by PCSK9 was identified Another cluster of residues, at the opposite end of the conserved protrusion, appears

to be involved in the physical interaction with a putative inhibitor of PCSK9 This study identifies the residues, sequence segments and surface patches of PCSK9 that are under strong purifying selection and provides important information for future studies of PCSK9 mutants and for inves-tigations on the function of this regulator of cholesterol homeostasis

Abbreviations

CRD, cysteine-rich domain of PCSK9, i.e the C-terminal domain; EGF-A, epidermal growth factor-like repeat A of LDLR; EST, expressed sequence tag; LDL, low-density lipoprotein; LDLR, low-density lipoprotein receptor; PC, proprotein convertase; PCSK9, proprotein

convertase subtilisin ⁄ kexin type 9; WT, wild-type.

*[Correction added on 16 July 2008, after first online publication: the author name has been amended]

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LDLR is internalized by endocytosis [7,8], and bound

PCSK9 somehow disrupts the recycling of the LDLR

As a consequence, the LDLR is transferred to the

lysosomes for degradation [7]

PCSK9 belongs to a superfamily of subtilisin-like

serine proteases and is the ninth mammalian member

identified in the proprotein convertase (PC) family [3]

The PC zymogens have an N-terminal signal sequence,

a prodomain, a catalytic subtilisin-like domain, and a

C-terminal domain [9] They undergo autocatalytic

cleavage in the endoplasmic reticulum, but the

prodo-main reprodo-mains noncovalently bound to the catalytic

domain In PCSK9, the backbone is cut between

Gln152 and Ser153 [4], and autocatalysis, as well as

correct folding of the protein, is necessary for secretion

of PCSK9 [3] Unlike other convertases, PCSK9 does

not appear to undergo a second autocatalytic event

resulting in the release of an active protease [4,10]

Instead, the prodomain remains tightly bound to the

mature, cleaved PCSK9 after secretion It has been

shown that the enzymatic activity of PCSK9 is not

necessary for its regulation of the LDLR [11,12] The

finding that individuals without any detectable plasma

PCSK9 are healthy and develop normally [13,14]

sug-gests that drugs targeting PCSK9 might represent a

promising new class of LDL cholesterol-lowering

drugs

The crystal structure of free PCSK9 has recently

been determined, and showed the catalytic domain to

have high structural similarity to other subtilisin-like

serine proteases [10,15,16] The prodomain

(resi-dues 31–152) is tightly bound to the catalytic domain

(residues 153–449), hindering access to the active site

catalytic triad, Asp186, His226, and Ser386 The

N-ter-minal part of the prodomain (residues 31–60) is

struc-turally disordered The C-terminal cysteine-rich

domain (CRD) is built from three modules arranged

with quasi-three-fold rotational symmetry, where each

module forms a two-sheet b-sandwich comprising six

b-strands Each b-sandwich of this pseudo-propeller

fold is structurally homologous to the C-terminal

region of resistin [15] and is held together by three

structurally conserved disulfide bonds

In humans, various mutations in the PCSK9 gene

have been found to cause autosomal dominant

hypo-cholesterolemia or hyperhypo-cholesterolemia [4,13,17–24]

For mutations that do not affect PCSK9 folding or

secretion, these effects appear to be largely mediated

by different affinities of the mutant PCSK9s for the

LDLR [11,25] However, another level of complexity

has been added with the recent finding that PCSK9

itself is cleaved by the PC furin, and, to a lesser extent,

by PC5⁄ 6A [26] PCSK9 is cleaved between

resi-dues 218 and 219 in what has been shown to be a structurally disordered loop on the surface of the PCSK9 catalytic domain [10,15,16] Furin-cleaved PCSK9 is inactive in degrading LDLR, and naturally occurring gain-of-function mutations such as R215H [24], F216L and R218S [17,27] are likely to be gain-of-function mutations due to reduced furin cleavage The exact mechanism by which PCSK9 binds to the LDLR and disrupts the normal recycling of the LDLR remains to be determined One strategy to elucidate the underlying mechanism is to study how mutations

in the PCSK9 gene affect the PCSK9-mediated degra-dation of the LDLR Candidate residues for being of functional importance for macromolecular interactions involving PCSK9 are those that are highly conserved between different species, especially conserved residues that are solvent-exposed in unbound PCSK9 and that

do not appear to be important for protein folding Specific and functionally important protein–protein interactions between PCSK9 and other macromole-cules are likely to be mediated through a contact area with complementary shape, hydrophobicity and charges for the two protein surfaces Mutations that change the properties of the interacting PCSK9 surface will result in altered, usually weakened and less specific interaction with LDLR or another binding partner Consequently, residues involved in protein–protein interactions will be more conserved during evolution than other surface-exposed residues We therefore extracted the sequences of homologs of human PCSK9 from public sequence databases in order to search for functional regions by mapping phylogenetic informa-tion onto the known protein structure

PCSK9 is present in the proteome of most verte-brates as well as in the invertebrate Branchiostoma flor-idae Whereas most residues exposed on the PCSK9 surface appear to be under limited selective pressure in vertebrates, a large protrusion on the catalytic domain contains a number of absolutely conserved residues This protrusion could play an important role in specific macromolecular interactions, e.g for the inter-action with and degradation of the LDLRs We have therefore performed site-directed mutagenesis of 13 residues within this protrusion in order to study how the mutant PCSK9s affect uptake of LDL We found that the conserved residues cluster in two groups: one group causes PCSK9 gain-of-function mutations, whereas the remaining residues are located in a small patch giving rise to mutations of the loss-of-function type Our data suggest that the conserved protrusion is involved in two separate specific macromolecular inter-actions of importance for the PCSK9-mediated degra-dation of the LDLRs

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PCSK9 has homologs in chordates and mollusks

Homologs of human PCSK9 were extracted from a

number of public databases, including the NCBI

non-redundant protein and expressed sequence tag (EST)

databases [28], uniprot [29], the ensembl resources

[30], and some sequencing project databases Protein

sequences homologous to full-length human PCSK9

from many vertebrates were found, including primates,

rat, mouse, squirrel (Spermophilus tridecemlineatus),

and a number of other placental mammals, opossum

(Monodelphis domestica), chicken, the Carolina anole

lizard (Anolis carolinensis), frogs (Xenopus tropicalis⁄

Xenopus laevis), and the fish species Oryzias latipes,

Danio rerio, Tetraodon nigroviridis, and Takifugu

rubri-pes (see supplementary Doc S1) No vertebrate with

more than a single PCSK9 homolog was found

Data from the Florida lancelet (B floridae)

sequenc-ing project, containing both genomic and EST

sequences, indicate at least two potential homologs of

full-length PCSK9 in this organism B floridae is a

representative of the cephalochordates, one of the

three chordate subphyla, the other two being

verte-brates and urochordates No homologs of full-length

PCSK9 were detected in any urochordate, e.g in the

fairly well-studied Ciona intestinalis, or in any other

invertebrates The C-terminal domain of PCSK9, the

CRD, was not found in any vertebrate protein apart

from PCSK9 itself However, homologs of the CRD

appear to be present in proteins in the marine

Califor-nia sea slug (Aplysia californica) and in the freshwater

snail Biomphalaria glabrata These CRD homologs

were extracted from ESTs from the Aplysia EST

project and the Biomphalaria sequencing project (see

supplementary Doc S1)

The sequence data for the PCSK9 homologs are

given in the supplementary Table S1 Multiple

sequence alignments for all PCSK9 homologs were

generated (Fig 1 and supplementary Figs S1 and S2)

Bovines might be lacking a functional PCSK9

Sequence searching with human PCSK9 in the NCBI

EST databases gave highly significant hits in human,

mouse, rat, dog, chicken, frog, fish and lancelet ESTs

However, there was not a single detected PCSK9

homolog in 1.3 million bovine EST sequences In a

recent Bos taurus genome assembly (Btau_3.1) from

the Baylor College of Medicine Human Genome

Sequencing Center, we detected a genomic sequence on

Bos taurus chromosome 3 with high similarity to

human PCSK9 exons 8–12 These putative PCSK9 exons have insertions⁄ deletions and nonsynonymous mutations in regions that are absolutely conserved in all other vertebrates, including fish, and there appears

to be a premature stop codon in putative bovine exon 10 Traces sequenced in both directions on the genome are available in the NCBI Trace Archive that supports the stop codon in exon 10 The Btau_3.1 ver-sion of the bovine genome is a preliminary assembly based on approximately 26 million reads and  7· sequence coverage Close to 95% of bovine ESTs were contained in the assembled contigs, indicating that less than one in 20 Bos taurus protein-coding genes are missing in this assembly

The above findings suggest that the region on bovine chromosome 3 with homology to PCSK9 is a remnant

of a PCSK9 pseudogene, and that extant Bos taurus might be lacking functional PCSK9

Site-directed mutagenesis of residues in a conserved protrusion on PCSK9

On the basis of a multiple sequence alignment of 18 vertebrate PCSK9 homologs, residue conservation was mapped onto a PCSK9 structural model with the consurf tool [31,32] (Fig 2) Residue conservation

on the solvent-exposed PCSK9 surface is limited The exception is a large protrusion on the catalytic domain with a surface area of roughly 1500 A˚2 (Fig 2B) Approximately half of this protrusion, the part closest to the prodomain, is built from the struc-turally disordered loop Gly213–Arg218 (Fig 2A) and residues partially covered by this loop (Fig 2C) Evo-lutionarily conserved regions on protein surfaces are likely to be of functional importance, such as being involved in specific interactions with other macro-molecules We therefore performed site-directed muta-genesis of the 13 most conserved residues in this region (i.e residues on yellow, blue, pink and green background in Fig 2C) and investigated how these mutations affected PCSK9 secretion and the internali-zation of LDL

To study whether the mutant PCSK9s were autocat-alytically cleaved and secreted in a normal fashion, HepG2 cells were transiently transfected with mutant PCSK9 plasmids harboring each of the 13 different mutations The amounts of pro-PCSK9 and mature PCSK9 in cell lysates were determined by western blot analysis using an antibody to PCSK9 In cells express-ing wild-type (WT) PCSK9, two bands of 73 kDa and

64 kDa were observed, which correspond to pro-PCSK9 and the mature form of pro-PCSK9, respectively (Fig 3) Unlike the catalytically inactive mutant

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S386A-PCSK9, the 13 new PCSK9 mutants appeared

to be autocatalytically cleaved in a fashion similar to

that of WT-PCSK9 Moreover, all 13 mutant PCSK9s,

except for C375A-PCSK9 and C378A-PCSK9, were

secreted in a normal fashion (Fig 3) The amount of

C378A-PCSK9 in the culture media was markedly

reduced, whereas no C375A-PCSK9 was observed in

the media It is likely that C375A-PCSK9 and

C378A-PCSK9 are completely or partially, respectively,

retained in the endoplasmic reticulum due to abnormal

protein folding caused by disruption of the disulfide

bond bridging the residues Cys375 and Cys378

Effect of PCSK9 mutants on the internalization

of LDL and on PCSK9 cleavage by furin

To study the effects of the 13 PCSK9 mutants on the PCSK9-mediated degradation of the LDLR, we used transiently transfected HepG2 cells and studied the amount of LDL internalization by flow cytometry HepG2 cells transfected with WT-PCSK9, empty plas-mid, the catalytically inactive S386A-PCSK9 plasmid [3,23] or one of the two gain-of-function plasmids, S127R-PCSK9 and D374Y-PCSK9 [23], were used as controls (Fig 4) Internalization of LDL by cells

A

B

C

Fig 1 Multiple sequence alignments of human PCSK9 homologs from vertebrates, a cephalochordate (B floridae) and the mollusks Aplysia and Biomphalaria, showing the signal sequence and N-terminus of the prodomain (A), two segments of the catalytic domain (B), and the full CRD, the C-terminal domain (C) Conserved residues are indicated by numbering referring to human PCSK9 The catalytic triad residues are marked with an asterisk The full alignment and sequence data are given in supplementary Figs S1, S2 and supplementary Table S1.

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expressing these control plasmids was comparable to

previous findings [23,24]

Cells expressing the two mutants C375A-PCSK9

and C378A-PCSK9 internalized 19% and 14% more

LDL, respectively, than cells expressing WT-PCSK9

Thus, as expected for PCSK9 mutants that are secreted

at markedly reduced levels, the two mutants present as

loss-of-function type Cells expressing R194A-PCSK9,

D238A-PCSK9, T377A-PCSK9 or F379A-PCSK9

also internalized more LDL than cells expressing

WT-PCSK9 The amounts of LDL internalized by these cells were higher or similar to those of cells expressing C375A-PCSK9 or C378A-PCSK9 (Fig 4) Thus, we also consider these four to be loss-of-func-tion mutants

Cells expressing R237A-PCSK9 did not show any significant difference in LDL internalization as com-pared with cells expressing WT-PCSK9 (Fig 4) R237A-PCSK9 is therefore a neutral variant Cells expressing one of the remaining six PCSK9 mutants

B

Fig 2 Structural model of human PCSK9 with the conserved protrusion (A) The structurally disordered loop Gly213–Arg218 (orange) with the furin recognition motif is located on the catalytic domain (green) Also shown is the prodomain (gray) blocking the active site and the CRD, the C-terminal domain (pink) (B) Amino acid residue conservation in 18 vertebrate PCSK9 homologs mapped, employing CONSURF [31], onto the space-filling representation of the PCSK9 model The spatial orientation is identical to (A) (upper), and rotated 180 around a vertical axis (lower) The color scale extends from cyan (highly variable residues), through white (intermediate) to magenta (highly conserved) Yellow residues are of intermediate variability, but with low statistical confidence [31] The conserved protrusion is visible in the panel as an extended patch in magenta (upper part, right-hand side) (C) Magnification of the conserved protrusion showing the 13 residues of the cur-rent study giving mutants with a low level of protein secretion (yellow background), loss-of-function mutants (blue), gain-of-function mutants (pink), no change (green), as well as three residues of the disordered loop Gly213–Arg218 previously shown to give rise to gain-of-function mutants (orange) The model is rotated 50 around a vertical axis with respect to (B), upper panel.

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S153A-PCSK9, Q190A-PCSK9, D204A-PCSK9,

K222A-PCSK9, D374A-PCSK9 and S376A-PCSK9

internalized less LDL than cells expressing WT-PCSK9

(Fig 4) The amounts of LDL internalized by cells

expressing these mutants were in the same range or

lower than in cells expressing the gain-of-function

mutant S127R-PCSK9 Thus, we consider these

mutants to be gain-of-function mutants

The four loss-of-function mutants involving Arg194,

Asp238, Thr377 or Phe379 are located close together

on the conserved protrusion (Fig 2C) Four

gain-of-function mutants, involving Gln190, Lys222, Asp374

and Ser376, are located together in a separate region

between the loss-of-function patch and the disordered

loop Gly213–Arg218 The two remaining

gain-of-func-tion mutants, involving Ser153 and Asp204, are

located on opposing edges of the conserved protrusion

(Fig 2C)

Five of the six gain-of-function mutant residues are clustered in the vicinity of the disordered loop consist-ing of residues Gly213–Arg218 (Fig 2C) This loop contains the furin cleavage site RFHR218 [26], and cleavage by furin at this site results in PCSK9 that is inactive in degrading the LDLR [26] To determine whether the gain-of-function mutants had reduced furin cleavage, the amounts of furin-cleaved PCSK9 in the media of HEK293 cells transiently transfected with the different PCSK9 plasmids were determined by wes-tern blot analysis HEK293 cells were chosen for these analyses because truncated PCSK9 due to cleavage by furin is more prominent than in the medium of HepG2 cells R215H-PCSK9 was included as a negative con-trol Furin-cut PCSK9 was present in small amounts

in the media of cells transfected with gain-of-function plasmids as well as in the media of cells transfected with WT-PCSK9 plasmid or with loss-of-function

Fig 4 Internalization of LDL by HepG2 cells transiently transfected with mutant PCSK9 plasmids The effects of mutants S153A-PCSK9, Q190A-PCSK9, R194A-PCSK9, D204A-PCSK9, K222A-PCSK9, R237A-PCSK9, D238A-PCSK9, D374A-PCSK9, C375A-PCSK9, S376A-PCSK9, T377A-PCSK9, C378A-PCSK9 and F379A-PCSK9 on the internalization of fluorescently labeled LDL (10 lgÆmL)1) were studied in transiently transfected HepG2 cells by flow cytometry WT-PCSK9 plasmid, empty plasmid, and the catalytically inactive S386A-PCSK9 plasmid, as well

as D374Y-PCSK9 and S127R-PCSK9, were used as controls The values relative to WT-PCSK9 are given as the mean from three experi-ments (± SEM) The amount of LDL internalized by cells transfected with WT-PCSK9 was assigned a value of 100.

Fig 3 Autocatalytic cleavage of the mutants S153A-PCSK9, Q190A-PCSK9, R194A-PCSK9, D204A-PCSK9, K222A-PCSK9, R237A-PCSK9, D238A-PCSK9, D374A-PCSK9, C375A-PCSK9, S376A-PCSK9, T377A-PCSK9, C378A-PCSK9 and F379A-PCSK9 was determined by western blot analysis of cell lysates from HepG2 cells transiently transfected with the mutant PCSK9 plasmids WT-PCSK9 plasmid, empty plasmid and the catalytically inactive S386A-PCSK9 plasmid were used as controls Uncleaved, pro-PCSK9 and mature, cleaved PCSK9 are indicated (upper panel) The lower panel shows the amount of mature, cleaved PCSK9 in the media Three separate experiments were performed; one representative experiment is shown.

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plasmids (Fig 5) Clearly, the relative levels of

full-length mature and furin-cut PCSK9 in the media do

not correlate with mutants being gain-of-function

or not

R194A-PCSK9 and D204A-PCSK9 are

post-translationally modified

As can be seen from Figs 3 and 5, abnormal migration

of mature, cleaved PCSK9 was observed in lysates and

media of HepG2 cells and HEK293 cells transfected

with the R194A-PCSK9 plasmid or the D204A-PCSK9

plasmid However, the corresponding uncleaved

pro-PCSK9 (Fig 3) and the furin-cleaved pro-PCSK9 (Fig 5)

appeared to migrate normally To study whether the

abnormal migration of the mature forms of

R194A-PCSK9 and D204A-R194A-PCSK9 was due to altered

auto-catalytic cleavage, western blot analyses of media from

transfected HepG2 cells were performed using an

anti-body against the prodomain of PCSK9 The

prodo-mains of R194A-PCSK9 and D204A-PCSK9 migrated

normally (Fig 6) Thus, the two mutants were

autocat-alytically cleaved in a normal fashion

To study whether the abnormal migration of

mature, cleaved R194A-PCSK9 and D204A-PCSK9

was due to abnormal glycosylation, the sensitivities of

R194A-PCSK9 and D204A-PCSK9 to an enzyme mix

designed to remove all sugars were determined in cell

lysates of transiently transfected HepG2 cells The

results showed that the differences in the migration of

mature PCSK9 remained after the enzyme treatment

(Fig 7) Thus, an abnormal post-translational

modifi-cation other than glycosylation appears to be

respon-sible for the abnormal migration of R194A-PCSK9 and D204A-PCSK9

Discussion

Vertebrate genome sequencing projects are currently supplying the research community with sequence data from a large number of species that have varying evo-lutionary relationships with humans The data from these projects make it possible to study in detail the level of evolutionary residue conservation in proteins, including estimates of statistical significance In the present study, we have extracted protein sequence data from 21 chordate proteomes and mapped the degree of residue conservation onto the surface of a PCSK9 structure model We found that most of the residues

on the surface of this LDLR-degrading protein appear

to be tolerant to substitutions However, a single large protrusion on the catalytic domain contains a number

of residues that are highly conserved (Fig 2B) We have performed site-directed mutagenesis of 13 resi-dues contributing to this protrusion (Fig 2C), and show that most mutants have either increased or decreased ability to degrade the LDLR and internalize

Fig 5 Amounts of furin-cleaved PCSK9 in the media of HEK293 cells transiently transfected with the mutant PCSK9 plasmids S153A-PCSK9, Q190A-PCSK9, R194A-PCSK9, D204A-PCSK9, K222A-PCSK9, R237A-PCSK9, D238A-PCSK9, D374A-PCSK9, C375A-PCSK9, S376A-PCSK9, T377A-PCSK9, C378A-PCSK9 and F379A-PCSK9 were determined by western blot analysis WT-PCSK9 plasmid, and the gain-of-function plasmids D374Y-PCSK9 and R215H-PCSK9, were used as controls R215H-PCSK9 is not cleaved by furin Three separate experiments were performed; one representative experiment is shown.

WT R194A D204A

PCSK9 prodomain

Fig 6 Western blot analysis using an antibody to PCSK9

recogniz-ing the prodomain was used to identify the prodomains of

WT-PCSK9, R194A-PCSK9 and D204A-PCSK9 in the media of

HepG2 cells.

Fig 7 Western blot analysis was performed for deglycosylated cell lysates The figure shows a representative western blot of cell lysates of HepG2 cells transiently transfected with WT plasmid or plasmids containing R194A-PCSK9 or D204A-PCSK9 with or with-out prior treatment with the Glycoprotein Deglycosylation Kit A horizontal dotted line is included to show that all the mature PCSK9s after deglycosylation have increased mobility due to degly-cosylation.

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LDL as compared to WT-PCSK9 (Fig 4) Only one

of these residues, Asp374, has previously been

associ-ated with hypercholesterolemia in human populations

[18,19,33]

Previous studies have described a number of

natu-rally occurring loss-of-function mutations in PCSK9

that result in proteins that are not autocatalytically

cleaved and⁄ or not folded properly [4,10,13,23,24]

Apart from the previously studied active site mutant

S386A-PCSK9 [23], the only mutants of the present

study that clearly have impaired secretion are

C375A-PCSK9 and C378A-C375A-PCSK9 (Fig 3) Both residues are

absolutely conserved in all chordates (Fig 1B and

sup-plementary Fig S1), demonstrating their importance

for the formation of a disulfide bridge stabilizing the

conformation and overall shape of the conserved

protrusion (Fig 2)

Four of the mutants, R194A-PCSK9,

D238A-PCSK9, T377A-D238A-PCSK9, and F379A-D238A-PCSK9, were

secreted in a similar fashion as WT-PCSK9 (Fig 3),

but nevertheless present as loss-of-function mutants

(Fig 4) The residues involved are located close

together on the conserved protrusion, at the far end

from both the prodomain and the disordered loop

Gly213–Arg218 (Fig 2C) All four residues are highly

conserved in chordates (Fig 1B and supplementary

Fig S1), and are clearly under strong purifying

selec-tive pressure; that is to say, there is substantial

nega-tive natural selection against amino acid replacements

for these residues Arg194 is conserved in all

verte-brates, but is replaced by Glu in B floridae, whereas

Asp238 is conserved in all vertebrates except for the

fish Fugu (T rubripes), where it is replaced by Glu,

a residue with similar properties to Asp Thr377 is

conserved in every single chordate, whereas Phe379 is

conserved in all vertebrates except for the rat, where it

is substituted by another aromatic residue, Tyr As

discussed above, conservation of these residues is not

necessary for protein expression, folding, autocatalysis

or secretion, strongly indicating that this patch on the

PCSK9 surface is, instead, of importance for the direct

physical protein–protein interactions leading to

PCSK9-mediated degradation of the LDLR

During the preparation of this manuscript, Kwon

et al [34] published the crystal structure of the protein

complex formed between PCSK9 and the EGF-A

domain of the LDLR They found that the interaction

between PCSK9 and EGF-A was primarily

hydropho-bic, with some additional specific polar interactions

Phe379 was in the center of the hydrophobic surface,

and Arg194, Asp238 and Thr377 were involved in the

polar interactions with EGF-A [34] Thus, the surface

region of PCSK9 involved in this interaction coincides

with the part of the conserved protrusion associated with loss-of-function mutants in the present study Our findings that mutations R194A, D238A, T377A and F379A were loss-of-function mutations are in agree-ment with the notion that they diminish the binding of PCSK9 to EGF-A

The crystal structure obtained by Kwon et al [34] shows that the N-terminal amine of mature PCSK9 Ser153 forms a salt bridge with a residue in EGF-A, but that the Ser153 side-chain does not directly contact the binding partner Correspondingly, our results showed that S153A-PCSK9 is not a loss-of-function mutant Instead, S153A-PCSK9 appears to lead to decreased internalization of LDL as compared to WT-PCSK9 One might speculate that this could be due to

a slight change in the ability of residue 153 to form a salt bridge to EGF-A, e.g through an inductive effect All the other residues that were associated with gain-of-function mutations in the present study were located either between the EGF-A binding patch and the disordered loop Gly213–Arg218 (Gln190, Lys222, Asp374, and Ser376), or between the disordered loop and the prodomain (Asp204) (Fig 2C) These residues are under selective pressure, with Asp204 and Asp374 being conserved in all vertebrates Lys222 is conserved

in nonfish vertebrates, whereas the conservation of Ser376 appears to be slightly lower (Fig 1B and sup-plementary Fig S1) Mutations of the disordered loop residues, Arg215 [24], Phe216, and Arg218 [26], located

in this part of the conserved protrusion, have previ-ously been shown to be associated with resistance to furin cleavage We therefore investigated whether the gain-of-function mutants of the present study showed reduced cleavage by furin However, we did not find any difference in the amounts of the furin-cleaved bands when investigating the media of cells transfected with loss-of-function mutants as compared with gain-of-function mutants (Fig 5.)

Some caution should be exercised when interpreting these data, as in our study overexpressed PCSK9 has

to be cut by endogenous furin, and these conditions may not be physiologically relevant for the in vivo situation Interestingly, the basic residues in the furin recognition sequence RFHR218 of the disordered loop Gly213–Arg218 are conserved in all vertebrates, but not in the pufferfish T rubripes and T nigroviridis or

in the opossum (Fig 1B) The cephalochordate homo-logs have a deletion of four residues in this loop as compared with the human PCSK9, and appear to completely lack the disordered loop It appears that

PC regulation of PCSK9 is a vertebrate invention and that this level of regulation has subsequently been lost

in some vertebrate subgroups

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If the gain-of-function character of the mutants of

the present study is not due to reduced furin affinity,

another possibility is that a different, unknown,

mac-romolecule is interacting in a specific manner with the

relevant part of the conserved protrusion of PCSK9

This macromolecule may be competing with EGF-A

binding or may inhibit the PCSK9-mediated

degrada-tion of the LDLR by another mechanism Fan et al

[35] have recently suggested that multimerization of

PCSK9 is important for its LDLR-regulating activity

They found that mutation of Asp374, a residue in the

conserved protrusion, affected PCSK9 self-association

It is, however, not obvious that PCSK9 self-association

is important in vivo when PCSK9 is secreted at low

concentrations Previous studies have found no

indica-tions of multimerization for mature PCSK9 [3]

Earlier studies have shown that the naturally

occur-ring mutant D374Y-PCSK9 binds LDLR more

effi-ciently than WT-PCSK9 [8,10,25], and Kwon et al [34]

suggested that this was due to an additional hydrogen

bond between PCSK9 Tyr374 and His306 of the

EGF-A We now show that D374A-PCSK9, which results in

a residue Ala374 that clearly cannot form any

hydro-gen bonds with its side-chain, is also a gain-of-function

mutant, although it is only half as potent as

D374Y-PCSK9 This may indicate that the naturally occurring

D374Y-PCSK9 is a gain-of-function mutant due to two

different mechanisms: one is to strengthen the

interac-tion between PCSK9 and EGF-A, and the other is to

disrupt the binding to PCSK9 of a putative inhibitory

macromolecule

The sequence data that were gathered for the present

study reveal interesting phylogenetic relationships in

addition to the identification of the conserved

protru-sion discussed above Homologs of full-length PCSK9

were found in a single copy in a number of

verte-brates, and at least in duplicate in the cephalochordate

B floridae PCSK9 thus appears to be restricted to

chordates, and possibly limited to the Cephalochordata

and Vertebrata On the basis of the presumed

diver-gence of the chordate subphyla, one might speculate

on a Cambrian or late Proterozoic origin of PCSK9

Interestingly, we were unable to find any bovine

PCSK9 homolog that appears to be functional, but the

Bos taurus genome does appear to contain a

PCSK9-like pseudogene One might speculate that the cow,

with its diet of mainly grasses and plant material,

might be thriving without PCSK9, as do some human

individuals without functional PCSK9 [13,14]

The CRD, whose function still appears to be a

mystery, is the C-terminal PCSK9 domain It does not

appear to occur in any vertebrate protein apart from

PCSK9 itself, but was detected in sequence data from

two mollusk proteins of unknown function Although the available data are limited, these mollusk CRDs do not appear to be present in proteins that contain pro-tease domains (see supplementary Doc S1) This might indicate that mollusks employ the CRD for a different purpose than vertebrates do in PCSK9 It is possible that investigations on mollusk CRD-containing pro-teins might give indications on the function of the PCSK9 CRD

The multiple sequence alignments of the PCSK9 homologs (Fig 1 and supplementary Figs S1 and S2) clearly show the catalytic domain to be more con-served than the CRD This is also the case for PCSK9 conservation within the group of primates [36] Resi-due identities between human and opossum are 76% and 53% for the catalytic domain and CRD, respec-tively The prodomain is also fairly well conserved, apart from the structurally disordered region compris-ing the N-terminal 30 residues (Fig 1A) This segment

is very rich in acidic residues, with seven of 10 N-ter-minal residues of human PCSK9 being Asp or Glu This is immediately followed by five small aliphatic residues and a segment with five more acidic residues The N-terminal region of the prodomain will clearly interact strongly and nonspecifically with a positively charged moiety The signal sequence is not conserved, except for a Leu-rich segment

The three catalytic residues are absolutely conserved

in all PCSK9 homologs (Fig 1B), as is the last residue

of the prodomain, Gln152, supporting the notion that these residues are essential for autocatalysis and effi-cient secretion of PCSK9 The 18 Cys residues of the PCSK9 CRD are conserved in all chordates, as well as

in the mollusk CRDs (Fig 1C and supplementary Fig S2) This clearly demonstrates that the nine disul-fide bridges covalently stabilizing the three modules of this domain are essential for its processing and func-tion The CRD also contains a number of conserved Ser, Thr and small aliphatic residues These are mainly located deep in the structure, and are most likely essential for correct folding of the CRD There is a single patch of conserved residues on the surface of the CRD, comprising Arg458, Thr459, Trp461, and Glu481 These residues all contribute to the part of the CRD surface that is interacting with the catalytic domain The evolutionary conservation of these resi-dues indicates that although this interaction might be weak [16], it appears to be of functional importance Piper et al [16] have noted a large number of His residues in the CRD With a pKa value for His between 6 and 7, it is likely that the net charge of the CRD will become substantially more positive at endosomal pH 5–5.5 than at pH 7.4 at the plasma

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membrane It is tempting to speculate that this could

result in an altered interaction with the strongly acidic

N-terminal region of the prodomain This might be the

reason why PCSK9 binds more strongly to the LDLR

in the endosomal⁄ lysosomal compartments than in the

plasma [7,10] However, the positions and number of

His residues are not particularly conserved in the CRD

(Fig 1C) Whereas human PCSK9 has 15 His residues

out of a total of 245 CRD residues (6.1%), the

propor-tions are 5.3% for rat, 5.0% for opossum, 3.0% for

medaka fish, and 1.3% for the mollusk Aplysia

Asn533, which is glycosylated in human PCSK9, has

been shown not to be essential for PCSK9 secretion

[13,26] It is conserved in placental mammals only The

corresponding residue is not likely to be glycosylated

in other vertebrates

In conclusion, there is a single, large, evolutionarily

conserved protrusion on the surface of the catalytic

domain of PCSK9 The lack of other residue

conserva-tion on the PCSK9 surface makes it less likely that

there are other parts of PCSK9 that interact with high

specificity with other macromolecules as part of the

PCSK9-mediated degradation of the LDLR A cluster

of residues on the conserved protrusion is involved in

the binding of PCSK9 to the EGF-A domain of the

LDLR, and mutations of these residues lead to loss of

function, as found in our study and in the study of

Kwon et al [34] The part of the protrusion located

around the disordered loop Gly213–Arg218 contains a

number of conserved residues for which site-directed

mutagenesis produced gain-of-function mutants These

residues appear to be involved in some form of

inhibi-tion of the PCSK9-mediated degradainhibi-tion of the

LDLR However, our data do not clearly support a

model that solely involves reduced cleavage by furin

Thus, further studies are needed to clarify whether

these residues are involved in the binding of a different

macromolecule that inhibits the degradation of the

LDLR by PCSK9

Experimental procedures

Data collection and bioinformatics analysis

Database resources provided by the NCBI [28], uniprot

[29], the ensembl project [30], the DOE Joint Genome

Institute (http://genome.jgi-psf.org), the Baylor College of

Medicine Human Genome Sequencing Center (http://

www.hgsc.bcm.tmc.edu/projects/bovine), the Aplysia EST

project (http://aplysia.cu-genome.org) and the B glabrata

Genome Initiative

(http://biology.unm.edu/biomphalaria-genome) were searched for homologs of human PCSK9 A

major proportion of the extracted 24 PCSK9 homologs from

23 species is due to automatic gene searching in genomic data from early-stage sequencing projects This necessitated some manual trimming and manipulation of the sequences (see supplementary Doc S1 and supplementary Table S1) Multiple sequence alignments were generated with mus-cle[37], and the multiple sequence alignments were viewed and manipulated with jalview [38] A PCSK9 structural model was generated from a published experimental struc-ture [10] as described previously [24] Amino acid conserva-tion in all vertebrate PCSK9 homologs, but excluding the two pufferfish species, was mapped onto the PCSK9 model employing consurf [31,32] The protein structure illustra-tions were generated with pymol [39]

Cell cultures

HepG2 cells and HEK293 cells, obtained from the Euro-pean Collection of Cell Cultures (Porton Down, UK), were cultured in MEM (Gibco, Carlsbad, CA, USA) containing penicillin (50 UÆmL)1), streptomycin (50 lgÆmL)1), l-gluta-mine (2 mm) and 10% fetal bovine serum (Invitrogen, Carlsbad, CA, USA), in a humidified atmosphere (37C, 5% CO2)

Mutagenesis, cloning and expression of PCSK9

R237A, D238A, D374A, C375A, S376A, T377A, C378A or F379A were introduced into a pCMV–PCSK9–FLAG plas-mid kindly provided by J D Horton (University of Texas Southwestern Medical Center, Dallas, TX, USA), using QuickChange XL Mutagenesis Kit (Stratagene, La Jolla,

CA, USA) according to the manufacturer’s instructions The primer sequences used for the mutagenesis are given in supplementary Table S2 The resulting mutant plasmids are referred to as S153A-PCSK9, Q190A-PCSK9, R194A-PCSK9, D204A-R194A-PCSK9, K222A-R194A-PCSK9, R237A-R194A-PCSK9, D238A-PCSK9, D374A-PCSK9, C375A-PCSK9,

F379A-PCSK9 The integrity of each plasmid was confirmed by DNA sequencing An empty plasmid, pcDNA3.1⁄ myc his-c (Invitrogen), as well as four previously published mutant PCSK9 plasmids containing mutations S386A, S127R, R215H or D374Y [23,24], were used as controls in the transfection experiments together with WT-PCSK9 plasmid Transient transfections of HepG2 cells and HEK293 cells with WT-PCSK9 plasmid or mutant PCSK9 plasmids were performed as described by Cameron et al [24]

Western blot analysis of transfected HepG2 and HEK293 cells

Western blot analyses of cell lysates and culture media of transiently transfected HepG2 cells or HEK293 cells were

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